• Anemia in patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
• Anemia in patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis who have failed an erythropoiesis stimulating agent and require ≥2 RBC units over 8 wk.
• Anemia in patients who have not previously used erythropoiesis-stimulating agents, have very low- to intermediate-risk myelodysplastic syndromes, and may require regular RBC transfusions.

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation
• Pedi: Not recommended for use in children (may ↑ risk of hematologic malignancies).

Use Cautiously in:

• Risk factors for thromboembolism
• Hypertension
• History of extramedullary hematopoietic masses, splenectomy, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL) (↑ risk of extramedullary hematopoietic masses)
• Rep: Women of reproductive potential.

CV: hypertension, DEEP VEIN THROMBOSIS, syncope.

EENT: vertigo.

GI: ↑ liver enzymes, abdominal pain, diarrhea, nausea.

GU: ↓ fertility (females).

Hemat: extramedullary hematopoietic masses.

Local: injection site reactions.

Metab: hyperuricemia.

MS: arthralgia, bone pain.

Neuro: dizziness, fatigue, headache, STROKE.

Resp: cough, PULMONARY EMBOLISM, upper respiratory tract infection.

Misc: hypersensitivity reactions.

Drug-Drug:

• None reported.

• Lyophilized powder for injection: 25 mg/vial; 75 mg/vial;

Anemia in Beta Thalassemia

• SC (Adults): 1 mg/kg every 3 wk. If no reduction in RBC transfusion burden occurs after 2 consecutive doses (6 wk), ↑ dose to 1.25 mg/kg every 3 wk. Discontinue therapy if no reduction in RBC transfusion burden occurs after 3 consecutive doses (9 wk) at maximum dose (1.25 mg/kg) or if unacceptable toxicity occurs.

Anemia in Myelodysplastic Syndromes

• SC (Adults): 1 mg/kg every 3 wk. If patient is not RBC transfusion-free after ≥2 consecutive doses (6 wk), ↑ dose to 1.33 mg/kg every 3 wk. Then, if patient is not RBC transfusion-free after ≥2 consecutive doses (6 wk) at 1.33 mg/kg dose, ↑ dose to 1.75 mg/kg every 3 wk. Discontinue therapy if no reduction in RBC transfusion burden occurs after 3 consecutive doses (9 wk) at maximum dose (1.75 mg/kg) or if unacceptable toxicity occurs.

Reblozyl

• A fusion protein that binds several endogenous transforming growth factor-beta (TGF-β) superfamily ligands. Inhibition of TGF-β superfamily results in increased differentiation and proliferation of erythroid precursors.

• Reduction in RBC transfusions.
• Increase in hemoglobin.

Therapeutic Classification: antianemics

Pharmacologic Classification: fusion proteins

Absorption: Unknown.

Distribution: Not significantly distributed to tissues.

Metabolism/Excretion: Broken down into amino acids.

Half-life: 11–13 days.

(↑ in hemoglobin levels)

• Explain purpose of luspatercept to patient. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
• Advise patient to notify health care professional immediately if signs and symptoms of blood clots (chest pain; trouble breathing or shortness of breath; pain in leg, with or without swelling; a cold or pale arm or leg; sudden numbness or weakness that are both short-term or continue to happen over a long period of time, especially on one side of the body; severe headache or confusion; sudden problems with vision, speech, or balance) occur.
• Inform patient that BP will be monitored before each dose. May require antihypertensive medication to treat elevated BP.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 3 mo after last dose. May impair female fertility.

lus-PAT-er-sept

NDC Code^*

• 59572- Celgene
  • 59572-711- Luspatercept
    • 59572-711-01- 1 VIAL, GLASS in 1 CARTON (59572-711-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

• 59572- Celgene
  • 59572-775- Luspatercept
    • 59572-775-01- 1 VIAL, GLASS in 1 CARTON (59572-775-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS