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ENSPRYNG Important Safety Information

Indication

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Contraindications

ENSPRYNG is contraindicated in patients with a known hypersensitivity to satralizumab or any of the inactive ingredients, an active hepatitis B infection, or active or untreated latent tuberculosis.

Warnings and Precautions

Infections
Delay ENSPRYNG administration in patients with an active infection until the infection is resolved. Vaccination with live or live attenuated vaccines is not recommended during treatment.

Elevated Liver Enzymes
Monitor ALT and AST levels during treatment; interruption of ENSPRYNG may be required.

Decreased Neutrophil Counts
Monitor neutrophils during treatment.

Most Common Adverse Reactions

The most common adverse reactions (≥15% in either trial) were nasopharyngitis (31%), headache (27%), upper respiratory tract infection (19%), rash (17%), arthralgia (17%), extremity pain (15%), gastritis (15%), fatigue (15%), and nausea (15%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

For additional safety information, please see the full Prescribing Information and Medication Guide.