Luspatercept
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From MedlinePlus, U.S. National Library of Medicine
Erythroid Maturation Agent
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration REBLOZYL should be reconstituted and administered by a healthcare professional. Reconstitute REBLOZYL with Sterile Water for Injection, USP only. [See table below.] 0.5 mL 75 mg vial 1.6 mL 75 mg/1.5 mL 1.5 mL (50 mg/mL) Reconstitute the number of REBLOZYL vials to achieve the appropriate dose based on the patient’s weight.
Use a syringe with suitable graduations for reconstitution to ensure accurate dosage. Reconstitution Instructions 1. Reconstitute with Sterile Water for Injection, USP using volumes described in Table 6 (Reconstitution Volumes) with the stream directed onto the lyophilized powder. Allow to stand for one minute. 2. Discard the needle and syringe used for reconstitution.
The needle and syringe used for reconstitution should not be used for subcutaneous injections. 3. Gently swirl the vial in a circular motion for 30 seconds. Stop swirling and let the vial sit in an upright position for 30 seconds. 4. Inspect the vial for undissolved particles in the solution. If undissolved powder is observed, repeat step 3 until the powder is completely dissolved. 5.
Invert the vial and gently swirl in an inverted position for 30 seconds. Bring the vial back to the upright position, and let it sit for 30 seconds. 6. Repeat step 5 seven more times to ensure complete reconstitution of material on the sides of the vial. 7. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
REBLOZYL is a colorless to slightly yellow, clear to slightly opalescent solution which is free of foreign particulate matter. Do not use if undissolved product or foreign particulate matter are observed. 8. If the reconstituted solution is not used immediately:
Store at room temperature at 20°C to 25°C (68°F to 77°F) in the original vial for up to 8 hours. Discard if not used within 8 hours of reconstitution.
Alternatively, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours in the original vial. Remove from refrigerated condition 15 to 30 minutes prior to injection to allow solution to reach room temperature for a more comfortable injection. Discard if not used within 24 hours of reconstitution.
Do not freeze the reconstituted solution. 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. Instructions for Subcutaneous Administration Calculate the exact total dosing volume of 50 mg/mL solution required for the patient.
Slowly withdraw the dosing volume of the reconstituted REBLOZYL solution from the single-dose vial(s) into a syringe. Divide doses requiring larger reconstituted volumes (i.e., greater than 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.
Administer the injection subcutaneously into the upper arm, thigh, and/or abdomen.
| * Do not increase the dose if the patient is experiencing an adverse reaction as described in Table 5. | |
| REBLOZYL Dosing Recommendation* | |
| Starting Dose | |
| Dose Increases for Insufficient Response | |
| If after at least 2 consecutive doses (6 weeks) at 1 mg/kg, a patient: | |
| If after at least 2 consecutive doses (6 weeks) at 1.33 mg/kg, a patient: | |
| If after at least 3 consecutive doses (9 weeks) at 1.75 mg/kg, a patient: | |
| Dose Modifications for Predose Hemoglobin Levels or Rapid Hemoglobin Rise | |
| Predose hemoglobin is greater than or equal to 12 g/dL in absence of transfusion | |
| Increase in hemoglobin greater than 2 g/dL within 3 weeks in absence of transfusion and | |
| Vial Size | Amount of Sterile Water for Injection, USP required for reconstitution | Final Concentration | Deliverable Volume |
|---|---|---|---|
| 25 mg vial | 0.68 mL | 25 mg/0.5 mL(50 mg/mL) | 0.5 mL |
| 75 mg vial | 1.6 mL | 75 mg/1.5 mL | 1.5 mL |
| (50 mg/mL) |
Contraindications
None. None ( 4 ).
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings in animal reproduction studies, REBLOZYL may cause fetal harm when administered to a pregnant woman . There are no available data on REBLOZYL use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In animal reproduction studies, administration of luspatercept-aamt to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes including embryo-fetal mortality, alterations to growth, and structural abnormalities at exposures (based on area under the curve [AUC]) above those occurring at the maximum recommended human dose (MRHD) ( see Data ). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies, luspatercept-aamt was administered subcutaneously at 5, 15, or 30 mg/kg on gestation days 3 and 10 (rats) or 5, 20, or 40 mg/kg on gestation days 4 and 11 (rabbits). Effects in both species included reductions in numbers of live fetuses and fetal body weights, and increases in resorptions, post-implantation losses, and skeletal variations (such as asymmetric sternal centra in rats and angulated hyoid in rabbits).
Effects were observed at exposures (based on AUC) approximately 7-times (rats) and 16-times (rabbits) the MRHD of 1.75 mg/kg. In a pre- and postnatal development study, pregnant rats were administered luspatercept-aamt subcutaneously at 3, 10, or 30 mg/kg once every 2 weeks during organogenesis and through weaning, gestation day 6 through postnatal day 20. At all dose levels lower F 1 pup body weights and adverse kidney findings (such as membranoproliferative glomerulonephritis, tubular atrophy/hypoplasia, and vessel ectasia occasionally associated with hemorrhage) were observed. These effects were observed at exposures (based on AUC) approximately 1.6-times the MRHD of 1.75 mg/kg.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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