Miscellaneous immune disorders:

Indications for: SAPHNELO

Moderate to severe systemic lupus erythematosus (SLE) in adults who are receiving standard therapy.

Limitations of Use:

Not for use in severe active lupus nephritis or severe active CNS lupus.

Adult Dosage:

Give by IV infusion over 30mins. ≥18yrs: 300mg every 4 weeks.

Children Dosage:

<18yrs: not established.

SAPHNELO Warnings/Precautions:

Increased risk of serious infections. Active infection: avoid initiation until resolved or adequately treated. Chronic infection, history of recurrent infections, or known risk factors for infection: consider benefit/risk for administration. Consider interrupting anifrolumab-fnia if infection develops or is not responding to anti-infective treatment; monitor closely. Consider premedication prior to infusion for those with a history of hypersensitivity or infusion-related reactions. Interrupt immediately if a serious infusion-related or hypersensitivity reaction occurs. Malignancy. Update immunizations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

SAPHNELO Classification:

Type I interferon (IFN) receptor antagonist.

SAPHNELO Interactions:

Avoid concomitant live or live-attenuated vaccines. Increased risk of malignancies with the use of immunosuppressants. Concomitant other biologic therapies (including B-cell-targeted): not recommended.

Adverse Reactions:

Nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, cough; hypersensitivity reactions.

Generic Drug Availability:


How Supplied:

Single-dose vial (2mL)—1