Posology : מינונים

4.2    Posology and method of administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of neuromyelitis optica (NMO) or NMOSD.

Posology

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.



Loading doses

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).

Maintenance doses

The recommended maintenance dose is 120 mg SC injection every four weeks.
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.

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      The recommended dose should be administered as soon as than 8 weeks during the            possible without waiting until the next planned dose.
maintenance period
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.

Dose modification advice for liver enzyme abnormalities
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 benefit- 
risk 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.

Dose modification advice for neutropenia
If the neutrophil count is below 1.0 x 109/L and confirmed by repeat testing, treatment should be interrupted until the neutrophil count is >1.0 x 109/L.

Dose modification advice for low platelet count

If the platelet count is below 75 x 109/L and confirmed by repeat testing, treatment should be interrupted until the platelet count is ≥75 x 109/L.

Special populations

Paediatric population
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.

Elderly

No dose adjustment is required in patients ≥65 years of age (see section 5.2).
Renal impairment

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).

Hepatic impairment

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.

Method of administration

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.

Administration by the patient and/or caregiver

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.