REBLOZYL Powder for solution for injection / infusion (2020)

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Celgene

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1. Indications and Usage

1.1 Beta Thalassemia REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. 1.2 Myelodysplastic Syndromes with ...

2. Dosage and Administration

2.1 Recommended Dosage in Beta Thalassemia The recommended starting dose of REBLOZYL is 1 mg/kg once every 3 weeks by subcutaneous injection for patients with beta thalassemia. Prior to each REBLOZYL dose, ...

3. Dosage Forms and Strengths

For injection: 25 mg white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: 75 mg white to off-white lyophilized powder in a single-dose vial for reconstitution. ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Thrombosis/Thromboembolism In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. Reported TEEs included deep vein thromboses, ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Thrombosis/Thromboembolism <em>[see Warnings and Precautions (5.1)]</em> Hypertension <em>[see Warnings and ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

8.1. Pregnancy

Risk Summary Based on findings in animal reproduction studies, REBLOZYL may cause fetal harm when administered to a pregnant woman. There are no available data on REBLOZYL use in pregnant women to inform ...

8.2. Lactation

Risk Summary Luspatercept-aamt was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are no data on the presence ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential before starting REBLOZYL treatment. Contraception Females REBLOZYL may cause embryo-fetal harm when administered ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Based on findings in juvenile animals, REBLOZYL is not recommended for use in pediatric patients <em>[see Non-Clinical Toxicology ...

8.5. Geriatric Use

Clinical studies of REBLOZYL in beta thalassemia did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients. Clinical studies ...

11. Description

Luspatercept-aamt is an erythroid maturation agent. Luspatercept-aamt is a receptor fusion protein consisting of a modified extracellular domain of the human activin receptor type IIB linked to a human ...

12.1. Mechanism of Action

Luspatercept-aamt is a recombinant fusion protein that binds several endogenous TGF-β superfamily ligands, thereby diminishing Smad2/3 signaling. Luspatercept-aamt promoted erythroid maturation through ...

12.2. Pharmacodynamics

Increases in Hemoglobin in Patients with Low RBC Transfusion Burden In patients having received <4 units of RBC transfusion within 8 weeks prior to study, hemoglobin increased within 7 days of initiating ...

12.3. Pharmacokinetics

Luspatercept-aamt exhibited linear pharmacokinetics (PK) over the dose range of 0.2 to 1.25 mg/kg (0.2 to 1.25 times the recommended starting dosage) in patients with beta thalassemia, and from 0.125 mg/kg ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenicity studies have been conducted with luspatercept-aamt. In a repeat-dose toxicity study, juvenile rats were administered luspatercept-aamt subcutaneously at 1, 3, or 10 mg/kg ...

14. Clinical Studies

14.1 Beta Thalassemia The efficacy of REBLOZYL was evaluated in adult patients with beta thalassemia in the BELIEVE trial (NCT02604433). BELIEVE was a multicenter, randomized, double-blind, placebo-controlled ...

16.1. How Supplied

REBLOZYL (luspatercept-aamt) for injection is a white to off-white lyophilized powder supplied in a single-dose vial. Each carton contains one vial. REBLOZYL 25 mg/vial (NDC 59572-711-01) REBLOZYL 75 mg/vial ...

16.2. Storage and Handling

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.

17. Patient Counseling Information

Discuss the following with patients prior to and during treatment with REBLOZYL. Thromboembolic Events Advise beta thalassemia patients of the potential risk of thromboembolic events. Review known risk ...