Infliximab
REMICADE
What it isTNF-alpha blocking chimeric antibody; inflammatory bowel disease, rheumatoid arthritis and psoriasis.
Why this oneIntravenous dosing allows weight-based escalation, which matters in severe or refractory bowel disease.
What limits itScreen for tuberculosis and hepatitis B. Infusion reactions and anti-drug antibodies, reduced by concomitant immunomodulator.
FDA-approved for
- Crohn disease (1998)
- rheumatoid arthritis, ulcerative colitis, psoriasis, ankylosing spondylitis
Off-label
- refractory sarcoidosis
- Behcet disease
- hidradenitis suppurativa
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Crohn's disease | Adults | 5 mg/kg IV at 0, 2, 6 wk | 5 mg/kg q8wk | 10 mg/kg q8wk |
| Crohn's disease | Pediatrics ≥6 yr | 5 mg/kg IV at 0, 2, 6 wk | 5 mg/kg q8wk | |
| Ulcerative colitis | Adults | 5 mg/kg at 0, 2, 6 wk | 5 mg/kg q8wk | |
| Ulcerative colitis | Pediatrics ≥6 yr | 5 mg/kg at 0, 2, 6 wk | 5 mg/kg q8wk | |
| Rheumatoid arthritis (with methotrexate) | Adults | 3 mg/kg at 0, 2, 6 wk | 3 mg/kg q8wk | 10 mg/kg q8wk or q4wk |
| Ankylosing spondylitis | Adults | 5 mg/kg at 0, 2, 6 wk | 5 mg/kg q6wk | |
| Psoriatic arthritis | Adults | 5 mg/kg at 0, 2, 6 wk | 5 mg/kg q8wk | |
| Plaque psoriasis | Adults | 5 mg/kg at 0, 2, 6 wk | 5 mg/kg q8wk |
Renal Undefined
Hepatic Undefined
Reconstituted infusion must begin within 3 h; doses >5 mg/kg contraindicated in moderate/severe heart failure
Instructions
- IV infusion over at least 2 h with an in-line filter
- Premedicate as needed (antihistamines, acetaminophen, corticosteroids); slow/stop infusion for reactions
- Test for latent TB before and during therapy; test for HBV
- Bring vaccinations up to date; no live vaccines; wait ≥6 mo before live vaccines in in-utero-exposed infants
Contraindications
- Doses >5 mg/kg in patients with moderate or severe (NYHA III/IV) heart failure
Cautions
- Serious infections (TB, invasive fungal, opportunistic)
- Malignancies — lymphoma, hepatosplenic T-cell lymphoma
- Hepatitis B reactivation
- Hepatotoxicity
- New/worsening heart failure
- Cytopenias
- Hypersensitivity/infusion reactions
- CV and cerebrovascular reactions during infusion
- Demyelinating disease
- Lupus-like syndrome
- Live vaccines contraindicated during therapy
Adverse reactions
- Infections (upper respiratory, sinusitis, pharyngitis)
- Infusion-related reactions
- Headache
- Abdominal pain
Pregnancy No increased major-malformation risk observed; crosses placenta in 3rd trimester — delay live vaccines in infant ≥6 mo
Lactation Present at low levels in milk; systemic infant exposure expected low
⚠ BOXED WARNINGS
- Serious infections
- Malignancy
Cost, est. cash$1,000–$15,000+/month
Generic entry2035 est. (biosimilar)
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilitySerious infection, cytopenias, hepatic injury and malignancy risk require laboratory and clinical monitoring.
Mechanism of action: Infliximab ballicule
Open Infliximab in the interactive console ↗
Memory aids: mascots and interaction avatars
