ANIFROLUMAB-FNIA INJ,SOLN
Clinical Criteria Summary
Indication & Patient Population
- Treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
- Not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus due to lack of evaluated efficacy in these situations.
Dosage & Administration
- 300 mg IV every 4 weeks.
- Available as injection: 300 mg/2 mL (150 mg/mL) in a single-dose vial.
Contraindications & Warnings/Precautions
- Contraindicated in patients with a history of anaphylaxis to anifrolumab-fnia.
- Serious infections, including disseminated herpes zoster.
- Hypersensitivity reactions, including anaphylaxis and infusion-related reactions; consider premedication before infusions for patients with a history of these reactions.
- Malignancy risk is unknown; immunosuppressants increase the risk of malignancies.
- Not recommended for concomitant use with other biologic therapies.
Monitoring & Safety Requirements
- Update immunizations prior to initiating therapy; avoid live or live attenuated vaccines during therapy.
- Consider high suspicion of tuberculosis (TB) and planned monitoring for active and latent TB, particularly in patients from endemic countries and those with high cumulative exposure to glucocorticoids.
- Potential increased risk of herpes zoster when used with immunosuppressive therapies.
- Potential increased risk of pneumonia with concomitant use of glucocorticoids.
- Potential increased risk of fatal infections, nervous system disorders, and chemistry abnormalities (e.g., increased serum glucose and gamma glutamyl transferase).
Place in Therapy & Standard of Care Alignment
- Must be used as an adjunct to standard therapy; monotherapy has not been evaluated.
- Standard therapy includes oral glucocorticoids, antimalarials, and/or conventional synthetic immunosuppressants.
- Should not be used concomitantly with cyclophosphamide or other targeted biologic or synthetic immunomodulators.
- Patients should be under the care of a VA or VA Community Care rheumatologist or locally designated SLE expert.
Special Populations (Renal & Hepatic Impairment)
- Not cleared renally; no dosage adjustment recommended for renal impairment.
- Clearance not expected to be affected by changes in hepatic function; no dosage adjustment recommended for hepatic impairment.
- Not studied in patients with severe renal impairment, end-stage renal disease (< 30 mL/min/1.73 m2), or urine protein-to-creatinine ratio (UPCR) > 2 mg/mg.