Infliximab

USUAL DOSE

Infliximab-dyyb (Inflectra)^a, infliximab-abda (Renflexis)^a, infliximab-qbtx (Ixifi)^a, and infliximab-axxq (Avsola)^aare biosimilar drugs to infliximab (Remicade). Unless specifically stated otherwise, the use of the name infliximab or infliximab product(s) applies to all formulations.

Pretreatment:

Patients should be tested for latent tuberculosis before infliximab use and periodically during therapy. Treatment for latent infection should be initiated before infliximab therapy. Patients should be tested for hepatitis B virus before infliximab use. See Precautions and Monitor.

Premedication:

Administer at the physician’s discretion. May include antihistamines (e.g., diphenhydramine), H₂ blockers (e.g., famotidine), acetaminophen, and/or corticosteroids (e.g., hydrocortisone).

Crohn’s disease and fistulizing Crohn’s disease:

Begin with an initial dose of 5 mg/kg as an IV infusion. Repeat at 2 and 6 weeks and every 8 weeks thereafter. For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. If there is no response by Week 14, response with continued dosing is unlikely; consider discontinuing infliximab. See Precautions.

Rheumatoid arthritis:

3 mg/kg as an IV infusion. Repeat dose at 2 and 6 weeks, then every 8 weeks thereafter. Given in combination with methotrexate. See methotrexate monograph. If response to infliximab is incomplete, dose may be adjusted up to 10 mg/kg or interval decreased to every 4 weeks. Risk of infection may be increased at higher doses.

Ankylosing spondylitis:

5 mg/kg as an IV infusion. Repeat at 2 and 6 weeks, then every 6 weeks thereafter.

Psoriatic arthritis:

5 mg/kg as an IV infusion. Repeat dose at 2 and 6 weeks, then every 8 weeks thereafter. May be used with or without methotrexate.

Ulcerative colitis:

5 mg/kg as an IV infusion. Repeat dose at 2 and 6 weeks, then every 8 weeks thereafter.

Plaque psoriasis:

5 mg/kg as an IV infusion. Repeat dose at 2 and 6 weeks, then every 8 weeks thereafter.

PEDIATRIC DOSE

Pretreatment:

See comments in Usual Dose and Maternal/Child.

Crohn’s disease:

5 mg/kg as an IV infusion. Repeat dose at 2 and 6 weeks. Follow with a maintenance regimen of 5 mg/kg every 8 weeks.

Ulcerative colitis:

5 mg/kg as an IV infusion. Repeat dose at 2 and 6 weeks. Follow with a maintenance regimen of 5 mg/kg every 8 weeks.

DOSE ADJUSTMENTS

Do not exceed a dose of 5 mg/kg in patients with moderate to severe CHF (NYHA Class III/IV); see Contraindications.

Dilution ⬆ ⬇

Each vial contains 100 mg of infliximab. When reconstituted as directed below, each milliliter of solution contains 10 mg of infliximab. Calculate the dose and the number of vials required and the total volume of reconstituted infliximab solution required. Reconstitute each 100-mg vial with 10 mL of SWFI, using a syringe equipped with a 21-gauge or smaller needle. Direct the stream of SWFI to side of vial. Swirl gently; do not shake. Allow reconstituted solution to stand for 5 minutes. Solutions of Remicade, Avsola, Inflectra, and Renflexis should be colorless to light yellow and opalescent. Ixifi should be colorless to light brown and opalescent. All products may develop a few translucent particles as infliximab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present. The total dose of reconstituted solution must be further diluted with NS to a final volume of 250 mL. (May withdraw a volume of NS equal to the calculated volume of reconstituted infliximab from a 250-mL bottle or bag of NS and slowly add reconstituted solution.) Do not dilute the reconstituted infliximab solution with any other diluent. Mix gently. Infusion concentration should range between 0.4 mg/mL and 4 mg/mL.

Filters:

Must be administered through an infusion set with an in-line, sterile, nonpyrogenic, low–protein binding filter (pore size equal to or less than 1.2 microns). Flush and prime tubing/filter system with NS before administration of infusion.

Storage:

Refrigerate unopened vials at 2° to 8° C (36° to 46° F). Protect Avsola from light. Discard any unused portion. Do not use beyond expiration date on vial. The infusion should begin within 3 hours of reconstitution and dilution. Remicade, Avsola, and Ixifi: Unopened vials may also be stored at temperatures up to a maximum of 30° C (86° F) for a single period of up to 6 months but not exceeding the original expiration date. The new expiration date must be written on the carton. Upon removal from refrigerated storage, Remicade, Avsola, and Ixifi cannot be returned to refrigerated storage.

Compatibality ⬆ ⬇

Manufacturer recommends not infusing concomitantly in the same IV line with other agents until specific compatibility data are available.

Rate of Administration ⬆ ⬇

Begin the infusion within 3 hours of reconstitution and dilution. Flush and prime tubing/filter system with NS before administration. A single dose should be given over a period of not less than 2 hours. Upon completion of infusion, IV line should be flushed thoroughly NS to ensure all active drug is delivered to the patient. Patients experiencing a mild to moderate infusion-related reaction may be able to continue therapy at a reduced rate; see Antidote.

Actions ⬆ ⬇

A chimeric IgG1K monoclonal antibody that binds specifically to human tumor necrosis factor alpha (TNFα). Is composed of human constant and murine variable regions. Produced by a recombinant cell line cultured by continuous perfusion and purified by a series of steps that include measures to inactivate and remove viruses. Neutralizes the biologic activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibiting binding of TNFα with its receptors. Infliximab does not neutralize TNFβ. Biologic activities attributed to TNFα include induction of pro-inflammatory cytokines such as IL-1 and IL-6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, and induction of acute phase reactants and other liver proteins, as well as tissue-degrading enzymes produced by synoviocytes and/or chondrocytes. Elevated concentrations of TNFα have been found in involved tissues and fluids of patients with Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. These elevated concentrations correlate with elevated disease activity. Treatment with infliximab blocks the biological activities attributed to TNFα. Infliximab is distributed predominantly within the vascular space. Has a prolonged terminal half-life of 7.7 to 9.5 days.

Indications and Uses ⬆ ⬇

Adult and pediatric patients 6 years of age and older:

Reduce the S/S and induce and maintain clinical remission in patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. ■ Reduce the S/S and induce and maintain clinical remission and mucosal healing, and eliminate corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; see Maternal/Child.

Adult patients:

Reduce the number of draining enterocutaneous and rectovaginal fistula(s) and maintain fistula closure in fistulizing Crohn’s disease. ■ Given in combination with methotrexate to improve physical function, inhibit progression of structural damage, and reduce S/S in patients with moderately to severely active rheumatoid arthritis. ■ Reduce S/S in active ankylosing spondylitis. ■ Reduce the S/S of active arthritis, inhibit progression of structural damage, and improve physical function in patients with psoriatic arthritis. ■ Used for treatment of patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic treatment and when other systemic treatments are less appropriate.

Contraindications ⬆ ⬇

Known hypersensitivity to infliximab, murine proteins, or other components of the product. ■ Administration of doses exceeding 5 mg/kg in patients with moderate to severe (NYHA Class III/IV) CHF.

Precautions ⬆ ⬇

Administer in a facility that is equipped to monitor the patient and respond to any medical emergency. ■ TNFα mediates inflammation and modulates cellular immune response. Anti-TNF therapies, including infliximab, may affect normal immune responses. ■ Patients treated with infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Many of the serious infections have occurred in patients undergoing concomitant immunosuppressive therapy (e.g., methotrexate, corticosteroids) that, in addition to their underlying disease, may predispose them to infections; see Drug/Lab Interactions. Discontinue infliximab if patient experiences a serious infection or sepsis. Reported infections with TNF-blockers include active tuberculosis, including reactivation of latent tuberculosis; invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, cryptococcus, candidiasis, aspergillosis, blastomycosis, and pneumocystosis); and bacterial, viral, parasitic, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.■ Patients with TB have frequently presented with disseminated or extrapulmonary disease.■ Cases of tuberculosis reactivation or new tuberculosis infections have been observed in patients receiving infliximab, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred in patients being treated with infliximab during treatment for latent tuberculosis. ■ Antituberculosis treatment of patients with a reactive TB skin test reduces the risk of TB reactivation in patients receiving infliximab. ■ Patients with histoplasmosis or other invasive fungal infections may present with disseminated rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative.■ Treatment with infliximab should not be initiated in patients with an active infection, including clinically important localized infections. Consider the risks and benefits of infliximab treatment before initiating therapy in patients with chronic or recurrent infection, patients who have been exposed to TB, patients with a history of an opportunistic infection, patients who have resided in or traveled to areas of endemic tuberculosis or endemic mycoses (e.g., histoplasmosis, coccidioidomycosis, or blastomycosis), or patients with underlying conditions that may predispose them to infection. ■ Has been associated with the reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen–positive). Fatalities have been reported. ■ Infliximab therapy has been associated with adverse outcomes in patients with heart failure and should be used in these patients only after consideration of other treatment options. Studies suggest a higher mortality in patients who receive 10 mg/kg, and higher rates of cardiovascular adverse events at doses of 5 mg/kg and 10 mg/kg. Do not use doses greater than 5 mg/kg in patients with moderate to severe CHF; see Contraindications. Discontinue for new-onset CHF or for worsening CHF. Use with caution in patients with mild CHF (NYHA Class I/II); monitor closely. ■ Hypersensitivity reactions characterized by urticaria, dyspnea, and/or hypotension have occurred in association with infliximab infusion. Most occur during or within 2 hours of the infusion. Discontinue infusion if severe reactions occur. Medications for management of hypersensitivity reaction (e.g., acetaminophen, diphenhydramine, corticosteroids [e.g., hydrocortisone] and/or epinephrine) should be readily available. ■ Serum sickness–like reactions (dysphagia, fever, hand and facial edema, headache, myalgias, polyarthralgias, rash, sore throat) have been reported and have occurred as early as after the second dose and when infliximab was interrupted and then re-initiated after an extended period. These reactions are associated with a marked increase in antibodies to infliximab, a loss of detectable serum concentrations of infliximab, and a possible loss of drug efficacy. ■ Readministration of infliximab after a period of no treatment resulted in a higher incidence of infusion reactions relative to regular maintenance treatment in clinical trials. Evaluate risk versus benefit of readministration after a period of no treatment, especially if considering a re-induction regimen given at 0, 2, and 6 weeks. For cases in which maintenance therapy for psoriasis has been interrupted, infliximab should be re-initiated with a single dose followed by maintenance therapy. ■ Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of infliximab infusion. Transient vision loss has been reported during or within 2 hours of initiation of infliximab infusion. ■ Infliximab therapy may result in formation of autoimmune antibodies and, rarely, in the development of a lupus-like syndrome. Discontinue therapy if this occurs. In clinical studies, symptoms resolved with discontinuation of therapy. ■ Lymphoma and other malignancies, some fatal, have been reported in children, adolescent, and young adult patients treated with TNF blockers, including infliximab. Most of the affected patients were receiving concomitant immunosuppressants.■ Cases of hepatosplenic T-cell lymphoma have been reported. The majority of reported cases have occurred in adolescents and young adult males being treated with infliximab for Crohn’s disease or ulcerative colitis. This type of lymphoma has a very aggressive disease course and is usually fatal. Almost all affected patients received concomitant treatment with a TNF-blocker and azathioprine or 6-mercaptopurine (Purinethol) at or before diagnosis. When treating patients with inflammatory bowel disease, particularly adolescents and young adults, the decision whether to use infliximab alone or in combination with other immunosuppressants should consider the possibility that there is a higher risk of developing hepatosplenic T-cell lymphoma (HSTCL) with combination therapy versus an observed increased risk of immunogenicity and hypersensitivity reactions with infliximab monotherapy. ■ Use caution in patients with moderate to severe COPD; may have an increased risk of malignancy, especially of the lungs and head or neck. ■ The potential role of TNF-blocking therapy in the development of lymphoma, leukemia, melanoma, Merkel cell carcinoma, and other malignancies is not known. Patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, or plaque psoriasis, particularly with highly active disease and/or exposure to immunosuppressant therapies, may be at higher risk (up to several-fold) than the general population for the development of lymphoma, leukemia, and other malignancies, even in the absence of TNF-blocking therapy. Use caution when considering infliximab therapy in patients with a history of malignancy or when continuing treatment in patients who develop a malignancy while receiving infliximab. ■ In clinical trials, nonmelanoma skin cancers were more common in psoriasis patients with previous phototherapy. ■ Women treated with infliximab for rheumatoid arthritis may have an increased risk of invasive cervical cancer. ■ Rare cases with CNS manifestations of systemic vasculitis, seizures, and new-onset or exacerbation of clinical symptoms and/or radiographic evidence of CNS demyelinating disorders (e.g., multiple sclerosis, optic neuritis) and peripheral demyelinating disorders (e.g., Guillain-Barré syndrome) have been reported. Use with caution in patients with any of these existing neurologic disorders. Consider discontinuing therapy if any of these disorders develop. ■ Severe hepatic reactions, including liver failure, jaundice, hepatitis, cholestasis, and autoimmune hepatitis, have been reported. Reactions have occurred anywhere from 2 weeks to more than a year after initiation of treatment and have resulted in death or the need for a liver transplant. ■ Leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with fatal outcome, have been reported. ■ Use caution when switching between biological disease-modifying antirheumatic drugs (e.g., abatacept, anakinra), or other TNF-blocking agents (e.g., adalimumab, etanercept, golimumab); overlapping biological activity may further increase the risk of infection; see Drug/Lab Interactions. ■ Administration of live virus vaccines or therapeutic infectious agents (e.g., BCG bladder instillation for treatment of cancer) concurrently with infliximab is not recommended. Could result in clinical infections, including disseminated infections. ■ See Drug/Lab Interactions and Maternal/Child.

Monitor:

Evaluate patients for tuberculosis risk factors and test for latent infection before initiating infliximab and periodically during therapy. Initiate treatment of latent TB before therapy with infliximab. Antituberculosis therapy should also be considered before initiating infliximab in patients with a history of latent or active tuberculosis for whom an adequate course of treatment cannot be confirmed and in patients with a negative test for latent tuberculosis but risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in deciding whether initiating antituberculosis therapy is appropriate for a given patient. ■ During and after treatment, monitor for the development of tuberculosis in patients who tested negative for latent tuberculosis infection before initiating therapy. Tests for latent tuberculosis infection may also be falsely negative while on therapy with infliximab. Tuberculosis should be strongly considered in patients who develop a new infection during infliximab therapy, especially in patients who have previously or recently traveled to countries with a high prevalence of TB or who have had close contact with a person with active TB. ■ Before initiating TNF-blocker therapy, including infliximab, patients should be tested for HBV infection. Consultation with a physician with expertise in the treatment of hepatitis B is recommended if a patient tests positive for hepatitis B surface antigen. ■ In patients who are carriers of HBV and require treatment with TNF-blockers, closely monitor for clinical and laboratory signs of active HBV infection throughout treatment and for several months after completion of treatment. If HBV reactivation occurs, discontinue infliximab; see Antidote. ■ Monitor for S/S of infection during and after treatment; discontinue if a serious infection occurs and initiate appropriate antimicrobial treatment. Empiric antifungal therapy may be appropriate pending results of a diagnostic workup in patients at risk for invasive fungal infections (e.g., patients who reside or travel in regions where mycoses are endemic); see Precautions. ■ Monitor cardiac status closely for new-onset or worsening CHF; see Precautions. ■ Patients may develop antibodies to infliximab. In clinical trials, patients who were antibody-positive were more likely to have higher rates of clearance and reduced efficacy and to experience an infusion reaction than were patients who were antibody-negative. The incidence of antibody development was lower among patients receiving immunosuppressant therapies (e.g., 6-mercaptopurine, azathioprine, corticosteroids). ■ Monitor for S/S of hepatotoxicity (e.g., jaundice and/or marked liver enzyme elevations [equal to or greater than 5 times the upper limit of normal]). ■ Monitor CBC with differential and platelet count periodically. ■ Monitor for S/S of hypersensitivity or infusion reaction (e.g., anaphylaxis, chills, dyspnea, fever, flu-like symptoms, GI symptoms, headache, hypotension, rash). ■ Monitor for S/S of malignancies such as HSTCL (e.g., abdominal pain, hepatomegaly, night sweats, persistent fever, weight loss) and lymphoma. ■ Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. ■ Screen women for cervical cancer periodically.

Patient Education:

Read manufacturer’s medication guide before each treatment with infliximab. ■ Tell health care professionals of heart conditions, previous or current infections, and recent or past exposure to TB or mycoses (e.g., histoplasmosis, coccidioidomycosis, blastomycosis). ■ Review all medicines and disease history with pharmacist or physician before initiating treatment. ■ Promptly report abdominal pain, fever, S/S of new or worsening heart failure (e.g., shortness of breath, swelling feet, sudden weight gain), infection, numbness, tingling, or visual disturbances. ■ Report S/S of hypersensitivity reactions (e.g., itching, rash, swelling in the throat). Usually occur during or immediately following the infusion but may occur from 3 to 12 days later. ■ Report changes of growths on your skin during or after infliximab treatment. ■ Report symptoms of a cytopenia such as bruising, bleeding, or persistent fever. ■ Report recently receiving or being scheduled to receive a live virus vaccine or treatment with a weakened bacteria (such as BCG for bladder cancer) to your physician.

Maternal/Child:

Remicade:

Category B: use during pregnancy only if clearly needed. ■ Has potential for harm to the nursing infant; discontinue breast-feeding.

Avsola, Inflectra, Ixifi, and Renflexis:

Available data from published literature on the use of infliximab products during pregnancy have not reported a clear association of infliximab products with adverse pregnancy outcomes. ■ Available information is insufficient to inform the amount of infliximab products present in human milk and the effects on the breast-fed infant. There are no data on the effects of infliximab products on milk production. Consider risk versus benefit.

All products:

At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab. Infliximab crosses the placental barrier and has been detected in these infants up to 6 months after the last dose of infliximab to the mother, and these infants may be at increased risk for infection. ■ Safety and effectiveness for use in pediatric patients with ulcerative colitis and/or Crohn’s disease who are under 6 years of age not established. ■ Effectiveness of infliximab in inducing and maintaining mucosal healing could not be established in pediatric patients. ■ Safety and effectiveness for use in pediatric patients with juvenile rheumatoid arthritis was evaluated in a multicenter trial. The study failed to establish effectiveness; see prescribing information for details. ■ Before initiating infliximab therapy in pediatric patients with Crohn’s disease or ulcerative colitis, all vaccinations should be brought up-to-date. ■ Long-term (greater than 1 year) safety and effectiveness in pediatric patients with Crohn’s disease not established.

Elderly:

Specific differences in safety and effectiveness not noted; the incidence of serious side effects may be increased. An increase in the incidence of serious infections has been noted in patients 65 years and older, and because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly. See Precautions.

Drug/Lab Interactions ⬆ ⬇

Specific interaction studies have not been performed. ■ Concurrent administration with anakinra, an antirheumatic interleukin-1 antagonist, or abatacept, an antirheumatic selective T-cell costimulation blocker, may be associated with an increased risk of serious infections. The added benefit of combination therapy has not been documented. Anakinra is also associated with an increased risk of neutropenia. Concurrent administration of TNF α-blocking agents (e.g., infliximab) with anakinra or abatacept is not recommended. ■ May cause increased immunosuppression and increased risk of infection with tocilizumab; concurrent use should be avoided. ■ Concurrent use of infliximab with other biological products (adalimumab, etanercept, golimumab, rituximab) used to treat the same conditions as infliximab is not recommended; may increase risk of infection. ■ The majority of patients with Crohn’s disease, rheumatoid arthritis, or psoriatic arthritis received one or more of the following concomitant medications without evidence of any type of negative drug interaction: aminosalicylates, antibiotics, antivirals, corticosteroids, 6-mercaptopurine (Purinethol), azathioprine, folic acid, methotrexate, narcotics, NSAIDs, and sulfasalazine. ■ Patients receiving immunosuppressants (e.g., 6-mercaptopurine, azathioprine, corticosteroids) tended to experience fewer infusion reactions as compared to patients on no immunosuppressants. ■ Concomitant methotrexate use may decrease incidence of anti-infliximab antibody production and increase infliximab concentrations. ■ Live virus vaccines and therapeutic infectious agents (e.g., BCG for bladder instillation for treatment of cancer) should not be given concurrently with infliximab. Could result in clinical infection, including disseminated infection. In addition, it is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth; see Precautions and Maternal/Child. ■ Cytochrome P₄₅₀ enzymes may be suppressed by increased levels of cytokines during inflammation. Infliximab antagonizes cytokine activity, and the formation of the CYP450 enzymes may be normalized. When initiating or discontinuing infliximab in patients treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentrations (e.g., cyclosporine or theophylline) is recommended. Dose adjustment may be necessary.

Side Effects ⬆ ⬇

Adult:

The most commonly reported side effects include abdominal pain, headache, infection (e.g., pharyngitis, sinusitis, upper respiratory tract, and urinary tract), and infusion-related reactions. The most common reasons for discontinuation of therapy were infusion-related reactions (e.g., dyspnea, fever, flushing, headache, rash) occurring during or within 2 hours of infusion or infections (bacterial, fungal, parasitic, and viral), including TB and invasive opportunistic infections (e.g., histoplasmosis, listeriosis, and pneumocystosis). See Precautions. Other less common side effects include arthralgia, autoantibodies/lupus-like syndrome, bronchitis, cough, diarrhea, dyspepsia, hepatitis B virus reactivation, hepatotoxicity (autoimmune hepatitis, increased liver function tests, jaundice, liver failure), hypertension, malignancies including lymphoma, moniliasis, nausea, new-onset or worsening CHF, pain, pruritus, and rash. Hematologic reactions, neurologic reactions, and deaths have been reported. See Precautions.

Pediatric patients with Crohn’s disease:

Anemia, bacterial infection, bone fracture, flushing, leukopenia, neutropenia, respiratory tract allergic reactions, and viral infections were reported more commonly in pediatric patients than in adult patients receiving similar treatment regimens. Serious side effects were infections (some fatal), including opportunistic infections and tuberculosis, infusion reactions, and hypersensitivity reactions.

Pediatric patients with ulcerative colitis:

Adverse reactions were similar to those seen in adult patients.

Post-Marketing:

Agranulocytosis (including infants exposed in utero to infliximab), cholestasis, erythema multiforme, hepatitis, idiopathic and/or thrombotic thrombocytopenic purpura, infusion-related reactions (cases of anaphylactic reactions, including anaphylactic shock, laryngeal/pharyngeal edema and severe bronchospasm; seizures; transient vision loss; cerebrovascular accidents; myocardial ischemia/infarction; and arrhythmia), interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and rapidly progressive disease), jaundice, liver failure, malignancies (including leukemia, melanoma, Merkel cell carcinoma, and cervical cancer), myocardial ischemia/infarction, neuropathies, neutropenia, pericardial effusion, peripheral demyelinating disorders (e.g., Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy), psoriasis (including new-onset and pustular, primarily palmar/plantar), Stevens-Johnson syndrome, systemic and cutaneous vasculitis, toxic epidermal necrolysis, transverse myelitis, and vaccine breakthrough infections (including bovine tuberculosis [disseminated BCG infection] following vaccination in an infant exposed in utero to infliximab) have been reported; fatalities have occurred.

Pediatric patients:

Hypersensitivity reactions, infections (including opportunistic infections and tuberculosis), infusion reactions, malignancies (including hepatosplenic T-cell lymphomas), lupus-like syndromes and the development of autoantibodies, and transient hepatic enzyme abnormalities.

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Pronounciation and Trade Name(s) ⬇

Drug Category(ies) ⬆ ⬇

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Dosage ⬆ ⬇