Drug Guide

Generic Name

Luspatercept-aamt

Brand Names Reblozyl

Classification

Therapeutic: Blood Modifier

Pharmacological: Erythroid Maturation Agent

FDA Approved Indications

  • Anemia in adult patients with beta-thalassemia who require regular blood transfusions
  • Anemia in adult patients with myelodysplastic syndromes (MDS) with ring sideroblasts who require red blood cell transfusions

Mechanism of Action

Luspatercept-aamt is a recombinant fusion protein that binds to transforming growth factor-beta (TGF-β) superfamily ligands, reducing signaling and promoting late-stage erythropoiesis to enhance red blood cell production.

Dosage and Administration

Adult: Starting dose is typically 1 mg/kg subcutaneously every 3 weeks; dose may be increased to 1.25 mg/kg based on response and tolerability.

Pediatric: Not approved for pediatric use; safety and efficacy have not been established.

Geriatric: No specific dosage adjustment required, but caution in older adults due to potential comorbidities.

Renal Impairment: No dose adjustment necessary for mild to moderate impairment; use caution in severe impairment.

Hepatic Impairment: No specific dosage adjustments identified.

Pharmacokinetics

Absorption: Rapidly absorbed after subcutaneous injection.

Distribution: Distributed in plasma with a typical protein binding profile.

Metabolism: Metabolized via proteolytic degradation; not via traditional hepatic pathways.

Excretion: Excreted mainly via proteolytic degradation in tissues.

Half Life: Approximately 13-16 days.

Contraindications

  • Known hypersensitivity to luspatercept or any component of the formulation.

Precautions

  • Monitor for hypertension, thromboembolic events, and secondary malignancies. Use with caution in patients with a history of or active thromboembolic disease or malignancy.

Adverse Reactions - Common

  • Fatigue (Common)
  • Headache (Common)
  • Hypertension (Common)

Adverse Reactions - Serious

  • Thromboembolic events (Less common)
  • Secondary malignancies (Less common)
  • Pure red cell aplasia (PRCA) (Rare)

Drug-Drug Interactions

  • Potential interactions are limited, but caution with other agents that increase blood pressure or thrombotic risk.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor hemoglobin levels, transfusion requirements, blood pressure, and signs of thromboembolism.

Diagnoses:

  • Risk for thrombosis
  • Ineffective tissue perfusion

Implementation: Administer subcutaneous injections as prescribed, monitor patient response.

Evaluation: Assess hemoglobin levels, transfusion frequency, and adverse effects regularly.

Patient/Family Teaching

  • Instruct to report symptoms of blood clots, hypertension, or unusual bleeding.
  • Advise adherence to dosing schedule and regular monitoring appointments.
  • Inform about potential side effects and when to seek medical attention.

Special Considerations

Black Box Warnings:

  • Serious cardiovascular and thromboembolic risks; use only under specified conditions.

Genetic Factors: No specific genetic considerations.

Lab Test Interference: May affect hemoglobin and hematocrit levels.

Overdose Management

Signs/Symptoms: Symptoms of excessive erythropoiesis or thrombotic events.

Treatment: Supportive care; discontinue drug and manage symptoms accordingly.

Storage and Handling

Storage: Store at 2°C to 8°C (36°F to 46°F); do not freeze.

Stability: Stable under recommended storage conditions until the expiration date.

This guide is for educational purposes only and is not intended for clinical use.