infliximab (Rx)

Brand and Other Names:Remicade, Inflectra, more...infliximab-dyyb, Renflexis, infliximab-abda, Ixifi, infliximab-qbtx
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/vial (Remicade, Inflectra, Renflexis, Ixifi)

Biosimilars to Remicade

  • Inflectra (infliximab-dyyb)
  • Renflexis (infliximab-abda)
  • Ixifi (infliximab-qbtx)
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Rheumatoid Arthritis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active rheumatoid arthritis in combination with methotrexate

3 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter 

If incomplete response is noted, dose may be increased to 10 mg/kg OR increasing the dosing frequency to q4Weeks

Psoriatic Arthritis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis

5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter 

May be used with methotrexate

Plaque Psoriasis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate

Should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter 

Can be used with or without methotrexate

Crohn Disease

Remicade, Inflectra, Renflexis, Ixifi

Indicated for moderately-to-severely active Crohn disease in patients who have had inadequate response to conventional therapy

Also, indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn disease

5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter 

For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg

Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue

Ulcerative Colitis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adults with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks 

Ankylosing Spondylitis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis

5 mg/kg IV at 0, 2, and 6 weeks, THEN q6Weeks thereafter 

Idiopathic Pulmonary Fibrosis (Orphan)

Treatment of idiopathic pulmonary fibrosis

Orphan indication sponsor

  • Foundation for Fatal Rare Diseases; Herrengasse 21; Furstentum Liechtenstein; Germany

Dosage Modifications

Moderate-to-severe (NYHA class III or IV) heart failure: Not to exceed 5 mg/kg/dose (see Contraindications)

Dosing Considerations

Prior to initiating treatment and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection

Higher incidence of serious infections in infliximab-treated patients ≥ 65 years; use with caution

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/vial (Remicade, Inflectra, Renflexis, Ixifi)

Biosimilars to Remicade

  • Inflectra (infliximab-dyyb)
  • Renflexis (infliximab-abda)
  • Ixifi (infliximab-qbtx)
more...

Crohn Disease

Remicade, Inflectra, Renflexis, Ixifi

Reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients aged ≥6 year with moderately to severely active Crohn disease who have had inadequate response to conventional therapy

≥6 to 17 years: 5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter 

Ulcerative Colitis

Remicade

Treatment of moderately to severely active ulcerative colitis in children aged ≥6 yr who have had inadequate response to conventional therapy

≥6: 5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter 

Juvenile Rheumatoid Arthritis (Orphan)

Orphan indication sponsor

  • Centocor, Inc; 200 Great Valley Parkway; Malvern, PA 19355-1307

Dosing Considerations

Children should be current with immunizations before starting infliximab

Do not administer live vaccines while patient is taking infliximab

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Interactions

Interaction Checker

and infliximab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Development of antinuclear antibodies (50%)

            Infection (36%)

            Upper respiratory tract infection (32%)

            Abdominal pain (12%; 26% with Crohn disease)

            Nausea (21%)

            Infusion-related reaction (20%)

            Headache (18%)

            Development of antibodies to double-stranded DNA (17%)

            Other respiratory infection (eg, sinusitis, cough) (12-14%)

            Diarrhea (12%)

            Elevated alanine transaminase (ALT), >1 to <3 ULN (12-34%)

            1-10% (Adults)

            Bronchitis (10%)

            Dyspepsia (10%)

            Rash (1-10%)

            Elevated ALT, ≥3 ULN (2-10%)

            Fatigue (9%)

            Back pain (8%)

            Rhinitis (8%)

            Urinary tract infection (8%)

            Arthralgia (1-8%)

            Fever (7%)

            Hypertension (7%)

            Pruritus (7%)

            Dyspnea (6%)

            Candidiasis (5%)

            Lupuslike symptoms (<5%)

            Elevated ALT, ≥5 ULN (<1-4%)

            1-10% (Children)

            Leukopenia (9%)

            Flushing (9%)

            Viral infection (8%)

            Neutropenia (7%)

            Bone fracture (7%)

            Bacterial infection (6%)

            Respiratory tract allergic reaction (6%)

            Postmarketing Reports

            Adults

            • Anaphylacticlike reactions, including anaphylactic shock, laryngeal/pharyngeal edema, severe bronchospasm, and seizure
            • Myocardial ischemia or infarction and transient visual loss have also been rarely reported during or within 2 hours of infusion
            • Serious infections and malignancies, including melanoma, leukemia, and Merkel cell carcinoma
            • Neutropenia, agranulocytosis (including infants exposed in utero to infliximab), interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and 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 Guillain- Barré 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), acute liver failure, jaundice, hepatitis, and cholestasis, serious infections, malignancies, including melanoma, Merkel cell carcinoma, and cervical cancer

            Children

            • Malignancies, including hepatosplenic T-cell lymphomas
            • Transient hepatic enzyme abnormalities, lupus-like syndromes, and the development of autoantibodies
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            Warnings

            Black Box Warnings

            Serious infection risk

            • Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
            • Patients older than 65 years may be at greater risk
            • Discontinue if patient develops serious infection or sepsis; reported infections include the following:
            • (1) Active tuberculosis, including reactivation of latent disease (frequently present with disseminated or extrapulmonary disease); test for latent tuberculosis before use and during therapy; treat latent infection before use
            • (2) Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, cryptococcosis, candidiasis, aspergillosis, salmonellosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may yield negative results in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops
            • (3) Infections caused by other opportunistic pathogens, including bacteria (eg, Legionella, Listeria), mycobacteria (eg, Mycobacterium tuberculosis), and viruses (eg, hepatitis B virus)

            Malignancy

            • Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers
            • Manufacturer is required to report all malignancies to FDA for complete and consistent analysis

            Hepatosplenic T-cell lymphoma

            • Hepatosplenic T-cell lymphoma (HSTCL) is an aggressive, rare type of T-cell lymphoma (usually fatal)
            • Rare postmarketing cases of HSTCL are reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with infliximab
            • Reports have also included 1 patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
            • Most reported cases with infliximab have occurred with concomitant treatment with azathioprine or 6-mercaptopurine (6-MP), though cases have been reported in patients receiving azathioprine or 6-MP alone
            • In the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network, HSTCL cases have been identified in association with the following agents: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and 6-MP (3)

            Contraindications

            Active serious infections

            Documented hypersensitivity

            Doses exceeding 5 mg/kg should not be administered to patients with moderate-to-severe heart failure; treatment with 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure

            Cautions

            Worsening or new onset congestive heart failure reported with TNF blockers; Exercise caution when using in patients who have heart failure; TNFalpha inhibitors should only be considered in patients with HF if there are no other reasonable treatment options, and then consider only in patients with compensated HF

            Hypersensitivity reactions reported; most hypersensitivity reactions, which include anaphylaxis, urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hr of infusion

            Caution in neurologic disorder

            Moderate-to-severe chronic obstructive pulmonary disease (COPD)

            Monitor closely for signs and symptoms of demyelinating disease (eg, confusion, numbness, vision changes); consider termination of therapy if significant CNS reactions develop

            Risk of tuberculosis, histoplasmosis, and other opportunistic infections, as well as hepatitis B reactivation; test for HBV infection before starting infliximab; monitor HBV carriers during and several months after therapy

            Immunizations should be current before therapy is initiated

            Consider discontinuance if hematologic disorder occurs (eg, leukopenia, thrombocytopenia, neutropenia, pancytopenia)

            Consider discontinuance if lupuslike symptoms occur

            Readministration after period of no treatment resulted in higher incidence of infusion reactions than was seen with regular maintenance treatment (4% vs <1%)

            Consider empiric antifungal therapy for patients who develop a systemic illness on infliximab and reside or travel to regions where mycoses are endemic

            Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hr of initiation of infliximab infusion; cases of transient visual loss have been reported during or within 2 hr of infliximab infusion; monitor patients during infusion and if serious reaction occurs, discontinue infusion

            Hepatoxicity

            • Severe hepatic reactions (eg, acute liver failure, jaundice, hepatitis and cholestasis), have been reported in postmarketing data
            • Severe hepatic reactions occurred between 2 weeks to more than 1 year after initiation of infliximab; elevations in hepatic aminotransferase levels were not noted prior to discovery of the liver injury in many of these cases
            • Some fatal or necessitating liver transplantation; stop therapy in cases of jaundice and/or marked liver enzyme elevations (≥5 ULN)

            Malignancies

            • Also see Black Box Warnings
            • Increased risk of lymphoma (including hepatosplenic T-cell lymphoma (HSTCL), especially if given with azathioprine or 6-MP), pneumonia, hepatotoxicity (including acute liver failure, jaundice, hepatitis, cholestasis)
            • Increased risk of lymphoma and other cancers is reported in children and adolescents
            • Skin cancer (eg, melanoma, Merkel cell carcinoma) is reported with TNF blockers
            • Increased incidence of invasive cervical cancer in women reported; a causal relationship between infliximab and cervical cancer cannot be excluded; periodic screening should continue in women receiving therapy
            • Occurrence of leukemia and new-onset psoriasis is reported in patients treated with TNF blockers

            Drug interactions overview

            • Information on concomitant use of infliximab products with other biological therapeutics used to treat the same conditions is insufficient; concomitant use of infliximab with these biologics is not recommended due to the possibility of an increased risk of infection
            • Coadministration of TNF blockers with abatacept is associated with greater risk of serious infection than use of TNF blockers alone; concurrent use is not recommended
            • Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection
            • Live vaccines or therapeutic infectious agents should not be given with infliximab; bring pediatric patients up to date with all vaccinations prior to initiating therapy; at least a six month waiting period following birth is recommended before administration of live vaccines to infants exposed in utero to infliximab
            • Administration of live virus vaccines should be delayed or avoided while patient is taking infliximab
            • Due to the risk of HSTCL, carefully assess the risk/benefit especially if the patient has Crohn disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment
            • Formation of CYP450 enzymes may be suppressed by increased levels of cytokines (eg, TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation; infliximab products may antagonize cytokine activity and normalize the formation of CYP450; upon initiation or discontinuation of treatment in patients being treated with CYP450 substrates with a narrow therapeutic index (eg, warfarin, cyclosporine, or theophylline), monitor and adjust doses as needed
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            Pregnancy & Lactation

            Pregnancy

            It is not known whether therapy can cause fetal harm when administered to pregnant woman or can affect reproduction capacity; administer therapy to a pregnant woman only if clearly needed

            As with other IgG antibodies, drug crosses placenta; drug has been detected in serum of infants up to 6 months following birth; consequently, these infants may be at increased risk of infection, including disseminated infection which can become fatal; >6 month waiting period following birth recommended before administration of live vaccines (eg, BCG vaccine or other live vaccines, such as the rotavirus vaccine) to these infants; cases of agranulocytosis in infants exposed in utero also reported

            Lactation

            Not known whether drug excreted in human milk or absorbed systemically after ingestion; because many drugs and immunoglobulins are excreted in human milk, and potential for adverse reactions in nursing infants, women should not breastfeed their infants while on therapy; a decision should be made whether to discontinue nursing or discontinue drug, taking into account importance of drug to mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant humanized monoclonal anti-TNF-α antibody; prevents synovial and intestinal inflammation

            Absorption

            Onset: 2 wk (Crohn disease)

            Duration: 12 wk

            Distribution

            Vd: 3-6 L

            Metabolism

            Unknown

            Elimination

            Half-life: 7.7-9.5 days

            Development of antibodies to infliximab increased infliximab clearance

            Excretion: Unknown

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            Administration

            IV Compatibility

            0.9% NaCl

            IV Incompatibilities

            Do not infuse with other agents

            IV Preparation

            Reconstitute vials aseptically with 10 mL SWI; swirl vial gently to dissolve powder, and do not shake

            Allow solution to stand for 5 minutes

            Dilute total volume of reconstituted infliximab solution dose to 250 mL with sterile 0.9% NaCl, by withdrawing a volume equal to volume of reconstituted infliximab from 0.9% NaCl 250 mL bottle or bag

            Do not dilute reconstituted infliximab solution with any other diluent; slowly add the total volume of reconstituted infliximab solution to 250 mL infusion bottle or bag; gently mix; final diluted concentration should range between 0.4 - 4 mg/ml

            Discard if particulate matter is present or discoloration observed

            Begin infusion within 3 hours of preparation (product contains no preservatives)

            IV Administration

            Infuse over ≥2 hours

            Use in-line filter

            Drug should not be infused in same line as other drugs

            Discontinue if infusion reaction occurs

            Must use an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less)

            Vials do not contain antibacterial preservatives

            Any unused portion of the infusion solution should not be stored for reuse

            Storage

            Unopen vials

            • Refrigerate at 2-8ºC (36-46ºF) or at temperatures up to 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date
            • New expiration date must be written on the carton
            • Upon removal from refrigerator, vials cannot be returned to refrigerated storage

            Diluted solutions

            • 0.4 mg/mL solutions: Refrigerate at 4°C for up to 14 days (Ikeda 2012)
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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.