Satralizumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Neuromyelitis optica spectrum disorder
Adult: As monotherapy or in combination with immunosuppressive therapy in anti-aquaporin-4 IgG (AQP4-IgG) seropositive patients: Loading dose: 120 mg once every 2 weeks for 3 doses at Weeks 0, 2 and 4. Maintenance: 120 mg once every 4 weeks. Doses are given via SC inj. Dosage adjustment, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).
Child: ≥12 years weighing ≥40 kg: Same as adult dose. Dosing recommendations may vary among countries or individual products. Refer to specific product guidelines.
Contraindications
Active hepatitis B infection, active or untreated latent TB. Concurrent administration of live-attenuated or live vaccines.
Special Precautions
Patient with active infection, including localised infections; baseline ALT/AST >1.5 times the upper limit of normal (ULN). In case of active infection, delay treatment until infection is resolved. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Mild to moderate liver enzyme elevations, decreased platelet counts, neutropenia, increased risk of infection (e.g. cellulitis, nasopharyngitis, pharyngitis, upper respiratory tract infection).
Blood and lymphatic system disorders: Hypofibrinogenaemia.
Cardiac disorders: Bradycardia.
Gastrointestinal disorders: Gastritis, nausea, diarrhoea.
General disorders and administration site conditions: Fatigue, peripheral oedema, inj site reactions (e.g. flushing, erythema, pruritus, pain, rash).
Investigations: Decreased WBC; increased bilirubin, total cholesterol, serum triglycerides, and blood creatine phosphokinase; increased weight.
Musculoskeletal and connective tissue disorders: Arthralgia, musculoskeletal stiffness, pain in extremities.
Nervous system disorders: Headache, migraine.
Psychiatric disorders: Insomnia, depression.
Respiratory, thoracic and mediastinal disorders: Allergic rhinitis.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Vascular disorders: Hypertension.
Potentially Fatal: Severe infections.
Monitoring Parameters
Obtain hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) tests prior to initiation of therapy. Evaluate for active or latent TB (including TB risk factors) or any active infection prior to initiation of therapy. Monitor ALT/AST (prior to initiation, every 4 weeks for the 1st 3 months of therapy, every 3 months for 1 year, then as clinically indicated), serum bilirubin (prior to initiation and as clinically indicated), and neutrophil counts (4-8 weeks after initiation then at regular intervals); signs and symptoms of TB (during treatment) or any active infection (prior to each therapy).
Drug Interactions
May alter the serum concentrations of CYP3A4, CYP1A2, CYP2C9 or CYP2C19 substrates with a narrow therapeutic index (e.g. warfarin, carbamazepine, phenytoin, theophylline).
Potentially Fatal: May increase the risk of infection with live-attenuated or live vaccines; administer vaccinations at least 4 weeks for live or live-attenuated vaccines, and at least 2 weeks for non-live vaccines prior to initiation of satralizumab.
Action
Description: Satralizumab is a humanised immunoglobulin (IgG2) monoclonal antibody. The exact mechanism by which it exerts its therapeutic effects in neuromyelitis optica spectrum disorder (NMOSD) is unknown, but it is presumed to inhibit interleukin-6 (IL-6) downstream signalling through binding to soluble and membrane-bound IL-6 receptors (IL-6R).
Pharmacokinetics:
Absorption: Bioavailability: 85%.
Distribution: Volume of distribution: 3.46 L (central); 2.07 L (peripheral).
Excretion: Elimination half-life: Approx 30 days (range: 22-37 days).
Storage
Store between 2-8°C. Do not freeze. Protect from light and moisture. Do not shake. If needed, unopened pre-filled syringes may be left out of the refrigerator and stored below 30°C for a single period of up to 8 days.
MIMS Class
Immunosuppressants
ATC Classification
L04AC19 - satralizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
References
Anon. Satralizumab-mwge. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 27/12/2021.

Anon. Satralizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/12/2021.

Enspryng (Roche Thailand Ltd). MIMS Thailand. http://www.mims.com/thailand. Accessed 27/12/2021.

Enspryng 120 mg Solution for Injection in Pre-filled Syringe (Roche Registration GmbH). European Medicines Agency [online]. Accessed 27/12/2021.

Enspryng 120 mg/1 mL (Roche [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/04/2022.

Enspryng Injection, Solution (Genentech Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/12/2021.

Preston CL (ed). Satralizumab - Live Vaccines Drug Interaction. Stockley’s Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/04/2022.

Disclaimer: This information is independently developed by MIMS based on Satralizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2023 MIMS. All rights reserved. Powered by MIMS.com
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