Formulary
Golimumab: Indications, Dosing, Side Effects and Interactions
Golimumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Golimumab: Indications, Dosing, Side Effects and Interactions
Golimumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Ulcerative colitis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): (body-weight 80 kg and above) Initially 200 mg, then 100 mg after 2 weeks; maintenance 100 mg every 4 weeks, review treatment if no response after 4 doses.
**Rheumatoid arthritis (initiated by a specialist),Psoriatic arthritis (initiated by a specialist),Ankylosing spondylitis (initiated by a specialist),Non-radiographic axial spondyloarthritis (initiated by a specialist)**
- **Adult** (By Subcutaneous Injection): (body-weight 100 kg and above) Initially 50 mg once a month for 3-4 doses, on the same date each month, dose may be increased if inadequate response, increased to 100 mg once a month, review treatment if inadequate response to this higher dose after 3-4 doses.
**Polyarticular juvenile idiopathic arthritis (initiated by a specialist) for golimumab**
- **Child (body-weight 40 kg and above)** (By subcutaneous injection): 50 mg once a month, on the same date each month, review treatment if no response after 3-4 doses.
Cautions
Active infection (do not initiate until active infections are controlled; discontinue if new serious infection develops until infection controlled); demyelinating disorders (risk of exacerbation); hepatitis B virus-monitor for active infection; history or development of malignancy; mild heart failure (discontinue if symptoms develop or worsen); predisposition to infection; risk factors for dysplasia or carcinoma of the colon-screen for dysplasia regularly Cautions, further information Tuberculosis Active tuberculosis should be treated with standard treatment for at least 2 months before starting golimumab. Patients who have previously received adequate treatment for tuberculosis can start golimumab 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 golimumab. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with golimumab. Patients who have tested negative for latent tuberculosis, and those who are receiving or who have completed treatment for latent tuberculosis, should be monitored closely for symptoms of active infection.
Contraindications
Moderate or severe heart failure; severe active infection
Side effects
Common or very common Abscess; alopecia; anaemia; asthenia; asthma; bone fracture; chest discomfort; depression; dizziness; fever; gastrointestinal discomfort; gastrointestinal disorders; gastrointestinal inflammatory disorders; headache; hypersensitivity; hypertension; increased risk of infection; insomnia; nausea; paraesthesia; respiratory disorders; skin reactions; stomatitis Uncommon Arrhythmia; balance impaired; bone marrow disorders; breast disorder; cholelithiasis; constipation; eye inflammation; eye irritation; flushing; goitre; hyperthyroidism; hypothyroidism; interstitial lung disease; leucopenia; liver disorder; menstrual disorder; myocardial ischaemia; neoplasms; sepsis; thrombocytopenia; thrombosis; thyroid disorder; vision disorders Rare or very rare Bladder disorder; congestive heart failure; demyelination; healing impaired; hepatitis B reactivation; lupus-like syndrome; Raynaud's phenomenon; renal disorder; sarcoidosis; taste altered; vasculitis Side-effects, further information Associated with infections, sometimes severe, including tuberculosis, septicaemia, and hepatitis B reactivation.
Interactions
**Other interactions (4):**
- Concurrent use with other biological therapeutics The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is...
- Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6).
- Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4).
- Methotrexate Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of...
Pregnancy
Use only if essential.
Breast feeding
Manufacturer advises avoid during and for at least 6 months after treatment-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution (no 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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