Where do I find the current FDA-approved prescribing information (package insert) for Humira (adalimumab), and what does it cover?

Where to find it: The current FDA-approved prescribing information for Humira is AbbVie's own label on DailyMed (the NLM's repository of FDA labeling), set ID 608d4f0d-b19f-46d3-749a-7159aa5f933d. It is titled "HUMIRA (ADALIMUMAB) KIT [ABBVIE INC.]", has an effective date of 23 December 2025, and is marked "Revised: 12/2025" ^[1]. It is licensed under BLA 125057 (351(a), AbbVie Inc., US licence 1889, CDER), first approved 31 December 2002 ^[2].

Approach: I searched DailyMed's current labels for "Humira" and the FDA Purple Book (August 2026 edition) for BLA 125057. I compared the three Humira labels DailyMed returned by labeler, effective date and section list.

Which DailyMed label to use

What the current label covers (from AbbVie's label ^[1])

• Recent major change: Warnings and Precautions, Autoimmunity (5.9), dated 7/2025. It now tells prescribers to stop Humira if a lupus-like syndrome or autoimmune hepatitis develops. The 2021 relabeler version only mentions lupus-like syndrome ^[4].
• Boxed warning, serious infections: TB (including reactivation of latent TB), invasive fungal infections, and opportunistic bacterial and viral infections. Patients must be tested for latent TB before and during therapy.
• Boxed warning, malignancy: lymphoma in children and adolescents, and postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), mostly in young patients with inflammatory bowel disease who were also taking azathioprine or 6-MP.
• 1 Indications: Humira is a TNF blocker indicated for:
  • rheumatoid arthritis (adults)
  • polyarticular juvenile idiopathic arthritis (age 2 and up)
  • psoriatic arthritis and ankylosing spondylitis (adults)
  • Crohn's disease (adults and age 6 and up)
  • ulcerative colitis (adults and age 5 and up). The label notes it has not been shown to work in patients who lost response to, or could not tolerate, TNF blockers.
  • plaque psoriasis (adults)
  • hidradenitis suppurativa (age 12 and up)
  • non-infectious intermediate, posterior and panuveitis (age 2 and up)
• 2 Dosage and Administration: TB evaluation first (2.1), dosing for each indication (2.2 to 2.7), and general administration (2.8).
• 3 Dosage forms:
  • pen: 80 mg/0.8 mL, 40 mg/0.8 mL and 40 mg/0.4 mL
  • prefilled glass syringe: 80/0.8, 40/0.8, 40/0.4, 20/0.2 and 10/0.1 (mg/mL)
• 4 Contraindications: none.
• 5 Warnings and Precautions (5.1 to 5.11):
  • serious infections and malignancies
  • hypersensitivity
  • hepatitis B reactivation
  • neurologic reactions (demyelination)
  • cytopenias
  • heart failure
  • autoimmunity
  • immunizations
  • higher infection risk when combined with anakinra or abatacept
• Remaining sections:
  • 6 Adverse reactions, including immunogenicity and postmarketing experience
  • 7 Drug interactions: methotrexate, other biologics, live vaccines and CYP450 substrates
  • 8 Specific populations: pregnancy, lactation, children and older adults
  • 10 to 13: overdosage, description, clinical pharmacology and nonclinical toxicology
  • 14 Clinical studies, sections 14.1 to 14.12 covering every indication
  • 15 References, 16 How supplied/storage, 17 Patient counseling
  • the Instructions for Use for each device are at the end of the document

Licensed presentations (Purple Book):

• Still marketed (Rx): products 001, 002, 006 to 011 ^{[2][5][6][7][8][9][10][11]}
• Discontinued: the 40 mg/0.8 mL vial (004) and the 20 mg/0.4 mL and 10 mg/0.2 mL syringes (003, 005) ^[12][13][14]
• Orphan exclusivity: expires 24 February 2028 ^[5]

I can pull the full text of any section next, for example the Section 2 dosing for each indication or the 5.9 autoimmunity wording.