Formulary
Infliximab: Indications, Dosing, Side Effects and Interactions
Infliximab clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 7 min read
Infliximab: Indications, Dosing, Side Effects and Interactions
Infliximab clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Active Crohn's disease (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, then (by intravenous infusion) 5 mg/kg after 2 weeks, then (by intravenous infusion) 5 mg/kg, may be taken at 6 weeks after initial dose if condition has responded; discontinue if no response within 6 weeks of initial infusion (after 2 doses), followed by (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the last intravenous infusion if a response has been seen. Maintenance treatment can be restarted after a drug-free interval if symptoms recur within 16 weeks of the last dose-consult product literature.
**Fistulating Crohn's disease (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, followed by (by intravenous infusion) 5 mg/kg after 2 weeks, then (by intravenous infusion) 5 mg/kg, may be taken at 6 weeks after initial dose, then (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the last intravenous infusion if a response has been seen. Discontinue if no response within 14 weeks of the initial infusion. Maintenance treatment can be restarted after a drug-free interval if symptoms recur within 16 weeks of the last dose-consult product literature.
**Active ulcerative colitis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, then (by intravenous infusion) 5 mg/kg after 2 weeks, then (by intravenous infusion) 5 mg/kg, may be taken at 6 weeks after initial dose, followed by (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the last intravenous infusion. Consider discontinuation if no response within 14 weeks.
**Rheumatoid arthritis (in combination with methotrexate) (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 3 mg/kg, then (by intravenous infusion) 3 mg/kg after 2 weeks; (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the second of the initial intravenous infusions. Consider discontinuation if no response within 12 weeks of the initial infusion. Treatment can be restarted after a drug-free interval if symptoms recur within 16 weeks of the last dose-consult product literature.
**Ankylosing spondylitis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, followed by (by intravenous infusion) 5 mg/kg after 2 weeks; (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the second of the initial intravenous infusions. Discontinue if no response within 6 weeks of the initial infusion (after 2 doses).
**Psoriatic arthritis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, followed by (by intravenous infusion) 5 mg/kg after 2 weeks; (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the second of the initial intravenous infusions.
**Plaque psoriasis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 5 mg/kg, followed by (by intravenous infusion) 5 mg/kg after 2 weeks; (by subcutaneous injection) maintenance 120 mg every 2 weeks, subcutaneous maintenance dosing to be started 4 weeks after the second of the initial intravenous infusions. Discontinue if no response after 14 weeks of the initial infusion (after 7 doses in total).
**Active Crohn's disease (under expert supervision) for infliximab**
- **Child 6-17 years** (By intravenous infusion): Initially 5 mg/kg, then 5 mg/kg, to be taken at week 2 and 6 after initial dose, then maintenance 5 mg/kg every 8 weeks, interval between maintenance doses adjusted according to response; discontinue if no response within 10 weeks of initial infusion (after 3 doses).
**Fistulating Crohn's disease (under expert supervision) for infliximab**
- **Child 6-17 years** (By intravenous infusion): Initially 5 mg/kg, then 5 mg/kg after 2 weeks, followed by 5 mg/kg after 4 weeks, if condition has responded consult product literature for guidance on further doses.
**Active ulcerative colitis (under expert supervision) for infliximab**
- **Child 6-17 years** (By intravenous infusion): Initially 5 mg/kg, then 5 mg/kg, to be taken at week 2 and 6 after initial dose, then 5 mg/kg every 8 weeks, discontinue if no response within 8 weeks of initial infusion (after 3 doses).
Cautions
Demyelinating disorders (risk of exacerbation); dermatomyositis; development of malignancy; hepatitis B virus-monitor for active infection; history of colon carcinoma (in inflammatory bowel disease); history of dysplasia (in inflammatory bowel disease); history of malignancy; history of prolonged immunosuppressant or PUVA treatment in patients with psoriasis; mild heart failure (discontinue if symptoms develop or worsen); predisposition to infection (discontinue if new serious infection develops); risk of delayed hypersensitivity reactions if drug-free interval exceeds 16 weeks (re-administration after interval exceeding 16 weeks not recommended) Cautions, further information Infection Manufacturer advises patients should be up-to-date with current immunisation schedule before initiating treatment. Tuberculosis Manufacturer advises to evaluate patients for active and latent tuberculosis before treatment. Active tuberculosis should be treated with standard treatment for at least 2 months before starting infliximab. If latent tuberculosis is diagnosed, treatment should be started before commencing treatment with infliximab. Patients who have previously received adequate treatment for tuberculosis can start infliximab 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 infliximab. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with infliximab. Patients should be advised to seek medical attention if symptoms suggestive of tuberculosis develop (e.g. persistent cough, weight loss and fever). Hypersensitivity reactions Hypersensitivity reactions (including fever, chest pain, hypotension, hypertension, dyspnoea, transient visual loss, pruritus, urticaria, serum sickness-like reactions, angioedema, anaphylaxis) reported during or within 1-2 hours after infusion (risk greatest during first or second infusion or in patients who discontinue other immunosuppressants). Manufacturer advises prophylactic antipyretics, antihistamines, or hydrocortisone may be administered.
Contraindications
Moderate or severe heart failure; severe infections
Side effects
Common or very common With parenteral use Abscess; alopecia; anaemia; arrhythmias; arthralgia; chest pain; chills; constipation; decreased leucocytes; depression; diarrhoea; dizziness; dyspnoea; eye inflammation; fatigue; fever; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; headache; hepatic disorders; hyperhidrosis; hypertension; hypotension; increased risk of infection; infusion related reaction; insomnia; lymphadenopathy; myalgia; nausea; neutropenia; oedema; pain; palpitations; respiratory disorders; sensation abnormal; sepsis; skin reactions; vasodilation; vertigo Uncommon With parenteral use Anxiety; cheilitis; cholecystitis; confusion; drowsiness; healing impaired; heart failure; hypersensitivity; lupus erythematosus; lymphocytosis; memory loss; neoplasms; nerve disorders; pancreatitis; peripheral ischaemia; pulmonary oedema; seborrhoea; seizure; syncope; thrombocytopenia; thrombophlebitis Rare or very rare With parenteral use Agranulocytosis; circulatory collapse; cyanosis; demyelinating disorders; granuloma; haemolytic anaemia; hepatitis B reactivation; interstitial lung disease; meningitis; pancytopenia; pericardial effusion; pulmonary fibrosis; sarcoid-like reaction; severe cutaneous adverse reactions (SCARs); transverse myelitis; vasculitis; vasospasm Frequency not known With parenteral use Dermatomyositis exacerbated; hepatosplenic T-cell lymphoma (increased risk in inflammatory bowel disease); myocardial infarction; myocardial ischaemia; sarcoidosis; stroke; vision loss
Interactions
**Other interactions (9):**
- In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies...
- However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
- Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
- The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
- It is recommended that live vaccines not be given concurrently with infliximab.
- It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for 12 months following birth.
Pregnancy
Use only if essential.
Breast feeding
Specialist sources indicate amount present in milk probably too small to be harmful.
Medicinal forms
Solution,Solution
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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