• Moderately to severely active rheumatoid arthritis (in combination with methotrexate).
• Moderately to severely active Crohn's disease in patients with an inadequate response to conventional therapy.
• Active psoriatic arthritis.
• Active ankylosing spondylitis.
• Moderately to severely active ulcerative colitis in patients with an inadequate response to conventional therapy.
• Chronic severe plaque psoriasis in patients who are candidates for systemic therapy and when other systemic therapies are less appropriate.

Contraindicated in:

• Hypersensitivity to infliximab, murine (mouse) proteins, or other components in the formulation
• Moderate to severe HF (doses >5 mg/kg)
• Concurrent anakinra or abatacept.

Use Cautiously in:

• History of chronic or recurrent infection or underlying illness/treatment predisposing to infection
• Patients being retreated after 2 yr without treatment (↑ risk of adverse reactions)
• History of tuberculosis or exposure (latent tuberculosis should be treated prior to infliximab therapy)
• History of opportunistic infection
• Moderate to severe HF (doses ≤5 mg/kg)
• Patients residing, or who have resided, where tuberculosis, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic
• Chronic obstructive pulmonary disease (↑ risk of malignancy)
• OB: Use only if potential maternal benefit justifies potential fetal risk; infants exposed in utero may be at ↑ risk for infection or agranulocytosis
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <6 yr (safety not established); ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL] in patients with Crohn's disease or ulcerative colitis), leukemia, and other malignancies
• Geri: ↑ risk of adverse reactions, including serious infections, in older adults.

CV: ARRHYTHMIAS, chest pain, edema, HF, hypertension, hypotension, MYOCARDIAL ISCHEMIA/INFARCTION, pericardial effusion, tachycardia, vasculitis.

Derm: acne, ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS (AGEP), alopecia, dry skin, ecchymosis, eczema, erythema, flushing, hematoma, hot flushing, pruritus, psoriasis, rash, STEVENS-JOHNSON SYNDROME, sweating, TOXIC EPIDERMAL NECROLYSIS, urticaria.

EENT: conjunctivitis, vision loss.

GI: abdominal pain, nausea, vomiting, constipation, diarrhea, dyspepsia, flatulence, hepatotoxicity, intestinal obstruction, oral pain, tooth pain, ulcerative stomatitis.

GU: dysuria, urinary frequency, urinary tract infection.

Hemat: neutropenia.

MS: arthralgia, arthritis, back pain, involuntary muscle contractions, myalgia.

Neuro: fatigue, headache, anxiety, depression, dizziness, insomnia, paresthesia, STROKE.

Resp: upper respiratory tract infection, bronchitis, cough, dyspnea, laryngitis, pharyngitis, respiratory tract allergic reaction, rhinitis, sinusitis.

Misc: fever, infusion reactions, chills, flu-like syndrome, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION (INCLUDING REACTIVATION TUBERCULOSIS AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, INVASIVE FUNGAL, VIRAL, MYCOBACTERIAL, AND PARASITIC PATHOGENS), lupus-like syndrome, MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, SKIN CANCER, AND CERVICAL CANCER), pain, SARCOIDOSIS.

Drug-Drug:

• Concurrent use with anakinra or abatacept ↑ risk of serious infections (not recommended).
• Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
• Use of live virus vaccines or therapeutic infectious agents may ↑ risk of infection; avoid concurrent use; wait for ≥6 mo before administering any live vaccines to infants exposed in utero.

(Generic available)

• Lyophilized powder for injection: 100 mg/vial;

Rheumatoid Arthritis

• IV (Adults): 3 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then repeat every 8 wk; dose may be adjusted in partial responders up to 10 mg/kg or treatment as often as every 4 wk (to be used with methotrexate).

Crohn's Disease

• IV (Adults): 5 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then maintenance dose of 5 mg/kg every 8 wk; dose may be adjusted up to 10 mg/kg in patients who initially respond and then lose their response.
• IV (Children): 5 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then maintenance dose of 5 mg/kg every 8 wk.

Ankylosing Spondylitis

• IV (Adults): 5 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then maintenance dose of 5 mg/kg every 6 wk.

Psoriatic Arthritis

• IV (Adults): 5 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then maintenance dose of 5 mg/kg every 8 wk (to be used with or without methotrexate).

Ulcerative Colitis

• IV (Adults and Children ≥6 yr): 5 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then maintenance dose of 5 mg/kg every 8 wk.

Plaque Psoriasis

• IV (Adults): 5 mg/kg initially, then repeat at 2 and 6 wk after initial infusion, then maintenance dose of 5 mg/kg every 8 wk.

Avsola, Inflectra, Remicade, Renflexis

• Neutralizes and prevents the activity of tumor necrosis factor-alpha (TNF-alpha), resulting in anti-inflammatory and antiproliferative activity.

• Decreased signs and symptoms, decreased rate of joint destruction, and improved physical function in rheumatoid arthritis and psoriatic arthritis.
• Decreased signs and symptoms and induction and maintenance of clinical remission in Crohn's disease.
• Reduction in number of fistulas and maintenance of closure of fistulae in Crohn's disease.
• Decreased signs and symptoms in ankylosing spondylitis.
• Decreased signs and symptoms, maintenance of clinical remission and mucosal healing, and eliminating corticosteroid use in ulcerative colitis.
• Decreased induration, scaling, and erythema of psoriatic lesions.

Therapeutic Classification: antirheumatics (DMARDs), gastrointestinal anti-inflammatories

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Predominantly distributed within the vascular compartment.

Metabolism/Excretion: Unknown.

Half-life: 9.5 days.

Remsima

(symptoms of Crohn’s disease)

†After infusion.

• Explain purpose of infliximab to patient.
• Advise patient that adverse reactions (myalgia, rash, fever, polyarthralgia, pruritus) may occur 3–12 days after delayed (>2 yr) retreatment with infliximab. Symptoms usually decrease or resolve within 1–3 days. Instruct patient to notify health care professional if symptoms occur.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to notify health care professional promptly if symptoms of fungal infection occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient of risk of malignancies such as hepatosplenic T-cell lymphoma. Instruct patient to report signs and symptoms (splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) to health care professional promptly.
• Advise patient to examine skin periodically during therapy and notify health care professional of any changes in appearance of skin or growths on skin.
• Instruct patient not to receive live vaccines during therapy.
• Advise females to continue regular PAP smears for cervical cancer screening.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and or if breast feeding. Infants exposed to infliximab in utero should wait at least 6 mo before receiving any live vaccine; may be at increased risk of infection.

in-FLIX-i-mab

NDC Code^*

• 0006- Merck Sharp and Dohme Corp.
  • 0006-4305- Renflexis
    • 0006-4305-02- 1 VIAL in 1 CARTON (0006-4305-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0006-4305-01)

• 57894- Janssen Biotech, Inc.
  • 57894-030- REMICADE
    • 57894-030-01- 10 VIAL, SINGLE-USE in 1 BOX (57894-030-01) > 10 mL in 1 VIAL, SINGLE-USE