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Enspryng is a brand name for Satralizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under the supervision of a physician experienced in the treatment of neuromyelitis optica (NMO) or NMOSD. 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 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 subcutaneous injection every four weeks.
3 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 dose for delayed or missed doses Last dose administered Recommended dose 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. 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 subcutaneous 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.
5%). Tabulated list of adverse reactions Table 3 summarises the adverse reactions that have been reported in association with the use of satralizumab as a monotherapy or in combination with IST in clinical trials. Adverse reactions from clinical trials (Table 3) are listed by MedDRA system organ class.
Adverse reactions are presented using number of adverse events per 100 patient years and by frequency figures. The corresponding frequency category for each adverse reaction is based on frequency figures and the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Table 3:
Adverse reactions System Organ Class Frequency Very common Common Blood and lymphatic system disorders Hypofibrinogenaemia Metabolism and nutrition disorders Hyperlipidaemia Psychiatric disorders Insomnia Nervous system disorders Headache Migraine Cardiac disorders Bradycardia Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders Allergic rhinitis Gastrointestinal disorders Gastritis Skin and subcutaneous tissue disorders Rash, pruritus Musculoskeletal and connective tissue disorders Arthralgia Musculoskeletal stiffness General disorders and administration site conditions Injection-related reactions Peripheral oedema Investigations White blood cell count decreased Neutrophil count decreased platelet count decreased, transaminases increased, blood bilirubin increased, weight increased Description of selected adverse reactions Injection-related reactions (IRRs) 8 IRRs reported in patients treated with satralizumab were predominantly mild to moderate, and most occurred within 24 hours after injections.
The most commonly reported systemic symptoms were diarrhoea and headache. The most commonly reported local injection site reactions were flushing, erythema, pruritus, rash and pain. 7% of patients receiving placebo (or plus IST). 6% of patients receiving placebo (or placebo plus IST).
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 2). Vigilance for the timely detection and diagnosis of infection is recommended for patients receiving treatment with satralizumab.
Treatment should be delayed in case the patient develops any serious or opportunistic infection and appropriate therapy should be initiated under further monitoring. Patients should be instructed on seeking early medical attention in case of signs and symptoms of infections to facilitate timely diagnosis of infections.
Patients should be provided with a patient alert card. Vaccinations Live and live-attenuated vaccines should not be given concurrently with satralizumab as clinical safety has not been established. The interval between live vaccinations and initiation of satralizumab treatment should be in accordance with current vaccination guidelines regarding immunomodulatory or immunosuppressive agents.
No data are available on the effects of vaccination in patients receiving satralizumab. It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating satralizumab treatment.
8). ALT and AST levels should be monitored every four weeks for the first three months of treatment, followed by every three months for one year, thereafter as clinically indicated. 2). 8). Neutrophil counts should be monitored 4 to 8 weeks after start of treatment and thereafter as clinically indicated.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8). 4 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. 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.
2). The safety and efficacy of satralizumab in children with body weight < 40 kg have not yet been established. No data are available. 2). Renal impairment The safety and efficacy of satralizumab have not been formally studied in patients with renal impairment.
2). Hepatic impairment The safety and efficacy of satralizumab have not been studied in patients with hepatic impairment. 2). 8). For dose adjustment, see above section Dose modification advice for liver enzyme abnormalities. Method of administration Satralizumab 120 mg is administered by subcutaneous injection using a single-dose pre-filled syringe.
The total content (1 mL) of the pre-filled syringe should be administered. 5 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.
The majority of neutrophil decreases were transient or intermittent. 4% receiving placebo (or placebo plus IST). 5% of patients receiving placebo or placebo plus IST. The decreased platelet count was not associated with bleeding events.
The majority of the decreased platelets were transient and not below 75 × 109/l. 5% of patients receiving placebo or placebo plus IST. The majority of the elevations were below 3 x ULN, were transient and resolved without interruption of satralizumab.
9% of patients treated with satralizumab (monotherapy or in combination with IST) respectively. These elevations were not associated with increases in total bilirubin. 4). 8% of patients receiving placebo. Paediatric population The safety and efficacy of satralizumab have been studied in 9 children ≥12 years of age.
Frequency, type and severity of adverse reactions in children from 12 years of age are expected to be the same as in adults. 9 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.