For clinicians · Medication guide

Anifrolumab

Saphnelo, anti-IFNAR1, type I interferon receptor antagonist

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Bottom lineType I interferon receptor (IFNAR1) antagonist for active, autoantibody-positive SLE, added to standard therapy.

Dosing and administration

For active, autoantibody-positive SLE as add-on to standard therapy. Available intravenously and subcutaneously. Not recommended in severe active lupus nephritis or severe active CNS lupus, or in combination with other biologics.

IndicationStarting doseTitration and maximum
Systemic lupus erythematosus (IV)300 mg IV infusion over 30 minutes, every 4 weeks.Continue as maintenance; reassess response.
Systemic lupus erythematosus (subcutaneous)120 mg subcutaneously once weekly.Continue as maintenance; reassess response.

Clinical notes

How it is used in lupus

An IFNAR1 antagonist added to standard therapy in active, autoantibody-positive SLE to reduce disease activity and flares. Not recommended in severe active lupus nephritis or severe active CNS lupus, and not for use with other biologics.[1]

Common side effects

Common: upper respiratory tract infection, bronchitis, herpes zoster (6.1% vs 1.3% placebo), oral herpes, and infusion-related reactions (9.4%).[1]

Before starting

Do not initiate with a clinically significant active infection until it resolves. Complete age-appropriate immunizations before starting and avoid live or attenuated vaccines during treatment. Use caution with chronic or recurrent infection or infection risk factors.[1]

Monitoring

Monitor for infections (including herpes zoster) and for hypersensitivity or infusion-related reactions. The effect on malignancy risk for an immunomodulator of this class is not established.[1]

+Reproductive health. Pregnancy, breastfeeding, and paternal guidance for this agent is maintained on the same record and is verified separately.

References

  1. SAPHNELO (anifrolumab) Product Monograph. AstraZeneca Canada Inc. Health Canada; 2026-03-05. https://pdf.hres.ca/dpd_pm/00083796.PDF