Adalimumab

Humira treats adult moderately/severely active rheumatoid arthritis, adult active psoriatic arthritis and ankylosing spondylitis, adult moderate/severe chronic plaque psoriasis when systemic therapy/phototherapy is appropriate and other systemic therapies are less appropriate, and noninfectious intermediate/posterior/panuveitis from age 2. It also treats polyarticular JIA from age 2, moderate/severe Crohn’s disease from age 6, ulcerative colitis from age 5, and hidradenitis suppurativa (HS) from age 12. Ulcerative-colitis effectiveness after loss of response or intolerance to TNF blockers is not established.

Humira is the reference biologic. FDA’s current Purple Book distinguishes adalimumab biosimilars from designated interchangeable products by product and presentation; a shared core name does not establish identical approved indications, concentrations or devices. Pharmacy substitution for an interchangeable product is subject to state law. This profile supplies Humira regimens only; verify the full prescribed biosimilar label and current record before switching.

RA/PsA/AS: 40 mg every other week. In RA without concomitant methotrexate, selected patients may benefit from 40 mg weekly or 80 mg every other week. Adult plaque psoriasis or uveitis: 80 mg initially, then 40 mg every other week beginning 1 week later. Do not transfer the RA escalation option to every indication.

Crohn’s disease or ulcerative colitis: 160 mg on day 1 (in one day or split over two consecutive days), 80 mg on day 15, then 40 mg every other week from day 29. Discontinue adult UC treatment without clinical remission by week 8 (day 57). Adult HS uses the same 160/80-mg loading schedule, then 40 mg weekly or 80 mg every other week from day 29.

From age 2, every-other-week dosing is weight-based: 10–<15 kg, 10 mg; 15–<30 kg, 20 mg; ≥30 kg, 40 mg. These uses were not studied below age 2 or below 10 kg. Select a presentation that delivers the full prescribed dose; do not split a single-dose pen or syringe.

Use the disease-specific loading and maintenance schedules below; UC includes an additional day-8 dose and higher maintenance exposure than Crohn’s disease. No dose below these weight bands is inferred. Continue the pediatric UC regimen in a well-controlled patient who turns 18, as directed by the label.

From age 12 and ≥30 kg: 30–<60 kg receives 80 mg on day 1, then 40 mg every other week beginning day 8. At ≥60 kg, use 160 mg on day 1, 80 mg on day 15, then 40 mg weekly or 80 mg every other week from day 29. Where a 160-mg day-1 dose is specified, it may be split over two consecutive days. Do not extrapolate to children under 12 or under 30 kg.

Train the patient/caregiver and supervise the first injection. Let the capped device reach room temperature for 15–30 minutes; do not actively heat it. Inspect the clear colorless solution and do not use discolored or particulate product. Inject the full device into a separate thigh/abdominal site, rotating sites and avoiding tender, bruised, red or hard skin. For a missed dose, give it as soon as possible, then resume the regular schedule. Discard unused portions and used devices safely.

The current Humira label lists no formal contraindications. This does not permit use during active infection or disregard serious hypersensitivity, live-vaccine avoidance and other warnings; those restrictions appear in warnings/interactions rather than a formal contraindication list.

The box warns of infections leading to hospitalization or death, including tuberculosis, invasive fungal infection, sepsis and opportunistic infection. It also warns of lymphoma and other sometimes-fatal malignancies in children/adolescents and hepatosplenic T-cell lymphoma, often in adolescent/young adult males with IBD and prior/concurrent azathioprine or 6-mercaptopurine. Causation by TNF blockade alone versus combination immunosuppression is uncertain; explicitly review that combination’s risks.

Common trial effects include injection-site reactions, infections such as upper respiratory infection/sinusitis, headache and rash. Serious effects are described above; postmarketing reports include severe skin reactions and hepatic injury, without reliable frequency estimates. Antidrug antibodies can affect exposure or response. Excess dosing warrants monitoring and immediate symptomatic treatment with poison-center/toxicology consultation as appropriate; high doses administered in trials do not establish a safe overdose threshold.

Do not routinely combine with other biologic DMARDs or other TNF blockers; anakinra/abatacept combinations increase serious infection without added RA benefit and are not recommended. Prior rituximab followed by TNF blockade also showed increased infection risk. Methotrexate reduces adalimumab clearance but label data do not require adjustment of either drug solely for that interaction. Thiopurine combinations need malignancy-risk review. Avoid live vaccines during treatment; bring pediatric immunizations up to date beforehand if possible.

Suppressing inflammatory cytokines may normalize CYP enzyme formation and change exposure to narrow-therapeutic-index substrates. When starting or stopping Humira, monitor warfarin effect or concentrations of medicines such as cyclosporine/theophylline and adjust individually. This is not a fixed CYP inhibitor dose-reduction rule.

Available pregnancy studies do not reliably establish an association with major birth defects; disease activity itself can worsen pregnancy outcomes. Placental transfer increases late in pregnancy and may affect the exposed infant’s immune response. Coordinate infant live-vaccine decisions with the pediatric team; the label does not supply a universal waiting interval. Limited milk reports suggest low infant systemic exposure, with no reported adverse infant or milk-production effects, but local gastrointestinal effects remain unknown. Balance maternal need and breastfeeding benefits.

Use only the indication/age/weight regimens above. Pediatric PsA, AS and plaque-psoriasis safety/effectiveness are not established in this U.S. label. In older adults, serious infection and malignancy were more frequent; assess benefits/risks and monitor closely rather than applying an automatic age-based dose change.

The label provides no pharmacokinetic data in renal or hepatic impairment and no numeric adjustment algorithm. Individualize clinical assessment and concomitant-drug management; lack of a required label adjustment is not evidence that every severe-impairment population has been studied. Monitor HBV, autoimmune hepatitis and other hepatic complications when relevant.

Adalimumab binds TNF-alpha and blocks its interaction with p55/p75 receptors, modifying inflammatory pathways. It does not neutralize TNF-beta. TNF blockade explains both therapeutic benefit and impaired host defense; it is not an antimicrobial treatment.

The mean terminal half-life is approximately 2 weeks (range 10–20 days). Single-dose subcutaneous bioavailability is about 64%. Methotrexate and antidrug antibodies can alter clearance; assay-dependent antibody rates should not be used to rank different adalimumab products. Label IV pharmacokinetic studies do not make Humira approved for IV administration.

Assess TB before and periodically during treatment and infection symptoms during/after exposure; evaluate HBV risk and monitor carriers. Review skin cancer, heart failure, neurologic symptoms, cytopenia symptoms and liver/autoimmune findings. Arrange indication-specific response follow-up, including the adult UC week-8 remission decision. The label gives no universal monthly CBC/LFT interval; select testing according to clinical risks and concomitant therapy.

Report fever, persistent cough, weight loss, new infection, bruising/bleeding, neurologic change, swelling or breathlessness promptly. Seek immediate care for serious allergy. Discuss vaccines and pregnancy exposure with the clinical team. Read the Medication Guide and the exact device instructions, record scheduled doses, and dispose of used pens/syringes in an appropriate sharps container. Confirm brand/suffix, strength, concentration and device after a biosimilar switch.

Humira 40 mg/0.4 mL two-pen carton is NDC 0074-0554-02; its black needle cover is not made with natural rubber latex. The 40 mg/0.8 mL two-pen carton is NDC 0074-4339-02 and its needle cover may contain natural rubber latex. The higher-concentration 40/0.4 and 80/0.8 products are citrate-free in this label, while 40/0.8 contains citrate. Biosimilar devices/excipients must be checked separately.

Current Humira pens: 40 mg/0.8 mL, 40 mg/0.4 mL and 80 mg/0.8 mL. Current prefilled syringes: those three strengths plus 20 mg/0.2 mL and 10 mg/0.1 mL. These are single-dose subcutaneous devices, with indication-specific starter packs. Older 20/0.4 and 10/0.2 presentations and biosimilar vials/pens are not included in the selected current Humira forms list.

Refrigerate at 2–8°C in the original carton protected from light. Do not freeze or use a previously frozen device, even after thawing. If needed, Humira may be kept at up to 25°C for up to 14 days protected from light; record first removal and discard if unused within that period. Avoid extreme heat/cold and do not extend this interval by assuming re-refrigeration restarts it. A biosimilar’s room-temperature allowance may differ.