luspatercept

REMS

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.

Contraind./Precautions ⬆ ⬇

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

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.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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.

Therapeutic effects:

Reduction in RBC transfusions.
Increase in hemoglobin.

Classifications ⬆ ⬇

Therapeutic Classification: antianemics

Pharmacologic Classification: fusion proteins

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Not significantly distributed to tissues.

Metabolism/Excretion: Broken down into amino acids.

Half-Life: 11–13 days.

Time/Action Profile ⬆ ⬇

(↑ in hemoglobin levels)

ROUTE	ONSET	PEAK	DURATION
SUBQ	Within 7 days	Unknown	8 wk

Patient/Family Teaching ⬆ ⬇

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.

Pronunciation ⬆ ⬇

Code ⬆

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

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Indications ⬇