ENSPRYNG is intended for self-administration at home under the guidance of a healthcare provider 1

At initiation, a loading dose of ENSPRYNG 120 mg is administered by subcutaneous injection every other week for a total of 3 injections. Maintenance doses are administered thereafter at an interval of once every 4 weeks.

 

Advise patients to consult with their healthcare provider if they suspect an active infection. In case of active infection, delay use of ENSPRYNG until the infection is resolved.

If a dose is missed for any reason other than liver enzymes, administer as soon as possible and do not wait until the next dose, provided it has been no longer than 8 weeks since the last dose was administered.

  • For further guidance on missed doses where the last dose administered exceeds 8 weeks, see Section 2.2 of the full Prescribing Information
  • For further guidance on missed doses due to liver enzyme elevations, see Section 2.4

 


Assessments prior to the first dose of ENSPRYNG 1

  • Hepatitis B virus screening: ENSPRYNG should not be initiated in patients with active HBV
  • Tuberculosis screening: Evaluate for active tuberculosis and test for latent infection
  • Liver transaminase screening: Liver transaminases and serum bilirubin should be assessed prior to initiation of treatment
  • Vaccination: Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ENSPRYNG for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior for non-live vaccines

Safety monitoring during treatment 1

  • Liver transaminases: Monitor ALT and AST levels every 4 weeks for the first 3 months of treatment, followed by every 3 months for 1 year, and thereafter as clinically necessary
  • Neutrophil counts: Monitor neutrophils 4 to 8 weeks after initiation of therapy and thereafter at regular clinically determined intervals

In clinical trials, ENSPRYNG was dosed as monotherapy (SAkuraStar) or concurrently with ISTs (SAkuraSky) 1

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