Enspryng Special Precautions

General: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Infections: Delay Enspryng administration in patients with an active infection until the infection is controlled (see Delayed or Missed Doses under Dosage & Administration).
Vaccinations: Live or live attenuated vaccines should not be given concurrently with Enspryng as clinical safety has not been established. The interval between live vaccinations and initiation of Enspryng therapy should be in accordance with current vaccination guidelines regarding immunomodulatory/immunosuppressive agents.
No data are available on the effects of vaccination in patients receiving Enspryng. It is recommended that all patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating Enspryng therapy.
Liver enzymes: Mild and moderate elevations of liver transaminases have been observed with Enspryng treatment, most elevations were below 5x ULN and not treatment-limiting and resolved while Enspryng was given.
ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for 1 year, thereafter as clinically indicated. For treatment discontinuation recommendations please refer to Dose Modifications under Dosage & Administration.
Neutrophil count: Decreases in neutrophil counts have occurred following treatment with Enspryng (see Clinical Trials under Adverse Reactions).
Neutrophil counts should be monitored 4 to 8 weeks after start of therapy and thereafter as clinically indicated. For recommended dose interruption see Indications/Uses.
Drug Abuse and Dependence: No studies on drug abuse and dependence have been conducted. However, there is no evidence from the available data that Enspryng treatment results in dependence.
Renal Impairment: The safety and efficacy of Enspryng in patients with renal impairment have not been formally studied, but given that Enspryng is a monoclonal antibody and cleared via catabolism (rather than renal excretion), a dose adjustment is not expected to be required for patients with renal impairment. Patients with mild renal impairment were included in clinical trials, the pharmacokinetics of satralizumab in these patients was not impacted (see Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Hepatic Impairment: The safety and efficacy of Enspryng in patients with hepatic impairment have not been studied (see Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Effects on ability to drive and use machine effects: No studies on the effects on the ability to drive and use machines have been performed. However, there is no evidence from the available data that Enspryng treatment affects the ability to drive and use machines.
Use in Children: The safety and efficacy of Enspryng have been studied in a limited number of adolescent patients ≥12 years of age. Pharmacokinetic, efficacy and safety results were consistent with those in adults (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies and Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
The safety and efficacy of Enspryng in pediatric patients <12 years of age has not yet been studied (see Special Dosage Instructions under Dosage & Administration).
Use in the Elderly: The safety and efficacy of Enspryng have been studied in geriatric patients up to 74 years of age (see Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
The safety and efficacy of Enspryng in geriatric patients >74 years of age have not been studied (see Special Dosage Instructions under Dosage & Administration).