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REBLOZYL is a brand name for Luspatercept, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 09/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 09/2024 7 WARNINGS AND PRECAUTIONS 09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 09/2024 7 WARNINGS AND PRECAUTIONS 09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
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). Monitor blood pressure prior to each administration. Treat new-onset hypertension or exacerbations of pre-existing hypertension as per current guidelines. Thrombosis / Thromboembolism In the BELIEVE β-thalassemia trial, thromboembolic events (TEE) were reported as an adverse event in more patients treated with Reblozyl® compared to placebo (see 8 ADVERSE REACTIONS).
Reported TEEs included deep vein thrombosis, pulmonary emboli, and ischemic stroke. The potential benefit of treatment with Reblozyl® should be weighed against the potential risk of thromboembolic events in β- thalassemia patients with a splenectomy and other risk factors for developing TEE.
Consider Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients subcutaneous injection 25 mg luspatercept off-white lyophilized powder for reconstitution / single-use vial citric acid monohydrate, hydrochloric acid, polysorbate 80, sodium hydroxide, sucrose, tri-sodium citrate dihydrate subcutaneous injection 75 mg luspatercept off-white lyophilized powder for reconstitution / single-use vial citric acid monohydrate, hydrochloric acid, polysorbate 80, sodium hydroxide, sucrose, tri-sodium citrate dihydrate REBLOZYL® Product Monograph Page 11 of 48 thromboprophylaxis in patients with β-thalassemia at higher risk at increased risk of TEE.
Monitor patients receiving Reblozyl® for signs and symptoms of TEE and institute treatment promptly as per standard clinical practice. Monitoring and Laboratory Tests Assess and review Hgb results prior to each administration of Reblozyl®.
2 Recommended Dose and Dosage Adjustment. Monitor blood pressure prior to each administration, see 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
Reproductive Health:
Female and Male Potential • Fertility There are no data on the effects of Reblozyl® on human fertility. In a fertility and early embryonic development study in rats, there were significant reductions in the average numbers of corpora lutea, implantations, and viable embryos in female rats receiving luspatercept.
09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 12 8 ADVERSE REACTIONS ................................................................................................
20 9 DRUG INTERACTIONS ................................................................................................ 22 10 CLINICAL PHARMACOLOGY .......................................................................................
23 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 25 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 25 PART II: SCIENTIFIC INFORMATION .......................................................................................
Reblozyl® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
REBLOZYL® Product Monograph Page 5 of 48
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There was no effect on mating, fertility, or litter parameters when male rats treated with luspatercept were mated with untreated female rats. Effects on fertility in female rats were reversible after a 14-week recovery period. Based on findings in animals, female fertility may be compromised with Reblozyl® (see 16 NON-CLINICAL TOXICOLOGY).
1 Pregnant Women Embryo-fetal toxicity There are no available human data to inform the drug-associated risk; however, based on findings in animals, Reblozyl® may cause fetal harm when administered to a pregnant woman. Luspatercept was a selective development toxicant in the rat, and a maternal and fetal development toxicant in the rabbit.
In both species, effects included increased resorptions and post-implementation loss, decreased litter size, and an increased incidence of skeletal alterations. See 16 NON-CLINICAL TOXICOLOGY. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Reblozyl®.
Pregnancy testing is recommended for females of childbearing potential prior to initiating treatment with Reblozyl®. Advise females of childbearing potential to use effective contraception during treatment with Reblozyl® and for at least 3 months after the last dose.
If Reblozyl® is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be informed of the potential for hazard to the fetus. 2 Breast-feeding Luspatercept was detected in the milk of lactating rats following a single subcutaneous dose of luspatercept (30 mg/kg); mean lacteal transfer was 12% (see 16 NON-CLINCIAL TOXICOLOGY).
The safe use of Reblozyl® during breast-feeding has not been established. It is unknown if the drug is excreted in human milk or absorbed systemically after ingestion by a nursing infant. As many drugs are excreted in human milk, and because of the unknown effects of luspatercept in infants, taking into account the importance of the drug to the mother, a decision should be made whether to discontinue breast-feeding during treatment with Reblozyl® and for 3 months after the final dose or to discontinue Reblozyl®.
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Geriatrics (> 65 years of age): Clinical studies of Reblozyl® in β-thalassemia did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients.
Clinical studies of Reblozyl® in MDS included patients with ages ranging from 18 to 95 years old, with a median age of 72 years. No differences in safety or effectiveness were observed between older (≥65 years) and younger patients when compared to placebo.
1 Adverse Reaction Overview β-thalassemia (BELIEVE Trial): In the double-blind, randomized, placebo-controlled, multicentre, Phase III, BELIEVE trial, 332 adult patients with transfusion-dependent (TD) β-thalassemia were included in the Safety Population: 223 in the Reblozyl® arm and 109 in the placebo arm following a 2:1 randomization scheme.
The most common treatment emergent adverse events (TEAEs) in patients treated with Reblozyl® (≥ 10% and with ≥ 1% frequency versus placebo) were: headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea, and dizziness.
2% of patients treated with placebo. 8% vs. 8%), including septic shock (1% vs. none), cellulitis (1% vs. none) and […]
26 13 PHARMACEUTICAL INFORMATION ............................................................................ 26 14 CLINICAL TRIALS ........................................................................................................
35 15 MICROBIOLOGY ........................................................................................................ 36 16 NON-CLINICAL TOXICOLOGY .....................................................................................
36 PATIENT MEDICATION INFORMATION – USE IN ΒETA-THALASSEMIA ................................... 39 PATIENT MEDICATION INFORMATION – USE IN MYELODYSPLASTIC SYNDROMES ................ 44 REBLOZYL® Product Monograph Page 4 of 48 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Reblozyl® (luspatercept for injection) is indicated for: Beta(β)-Thalassemia • the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia […]