Enspryng Generic Name & Formulations
Satralizumab-mwge 120mg/mL; soln for SC inj; preservative-free.
Single-dose prefilled syringe (1mL)—1
Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.
Enspryng Dosage and Administration
Give by SC inj into the abdomen or thigh; rotate inj sites. 120mg at Weeks 0, 2, and 4, followed by 120mg every 4 weeks. Restart of treatment after liver transaminase elevation (<12 weeks since last dose): 120mg every 4 weeks; (≥12 weeks since last dose): 120mg at Weeks 0, 2, and 4, followed by 120mg every 4 weeks.
Active hepatitis B infection. Active or untreated latent tuberculosis.
Enspryng Boxed Warnings
Increased risk of infections. Assess for infections prior to every injection; if active, delay Enspryng treatment until resolved. Risk of HBV reactivation. Perform HBV screening in all patients prior to initiation. Evaluate for TB risks and test/treat latent TB prior to initiation. Assess liver transaminases and serum bilirubin prior to initiation. Patients with AST/ALT levels >1.5×ULN: initiate cautiously. Monitor ALT/AST levels every 4 weeks for the first 3 months, then every 3 months for one year and thereafter as clinically indicated. If ALT/AST >5×ULN occurs: discontinue if associated with any bilirubin elevation (reinitiation is not recommended); if not associated with any bilirubin elevation, ALT/AST has returned to normal range and following a patient benefit/risk assessment (treatment can be restarted; see Adult dose). Monitor neutrophil counts 4–8 weeks after initiation, and thereafter at regular determined intervals; interrupt treatment if neutrophil count is <1.0×109/L. Prior to initiation, complete all immunizations according to guidelines ≥4 weeks for live or live-attenuated vaccines, and if possible, ≥2 weeks for non-live vaccines. Pregnancy (esp. 3rd trimester; consider risks/benefits prior to live or live-attentuated vaccinations to infants exposed in utero). Nursing mothers.
Concomitant live or live-attenuated vaccines: not recommended during treatment.
Enspryng Adverse Reactions
Nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue, nausea, diarrhea, inj site reactions; infections, lab abnormalities (eg, elevated liver enzymes, decreased neutrophils, decreased platelets, lipid abnormalities, others), hypersensitivity reactions.
Enspryng Clinical Trials
Enspryng Patient Counseling