SubcutaneousNeuromyelitis optica spectrum disorderAdult: 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.
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Active hepatitis B infection, active or untreated latent TB. Concurrent administration of live-attenuated or live vaccines.
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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.
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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.
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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).
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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.
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Description:
Mechanism of Action: 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).
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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.
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L04AC19 - satralizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
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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.
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