Reblozyl
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Reblozyl is an Erythroid Maturation Agent that is FDA approved for the treatment of anemia in adult patients. More specifically anemia due to Beta Thalassemia, Myelodysplastic Syndromes (MDS), MDS with Ring Sideroblasts (MDS-RS) or Myelodysplastic/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T).. Common adverse reactions include Fatigue, Headache, Musculoskeletal pain, Dizziness, Nausea, Diarrhea, Cough, Abdominal pain, Dyspnea. These reactions are generally mild to moderate in severity. .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Beta Thalassemia:
Starting Dose: 1 mg/kg once every 3 weeks by subcutaneous injection.
Dose Titration: If a reduction in RBC transfusion burden is not achieved after at least 2 consecutive doses (6 weeks) at the starting dose, increase to 1.25 mg/kg. Do not exceed the maximum dose of 1.25 mg/kg.
Dose Reduction: If hemoglobin increases by more than 2 g/dL within 3 weeks in the absence of transfusions, reduce the dose as per guidelines.
Myelodysplastic Syndromes (MDS):
Starting Dose: 1 mg/kg once every 3 weeks by subcutaneous injection.
Dose Titration: If an increase in hemoglobin is not achieved after at least 2 consecutive doses (6 weeks) at the starting dose, increase to 1.33 mg/kg, and subsequently to 1.75 mg/kg if needed.
Dose Reduction: If hemoglobin increases by more than 2 g/dL within 3 weeks or reaches a level that requires dose interruption, reduce the dose as per guidelines.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Reblozyl in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Reblozyl in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Reblozyl FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Reblozyl in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Reblozyl in pediatric patients.
Contraindications
Pregnancy: Reblozyl may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.
Hypersensitivity: Reblozyl is contraindicated in patients with known hypersensitivity to luspatercept-aamt or any of its excipients.
Warnings
Thrombosis/Thromboembolism
Hypertension
Extramedullary Hematopoietic (EMH) Masses
Adverse Reactions
Clinical Trials Experience
Fatigue, Headache, Musculoskeletal pain, Dizziness, Nausea, Diarrhea, Cough, Abdominal pain, Dyspnea. These reactions are generally mild to moderate in severity.
Postmarketing Experience
There is limited information regarding Reblozyl Postmarketing Experience in the drug label.
Drug Interactions
No Known Drug Interactions
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Reblozyl may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Reblozyl in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Reblozyl during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Reblozyl in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Reblozyl in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Reblozyl in geriatric settings.
Gender
There is no FDA guidance on the use of Reblozyl with respect to specific gender populations.
Race
There is no FDA guidance on the use of Reblozyl with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Reblozyl in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Reblozyl in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Reblozyl in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Reblozyl in patients who are immunocompromised.
Administration and Monitoring
Administration
Reblozyl is supplied as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials. Reconstitute with Sterile Water for Injection, USP, prior to subcutaneous administration. Administer Reblozyl by subcutaneous injection into the upper arm, thigh, or abdomen. Rotate injection sites.
Monitoring
Monitor hemoglobin levels prior to each administration. If an RBC transfusion occurred prior to dosing, the pretransfusion hemoglobin must be considered for dosing purposes.
Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.
IV Compatibility
There is limited information regarding the compatibility of Reblozyl and IV administrations.
Overdosage
There is limited information regarding Reblozyl overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Reblozyl Pharmacology in the drug label.
Mechanism of Action
Reblozyl is a recombinant fusion protein that binds select transforming growth factor-beta (TGF-β) superfamily ligands, thereby diminishing Smad2/3 signaling. This reduction in signaling leads to enhanced erythroid maturation.
Structure
There is limited information regarding Reblozyl Structure in the drug label.
Pharmacodynamics
In clinical studies, treatment with Reblozyl resulted in increased hemoglobin levels and reduced transfusion burden in patients with beta thalassemia and myelodysplastic syndromes.
Pharmacokinetics
Absorption:
Following subcutaneous administration, Reblozyl has a mean half-life of approximately 11 days. Metabolism and Excretion:
The metabolism of Reblozyl has not been fully characterized.
Nonclinical Toxicology
There is limited information regarding Reblozyl Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Reblozyl Clinical Studies in the drug label.
How Supplied
Reblozyl is supplied as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials containing 25 mg or 75 mg of luspatercept-aamt.
Storage
Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Risk of Thrombosis/Thromboembolism:
Advise patients to seek immediate medical attention if they experience symptoms of blood clots, such as sudden shortness of breath, chest pain, or swelling in the arms or legs. Monitoring of Blood Pressure:
Inform patients that their blood pressure will be monitored during treatment and that they should adhere to their antihypertensive medications as prescribed. Potential for Fetal Harm:
Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose. Injection Site Reactions:
Inform patients that injection site reactions, such as redness or pain, may occur and to notify their healthcare provider if these reactions are severe.
Precautions with Alcohol
Alcohol-Reblozyl interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Luspatercept-aamt is marketed under the brand name Reblozyl.
Look-Alike Drug Names
There is limited information regarding Reblozyl Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.