No black box warning on record for Anifrolumab

As of the latest FDA labeling reviewed, Anifrolumab (anifrolumab) does not carry a black box warning. Standard warnings and precautions still apply — see the full Anifrolumab medicine page for the complete safety profile.

Other warnings & precautions

Infections: type I IFN blockade may impair immune response to infections, particularly viral infections. Screen for TB before initiation. Monitor closely for infections during therapy.
Herpes zoster: higher incidence in anifrolumab-treated patients (6% vs. 2% placebo in TULIP trials). Ensure VZV vaccination (Shingrix — recombinant, not live) before initiation in appropriate patients.
Anaphylaxis: infusion reactions possible. Pre-medicate with antihistamine; have resuscitative equipment available.
Malignancy: as with other immunosuppressants, monitor for signs of malignancy.
Live vaccines: avoid during therapy and discuss timing with all vaccinations.
Interferon signature: anifrolumab is most effective in patients with high type I IFN gene signature activity (pharmacodynamic biomarker), but was approved based on pooled TULIP-1 and TULIP-2 data regardless of IFN signature status.

No black box warning on record for Anifrolumab

Other warnings & precautions

Infections: type I IFN blockade may impair immune response to infections, particularly viral infections. Screen for TB before initiation. Monitor closely for infections during therapy.
Herpes zoster: higher incidence in anifrolumab-treated patients (6% vs. 2% placebo in TULIP trials). Ensure VZV vaccination (Shingrix — recombinant, not live) before initiation in appropriate patients.
Anaphylaxis: infusion reactions possible. Pre-medicate with antihistamine; have resuscitative equipment available.
Malignancy: as with other immunosuppressants, monitor for signs of malignancy.
Live vaccines: avoid during therapy and discuss timing with all vaccinations.
Interferon signature: anifrolumab is most effective in patients with high type I IFN gene signature activity (pharmacodynamic biomarker), but was approved based on pooled TULIP-1 and TULIP-2 data regardless of IFN signature status.

Anifrolumab Black Box Warning

No black box warning on record for Anifrolumab

Other warnings & precautions

Anifrolumab Black Box Warning

No black box warning on record for Anifrolumab

Other warnings & precautions