ENSPRYNG SOLUTION FOR INJECTION IN PREFILLED SYRINGE 120MG/1ML [SIN16348P]

Product Info

ENSPRYNG SOLUTION FOR INJECTION IN PREFILLED SYRINGE 120MG/1ML

[SIN16348P]

2.1 THERAPEUTIC INDICATION(S)

Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescents who are anti-aquaporin 4 (AQP4) seropositive.

2.2 DOSAGE AND ADMINISTRATION

General
Substitution by any other biological medicinal product requires the consent of the prescribing physician.

The safety and efficacy of alternating or switching between Enspryng and products that are biosimilar but not deemed interchangeable have not been established. Therefore, the benefit-risk of alternating or switching needs to be carefully considered.

In order to prevent medication errors, it is important to check the prefilled syringe label to ensure that the drug being administered is Enspryng.

Recommended Dosage
Enspryng must be administered as a subcutaneous injection.

Advise patients to consult with their healthcare professional (HCP) if they suspect an active infection (including localized infections) before administration or the next dose of Enspryng. In case of active infection, delay use of Enspryng until the infection is controlled (see section 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Enspryng can be used as a monotherapy or in combination with either oral corticosteroids (OCs), azathioprine (AZA) or mycophenolate mofetil (MMF) (see section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Please also refer to the full prescribing information for these products.

Loading Dose
The recommended loading dose is 120 mg SC injection every 2 weeks (first dose at week 0, second dose at week 2 and third dose at week 4) for the first three administrations.

Maintenance Dose
The recommended maintenance dose is 120 mg SC injection every 4 weeks.

Method of administration
The recommended injection sites are the abdomen and thigh. Injection sites should be rotated, and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Comprehensive instructions for the administration of Enspryng are given in the Instructions for Use (IFU).

The first injection must be performed under the supervision of a qualified healthcare professional (HCP). After adequate training on how to prepare and perform the injection, an adult patient/caregiver may administer Enspryng at home if the treating physician determines that it is appropriate and the adult patient/caregiver can perform the injection technique.

Patients/caregivers should seek immediate medical attention if the patient develops symptoms of serious allergic reactions and should check with their HCP to confirm whether treatment with Enspryng can be continued or not.

Duration of Treatment
Enspryng is intended for long-term treatment.

Delayed or Missed Doses
If an injection is missed, for any reason other than increases in liver enzymes, it should be administered as described in Table 1.

Dose Modifications

Liver Enzyme Abnormalities
If the alanine aminotransferase (ALT) or aspartate transaminase (AST) elevation is >5x Upper Limit of Normal (ULN) and associated with any bilirubin elevation, treatment with Enspryng must be discontinued, and reinitiation is not recommended.

If the ALT or AST elevation is >5x ULN and not associated with any bilirubin elevation, treatment with Enspryng should be discontinued; it can be restarted (120 mg SC injection every 4 weeks) when the ALT and AST levels have returned to the normal range and based on assessment of benefit-risk of treatment in the patient. If the decision is taken to restart treatment, the liver parameters must be closely monitored, and if any subsequent increase in ALT/AST and/or bilirubin is observed, the drug must be discontinued, and reinitiation is not recommended.

Neutropenia
If the neutrophil count is below 1.0 x10⁹/L and confirmed by repeat testing, Enspryng should be interrupted until the neutrophil count is > 1.0 x10⁹/L.

2.2.1 Special Dosage Instructions

Pediatric use
The posology in adolescent patients ≥12 years of age with body weight ≥ 40 kg and adult patients is the same. The safety and efficacy of Enspryng in pediatric population <12 years of age have not been studied (see section 2.5.4 Pediatric Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric use
No dose adjustment is required in patients ≥65 years of age (see sections 2.5.5 Geriatric Use and 3.2.5 Pharmacokinetics in special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment
The safety and efficacy of Enspryng have not been formally studied in patients with renal impairment; however, a dose adjustment is not expected to be required for patients with renal impairment (see sections 2.5.6 Renal Impairment and 3.2.5 Pharmacokinetics in special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic Impairment
The safety and efficacy of Enspryng have not been studied in patients with hepatic impairment (see sections 2.5.7 Hepatic Impairment and 3.2.5 Pharmacokinetics in special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Other Special Patient Populations
Not applicable

2.3 CONTRAINDICATIONS

Enspryng is contraindicated in patients with a known hypersensitivity to satralizumab or any of the excipients.