Main indications in lupus

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

Dosage

The recommended dose of Anifrolumab is 300 mg, administered by intravenous infusion lasting 30 minutes every 4 weeks.

Main side effects

- Upper respiratory tract infection, bronchitis, shingles, respiratory tract infection.

- Hypersensitivity or anaphylactic reaction.

- Reaction to infusion with headache, nausea, vomiting, fatigue, weakness, dizziness.

Contraindications

Hypersensitivity to the active substance or any of its excipients.

Precautions for use

Anifrolumab has not been studied in patients with severe active lupus of the central nervous system or severe active lupus nephritis.

There are no data available on the immune response to vaccines.

The impact of Anifrolumab treatment on the potential development of cancer is not known. In patients with known risk factors for the development or recurrence of cancer, the individual risk-benefit balance should be taken into account.

Anifrolumab should not be used during pregnancy, but animal studies have not shown any direct or indirect negative effects on reproduction.

It is not known whether Anifrolumab is expelled in breast milk. A risk to newborns/infants cannot be excluded.

There is no data on fertility in men