Reblozyl (luspatercept-aamt)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Luspatercept-aamt, a recombinant fusion protein, is an erythroid maturation agent.
Luspatercept-aamt is a recombinant fusion protein that binds several endogenous TGF-beta superfamily ligands, resulting in diminished Smad2/3 signaling. Luspatercept-aamt promotes erythroid maturation through differentiation and increases the percentage of late-stage erythroid precursors in the bone marrow of mice and increases erythroid precursors in humans, thereby increasing erythropoiesis.
Luspatercept-aamt is absorbed with a median time to peak concentration at approximately 5 (3 to 8) days post-dose in adults with beta thalassemia or 6 (3 to 7) days post-dose in adults with myelodysplastic syndrome (MDS). Absorption of luspatercept-aamt is not significantly affected by subcutaneous injection site (upper arm, thigh, or abdomen). The drug is expected to be catabolized into small peptides and amino acids via catabolic degradation processes in multiple tissues.
The geometric mean half-lives of luspatercept-aamt were approximately 11 days in patients with beta thalassemia and 14 days in patients with MDS. No clinically significant differences in luspatercept-aamt pharmacokinetics were observed based on age (18-95 years), sex, race/ethnicity (Asian, white), mild to severe hepatic impairment, mild to moderate renal impairment, baseline serum erythropoietin, RBC tranfusion burden, beta thalassemia genotype, splenectomy, and ring sideroblasts status in MDS.
USES: This medication is used to treat anemia caused by certain blood and bone marrow disorders (such as beta thalassemia, myelodysplastic syndromes). In these conditions, your body does not make enough healthy red blood cells. This medication is thought to work by increasing your body's production of healthy red blood cells and hemoglobin.
This effect may lessen your symptoms caused by anemia and decrease your need for regular blood transfusions.
Generic name: luspatercept-aamt
Pronunciation: (lus-PAT-er-sept)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Reblozyl
Indications
The following indications are listed for Reblozyl:
- Anemia Due To Myelodysplastic Syndrome
- Anemia In Beta Thalassemia
- Anemia In Myelodysplastic Syndrome With Ring Sideroblasts
- Anemia In Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts And Thrombocytosis
Also known as: Anemia Due To Mds, Refractory Anemia With Ringed Sideroblasts Associated With Marked Thrombocytosis.
Dosing
Interrupt treatment for adverse reactions as described in Table 4 (beta thalassemia) and Table 5 (MDS associated anemia).
Table 4. Dosing Modification for Adverse Reactions - Beta Thalassemia.
AdverseReaction Dosing Recommendation Grade 3 or 4 hypersensitivity Discontinue therapy reactions Other grade 3 or 4 adverse reactions Interrrupt therapy and restart when adverse reaction resolves to no more than grade 1 EMH masses causing serious Discontinue therapy complications
Table 5. Dosing Modification for Adverse Reactions - MDS Associated Anemia.
Adverse Reaction Dosing Recommendation Grade 3 or 4 hypersensitivity Discontinue therapy reactions Other grade 3 or 4 adverse reactions Interrupt therapy and restart treatment at next lower dose level (see Table 3) when the adverse reaction resolves to no more than grade 1 If dose delay is >12 consecutive weeks, discontinue therapy
Luspatercept-aamt is administered via subcutaneous injection into the upper arm, thigh, and/or abdomen by a healthcare professional. The drugis available as a lyophilized powder that must be reconstituted prior to use.
Visually inspect luspatercept-aamt for particulate matter and discoloration prior to administration. Reconstituted luspatercept-aamt is a colorless to slightly yellow, clear to slightly opalescent solution which is free of foreign particulate matter.
Calculate the exact total dosing volume of 50 mg/mL solution required for the patient. Divide doses requiring larger reconstituted volumes (i.e., >1.2 mL) into separate similar volume injections and inject into separate sites. If multiple injections are required, use a new syringe and needle for each subcutaneous injection.
Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than 1 dose from a vial. Do not mix with other medications.
If a dose of luspatercept-aamt is delayed or missed, administer the dose as soon as possible and continue therapy as prescribed, with at least 3 weeks between doses.
Store vials at 2-8degreesC in original carton; protect from light. Do not freeze.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No clinically significant differences in luspatercept-aamt pharmacokinetics were observed when used concomitantly with iron-chelating agents.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common (>10%) adverse reactions with luspatercept-aamt in clinical trials include fatigue, headache, musculoskeletal pain, arthralgia, dizziness/vertigo, nausea, diarrhea, cough, abdominal pain, dyspnea, COVID-19, peripheral edema, hypertension, and hypersensitivity.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of luspatercept-aamt are not established in pediatric patients. Luspatercept-aamt is not recommended for use in pediatric patients based on findings in juvenile animals.
There are no available data on luspatercept-aamt use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Luspatercept-aamt may cause fetal harm based on animal reproduction studies. In embryo-fetal development studies, luspatercept-aamt was administered subcutaneously in rats (5, 15, or 30 mg/kg) on gestation days 3 and 10 or in rabbits (5, 20, or 40 mg/kg) on gestation days 4 and 11. Adverse effects observed in both species included reduced live fetuses, decreased fetal body weights, and increased resorptions, post-implantation losses, and skeletal variations.
In a pre- and postnatal development study in pregnant rats, luspatercept-aamt was given subcutaneously (3, 10, or 30 mg/kg) once every 2 weeks during organogenesis through weaning. Lower F1 pup body weights and adverse kidney findings were observed at all dose levels.
There are no data on the presence of luspatercept-aamt in human milk, the effects on the breastfed child, or the effects on milk production. Luspatercept-aamt was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that it is present in human milk. Due to potential serious adverse reactions in the breastfed child, advise against breastfeeding during luspatercept-aamt treatment and for 3 months after the last dose.
The manufacturer recommends no specific dosage adjustments for geriatric patients.
In clinical studies of luspatercept-aamt in beta thalassemia, an insufficient number of patients >=65 years of age were enrolled in order to determine a difference in response from younger patients.
In clinical studies of luspatercept-aamt for the treatment of anemia in ESA-naive and ESA-refractory or -intolerant MDS, 347 (82%) patients were >=65 years of age and 167 (39%) patients were >=75 years of age. No differences in efficacy or safety were noted between patients >=65 years of age and younger patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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