Moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE)

Active Ingredient: Anifrolumab

Indication for Anifrolumab

Population group: only adults (18 years old or older)
Therapeutic intent: Adjuvant - intent

Anifrolumab is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

For this indication, competent medicine agencies globally authorize below treatments:

300 mg once every 4 weeks

Route of admnistration

Intravenous

Defined daily dose

300 - 300 mg

Dosage regimen

From 300 To 300 mg once every 28 day(s)

Detailed description

The recommended dose is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.

In patients with a history of infusion-related reactions, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab (see section 4.4).

Missed dose

If a planned infusion is missed, treatment should be administered as soon as possible. A minimum interval of 14 days should be maintained between doses.

Dosage considerations

Anifrolumab must not be administered as an intravenous push or bolus injection.

Do not co-administer any other medicinal products through the same infusion line.

Active ingredient

Anifrolumab

Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biologic activity of type I IFNs. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T-cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in SLE.

Read more about Anifrolumab

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