Formulary
Sarilumab: Indications, Dosing, Side Effects and Interactions
Sarilumab is a recombinant human monoclonal antibody that specifically binds to interleukin-6 receptors and blocks the activity of pro-inflammatory cytokines.
MedNext Academy | 3 min read
Sarilumab: Indications, Dosing, Side Effects and Interactions
Sarilumab is a recombinant human monoclonal antibody that specifically binds to interleukin-6 receptors and blocks the activity of pro-inflammatory cytokines.
Drug action
Sarilumab is a recombinant human monoclonal antibody that specifically binds to interleukin-6 receptors and blocks the activity of pro-inflammatory cytokines.
Indications and dose
**Moderate-to-severe active rheumatoid arthritis in patients who have had an inadequate response to, or are intolerant to one or more disease-modifying anti-rheumatic drugs (as monotherapy or in combination with methotrexate) (specialist use only)**
- **Adult** (By Subcutaneous Injection): 200 mg every 2 weeks, for dose adjustments due to neutropenia, thrombocytopenia, or liver enzyme elevations-consult product literature.
Cautions
Chronic or recurrent infection; elderly (increased risk of infection); history of diverticulitis; history of intestinal ulceration; history of serious or opportunistic infection; predisposition to infection Cautions, further information Infection Manufacturer advises caution in patients who have been exposed to tuberculosis, or who have lived in or travelled to areas of endemic tuberculosis or mycoses. Patients with latent tuberculosis should complete anti-tuberculosis therapy before initiation of sarilumab; consider anti-tuberculosis therapy before initiation of sarilumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for those with a negative test for latent tuberculosis but have risk factors for tuberculosis-consultation with a tuberculosis specialist may be appropriate. Manufacturer advises patients should be brought up-to-date with current immunisation schedule before initiating treatment.
Contraindications
Do not initiate if absolute neutrophil count less than 2 x 10 9 /litre; do not initiate if platelet count less than 150 x 10 3 /microlitre; do not initiate if serum transaminases (ALT or AST) greater than 1.5 times the upper limit of normal; severe active infection
Side effects
Common or very common Dyslipidaemia; increased risk of infection; leucopenia; neutropenia; thrombocytopenia Rare or very rare Gastrointestinal perforation Frequency not known Hypersensitivity (discontinue); skin reactions
Interactions
**Other interactions (7):**
- Sarilumab exposure was not affected when co-administered with MTX based on the population pharmacokinetic analyses and across study comparisons.
- Sarilumab has not been investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as tumour necrosis factor (TNF) antagonists.
- Blockade of IL-6 signalling by IL-6R antagonists such as sarilumab might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered medicinal products concentrations.
- The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted.
- Upon initiation or discontinuation of sarilumab in patients being treated with CYP substrate medicinal products, therapeutic monitoring of effect (e.g., warfarin) or concentration of the medicinal...
- Caution should be exercised in patients who start sarilumab treatment while on therapy with CYP3A4 substrates (e.g., oral contraceptives or statins), as sarilumab may reverse the inhibitory effect...
Pregnancy
Manufacturer advises avoid unless essential-limited information available.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises avoid (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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