Luspatercept (REBLOZYL), developed by Bristol-Myers Squibb, has been approved for marketing in many countries for the treatment of adult patients with β-thalassemia who require regular red blood cell transfusions and whose red blood cell transfusions are ≤15 units/24 weeks. This is an erythrocyte maturation agent used to regulate late red blood cell maturation and increase hemoglobin levels.

Reblozyl instructions

Approval history

Previously, Luspatercept has been approved in the United States, the European Union, and Canada for the treatment of adult patients with β-thalassemia who require regular red blood cell transfusions; and in the United States and the European Union for the treatment of anemia associated with myelodysplastic syndrome with ring sideroblasts or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis.

Specifications

25mg/75mg, lyophilized powder.

Dosage and administration

The recommended starting dose is 1 mg/kg, subcutaneously injected once every 3 weeks; check hemoglobin (Hgb) results before each dose.

Adverse reactions

The most common (>10%) adverse reactions are fatigue, headache, musculoskeletal pain, arthralgia, dizziness/vertigo, nausea, diarrhea, cough, abdominal pain, dyspnea, and allergies. In addition, thrombosis/thromboembolism, hypertension, and embryo-fetal toxicity are also included.

Use in specific populations

Pregnancy

Based on the results of animal studies, pregnant women using rotesip may cause fetal harm.

Lactation

Due to the possibility of serious adverse reactions in breastfed children, lactating patients are advised not to breastfeed during treatment with rotesip and within 3 months after the last dose.

Women and men with fertility plans

Roltesip may cause harm to female fertility. Women are advised to undergo pregnancy testing before receiving rotesip treatment and to take effective contraceptive measures during treatment and for at least 3 months after the last dose.