Saphnelo

— THERAPEUTIC CATEGORIES —
  • Miscellaneous immune disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    AstraZeneca Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    Anifrolumab-fnia is a human IgG1κ monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets.

    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 (including COVID-19). 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

    Elimination

    Estimated systemic clearance: 0.193 L/day.

    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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