infliximab (Rx)

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

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

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

Biosimilars to Remicade

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

Rheumatoid Arthritis

Remicade, Inflectra, Renflexis

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 every 8 weeks 

If incomplete response is noted, dose may be increased to 10 mg/kg or dosing frequency to every 4 weeks

Psoriatic Arthritis

Remicade, Inflectra, Renflexis

Indicated for reducing signs and symptoms in patients with active psoriatic arthritis

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 every 8 weeks 

May be used with methotrexate

Plaque Psoriasis

Remicade, Inflectra, Renflexis

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 every 8 weeks 

Can be used with or without methotrexate

Crohn Disease

Remicade, Inflectra, Renflexis

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 every 8 weeks; may be increased to 10 mg/kg 

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

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

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

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

Dosage Modifications

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

Idiopathic Pulmonary Fibrosis (Orphan)

Treatment of idiopathic pulmonary fibrosis

Orphan indication sponsor

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

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

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

Biosimilars to Remicade

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

Crohn Disease

Remicade, Inflectra, Renflexis

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

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

Ulcerative Colitis

Remicade

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

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

Dosing Considerations

Children should be current with immunizations before starting infliximab

Do not administer live vaccines while patient is taking infliximab

Juvenile Rheumatoid Arthritis (Orphan)

Orphan indication sponsor

  • Centocor, Inc; 200 Great Valley Parkway; Malvern, PA 19355-1307
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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 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; rarely >3 times upper limit of normal)

            1-10% (selected)

            Bronchitis (10%)

            Dyspepsia (10%)

            Rash (1-10%)

            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%)

            Postmarketing Reports

            Anaphylacticlike reactions, including 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 and Merkel cell carcinoma

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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, candidiasis, aspergillosis, 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

            Caution in neurologic disorder

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

            History of malignancy

            Elderly

            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

            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

            Immunizations should be current before therapy is initiated

            Administration of live virus vaccines should be delayed or avoided while patient is taking infliximab

            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); see Black Box Warnings

            Enhanced safety surveillance requirements to capture malignancy data: Manufacturer is required to report all malignancies to FDA for complete and consistent analysis

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

            Consider discontinuance if lupuslike symptoms occur

            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

            Occurrence of leukemia and new-onset psoriasis is reported in patients treated with TNF blockers

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

            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

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

            Due to the risk of HSTCL, carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment

            Rare severe hepatic reactions reported; some fatal or necessitating liver transplantation; stop therapy in cases of jaundice and/or marked liver enzyme elevations

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Unknown whether drug is excreted in breast milk; discontinue drug, or do not nurse

            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: 7-12 days

            Excretion: Unknown

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            Administration

            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% sodium chloride injection, USP, by withdrawing a volume equal to volume of reconstituted infliximab from 0.9% sodium chloride injection, USP, 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; the resulting infusion concentration should range between 0.4 mg/mL and 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

            Storage

            Store vials at 2-8°C (36-46°F)

            Do not freeze

            Product does not contain preservative

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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