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Reblozyl is a brand name for Luspatercept. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) (see section 5.1). Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by a physician experienced in treatment of haematological diseases. Posology Prior to each Reblozyl administration, the haemoglobin (Hb) level of patients should be assessed. In case of a red blood cell (RBC) transfusion occurring prior to dosing, the pre-transfusion Hb level must be considered for dosing purposes.
The recommended starting dose of Reblozyl is 1 mg/kg administered once every 3 weeks. 3 • Myelodysplastic syndromes The recommended desired Hb concentration range is between 10 g/dL and 12 g/dL. Dose increase for insufficient response is provided below.
75 mg/kg every 3 weeks. The dose should not be increased immediately after a dose delay. For patients with a pre-dose Hb level of > 9 g/dL and who have not yet achieved transfusion independence, a dose increase may be required at the physician’s discretion; the risk of Hb increasing above the target threshold with concomitant transfusion cannot be excluded.
e. transfusion independence), the dose should be increased by one dose level (see Table 2). 25 mg/kg. 25 mg/kg every 3 weeks. If a patient loses response (if the RBC transfusion burden increases again after an initial response) the dose should be increased by one dose level (see Table 3).
e. at least 3 weeks after the last transfusion), the dose should be increased by one dose level (see Table 3). 25 mg/kg every 3 weeks. Increase to next dose level Increase to next dose level based on current dose is provided below. 25 mg/kg * Applicable only to non-transfusion-dependent β-thalassaemia.
Dose reduction and dose delay In case of Hb increase > 2 g/dL within 3 weeks in absence of transfusion compared with the Hb value at previous dose, Reblozyl dose should be reduced by one dose level. If the Hb is ≥ 12 g/dL in the absence of transfusion for at least 3 weeks, the dose should be delayed until the Hb is ≤ 11 g/dL.
If there is also a concomitant rapid increase in Hb from the Hb value at previous dose (> 2 g/dL within 3 weeks in absence of transfusion), a dose reduction to one step down should be considered after the dose delay. 6 mg/kg (for non-transfusion-dependent β-thalassaemia).
Reduced dose during treatment with luspatercept are provided below. 6 mg/kg* * Applicable only to non-transfusion-dependent β-thalassaemia. Dose modification due to adverse reactions Instructions on dose interruptions or reductions for luspatercept treatment-related adverse reactions are outlined in Table 6.
Summary of the safety profile • Myelodysplastic syndromes The most frequently reported adverse drug reactions in patients receiving Reblozyl (at least 15% of patients) were fatigue, diarrhoea, nausea, asthenia, dizziness, oedema peripheral and back pain.
4%). 2%). 9 Asthenia, fatigue, nausea, diarrhoea, hypertension, dyspnoea, dizziness and headache occurred more frequently during the first 3 months of treatment. 1% of patients treated with luspatercept. The most common reason for discontinuation in the luspatercept treatment arm was progression of underlying MDS.
3% of luspatercept treated patients. • Transfusion-dependent β-thalassaemia The most frequently reported adverse drug reactions in patients receiving Reblozyl (at least 15% of patients) were headache, bone pain and arthralgia. The most commonly reported Grade ≥ 3 adverse drug reaction was hyperuricaemia.
4). Bone pain, asthenia, fatigue, dizziness and headache occurred more frequently during the first 3 months of treatment. 6% of patients treated with luspatercept. The adverse reactions leading to treatment discontinuation in the luspatercept treatment arm were arthralgia, back pain, bone pain and headache.
• Non-transfusion-dependent β-thalassaemia The most frequently reported adverse drug reactions in patients receiving Reblozyl (at least 15% of patients) were bone pain, headache, arthralgia, back pain, prehypertension and hypertension.
The most commonly reported Grade ≥ 3 and most serious adverse reaction (at least 2% of patients) reported was traumatic fracture. Spinal cord compression due to EMH masses occurred in 1% of patients. Bone pain, back pain, upper respiratory tract infection, arthralgia, headache and prehypertension occurred more frequently during the first 3 months of treatment.
The majority of adverse drug reactions were non-serious and did not require discontinuation. 1% of patients treated with luspatercept. Adverse reactions leading to treatment discontinuation were spinal cord compression, extramedullary haemopoiesis and arthralgia.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 7% (1/134) of patients during the open-label phase of the pivotal study in non-transfusion-dependent patients.
8). g. history of thrombocytosis or concomitant use of hormone replacement therapy). The occurrence of TEE was not correlated with elevated Hb levels. The potential benefit of treatment with luspatercept should be weighed against the potential risk of TEEs in β-thalassaemia patients with a splenectomy and other risk factors for developing TEE.
Thromboprophylaxis according to current clinical guidelines should be considered in patients with β-thalassaemia at higher risk. 9% (13/335) of patients treated with luspatercept. 2% (4/335) of patients. All TEEs occurred in patients with significant risk factors (atrial fibrillation, stroke or heart failure and peripheral vascular disease) and were not correlated with elevated Hb, platelet levels or hypertension.
2% (10/315) of patients treated with luspatercept in the pivotal study and in the long-term follow-up study. 8). 3% (6/96) of patients treated with luspatercept in the pivotal study. 0% (1/96) of patients treated with luspatercept. 8).
Patients with EMH masses may experience worsening of these masses and complications during treatment. Signs and symptoms may vary depending on anatomical location. Patients should be monitored at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses, and be treated according to clinical guidelines.
Treatment with luspatercept must be discontinued in case of serious complications due to EMH masses. 8). 8). The treatment must be started only if the blood pressure is adequately controlled. Blood pressure should be monitored prior to each luspatercept administration.
1. 6). 4).
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8) • Discontinue treatment * Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: life-threatening. Missed doses In case of a missed or delayed scheduled treatment administration, the patient should be administered Reblozyl as soon as possible and dosing continued as prescribed with at least 3 weeks between doses.
g. a bleeding event) should be assessed. If typical causes for a loss of haematological response are excluded, dose increase should be considered as described above for the respective indication being treated (see Table 2 and Table 3).
Discontinuation Reblozyl should be discontinued if patients do not […]
Tabulated list of adverse reactions The highest frequency for each adverse reaction that was observed and reported in patients in the pivotal studies in MDS, β-thalassaemia and the long-term follow-up study is shown in Table 7 below.
The adverse reactions are listed below by body system organ class and preferred term. Frequencies are defined as: 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) and not known (frequency cannot be estimated from the available data).
10 Table 7: Adverse drug reactions (ADRs) in patients treated with Reblozyl for MDS and / or β-thalassaemia in the four pivotal studies System organ class Preferred term Frequency (all grades) for MDS Frequency (all grades) for β-thalassaemia Infections and infestations bronchitis Common Commona urinary tract infection Very common Commona respiratory tract infection Common upper respiratory tract infection Common Very commona influenza Common Very common Blood and lymphatic system disorders extramedullary haemopoiesis VI Not known VII Common thrombocytopenia Common Immune system disorders hypersensitivity I, VI Common Common Metabolism and nutrition disorders hyperuricaemia Common Common dehydration Common decreased appetite Common electrolyte imbalanceIX Very common Psychiatric disorders insomnia Common Very commonb anxiety Common Common irritability Common confusional state Common Nervous system disorders dizziness Very common Very common headache Very common Very common migraine Commonb spinal cord compressionVI Common syncope/presyncope Common Commona Ear and labyrinth disorders vertigo/vertigo positional Common Commona Cardiac disorders atrial fibrillation Common cardiac failure Common Vascular disorders prehypertension Very commonb hypertensionII, VI Very common Very common tachycardia Common thromboembolic eventsIV, VI Common Common Respiratory, thoracic and mediastinal disorders cough Very common epistaxis Common Commonb dyspnoeaVIII Very common Common 11 System organ class Preferred term Frequency (all grades) for MDS Frequency (all grades) for β-thalassaemia Gastrointestinal disorders abdominal pain Common Very commonb abdominal discomfort Common diarrhoea Very common Very commona nausea Very common Very common Skin and subcutaneous tissue disorders hyperhidrosis Common Musculoskeletal and connective tissue disorders back pain Very common Very common arthralgiaVI Common Very common bone painVI Common Very common myalgia Common muscular weakness Common Renal and urinary disorders proteinuria Commonb albuminuria Commonb kidney injuryX Common General disorders and administration site conditions non-cardiac chest pain Common influenza-like illness Common fatigue Very common Very commona asthenia Very common Very common injection site reactionsIII, VI Common Common oedema peripheral Very common Investigations alanine aminotransferase increased Common CommonV aspartate aminotransferase increased Common Very commonV blood bilirubin increased Common Very commonV gamma- glutamyltransferase increased Common Injury, poisoning and procedural complications traumatic […]
2). The potential benefit of treatment with Reblozyl should be re-evaluated in case of persistent hypertension or exacerbations of pre-existing hypertension. 4% (1/223) of patients treated with luspatercept. 3% (8/96) of patients treated with luspatercept.
Patients should be informed of the risk of traumatic fracture. Excipients Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 2 mg/mL. Polysorbates may cause allergic reactions.