SubcutaneousTransfusion-dependent anaemia associated with myelodysplastic syndromes with ring sideroblasts, Transfusion-dependent anaemia associated with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosisAdult: In patients who had an insufficient response to or are ineligible for erythropoietin-based therapy: Initially, 1 mg/kg once every 3 weeks; may increase to 1.33 mg/kg once every 3 weeks if patient is not RBC transfusion-free after at least 6 weeks (2 consecutive doses), and a further increase to a Max of 1.75 mg/kg once every 3 weeks after at least another 6 weeks (2 consecutive doses) if the patient is still not RBC transfusion-free. Discontinue treatment if there is no reduction in transfusion burden after 9 weeks (3 doses) at Max dose level. Dose reduction, interruption, or discontinuation may be required if Hb concentration increases too rapidly or if persistent or serious adverse reactions occur (refer to detailed product guidelines).
SubcutaneousTransfusion-dependent anaemia associated with beta thalassaemiaAdult: Initially, 1 mg/kg once every 3 weeks; may increase to a Max of 1.25 mg/kg once every 3 weeks after at least 6 weeks (2 consecutive doses) if the desired response is not achieved. Discontinue treatment if there is no reduction in transfusion burden after 9 weeks (3 doses) at Max dose level. Dose reduction, interruption, or discontinuation may be required if Hb concentration increases too rapidly or if persistent or serious adverse reactions occur (refer to detailed product guidelines).
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Reconstitute with 0.68 mL (for 25 mg vial) or 1.6 mL (for 75 mg vial) of sterile water for inj to make a final concentration of 25 mg/0.5 mL or 75 mg/1.5 mL, respectively. Gently swirl to mix. Refer to detailed product guidelines for specific instructions on reconstitution.
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Hypersensitivity. Pregnancy and lactation.
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Patient with known risk factors for thromboembolism (e.g. splenectomy, concomitant use of hormone replacement therapy) or extramedullary haematopoietic (EMH) masses (e.g. history of EMH masses, splenomegaly, hepatomegaly, low baseline Hb [<8.5 mg/dL]). Avoid use in patients requiring treatment to control the growth of EMH masses. Consider thromboprophylaxis in patients with β thalassaemia at increased risk of thromboembolic events. Not indicated as a substitute for RBC transfusions in patients requiring immediate correction of anaemia.
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Significant: Hypertension; thromboembolic events (e.g. DVT, pulmonary embolism, portal vein thrombosis, ischaemic stroke) and EMH masses (particularly in patients with β thalassaemia).
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, diarrhoea, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia, inj site reactions (e.g. erythema, pruritus, rash, swelling).
Immune system disorders: Hypersensitivity reactions (e.g. eyelid oedema, angioedema).
Metabolism and nutrition disorders: Hyperuricaemia.
Musculoskeletal and connective tissue disorders: Bone pain, arthralgia, back pain.
Nervous system disorders: Dizziness, headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Bronchitis, upper respiratory tract infection, influenza, dyspnoea, cough.
Vascular disorders: Syncope/presyncope.
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Parenteral/SC: Z (Should not be used during pregnancy or contraindicated (manufacturer specific))
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Women of childbearing potential must use proven birth control methods during therapy and for at least 3 months after stopping the treatment.
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Prior to each administration, monitor blood pressure and assess Hb results and transfusion history. Verify pregnancy status of women of childbearing potential before initiating treatment. Monitor for signs or symptoms of thromboembolism; EMH masses in patients with β thalassaemia (at initiation and during treatment).
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Description:
Mechanism of Action: Luspatercept is a recombinant fusion protein that binds several endogenous transforming growth factor-β (TGF-β) superfamily ligands, thereby diminishing Smad2/3 signalling. Inhibition of TGF-β superfamily leads to erythroid maturation via differentiation of late-stage erythroid precursors (normoblasts) in the bone marrow and improvement of haematology parameters associated with ineffective erythropoiesis.
Onset: Increased Hb: Within 7 days.
Duration: Return of Hb to baseline: Approx 6-8 weeks (from the last dose).
Pharmacokinetics:
Absorption: Slowly absorbed. Time to peak plasma concentration: Approx 7 days (range: 6-10 days for β thalassaemia; 5-21 days in myelodysplastic syndromes [MDS]).
Distribution: Volume of distribution: 7.1 L (β thalassaemia); 9.7 L (MDS).
Metabolism: Expected to be catabolised in multiple tissues via general protein degradation processes into amino acids.
Excretion: Elimination half-life: Approx 11 days (β thalassaemia); approx 13 days (MDS).
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Intact vials: Store between 2-8°C. Protect from light. Do not freeze. Reconstituted solution: If not used immediately, may store between 20-25°C for up to 8 hours or between 2-8°C for up to 24 hours. Do not freeze.
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B03XA06 - luspatercept ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
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Anon. Luspatercept (Briggs Drugs in Pregnancy and Lactation). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/10/2022. Anon. Luspatercept-aamt. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/10/2022. Anon. Luspatercept. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/10/2022. Buckingham R (ed). Luspatercept. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/10/2022. Reblozyl 75 mg Powder for Solution for Injection (Bristol-Myers Squibb Pharma EEIG). MHRA. https://products.mhra.gov.uk. Accessed 03/10/2022. Reblozyl Injection, Powder, Lyophilized, for Solution (Celgene Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/10/2022.
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