Formulary
Adalimumab: Indications, Dosing, Side Effects and Interactions
Adalimumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 7 min read
Adalimumab: Indications, Dosing, Side Effects and Interactions
Adalimumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Plaque psoriasis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 80 mg, then 40 mg every 2 weeks, to be started 1 week after initial dose, review treatment if no response within 16 weeks-consult product literature.
**Rheumatoid arthritis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): 40 mg every 2 weeks, then increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, dose to be increased only in patients receiving adalimumab alone, review treatment if no response within 12 weeks.
**Psoriatic arthritis (initiated by a specialist),Ankylosing spondylitis (initiated by a specialist),Axial spondyloarthritis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): 40 mg every 2 weeks, review treatment if no response within 12 weeks.
**Crohn's disease (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 80 mg, then 40 mg after 2 weeks; maintenance 40 mg every 2 weeks, increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, review treatment if no response within 12 weeks.
**Crohn's disease (accelerated regimen) (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 160 mg, dose can alternatively be given as divided injections over 2 days, then 80 mg after 2 weeks; maintenance 40 mg every 2 weeks, increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, review treatment if no response within 12 weeks.
**Ulcerative colitis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 160 mg, dose can alternatively be given as divided injections over 2 days, then 80 mg after 2 weeks, then maintenance 40 mg every 2 weeks, increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, review treatment if no response within 8 weeks.
**Hidradenitis suppurativa (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 160 mg, dose can alternatively be given as divided injections over 2 days, followed by 80 mg after 2 weeks, then maintenance 40 mg once weekly, after 2 weeks, alternatively 80 mg every 2 weeks, after 2 weeks, review treatment if no response within 12 weeks; if treatment interrupted-consult product literature.
**Uveitis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): Initially 80 mg, then 40 mg after 1 week; maintenance 40 mg every 2 weeks.
**Plaque psoriasis (initiated by a specialist) for adalimumab**
- **Child 4-17 years (body-weight 15-29 kg)** (By subcutaneous injection): Initially 20 mg once weekly for 2 doses, then 20 mg every 2 weeks, review treatment if no response within 16 weeks.
- **Child 4-17 years (body-weight 30 kg and above)** (By subcutaneous injection): Initially 40 mg once weekly for 2 doses, then 40 mg every 2 weeks, review treatment if no response within 16 weeks.
**Polyarticular juvenile idiopathic arthritis (initiated by a specialist) for adalimumab**
- **Child 2-17 years (body-weight 10-29 kg)** (By subcutaneous injection): 20 mg every 2 weeks, review treatment if no response within 12 weeks.
- **Child 2-17 years (body-weight 30 kg and above)** (By subcutaneous injection): 40 mg every 2 weeks, review treatment if no response within 12 weeks.
**Enthesitis-related arthritis (initiated by a specialist) for adalimumab**
- **Child 6-17 years (body-weight 15-29 kg)** (By subcutaneous injection): 20 mg every 2 weeks.
- **Child 6-17 years (body-weight 30 kg and above)** (By subcutaneous injection): 40 mg every 2 weeks.
**Crohn's disease (initiated by a specialist) for adalimumab**
- **Child 6-17 years (body-weight up to 40 kg)** (By subcutaneous injection): Initially 40 mg, then 20 mg after 2 weeks; maintenance 20 mg every 2 weeks, increased if necessary to 20 mg once weekly, review treatment if no response within 12 weeks.
- **Child 6-17 years (body-weight 40 kg and above)** (By subcutaneous injection): Initially 80 mg, then 40 mg after 2 weeks; maintenance 40 mg every 2 weeks, increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, review treatment if no response within 12 weeks.
**Crohn's disease (accelerated regimen) (initiated by a specialist) for adalimumab**
- **Child 6-17 years (body-weight up to 40 kg)** (By subcutaneous injection): Initially 80 mg, then 40 mg after 2 weeks; maintenance 20 mg every 2 weeks, increased if necessary to 20 mg once weekly, review treatment if no response within 12 weeks.
- **Child 6-17 years (body-weight 40 kg and above)** (By subcutaneous injection): Initially 160 mg, dose can alternatively be given as divided injections over 2 days, then 80 mg after 2 weeks; maintenance 40 mg every 2 weeks, then increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, review treatment if no response within 12 weeks.
**Ulcerative colitis (initiated by a specialist) for adalimumab**
- **Child 6-17 years (body-weight up to 40 kg)** (By subcutaneous injection): Initially 80 mg, followed by 40 mg after 2 weeks, then maintenance 40 mg every 2 weeks, review treatment if no response within 8 weeks.
- **Child 6-17 years (body-weight 40 kg and above)** (By subcutaneous injection): Initially 160 mg, dose can alternatively be given as divided injections over 2 days, followed by 80 mg after 2 weeks, then maintenance 80 mg every 2 weeks, review treatment if no response within 8 weeks.
**Hidradenitis suppurativa (initiated by a specialist) for adalimumab**
- **Child 12-17 years (body-weight 30 kg and above)** (By subcutaneous injection): Initially 80 mg, followed by 40 mg after 1 week, then maintenance 40 mg every 2 weeks; increased if necessary to 40 mg once weekly, alternatively 80 mg every 2 weeks, review treatment if no response within 12 weeks; if treatment interrupted-consult product literature.
**Uveitis (initiated by a specialist) for adalimumab**
- **Child 2-17 years (body-weight up to 30 kg)** (By subcutaneous injection): Initially 40 mg, then 20 mg after 1 week; maintenance 20 mg every 2 weeks.
- **Child 2-17 years (body-weight 30 kg and above)** (By subcutaneous injection): Initially 80 mg, then 40 mg after 1 week; maintenance 40 mg every 2 weeks.
Cautions
Demyelinating disorders (risk of exacerbation); development of malignancy; do not initiate until active infections are controlled (discontinue if new serious infection develops); hepatitis B virus-monitor for active infection; history of malignancy; mild heart failure (discontinue if symptoms develop or worsen); predisposition to infection Cautions, further information Tuberculosis Active tuberculosis should be treated with standard treatment for at least 2 months before starting adalimumab. Patients who have previously received adequate treatment for tuberculosis can start adalimumab but should be monitored every 3 months for possible recurrence. In patients without active tuberculosis but who were previously not treated adequately, chemoprophylaxis should ideally be completed before starting adalimumab. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with adalimumab.
Contraindications
Moderate or severe heart failure; severe infections
Side effects
Common or very common Agranulocytosis; alopecia; anaemia; anxiety; arrhythmias; asthma; broken nails; chest pain; coagulation disorder; connective tissue disorders; cough; dehydration; depression; dyspnoea; electrolyte imbalance; eye inflammation; fever; flushing; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; headaches; healing impaired; hyperglycaemia; hypersensitivity; hypertension; increased risk of infection; insomnia; leucocytosis; leucopenia; mood altered; muscle spasms; musculoskeletal pain; nausea; neoplasms; nerve disorders; neutropenia; oedema; renal impairment; seasonal allergy; sensation abnormal; sepsis; skin reactions; sweat changes; thrombocytopenia; vertigo; vision disorders; vomiting Uncommon Aortic aneurysm; arterial occlusion; congestive heart failure; deafness; dysphagia; embolism and thrombosis; erectile dysfunction; gallbladder disorders; hepatic disorders; inflammation; interstitial lung disease; lupus erythematosus; meningitis viral; myocardial infarction; nocturia; pancreatitis; respiratory disorders; rhabdomyolysis; sarcoidosis; solid organ neoplasm; stroke; tinnitus; tremor; vasculitis Rare or very rare Bone marrow disorders; cardiac arrest; demyelinating disorders; pulmonary fibrosis; reactivation of infections; Stevens-Johnson syndrome Frequency not known Weight increased Side-effects, further information Associated with infections, sometimes severe, including tuberculosis, septicaemia, and hepatitis B reactivation.
Interactions
**Other interactions (5):**
- Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant...
- Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy.
- Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
- The combination of AMGEVITA and anakinra is not recommended (see section 4.4 "Concurrent administration of biologic DMARDs or TNF-antagonists").
- The combination of AMGEVITA and abatacept is not recommended (see section 4.4 "Concurrent administration of biologic DMARDs or TNF-antagonists").
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk.
Breast feeding
Manufacturer advises can be used-excreted in breast milk at very low concentrations (limited information available).
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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