Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
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 adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive (see section 5.1).
Treatment should be initiated under the supervision of a physician experienced in the treatment of neuromyelitis optica (NMO) or NMOSD.
Enspryng can be used as a monotherapy or in combination with oral corticosteroids (OCs), azathioprine (AZA) or mycophenolate mofetil (MMF) (see section 5.1). The posology in adolescent patients ≥12 years of age with body weight ≥40 kg and adult patients is the same.
The recommended loading dose is 120 mg subcutaneous (SC) injection every two weeks for the first three administrations (first dose at week 0, second dose at week 2 and third dose at week 4).
The recommended maintenance dose is 120 mg SC injection every four weeks.
Enspryng is intended for long-term treatment.
If an injection is missed, for any reason other than increases in liver enzymes, it should be administered as described in table 1.
Table 1. Recommended dosage for delayed or missed doses:
| Last dose administered | Recommended dosage for delayed or missed doses |
|---|---|
| Missed a loading dose or less than 8 weeks during the maintenance period | The recommended dose should be administered as soon as possible without waiting until the next planned dose. Loading period: If the second loading dose is delayed or missed, this dose should be administered as soon as possible and the third and final loading dose 2 weeks later. If the third loading dose is delayed or missed, this dose should be administered as soon as possible and the first maintenance dose 4 weeks later. Maintenance period: After the delayed or missed dose is administered, the dosing schedule should be reset to every 4 weeks. |
| 8 weeks to less than 12 weeks | The recommended dose should be administered at 0*, 2 weeks and every 4 weeks thereafter. |
| 12 weeks or longer | The recommended dose should be administered at 0*, 2, 4 weeks and every 4 weeks thereafter. |
* “0 weeks” refers to time of the first administration after the missed dose.
If the alanine aminotransferase (ALT) or aspartate transaminase (AST) elevation is >5 x upper limit of normal (ULN) and associated with any bilirubin elevation, treatment must be discontinued, and reinitiation is not recommended.
If the ALT or AST elevation is >5 x ULN and not associated with any bilirubin elevation, treatment should be discontinued. Treatment can be restarted at a dose of 120 mg SC injection every four weeks when the ALT and AST levels have returned to the normal range and based on assessment of benefitrisk of treatment in the patient. If the decision is taken to restart treatment, liver parameters must be closely monitored, and if any subsequent increase in ALT/AST and/or bilirubin is observed, treatment must be discontinued, and reinitiation is not recommended (see sections 4.4 and 4.8).
Table 2. Recommended dose for restart of treatment after liver transaminase elevation:
| Last dose administered | Recommended dose for restart of treatment |
|---|---|
| Less than 12 weeks | Treatment should be restarted using the recommended dose, given every 4 weeks. |
| 12 weeks or longer | Treatment should be restarted using the recommended dose, given at weeks 0*, 2, 4 and every 4 weeks thereafter. |
* “0 weeks” refers to time of the first administration after the restart of treatment.
If the neutrophil count is below 1.0 × 109/L and confirmed by repeat testing, treatment should be interrupted until the neutrophil count is >1.0 × 109/L.
If the platelet count is below 75 × 109/L and confirmed by repeat testing, treatment should be interrupted until the platelet count is ≥75 × 109/L.
The posology in adolescent patients ≥12 years of age with body weight ≥ 40 kg and adult patients is the same (see sections 5.1 and 5.2). The safety and efficacy of satralizumab in children with body weight <40 kg have not yet been established. No data are available.
No dose adjustment is required in patients ≥65 years of age (see section 5.2).
The safety and efficacy of satralizumab have not been formally studied in patients with renal impairment. No dose adjustment is recommended for patients with mild renal impairment (see section 5.2).
The safety and efficacy of satralizumab have not been studied in patients with hepatic impairment. No data are available (see section 5.2).
Elevations of liver enzymes have been observed during treatment with satralizumab (see sections 4.4 and 4.8). For dose adjustment, see above section Dose modification advice for liver enzyme abnormalities.
Satralizumab 120 mg is administered by SC injection using a single-dose PFS. The total content (1 mL) of the PFS should be administered.
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 satralizumab are given at the end of the package leaflet.
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 all other doses 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 can be continued or not.
In the event of an overdose, the patient should be closely supervised, treated symptomatically, and supportive measures instituted as required.
2 years.
Store in a refrigerator (2°C–8°C).
Do not freeze. Do not use the syringe if it has been frozen.
Always keep the syringe dry.
Keep the PFS in the outer carton in order to protect from light and moisture.
If unopened and kept in the outer carton, the syringe may be left out of the refrigerator below 30°C for a single period up to 8 days. After storage at room temperature the product should not be returned to the refrigerator and should be either used or discarded.
1 mL solution in a PFS (polymer) with a staked-in, stainless steel needle, fitted with a chlorinated butyl rubber-polypropylene rigid needle shield and sealed with a chlorinated butyl rubber plunger stopper. The PFS is labelled and assembled with an automatic needle guard, plunger rod, and extended finger flanges (EFF).
Pack size of 1 PFS and multipack of 3 (3 packs of 1) PFS. Not all pack sizes may be marketed.
After removing the carton from the refrigerator, the sealed carton should be open and the PFS carefully lifted out of the carton by holding the barrel. It is important to let the PFS reach room temperature by waiting for 30 minutes before initiating the administration process.
The medicinal product should not be used if the liquid is cloudy, discoloured, has visible particles in it or if any part of the PFS appears to be damaged.
The injection must be performed right after removing the cap and no later than 5 minutes, to prevent the medicinal product from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of removing the cap, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
