Saphnelo Generic Name & Formulations
Legal Class
Rx
General Description
Anifrolumab-fnia 300mg/vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Type I interferon (IFN) receptor antagonist.
How Supplied
Single-dose vial (2mL)—1
Manufacturer
Generic Availability
NO
Saphnelo Indications
Indications
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
Adult
Give by IV infusion over 30mins. ≥18yrs: 300mg every 4 weeks.
Children
<18yrs: not established.
Saphnelo Contraindications
Not Applicable
Saphnelo Boxed Warnings
Not Applicable
Saphnelo Warnings/Precautions
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 Pharmacokinetics
See Literature
Saphnelo Interactions
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.
Saphnelo Adverse Reactions
Adverse Reactions
Nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, cough; hypersensitivity reactions.
Saphnelo Clinical Trials
See Literature
Saphnelo Note
Not Applicable
Saphnelo Patient Counseling
See Literature
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