Drug Guide
Luspatercept-aamt
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/ADrug-Herb Interactions
N/ANursing 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.