Saphnelo

Anifrolumab-fnia · AstraZeneca Pharmaceuticals LP
PRESCRIPTION ONLY (USA)

Saphnelo ingredients

Active ingredientStrength
Anifrolumab120 mg/.8mL, 300 mg/2mL

What Saphnelo is used for

The FDA lists the approved uses on the official label (below). In the EU, anifrolumab is approved as Saphnelo for:

Saphnelo 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.

EU wording from the European Medicines Agency; US approved uses can differ.

Key facts

Brand
Saphnelo
Generic name
Anifrolumab-fnia
Made by
AstraZeneca Pharmaceuticals LP
Forms
Injection, Solution
Given
Intravenous, Subcutaneous
Drug class
Type I Interferon Receptor Antagonist
FDA approval
Biologic licence (BLA) BLA761451
On the US market since
2021

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Saphnelo?

Saphnelo (Anifrolumab-fnia) is a specialist medicine made by AstraZeneca Pharmaceuticals LP, approved by the US FDA.

What are the ingredients of Saphnelo?

Saphnelo contains Anifrolumab (120 mg/.8mL, 300 mg/2mL).

Is Saphnelo approved in Europe?

The same active substance is approved in the EU as Saphnelo.

From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, USA

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.