Adalimumab
HUMIRA
What it isTNF-alpha blocking monoclonal antibody; rheumatoid arthritis, psoriasis, inflammatory bowel disease, and uveitis.
Why this oneIts unusually broad indication set spans joints, skin, bowel, and eye disease; biosimilars have transformed access.
What limits itScreen for latent tuberculosis and hepatitis B before starting; serious infection and anti-drug antibodies can end treatment.
FDA-approved for
- rheumatoid arthritis (2002)
- psoriasis, Crohn disease, ulcerative colitis
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Rheumatoid arthritis / psoriatic arthritis / ankylosing spondylitis | Adult | 40 mg SC every other week | 40 mg every other week (RA without MTX may increase to 40 mg weekly or 80 mg EOW) | |
| Polyarticular JIA (≥2 yr), weight-based | Pediatric | 10–<15 kg: 10 mg EOW | 15–<30 kg: 20 mg EOW; ≥30 kg: 40 mg EOW | |
| Crohn's disease | Adult | 160 mg Day 1 (may split over 2 days), 80 mg Day 15 | 40 mg every other week starting Day 29 | |
| Crohn's disease (≥6 yr), weight-based | Pediatric | 17–<40 kg: 80 mg D1, 40 mg D15 → 20 mg EOW | ≥40 kg: 160 mg D1, 80 mg D15 → 40 mg EOW | |
| Ulcerative colitis | Adult | 160 mg Day 1, 80 mg Day 15 | 40 mg every other week from Day 29; d/c if no remission by wk 8 | |
| Plaque psoriasis / adult uveitis | Adult | 80 mg initial | 40 mg every other week starting 1 week after initial dose | |
| Hidradenitis suppurativa | Adult | 160 mg Day 1, 80 mg Day 15 | 40 mg weekly or 80 mg EOW from Day 29 |
Renal Undefined
Hepatic Undefined
Instructions
- Subcutaneous injection into thigh or abdomen; rotate sites; avoid tender/bruised/hard skin.
- May self-inject after training; let device reach room temperature 15–30 min before (keep cap on).
- Inspect for particulates/discoloration and discard if present; no preservative — discard unused portion.
- Evaluate for active TB and test for latent TB before and periodically during therapy.
- If a dose is missed, give as soon as possible, then resume the regular schedule.
Cautions
- Serious infections (TB, invasive fungal, opportunistic) — do not start during active infection; discontinue if serious infection/sepsis develops.
- Concomitant anakinra or abatacept not recommended — higher risk of serious infections with TNF-blocker combination.
- Malignancies — lymphoma (incl. hepatosplenic T-cell lymphoma), leukemia, non-melanoma skin cancer.
- Anaphylaxis / serious hypersensitivity reactions.
- Hepatitis B reactivation — monitor carriers during and after therapy.
- Demyelinating disease (new onset or exacerbation).
- Cytopenias/pancytopenia.
- New or worsening heart failure.
- Autoimmunity — stop if lupus-like syndrome or autoimmune hepatitis develops.
Adverse reactions
- Infections (upper respiratory, sinusitis)
- Injection-site reactions (erythema, itching, pain, swelling)
- Headache, rash
- Nausea, abdominal pain
- Elevated lipids, hematuria, UTI, hypertension
- ALT elevations
Pregnancy Registry data do not reliably establish a birth-defect association; actively crosses placenta in the 3rd trimester and may affect infant immune response (consider before live/live-attenuated infant vaccines).
Lactation Present in human milk at low levels (0.1–1% of maternal serum); infant systemic exposure expected to be low (large molecule, degraded in GI tract).
⚠ BOXED WARNINGS
- Serious infections
- Malignancy
Cost, est. cash$1,000–$15,000+/month
Generic entry2039 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: Adalimumab ballicule
Open Adalimumab in the interactive console ↗
Memory aids: mascots and interaction avatars
