Saphnelo Generic Name & Formulations
Anifrolumab-fnia 300mg/vial; soln for IV infusion after dilution; preservative-free.
Type I interferon (IFN) receptor antagonist.
Single-dose vial (2mL)—1
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.
Saphnelo Dosage and Administration
Give by IV infusion over 30mins. ≥18yrs: 300mg every 4 weeks.
<18yrs: not established.
Saphnelo Boxed Warnings
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.
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.
Saphnelo Adverse Reactions
Nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, cough; hypersensitivity reactions.
Saphnelo Clinical Trials
Saphnelo Patient Counseling