What is Remicade?

Remicade (infliximab) reduces the effects of a substance in the body that can cause inflammation. Remicade is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. It is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin). Remicade is often used when other medicines have not been effective. Remicade may also be used for purposes not listed in this medication guide.

Important information about Remicade

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia). Some people using Remicade have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Remicade or similar medicines to treat Crohn's disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling lightheaded or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Remicade can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with Remicade. Contact your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, or pain, warmth, or redness of your skin. Before you receive Remicade, tell your doctor if you have heart failure or other heart problems, an active or recent infection, diabetes, liver disease, seizures, chronic obstructive pulmonary disease (COPD), a history of cancer, a weak immune system, numbness or tingling, a nerve or muscle disorder, or if you have recently received a vaccine. Before you start treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment. Do not receive a "live" vaccine while you are being treated with Remicade.

Before using Remicade

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia). Some people using Remicade have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Remicade or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk. Before using Remicade, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common. To make sure you can safely take Remicade, tell your doctor if you have any of these other conditions: severe heart failure, or other heart problems; an active or recent infection, open sores or skin wounds; diabetes; liver disease (especially hepatitis B); epilepsy or other seizure disorder; chronic obstructive pulmonary disease (COPD); a history of cancer; a weak immune system; numbness or tingling anywhere in your body; a disease that affects the nerves or muscles, such as multiple sclerosis or Guillain-Barre syndrome; if you have recently been vaccinated with BCG (Bacille Calmette-Gurin); or if you are scheduled to receive any vaccines.

FDA pregnancy category B. It is not known whether Remicade will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Remicade. It is not known whether infliximab passes into breast milk. You should not breast-feed while you are receiving infliximab. Remicade is not for use in children younger than 6 years old.

How should I use Remicade?

Use Remicade exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Before you start treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment. Remicade is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. This medicine is usually given at intervals of 2 to 8 weeks.

Remicade must be injected slowly, over about 2 hours. Your doctor may wish to observe you after the injection to make sure the medicine has not caused any serious side effects. If you need surgery, tell the surgeon ahead of time that you are using Remicade. Infliximab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with Remicade. Contact your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, or pain, warmth, or redness of your skin. If you have hepatitis B you may develop liver symptoms during treatment with Remicade or after you stop using the medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Remicade. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Remicade injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Remicade?

Do not receive a "live" vaccine while using Remicade. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Gurin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine. Make sure your child is current on all vaccines before he or she starts treatment with Remicade.

Remicade side effects

Some people receiving an Remicade injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy or tingly, swollen, short of breath, or have a headache, fever, chills, flu symptoms, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection. Get emergency medical help if you have any of these signs of an allergic reaction to Remicade: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Remicade and call your doctor right away if you have any of these symptoms of lymphoma: fever, night sweats, weight loss, tiredness; feeling full after eating only a small amount; pain in your upper stomach that may spread to your shoulder; easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). signs of infection (fever, chills, flu symptoms, confusion, or pain, warmth, or redness of your skin); chest pain, ongoing cough, coughing up mucus or blood; shortness of breath with swelling of your ankles or feet, rapid weight gain; numbness or tingling; easy bruising or bleeding, pale skin, unusual weakness; weak feeling in your arms or legs; problems with vision; neck stiffness, seizure (convulsions); pain or burning when you urinate; or red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores. stuffy nose, sinus pain, headache; mild stomach pain; mild skin rash; or flushing (warmth, redness, or tingly feeling).

Call your doctor at once if you have any of these other serious side effects:

Less serious Remicade side effects may include:

What other drugs will affect Remicade?

Tell your doctor about all other medicines you use, especially: azathioprine (Imuran); mercaptopurine (Purinethol); or medications and phototherapy for psoriasis.

There may be other drugs that can interact with Remicade. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Remicade Side Effects

Generic Name: infliximab Please note - some side effects for Remicade may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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Side Effects of Remicade - for the Consumer

Remicade

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Remicade: Back pain; headache; mild stomach pain or upset; pain, redness, or swelling at the injection site; runny or stuffy nose; tiredness.
Seek medical attention right away if any of these SEVERE side effects occur when using Remicade:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; butterfly-shaped rash on the nose and cheeks; change in the amount of urine produced; change in the appearance of a mole; chest pain; dark urine; dizziness; fainting; fast, slow, or irregular heartbeat; flushing; joint or muscle pain; loss of appetite; nausea, vomiting, or diarrhea; numbness or tingling of the skin, arms, or legs; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache; severe or persistent stomach or back pain; shortness of breath; sudden, unexplained weight gain or loss; suicidal thoughts or attempts; swelling of the hands, legs, feet, or ankles; symptoms of infection (eg, fever or chills, painful or frequent urination, persistent cough or sore throat, flu-like symptoms, persistent feeling of being unwell, unusual vaginal discharge or odor, white patches in the mouth, red or painful skin); trouble swallowing; unusual bruising or bleeding; unusual lumps; unusual skin growths or other skin changes; unusual tiredness or weakness; very pale skin; vision changes; weakness in the arms or legs; yellowing of the skin or eyes. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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Remicade Side Effects - for the Professional

Remicade
Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of

another drug and may not predict the rates observed in broader patient populations in clinical practice. Adverse Reactions in Adults The data described herein reflect exposure to Remicade in 4779 adult patients (1304 patients with rheumatoid arthritis, 1106 patients with Crohn's disease, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 484 with ulcerative colitis, 1373 with plaque psoriasis, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year. [For information on adverse reactions in pediatric patients see Adverse Reactions (6.1).] One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache and rash). Infusion-related Reactions An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 hour after an infusion. In phase 3 clinical studies, 18% of Remicade-treated patients experienced an infusion reaction compared to 5% of placebo-treated patients. Of infliximab-treated patients who had an infusion reaction during the induction period, 27% experienced an infusion reaction during the maintenance period. Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period. Among all Remicade infusions, 3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions. Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension. Approximately 3% of patients discontinued Remicade because of infusion reactions, and all patients recovered with treatment and/or discontinuation of the infusion. Remicade infusions beyond the initial infusion were not associated with a higher incidence of reactions. The infusion reaction rates remained stable in psoriasis through 1 year in psoriasis Study I. In psoriasis Study II, the rates were variable over time and somewhat higher following the final infusion than after the initial infusion. Across the 3 psoriasis studies, the percent of total infusions resulting in infusion reactions (i.e., an adverse event occurring within 1 hour) was 7% in the 3 mg/kg group, 4% in the 5 mg/kg group, and 1% in the placebo group. Patients who became positive for antibodies to infliximab were more likely (approximately twoto three-fold) to have an infusion reaction than were those who were negative. Use of concomitant immunosuppressant agents appeared to reduce the frequency of both antibodies to infliximab and infusion reactions [see Adverse Reactions (6.1) and Drug Interactions (7.3)]. Infusion reactions following re-administration In a clinical trial of patients with moderate to severe psoriasis designed to assess the efficacy of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade following disease flare, 4% (8/219) of patients in the re-treatment therapy arm experienced serious infusion reactions versus < 1% (1/222) in the maintenance therapy arm. Patients enrolled in this trial did not receive any concomitant immunosuppressant therapy. In this study, the majority of serious infusion reactions occurred during the second infusion at Week 2. Symptoms included, but were not limited to, dyspnea, urticaria, facial edema, and hypotension. In all cases, Remicade treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.

Delayed Reactions/Reactions Following Re-administration In psoriasis studies, approximately 1% of Remicade-treated patients experienced a possible delayed hypersensitivity reaction, generally reported as serum sickness or a combination of arthralgia and/or myalgia with fever and/or rash. These reactions generally occurred within 2 weeks after repeat infusion. Infections In Remicade clinical studies, treated infections were reported in 36% of Remicade-treated patients (average of 51 weeks of follow-up) and in 25% of placebo-treated patients (average of 37 weeks of follow-up). The infections most frequently reported were respiratory tract infections (including sinusitis, pharyngitis, and bronchitis) and urinary tract infections. Among Remicadetreated patients, serious infections included pneumonia, cellulitis, abscess, skin ulceration, sepsis, and bacterial infection. In clinical trials, 7 opportunistic infections were reported; 2 cases each of coccidioidomycosis (1 case was fatal) and histoplasmosis (1 case was fatal), and 1 case each of pneumocystosis, nocardiosis and cytomegalovirus. Tuberculosis was reported in 14 patients, 4 of whom died due to miliary tuberculosis. Other cases of tuberculosis, including disseminated tuberculosis, also have been reported post-marketing. Most of these cases of tuberculosis occurred within the first 2 months after initiation of therapy with Remicade and may reflect recrudescence of latent disease [see Warnings and Precautions (5.1)]. In the 1-year placebocontrolled studies RA I and RA II, 5.3% of patients receiving Remicade every 8 weeks with MTX developed serious infections as compared to 3.4% of placebo patients receiving MTX. Of 924 patients receiving Remicade, 1.7% developed pneumonia and 0.4% developed TB, when compared to 0.3% and 0.0% in the placebo arm respectively. In a shorter (22-week) placebocontrolled study of 1082 RA patients randomized to receive placebo, 3 mg/kg or 10 mg/kg Remicade infusions at 0, 2, and 6 weeks, followed by every 8 weeks with MTX, serious infections were more frequent in the 10 mg/kg Remicade group (5.3%) than the 3 mg/kg or placebo groups (1.7% in both). During the 54-week Crohn's II Study, 15% of patients with fistulizing Crohn's disease developed a new fistula-related abscess. In Remicade clinical studies in patients with ulcerative colitis, infections treated with antimicrobials were reported in 27% of Remicade-treated patients (average of 41 weeks of follow-up) and in 18% of placebo-treated patients (average 32 weeks of follow-up). The types of infections, including serious infections, reported in patients with ulcerative colitis were similar to those reported in other clinical studies. The onset of serious infections may be preceded by constitutional symptoms such as fever, chills, weight loss, and fatigue. The majority of serious infections, however, may also be preceded by signs or symptoms localized to the site of the infection. Autoantibodies/Lupus-like Syndrome Approximately half of Remicade-treated patients in clinical trials who were antinuclear antibody (ANA) negative at baseline developed a positive ANA during the trial compared with approximately one-fifth of placebo-treated patients. Anti-dsDNA antibodies were newly detected in approximately one-fifth of Remicade-treated patients compared with 0% of placebo-treated patients. Reports of lupus and lupus-like syndromes, however, remain uncommon. Malignancies In controlled trials, more Remicade-treated patients developed malignancies than placebo-treated patients [see Warnings and Precautions (5.2)].

In a randomized controlled clinical trial exploring the use of Remicade in patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease. Of these Remicade-treated patients, 9 developed a malignancy, including 1 lymphoma, for a rate of 7.67 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% CI 3.51 14.56). There was 1 reported malignancy among 77 control patients for a rate of 1.63 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% CI 0.04 9.10). The majority of the malignancies developed in the lung or head and neck. Patients with Heart Failure In a randomized study evaluating Remicade in moderate to severe heart failure (NYHA Class III/IV; left ventricular ejection fraction 35%), 150 patients were randomized to receive treatment with 3 infusions of Remicade 10 mg/kg, 5 mg/kg, or placebo, at 0, 2, and 6 weeks. Higher incidences of mortality and hospitalization due to worsening heart failure were observed in patients receiving the 10 mg/kg Remicade dose. At 1 year, 8 patients in the 10 mg/kg Remicade group had died compared with 4 deaths each in the 5 mg/kg Remicade and the placebo groups. There were trends toward increased dyspnea, hypotension, angina, and dizziness in both the 10 mg/kg and 5 mg/kg Remicade treatment groups, versus placebo. Remicade has not been studied in patients with mild heart failure (NYHA Class I/II) [see Contraindications (4) and Warnings and Precautions (5.5)]. Immunogenicity Treatment with Remicade can be associated with the development of antibodies to infliximab. The assay used to measure anti-infliximab antibodies in patient samples is subject to interference by serum infliximab, possibly resulting in an underestimation of the rate of patient antibody formation. The incidence of antibodies to infliximab in patients given a 3-dose induction regimen followed by maintenance dosing was approximately 10% as assessed through 1 to 2 years of Remicade treatment. A higher incidence of antibodies to infliximab was observed in Crohn's disease patients receiving Remicade after drug-free intervals >16 weeks. In a study of psoriatic arthritis in which 191 patients received 5 mg/kg with or without MTX, antibodies to infliximab occurred in 15% of patients. The majority of antibody-positive patients had low titers. Patients who were antibody-positive were more likely to have higher rates of clearance, reduced efficacy and to experience an infusion reaction [see Adverse Reactions (6.1)] than were patients who were antibody negative. Antibody development was lower among rheumatoid arthritis and Crohn's disease patients receiving immunosuppressant therapies such as 6-MP/AZA or MTX. In the psoriasis Study II, which included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 36% of patients treated with 5 mg/kg every 8 weeks for 1 year, and in 51% of patients treated with 3 mg/kg every 8 weeks for 1 year. In the psoriasis Study III, which also included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 20% of patients treated with 5 mg/kg induction (weeks 0, 2 and 6), and in 27% of patients treated with 3 mg/kg induction. Despite the increase in antibody formation, the infusion reaction rates in Studies I and II in patients treated with 5 mg/kg induction followed by every 8 week maintenance for 1 year and in Study III in patients treated with 5 mg/kg induction (14.1%23.0%) and serious infusion reaction rates (<1%) were similar to those observed in other study populations. The clinical significance of apparent increased immunogenicity on efficacy and infusion reactions in psoriasis patients as compared to patients with other diseases treated with Remicade over the long term is not known.

The data reflect the percentage of patients whose test results were positive for antibodies to infliximab in an ELISA assay, and they are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to infliximab with the incidence of antibodies to other products may be misleading. Hepatotoxicity Severe liver injury, including acute liver failure and autoimmune hepatitis, has been reported rarely in patients receiving Remicade [see Warnings and Precautions (5.4)]. Reactivation of hepatitis B virus has occurred in patients receiving TNF-blocking agents, including Remicade, who are chronic carriers of this virus [see Warnings and Precautions (5.3)]. In clinical trials in rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis, elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving Remicade than in controls (Table 1), both when Remicade was given as monotherapy and when it was used in combination with other immunosuppressive agents. In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, or modification of concomitant medications.
Table 1 Proportion of patients with elevated ALT in clinical trials >1 to <3 ULN Placebo * Placebo patients received methotrexate while Remicade patients received both Remicade and methotrexate. Median follow-up was 58 weeks. Placebo patients in the 2 Phase 3 trials in Crohn's disease received an initial dose of 5 mg/kg Remicade at study start and were on placebo in the maintenance phase. Patients who were randomized to the placebo maintenance group and then later crossed over to Remicade are included in the Remicade group in ALT analysis. Median follow-up was 54 weeks. Median follow-up was 30 weeks. Specifically, the median duration of followup was 30 weeks for placebo and 31 weeks for Remicade. Median follow-up was 24 weeks for the placebo group and 102 weeks for the Remicade group. Median follow-up was 39 weeks for the Remicade group and 18 weeks for the Remica de 3 ULN Placebo Remica de 5 ULN Placebo Remica de

Table 1 Proportion of patients with elevated ALT in clinical trials >1 to <3 ULN Placebo Remica de 3 ULN Placebo Remica de 5 ULN Placebo Remica de

placebo group. # ALT values are obtained in 2 Phase 3 psoriasis studies with median follow-up of 50 weeks for Remicade and 16 weeks for placebo. Rheumatoid arthritis* Crohn's disease Ulcerative colitis Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis# 24% 34% 12% 15% 16% 24% 34% 39% 17% 51% 50% 49% 3% 4% 1% 0% 0% <1% 4% 5% 2% 10% 7% 8% <1% 0% <1% 0% 0% 0% <1% 2% <1% 4% 2% 3%

Adverse Reactions in Psoriasis Studies During the placebo-controlled portion across the 3 clinical trials up to week 16, the proportion of patients who experienced at least 1 serious adverse reaction (SAE; defined as resulting in death, life threatening, requires hospitalization, or persistent or significant disability/incapacity) was 0.5% in the 3 mg/kg Remicade group, 1.9% in the placebo group, and 1.6% in the 5 mg/kg Remicade group. Among patients in the 2 Phase 3 studies, 12.4% of patients receiving Remicade 5 mg/kg every 8 weeks through 1 year of maintenance treatment experienced at least 1 SAE in Study I. In Study II, 4.1% and 4.7% of patients receiving Remicade 3 mg/kg and 5 mg/kg every 8 weeks, respectively, through 1 year of maintenance treatment experienced at least 1 SAE. One death due to bacterial sepsis occurred 25 days after the second infusion of 5 mg/kg Remicade. Serious infections included sepsis, and abscesses. In Study I, 2.7% of patients receiving Remicade 5 mg/kg every 8 weeks through 1 year of maintenance treatment experienced at least 1 serious infection. In Study II, 1.0% and 1.3% of patients receiving Remicade 3 mg/kg and 5 mg/kg, respectively, through 1 year of treatment experienced at least 1 serious infection. The most common serious infection (requiring hospitalization) was abscess (skin, throat, and peri-rectal) reported by 5 (0.7%) patients in the 5 mg/kg Remicade group. Two active cases of tuberculosis were reported: 6 weeks and 34 weeks after starting Remicade.

In the placebo-controlled portion of the psoriasis studies, 7 of 1123 patients who received Remicade at any dose were diagnosed with at least one NMSC compared to 0 of 334 patients who received placebo. In the psoriasis studies, 1% (15/1373) of patients experienced serum sickness or a combination of arthralgia and/or myalgia with fever, and/or rash, usually early in the treatment course. Of these patients, 6 required hospitalization due to fever, severe myalgia, arthralgia, swollen joints, and immobility. Other Adverse Reactions Safety data are available from 4779 Remicade-treated adult patients, including 1304 with rheumatoid arthritis, 1106 with Crohn's disease, 484 with ulcerative colitis, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 1373 with plaque psoriasis and 17 with other conditions. [For information on other adverse reactions in pediatric patients, see Adverse Reactions (6.1)]. Adverse reactions reported in 5% of all patients with rheumatoid arthritis receiving 4 or more infusions are in Table 2. The types and frequencies of adverse reactions observed were similar in Remicade-treated rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and Crohn's disease patients except for abdominal pain, which occurred in 26% of Remicadetreated patients with Crohn's disease. In the Crohn's disease studies, there were insufficient numbers and duration of follow-up for patients who never received Remicade to provide meaningful comparisons.
Table 2 Adverse reactions occurring in 5% or more of patients receiving 4 or more infusions for rheumatoid arthritis Placebo Remicade (n=350) (n=1129) Average weeks of follow-up Gastrointestinal Nausea Abdominal pain Diarrhea Dyspepsia Respiratory Upper respiratory tract infection Sinusitis Pharyngitis Coughing Bronchitis 25% 8% 8% 8% 9% 32% 14% 12% 12% 10% 20% 8% 12% 7% 21% 12% 12% 10% 59 66

Table 2 Adverse reactions occurring in 5% or more of patients receiving 4 or more infusions for rheumatoid arthritis Placebo Remicade (n=350) (n=1129)

Skin and appendages disorders Rash Pruritus Body as a whole-general disorders Fatigue Pain Resistance mechanism disorders Fever Moniliasis Central and peripheral nervous system disorders Headache Musculoskeletal system disorders Arthralgia Urinary system disorders Urinary tract infection Cardiovascular disorders, general Hypertension 5% 7% 6% 8% 7% 8% 14% 18% 4% 3% 7% 5% 7% 7% 9% 8% 5% 2% 10% 7%

The most common serious adverse reactions observed in clinical trials were infections [see Adverse Reactions (6.1)]. Other serious, medically relevant adverse reactions 0.2% or clinically significant adverse reactions by body system were as follows:
Body as a whole: allergic reaction, edema

Blood: pancytopenia

Cardiovascular: hypotension

Gastrointestinal: constipation, intestinal obstruction

Central and Peripheral Nervous: dizziness

Heart Rate and Rhythm: bradycardia

Liver and Biliary: hepatitis

Metabolic and Nutritional: dehydration

Platelet, Bleeding and Clotting: thrombocytopenia

Neoplasms:lymphoma

Red Blood Cell: anemia, hemolytic anemia

Resistance Mechanism: cellulitis, sepsis, serum sickness, sarcoidosis

Respiratory: lower respiratory tract infection (including pneumonia), pleurisy, pulmonary edema

Skin and Appendages: increased sweating

Vascular (Extracardiac): thrombophlebitis

White Cell and Reticuloendothelial: leukopenia, lymphadenopathy

Adverse Reactions in Pediatric Patients Pediatric Crohn's Disease There were some differences in the adverse reactions observed in the pediatric patients receiving Remicade compared to those observed in adults with Crohn's disease. These differences are discussed in the following paragraphs. The following adverse reactions were reported more commonly in 103 randomized pediatric Crohn's disease patients administered 5 mg/kg Remicade through 54 weeks than in 385 adult Crohn's disease patients receiving a similar treatment regimen: anemia (11%), leukopenia (9%), flushing (9%), viral infection (8%), neutropenia (7%), bone fracture (7%), bacterial infection (6%), and respiratory tract allergic reaction (6%). Infections were reported in 56% of randomized pediatric patients in Study Peds Crohn's and in 50% of adult patients in Study Crohn's I. In Study Peds Crohn's, infections were reported more frequently for patients who received every 8-week as opposed to every 12-week infusions (74% and 38%, respectively), while serious infections were reported for 3 patients in the every 8-week and 4 patients in the every 12-week maintenance treatment group. The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess. Pneumonia was reported for 3 patients, (2 in the every 8week and 1 in the every 12-week maintenance treatment groups). Herpes zoster was reported for 2 patients in the every 8-week maintenance treatment group. In Study Peds Crohn's, 18% of randomized patients experienced 1 or more infusion reactions, with no notable difference between treatment groups. Of the 112 patients in Study Peds Crohn's, there were no serious infusion reactions, and 2 patients had non-serious anaphylactoid reactions. In Study Peds Crohn's, in which all patients received stable doses of 6-MP, AZA, or MTX, excluding inconclusive samples, 3 of 24 patients had antibodies to infliximab. Although 105 patients were tested for antibodies to infliximab, 81 patients were classified as inconclusive because they could not be ruled as negative due to assay interference by the presence of infliximab in the sample. Elevations of ALT up to 3 times the upper limit of normal (ULN) were seen in 18% of pediatric patients in Crohn's disease clinical trials; 4% had ALT elevations 3 ULN, and 1% had elevations 5 ULN. (Median follow-up was 53 weeks.) Pediatric Ulcerative Colitis Overall, the adverse reactions reported in the pediatric ulcerative colitis trial and adult ulcerative colitis (Study UC I and Study UC II) studies were generally consistent. In a pediatric UC trial, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache. Infections were reported in 31 (52%) of 60 treated patients in the pediatric UC trial and 22 (37%) required oral or parenteral antimicrobial treatment. The proportion of patients with infections in the pediatric UC trial was similar to that in the pediatric Crohn's disease study (Study Peds Crohn's) but higher than the proportion in the adults' ulcerative colitis studies (Study UC I and

Study UC II). The overall incidence of infections in the pediatric UC trial was 13/22 (59%) in the every 8 week maintenance treatment group. Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections. Serious infections were reported in 12% (7/60) of all treated patients. In the pediatric UC trial, excluding inconclusive samples, 4 of 19 patients had antibodies to infliximab. Although 52 patients were tested, 33 patients were classified as inconclusive because they could not be ruled as negative due to assay interference by the presence of infliximab in the sample. Elevations of ALT up to 3 times the upper limit of normal (ULN) were seen in 17% (10/60) of pediatric patients in the pediatric UC trial; 7% (4/60) had ALT elevations 3 ULN, and 2% (1/60) had elevations 5 ULN (median follow-up was 49 weeks). Overall, 8 of 60 (13%) treated patients experienced one or more infusion reactions, including 4 of 22 (18%) patients in the every 8-week treatment maintenance group. No serious infusion reactions were reported. In the pediatric UC trial, 45 patients were in the 12 to 17 year age group and 15 in the 6 to 11 year age group. The numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events. There were higher proportions of patients with serious adverse events (40% vs. 18%) and discontinuation due to adverse events (40% vs. 16%) in the younger age group than in the older age group. While the proportion of patients with infections was also higher in the younger age group (60% vs. 49%), for serious infections, the proportions were similar in the two age groups (13% in the 6 to 11 year age group vs. 11% in the 12 to 17 year age group). Overall proportions of adverse reactions, including infusion reactions, were similar between the 6 to 11 and 12 to 17 year age groups (13%).
Post-marketing Experience

Adverse reactions have been reported during post approval use of Remicade in adult and pediatric patients. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Remicade exposure. The following adverse reactions, some with fatal outcome, have been reported during postapproval use of Remicade: neutropenia [see Warnings and Precautions (5.6)], interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and very rare rapidly progressive disease), idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, pericardial effusion, systemic and cutaneous vasculitis, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, peripheral demyelinating disorders (such as GuillainBarr syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy), new onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar), transverse myelitis, and neuropathies (additional neurologic reactions have also been observed) [see Warnings and Precautions (5.8)], acute liver failure, jaundice, hepatitis, and cholestasis [see Warnings and Precautions (5.4)], serious infections [see Warnings and Precautions (5.1)] and malignancies [ see Warnings and Precautions (5.2)]. Infusion-related Reactions In post-marketing experience, cases of anaphylactic reactions, including laryngeal/pharyngeal edema and severe bronchospasm, and seizure have been associated with Remicade administration.

Cases of myocardial ischemia/infarction and transient visual loss have also been rarely reported in association with Remicade during or within 2 hours of infusion. Adverse Reactions in Pediatric Patients The following serious adverse reactions have been reported in the post-marketing experience in children: infections (some fatal) including opportunistic infections and tuberculosis, infusion reactions, and hypersensitivity reactions. Serious adverse reactions in the post-marketing experience with Remicade in the pediatric population have also included malignancies, including hepatosplenic T-cell lymphomas [see Boxed WARNINGS and Warnings and Precautions (5.2)], transient hepatic enzyme abnormalities, lupus-like syndromes, and the development of autoantibodies.
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Side Effects by Body System - for Healthcare Professionals

General

Most of the following data reflect infliximab exposure in 4779 patients, including 2625 and 374 patients exposed beyond 30 weeks and 1 year, respectively. One of the most common reasons for treatment discontinuation was infusion-related reactions (e.g., dyspnea, flushing, headache, and rash). Approximately 3% of patients discontinued infliximab due to infusion reactions. The types and frequencies of side effects reported were similar in infliximab-treated rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and Crohn's disease patients except for abdominal pain.
Immunologic

Immunologic side effects have included treated infections in 36% of patients. The most common infections reported were respiratory tract infections (including sinusitis, pharyngitis, and bronchitis) and urinary tract infections. Serious infections reported included pneumonia, cellulitis, abscess (skin, throat, and perirectal), skin ulceration, sepsis, and bacterial infection. During clinical studies, 7 opportunistic infections were reported; 2 cases each of coccidioidomycosis and histoplasmosis (1 case each was fatal), and 1 case each of pneumocystosis, nocardiosis, and cytomegalovirus. During clinical trials, tuberculosis was reported in 14 patients, with 4 deaths due to miliary tuberculosis. During one study, 15% of patients with fistulizing Crohn's disease developed a new fistula-related abscess. Constitutional symptoms (such as fever, chills, weight loss, and fatigue) may precede the onset of serious infections; however, signs or symptoms localized to the site of infection may also precede the

majority of serious infections. Development of antibodies to infliximab (up to 51%), development of antinuclear antibodies (about 50%), newly detected anti-dsDNA antibodies (about 20%), moniliasis (5%), lupus and lupus-like syndromes (uncommon), listeriosis, sporotrichosis, and Borrelia infection have been reported. At least one case each of disseminated Salmonella typhimurium infection, disseminated cryptococcal infection, and protothecosis have been reported. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms (including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis) have been reported with TNF blockers. Listeria monocytogenes infections (with some cases resulting in death), other cases of tuberculosis (including miliary and disseminated), and infections with various pathogens (including viral, bacterial, fungal, and protozoal organisms) have been reported in postmarketing experience. Inflammation and modulation of cellular immune response are mediated by TNF-alpha. It is possible that therapy with infliximab could affect normal immune responses. A meta-analysis has reported that there is evidence of an increased risk of serious infections in patients with rheumatoid arthritis treated with anti-TNF antibody therapy. Most cases of tuberculosis occurred within the first two months after the start of infliximab therapy and may reflect recrudescence of latent disease. Cutaneous and miliary tuberculosis, as a result of tuberculosis reactivation, has been reported in a 56-year-old white male with a history of Crohn's disease treated with infliximab. Infections have been observed in all organ systems and have been reported in patients receiving infliximab alone or in combination with immunosuppressive agents. Patients with antibodies to infliximab were more likely to have higher rates of clearance, reduced efficacy, and to experience an infusion reaction. Crohn's patients with (+) ANA prior to infliximab were approximately 2 times as likely to develop anti-dsDNA antibodies. Various case reports of non-Crohn's and Crohn's patient, developed clinical symptoms of a lupus-like syndrome. Symptoms resolved and antibodies disappeared when infliximab was discontinued. Disseminated Salmonella typhimurium infection has been reported in a Fijian Indian man while undergoing his twenty-eighth week of infliximab therapy for the treatment of psoriasis and psoriatic arthritis. Patient's symptoms resolved after treatment with intravenous ciprofloxacin. Disseminated cryptococcal infection has been reported in a 72-year-old male after his second infusion of infliximab for rheumatoid arthritis. A 56-year-old male developed protothecosis after a stem cell transplantation coincident with infliximab therapy. He was administered infliximab for graft-versus-host disease. Two weeks later, he became lethargic and developed bilateral olecranon bursitis and bullous skin lesions. Blood cultures grew Klebsiella pneumoniae and Prototheca wickerhamii. The patient

subsequently developed multiorgan failure and died after 5 weeks of hospitalization. The use of infliximab likely played a role in this case.
Respiratory

Most of the cases of tuberculosis occurred within the first two months after the start of infliximab therapy and may reflect recrudescence of latent disease. Life-threatening histoplasmosis (n=9) reported in postmarketing experience developed within 1 week to 6 months after the first dose. A 34-year-old male with a 15-year history of seronegative arthritis with both peripheral and axial features experienced pulmonary sarcoidosis coincident with infliximab therapy. The patient was administered infliximab at 5 mg/kg every 8 weeks intravenously, which led to a prompt and dramatic improvement in the manifestations of his disease. However, after about 5 years of disease remission, he developed pleuritic chest pain, a productive cough, and dyspnea. The patient was diagnosed with sarcoidosis based on pathological findings. A chest radiograph revealed persistent mediastinal hilar adenopathy with clear lung fields. He was treated with prednisone 40 mg per day, which resulted in complete resolution of his pulmonary symptoms. A follow-up thorax CT after 4 months of steroid treatment showed that the left pleural effusion had resolved but the mediastinal lymphadenopathy was unchanged. A 36-year-old female with history of Crohn disease experienced pneumocystis carinii jiroveci pneumonia (PCP) coincident with infliximab therapy. She presented with complaints of fever and shortness of breath for one day. Two months before presentation, she required hospitalization for partial small bowel obstruction, at which time infliximab was initiated. Bronchoalveolar lavage showed PCP on silver stain. Intravenous Bactrim (sulfamethoxazoletrimethoprim) and Solumedrol (methylprednisolone) were started. The patient had a slow recovery with subsequent chest x-ray showing clearing of the lung infiltrates. Respiratory side effects have included upper respiratory tract infections (up to 32%), sinusitis (up to 14%), pharyngitis (up to 12%), coughing (up to 12%), bronchitis (up to 10%), rhinitis (up to 8%), adult respiratory distress syndrome, lower respiratory tract infection (including pneumonia), pleural effusion, pleurisy, pulmonary edema, respiratory insufficiency, pulmonary embolism, and shortness of breath. Serious and sometimes fatal opportunistic infections including tuberculosis, histoplasmosis, and pneumocystosis have also been reported. At least one case each of streptococcal pharyngitis, pulmonary sarcoidosis, and pneumocystis carinii jiroveci pneumonia have been reported. Interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and very rare rapidly progressive disease) has been reported during postmarketing experience.
Other

Other side effects have included infusion reactions (up to 20%), fatigue (up to 11%), fever (up to 10%), pain (8%), diaphragmatic hernia, edema, surgical/procedural sequela, influenza-like illness, and falls. Nonspecific symptoms (such as fever or chills; 3%), cardiopulmonary reactions (primarily chest pain, hypotension, hypertension, or dyspnea; 1%), and pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions (less than 1%) accompanied infliximab infusions. Serious infusion reactions (including anaphylaxis, convulsions, erythematous rash, and hypotension) were reported in less than 1% of patients.

Serious infusion reactions (symptoms included, but were not limited to, dyspnea, urticaria, facial edema, and hypotension) have also been reported following retreatment. An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 to 2 hours after an infusion. Patients who became positive for antibodies to infliximab were approximately 2- to 3-fold more likely to have an infusion reaction than patients who were negative. Use of concomitant immunosuppressant agents appeared to reduce infusion reaction frequency. During a clinical trial of psoriasis patients that assessed the efficacy of long-term maintenance versus retreatment with an induction regimen after disease flare, serious infusion reactions were reported in 4% of patients in the retreatment arm versus less than 1% in the maintenance arm. Patients in this trial did not receive concomitant immunosuppressant therapy. Most of the serious infusion reactions occurred during the second infusion at Week 2. In all cases, infliximab was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Hypersensitivity

Hypersensitivity side effects have included possible delayed hypersensitivity reaction, generally reported as serum sickness or a combination of arthralgia and/or myalgia with fever and/or rash, in about 1% of patients during psoriasis studies. Reactions occurring following readministration in Crohn's disease patients were reported 3 to 12 days after infusion and the signs and symptoms included myalgia and/or arthralgia with fever and/or rash, with some patients also experiencing pruritus, facial, hand, or lip edema, dysphagia, urticaria, sore throat, and headache. Allergic reaction, leukocytoclastic vasculitis, and allergic bronchopulmonary aspergillosis have been reported. Anaphylactic-like reactions (including laryngeal/pharyngeal edema and severe bronchospasm) have been associated with infliximab administration during postmarketing experience. In order to avoid the development of delayed severe systemic reactions, some researchers recommend multiple early infusions of infliximab if retreatment is anticipated. Delayed hypersensitivity reactions during psoriasis studies generally occurred within 2 weeks following repeat infusion. During one clinical trial, Crohn's disease patients were retreated following 2 to 4 years without infliximab. Patients experiencing side effects following readministration did not have infusionrelated side effects associated with their initial infliximab treatment.
Nervous system

One patient reported hypoesthesia in the left leg eight hours after her first infliximab infusion. Another patient reported dysesthesia in the distribution of the left peroneal nerve, after her 6th intravenous infliximab infusion. Although demyelination observed in postmarketing experience did not show causal relationship between adverse events and infliximab, the neurologic side effects resolved, partially or completely, on discontinuation of therapy. A 51-year-old female with Crohn's disease experienced meningitis coincident with infliximab

therapy. The patient developed a headache, fever, arthralgia, myalgia, and meningismus after receiving an infliximab infusion. Cerebrospinal fluid analysis was remarkable for a neutrophilic pleocytosis and elevated protein. Other potential causes of meningitis were ruled out. The patient's symptoms completely resolved within 24 hours of presentation. A 28-year-old female with a 7-year history of Crohn disease experienced acute neuropathy with multiple conduction blocks coincident with infliximab therapy. Infliximab (5 mg/kg, 4 infusions in 2 years) therapy was added to azathioprine (150 mg per day) 5 years into her disease. Three weeks after the overall fourth dose of infliximab treatment, she developed left radial nerve palsy and slight weakness of left foot flexion and extension. Neurologic examination and motor nerve conduction studies were positive for acute neuropathy with multiple conduction blocks. A 66-year-old male with rheumatoid arthritis experienced West Nile virus (WNV) coincident with infliximab therapy. The patient presented with a 2-day history of fever, headache, confusion, agitation, nausea, malaise, myalgias, gait instability, and rapidly worsening lower extremity weakness. He had received infliximab 3 weeks prior to symptom onset. His only other medications were amlodipine (5 mg per day) and methotrexate (15 mg per week). WNF was confirmed by with cerebral spinal fluid positive for WNV IgM antibodies by ELISA capture technique. The patient eventually died due to WNF infection. A 41-year-old female with erosive rheumatoid arthritis experienced neurosarcoidosis coincident with infliximab therapy. She had been successfully treated with infliximab 3 mg/kg every 6 to 8 weeks together with methotrexate, without side effects. Approximately five years later, after receiving an infliximab infusion, she experienced feeling tired, a low grade fever, and headache. Two weeks later, she presented without any neurological symptoms besides headache. She was hospitalized one week later. The headache remained unchanged and 4 weeks after admission, she developed diplopia. At neuron-ophthalmological examination, nerve palsy of the left eye and a severe papilledema in both eyes were observed. Further, bilateral granulomatous iridocyclitis and retinal periphlebitis, typical for sarcoidosis, were noted. The sarcoidosis diagnosis was supported by the increased activity in the mediastinal lymph nodes bilaterally and in the parotid glands observed with In-DTPA-octreotide scintigraphy. She received a ventriculoperitoneal shunt 5 weeks after being admitted. Following surgery, the patient became free of headache and the pathological ophthalmologic changes slowly subsided. A 62-year-old female reported she was hospitalized for five days due to a reaction characterized by shaking uncontrollably due to taking infliximab. The patient did not know the date of admission stating it was a long time ago when she was in her twenties. The patient reported being diagnosed with Crohn's disease at age 21. Nervous system side effects have included headache (up to 23%), meningitis, brain infarction, neuritis, peripheral neuropathy, dizziness, and syncope. Infliximab and other tumor necrosis factor blockers have been associated in rare cases with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of CNS demyelinating disorders (including multiple sclerosis and optic neuritis), and peripheral demyelinating disorders (including Guillain-Barre syndrome). Rheumatoid vasculitis has also been reported rarely. It presents with peripheral nervous system symptoms involvement. Herpes zoster and Miller Fisher syndrome have been reported. At least one case each of hypoesthesia, dysesthesia, West Nile virus meningoencephalitis and acute flaccid paralysis, and neurosarcoidosis and at least two cases of acute neuropathy with multiple

conduction blocks have been reported. Seizure associated with infliximab administration, peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy), transverse myelitis, and neuropathies have been reported during postmarketing experience.
Gastrointestinal

Gastrointestinal side effects have included nausea (up to 21%), abdominal pain (Crohn's disease: 26%; other indications: up to 12%), diarrhea (up to 12%) dyspepsia (10%), vomiting, constipation, gastrointestinal hemorrhage, ileus, abdominal hernia, abscess, intestinal obstruction, intestinal perforation, intestinal stenosis, pancreatitis, peritonitis, and proctalgia. Gastrointestinal infection, sialadenitis, dental/periodontal infection, and oral mycosis have also been reported. At least four cases of gum infection and at least one case each of rectal abscess and stomatitis have been reported.
Cardiovascular

Cardiovascular side effects have included higher incidences of mortality and hospitalization due to worsening heart failure and trends towards increased dyspnea, hypotension, angina, and dizziness in patients with moderate to severe heart failure. Cardiopulmonary reactions (primarily chest pain, hypotension, hypertension, or dyspnea; 1%) or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions (less than 1%) have accompanied infliximab infusions. Hypertension (7%), circulatory failure, hypotension, arrhythmia, bradycardia, cardiac arrest, tachycardia, myocardial infarction, thrombophlebitis, and palpitations have been reported. Heart block has been reported in at least two patients during infliximab infusion. At least one patient also developed bradycardia with the ECG showing second-degree atrioventricular block thirty minutes into the infliximab infusion. Pericardial effusion, vasculitis (systemic and cutaneous), worsening heart failure (with and without identifiable precipitating factors), and new-onset heart failure (including heart failure in patients without known preexisting cardiovascular disease) have been reported during postmarketing experience. Cases of myocardial ischemia/infarction associated with infliximab administration (during or within 2 hours of infusion) have also been rarely reported during postmarketing experience. A higher incidence of mortality and hospitalization for worsening heart failure have been reported among patients with moderate to severe (NYHA class III-IV) heart failure treated with the higher dose of infliximab (10 mg/kg). At 1 year, eight patients in the infliximab 10 mg/kg group had died compared with four deaths each in the infliximab 5 mg/kg and the placebo group. Heart failure (n=18) reported in postmarketing experience developed on average 6 months after initiation of infliximab therapy. Bradycardia with second degree atrioventricular (AV) block has been reported to occur, as soon as 30 minutes into the infliximab infusion, in a 52-year-old woman with fistulizing Crohn's disease who had no previous history of cardiac disease. The bradycardia, and second degree AV block, persisted for 36 hours after infliximab was discontinued. After a cardiology consult, and placement of a pacemaker, patient resumed her infliximab therapy without adverse events reported. A 70-year-old man with fistulizing Crohn's disease, and a prior history of coronary artery disease and taking atenolol, developed dyspnea, chest heaviness, and dizziness while receiving his third

infusion of infliximab. He had reported chills and pruritus during previous infusions of infliximab. He presented with a drop in heart rate with ECG showing type 2 Sinoatrial block. Patient received a permanent pacemaker. Infliximab therapy was stopped and patient had surgery for fistulizing Crohn's disease.
Dermatologic

Dermatologic side effects have included rash (up to 10%), pruritus (7%), cellulitis, increased sweating, ulceration, and interstitial granulomatous dermatitis. Pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions (less than 1%) have accompanied infliximab infusions. Furunculosis reported as a serious event occurred at a frequency of less than 2%. Psoriasiform eruption (erythematous, slightly scaling, well-shaped pruriginous plaques) has been reported following a third dose of infliximab. Vasculitis and/or vasculitic rash has been reported in a case series (n=8) of patients with rheumatoid arthritis after receiving infliximab infusions. Patients recovered after discontinuation of infliximab and treatment with cyclophosphamide and a corticosteroid. Furuncle/folliculitis, erysipelas cellulitis paronychia, wound infection, fungal skin infection, and severe atopic dermatitis have been reported. At least one case each of necrotizing fasciitis, bullous skin lesions, acne, tinea corporis, primary cutaneous Nocardia otitidiscaviarum infection, atypical varicella exanthema, skin leishmaniosis after injury, palmoplantar pustulosis, alopecia areata, and herpes labialis have been reported. At least two cases of aggressive cutaneous T-cell lymphomas and at least two cases of leprosy and type 1 leprosy reactions have been reported. Psoriasis-like skin lesions have been associated with TNF blockers. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and new-onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar) have been reported during postmarketing experience. Necrotizing fasciitis resulting in death has been reported in a 54-year-old man with rheumatoid arthritis receiving infliximab every 8 weeks along with intramuscular methotrexate weekly dosage. Blood cultures and skin swabs grew hemolytic group A streptococcus. Bullous skin lesions have been reported in a 72-year-old white man one day after his fourth dose of infliximab for the treatment of severe rheumatoid arthritis. Although proximity of symptoms point to infliximab, causality was not definitive. Two cases of aggressive cutaneous T-cell lymphomas that progressed rapidly have been reported during therapy with infliximab. Sezary syndrome developed in one patient after 18 months of treatment and systemic anaplastic large cell lymphoma with cutaneous involvement developed in the other patient four weeks following the third dose of infliximab. A 40-year-old female with Crohn disease experienced acne coincident with infliximab therapy. The patient had been administered infliximab 5 mg/kg with rapid and effective symptomatic control. Several weeks after initiating infliximab therapy, the patient developed a papulopustular eruption on the face and back with some comedones. The eruption persisted, albeit with fluctuating severity, and dermatological opinion was obtained. Histology was consistent with the clinical diagnosis of acne and other Crohn disease-associated dermatoses were excluded. Infliximab was not discontinued because of the excellent control of the bowel disease. Instead, the patient was treated with minocycline 100 mg daily. A 70-year-old male with rheumatoid arthritis (RA) experienced a primary cutaneous Nocardia otitidiscaviarum infection after a skin injury coincident with infliximab therapy. He was treated

for RA with infliximab (3 mg/kg) for 3 years, as well as methotrexate (20 mg/week), and corticosteroids. Two weeks before the 18th infusion of infliximab, he was injured, and had a deep wound in his right palm. The hand lesion was not inflamed, but an erythematous pustular lesion appeared on the anterior side of his right forearm. Two weeks later the lesion spontaneously drained and formed a cutaneous nonpainful ulcer covered by white pus, with erythematous periphery. Nocardia otitidiscaviarum was subsequently isolated from the ulcer and biological samples showed inflammation. Infliximab therapy was discontinued. He was treated with combination clindamycin and ofloxacin antibiotic therapy for 3 months. Twenty days later, the skin ulcer had completely healed. A 63-year-old female with a history of rheumatoid arthritis (RA) experienced atypical varicella exanthema coincident with infliximab therapy. The patient presented with a 10-day history of pruritic generalized papulovesicles which quickly progressed to flaccid vesicles, pustules, or erosions accompanied by fever and sore throat. Her RA had been treated with methotrexate (10 mg per week) and bucillamine (200 mg per day) for 6 years. Despite this medication, her RA was poorly controlled, so infliximab (3 mg/kg) was additionally administered twice, separated by 2-weekly intervals. Two days after the second course of infliximab therapy, a cutaneous eruption developed abruptly. Polymerase chain reaction showed varicella zoster virus. Based on these findings, the patient was diagnosed with varicella and was promptly started on a course of intravenous acyclovir and prophylactic antibiotics for 7 days. Three weeks later, her recovery was complete with minimal scars. A 60-year-old male with a 5-year history of diffuse polyarthritis experienced leprosy and type 1 leprosy reaction coincident with infliximab therapy. The patient had been given 3 courses of infliximab; the last had been given 3 months prior to admission. One month after he received the first dose of infliximab, the patient developed a rash on 1 extremity that progressed to all extremities. Results of a skin biopsy suggested leprosy or Hansen disease. He was treated with multidrug therapy (MDT) of dapsone (100 mg daily), clofazimine (50 mg daily), and rifampin (300 mg monthly). One month after starting this treatment, the patient developed "reversal," or type 1, reactions. After 4 years, the cutaneous lesions had resolved, and MDT was withdrawn. Results of a skin biopsy performed 5 years after diagnosis showed advanced regression of the lesion with no residual bacilli. A 37-year-old female with Crohn disease developed palmoplantar pustulosis (PPP) coincident with infliximab therapy. The patient was given a regimen of infliximab of 5 mg/kg resulting in complete remission of her bowel symptoms. One month later, she experienced classic PPP together with a mild psoriasiform eruption on the lower legs. In particular, the patient's feet were painful, which adversely affected her mobility. As treatment, she was prescribed betamethasone dipropionate twice daily, polythene occlusion at night, and soap-free wash and moisturizer. Over the following 3 to 4 weeks, the patient improved clinically and symptomatically and did not need additional psoriasis therapy. Alopecia areata has been reported in a 51-year-old white woman with rheumatoid arthritis and Sjogren syndrome after 11 months of infliximab therapy. The hair loss eventually involved 100% of the scalp as well as her eyebrows and eyelashes.

Oncologic

Oncologic side effects have included malignancies (including lymphoma, nonmelanoma skin cancer, and neoplasms [basal cell and breast]). The majority of malignancies in chronic obstructive pulmonary disease (COPD) patients developed in the lung or head and neck. Other malignancies, reported to occur with similar incidence to the general population, have included breast, colorectal, and melanoma. At least one case of acute lymphoblastic leukemia and at least one case of Sezary syndrome have been reported. Malignancies (including non-Hodgkin's lymphoma and Hodgkin's disease) and lymphoproliferative disorders (including hepatosplenic Tcell lymphomas) have been reported during postmarketing experience. Cases of acute and chronic leukemia have been reported with TNF blockers during postmarketing experience. Clinical trials of infliximab have reported a 3-fold higher incidence than expected in the general population of developing lymphomas among rheumatoid arthritis patients. Among patients diagnosed with Crohn's disease and rheumatoid arthritis, there is 6-fold higher incidence than expected in the general population. Patients with highly active disease and/or chronic exposure to immunosuppressants may be at a higher risk (up to several fold) than the population at large for the development of lymphoma. During a controlled clinical trial studying the use of infliximab in 157 patients with moderate to severe COPD who were either current smokers or ex-smokers, 9 patients developed a malignancy, including 1 lymphoma. Acute lymphoblastic leukemia has been diagnosed in a patient eight days after receiving a third infusion of infliximab 5 mg/kg for the treatment of Crohn's disease. A causal relationship was not clearly established. Postmarketing adverse events reports have included lymphoproliferative disorders (n=8) that developed, on average, 8 weeks after initiation of therapy with infliximab. The majority of cases (81%) were non-Hodgkin's lymphomas. A meta-analysis has reported that there is dose-dependent increased risk of malignancies in patients with rheumatoid arthritis treated with anti-TNF antibody therapy. A 75-year-old male with ankylosing spondylitis experienced Sezary syndrome coincident with infliximab therapy. He had been initially treated with nonsteroidal antiinflammatory drugs, then with prednisone 10 mg daily for 6 months, and thereafter treatment was switched to infliximab 3 mg/kg at 2 monthly intervals. After 17 months of this therapy, he was diagnosed with Sezary syndrome. Cutaneous lesions partially remitted following infliximab discontinuation and methotrexate treatment.
Hepatic

Hepatic side effects have rarely included severe liver injury, including acute liver failure and autoimmune hepatitis. Reactivation of hepatitis B virus has been reported in patients who are chronic carriers of this virus (i.e., surface antigen positive). Elevated aminotransferases (ALT more common than AST), biliary pain, cholecystitis, cholelithiasis, and hepatitis have been reported. At least one case of cholestatic liver disease and one case of cytomegalovirus hepatitis have been reported. Severe hepatic reactions (including acute liver failure, jaundice, hepatitis,

cholestasis, and autoimmune hepatitis) have been reported during postmarketing experience. Some of the cases resulted in death or the need for liver transplantation. Severe hepatic reactions have occurred between weeks two to more than a year after initiation of infliximab. In general, patients who developed elevated ALT and AST were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant medications. Cholestatic liver disease has been reported in a 44-year-old woman 19 days after a single dose of infliximab. A 45-year-old female with a history of Crohn disease experienced cytomegalovirus hepatitis coincident with infliximab therapy. She had been administered mercaptopurine 50 mg per day for the past 8 years until intravenous infliximab 5 mg/kg at 4 to 8 week intervals was added for better control of the disease. Approximately one year later, the patient was admitted to the hospital with a 4-week history of daily fever and chills unresponsive to several courses of empirical antimicrobial therapy. Histological examination of a liver biopsy specimen showed intranuclear inclusion bodies, confirmed by cytomegalovirus by paraffin immunoperoxidase staining with antibody against this virus. After intravenous ganciclovir 5 mg/kg twice daily therapy, the patient's symptoms and laboratory values improved within a few days.
Hematologic

Some cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia had a fatal outcome. Hematologic side effects have included pancytopenia, thrombocytopenia, anemia, hemolytic anemia, leukopenia, lymphadenopathy, aplastic anemia, splenic infarction, and splenomegaly. Neutropenia, idiopathic thrombocytopenic purpura, and thrombotic thrombocytopenic purpura have been reported during postmarketing experience.
Musculoskeletal

Musculoskeletal side effects have included back pain (up to 8%), arthralgia (8%), intervertebral disk herniation, tendon disorder, myalgia, and infective arthritis. At least one case of swelling of fingers and one case of paresthesia in the forearm region have been reported.
Renal

IgA nephropathy has been reported in a 38-year-old male with fistulizing Crohn's ileocolitis and perianal disease two years after the start of treatment with infliximab infusions every 8 weeks and 6-mercaptopurine. Renal side effects have included renal calculus, renal failure, pyelonephritis, and kidney infarction (reported within a group of serious events). At least one case of IgA nephropathy has been reported.
Metabolic

Metabolic side effects have included dehydration and extra-high levels of VLDL-triglycerides.

Local

Local side effects have included injection site reactions that were mainly erythema, pruritus, rash, and pain of mild to moderate severity. At least one case of repeated local infections has also been reported.
Genitourinary

Genitourinary side effects have included urinary tract infections (8%), menstrual irregularity, herpes simplex, and endometritis. Serious genitourinary events have included dysuria and urethral obstruction.
Ocular

A 55-year-old woman diagnosed with rheumatoid arthritis developed decreased vision in the left eye accompanied by pain with eye movement 3 days after her 9th infusion (at 1 year of treatment) with infliximab. Patient's vision slowly improved and her visual field deficit resolved after treatment with 1 g methylprednisolone injection per day for 3 days followed by a tapering dose of oral prednisone over 10 days. A week after the seventh infusion of infliximab 5 mg/kg, a 45-year-old woman with type 2 diabetes mellitus and Crohn's disease developed pain and blurred vision in the left eye. Visual acuity was 20/70. Patient recovered after treatment with intravenous methylprednisolone, followed by a tapering dose of oral prednisone. On examination 3 months later she had 20/20 visual acuity, normal color vision, mild residual left-sided headache, and a normal-appearing optic nerve in the left eye. A 42-year-old male developed severe unilateral orbital cellulitis while receiving infliximab therapy for ankylosing spondylitis during a clinical trial. Cultures showed Staphylococcus aureus. Infliximab therapy was stopped and the patient made a full recovery after receiving appropriate antibiotic therapy. Infliximab treatment was resumed after three weeks. A 47-year-old male with rheumatoid arthritis experienced third nerve palsy coincident with infliximab therapy. He received monthly infusions of 300 mg of infliximab for the disease. He initially presented with painless ptosis of his right upper eyelid along with double vision in left and up gaze. Brain magnetic resonance imaging (MRI) showed gadolinium enhancement of the cisternal segment of the right oculomotor nerve. After stopping infliximab therapy, the diplopia and ptosis gradually resolved during 3 months. Repeat MRI imaging showed resolution of the oculomotor nerve enhancement. Ocular side effects have been extremely rare. Retrobulbar optic neuritis of the left eye has been reported after the seventh infusion of infliximab in one patient and after the ninth infusion on another patient. At least one case of orbital cellulitis and at least one case of third nerve palsy have been reported. Uveitis has been reported during postmarketing experience. Cases of transient visual loss associated with infliximab administration (during or within 2 hours of infusion) have also been rarely reported during postmarketing experience.
Psychiatric

Psychiatric side effects have included confusion and suicide attempt.

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Availability Prescription only

CSA Schedule Not a controlled drug

Pregnancy Category No proven risk in humans

Approval History Drug history at FDA

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Omega 3 Oil - increased energy and vigour, anti-inflammatory, de-age your skin www.xtend-life.com Weight Loss Medicine Immediate weight loss - reduces fat absorbtion - less fat means less pounds www.pharmcom.com Related Questions & Answers Can low dose naltrexone be taken with Methotrexate & remicade (drugs for rheumatoid arthritis)? Does anybody know what Insurance provider will cover the cost of using Remicade to treat Uveitis? What are the side-effects of Remicade. I have uveitis. I'm 18 Has anyone used Remicade with good results, gone off for one year, restarted and had same good? My 17 year old son was diagnosed with severe chrones disease a couple of days ago.They are?

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