Reblozyl

Pronunciation: REB-low-zil
Generic name: luspatercept [ lus-PAT-er-sept ]
Dosage form: subcutaneous injection (25 mg/vial, 75 mg/vial)
Drug class: Miscellaneous erythropoiesis agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 28, 2024.

What is Reblozyl?

Reblozyl (luspatercept) is used to treat anemia (low red blood cells) in specific patients with beta thalassemia or myelodysplastic syndromes (MDS); it helps improve anemia, so fewer transfusions are needed. Reblozyl works by helping immature red blood cells become mature, this increases the number of red blood cells (RBC) in the bloodstream, and this reduces the amount of blood transfusions required. Reblozyl mechanism of action is as an erythroid maturation agent.

Reblozyl should not be used instead of RBC blood transfusions in patients with severe anemia who need immediate treatment.

Roblozyl FDA approval was originally for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions, and since then the FDA approval has been extended to include other conditions.

Beta thalassemia is a rare inherited blood disease that causes a problem with the production of red blood cells (erythropoiesis). This means that fewer and less healthy red blood cells are produced, resulting in anemia.

Myelodysplastic syndromes (MDS) are a group of blood cancers in which the body cannot properly make healthy red blood cells, white blood cells, and platelets. Because of the low number of red blood cells, patients become anemic and need to have blood transfusions or treatments to increase their red blood cell levels.

Reblozyl Indications

Reblozyl indications approved by the FDA is to treat anemia in adult patients with:

• beta thalassemia who need to have regular red blood cell (RBC) transfusions
• myelodysplastic syndromes (very low- to intermediate-risk ) who have anemia without having used previous erythropoiesis stimulating agent use (ESA-naïve), who may require regular red blood cell (RBC) transfusions
• myelodysplastic syndromes (very low- to intermediate-risk) with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T), who need to have regular RBC transfusions (2 or more RBC units over 8 weeks) and have not responded well to or cannot receive an erythropoiesis stimulating agent (ESA).

Reblozyl side effects

Common Reblozyl side effects

The most common Reblozyl side effects include:

• stomach pain, diarrhea; nausea;
• headache, dizziness;
• feeling tired;
• cough; trouble breathing;
• muscle pain, bone pain, joint pain: or
• allergic reactions.

Serious Reblozyl side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• severe headache, blurred vision, pounding in your neck or ears;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot deep in the body - swelling, warmth, or redness in an arm or leg.

Your Reblozyl injections may be delayed or permanently discontinued if you have certain side effects.

Reblozyl may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you. See more information below about pregnancy and breastfeeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Before using Reblozyl tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Thrombosis/Thromboembolism: Increased risk for patients with beta thalassemia. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension: Monitor blood pressure (BP) during treatment, start anti-hypertensive treatment if necessary.

Extramedullary Hematopoietic (EMH) Masses: Increased risk in patients with beta thalassemia. Monitor patients for symptoms and signs or complications resulting from the EMH masses.

Embryo-Fetal Toxicity: May cause fetal harm. Females of reproductive potential should use of effective contraception.

Before taking this medicine

Tell your doctor if you have ever had:

• spleen removal surgery, or have or have had enlarged spleen or liver;
• a stroke or blood clot;
• high blood pressure;
• high cholesterol;
• diabetes;
• if you smoke;
• if you use birth control pills or hormone replacement therapy; or
• have a history of extramedullary hematopoietic (EMH) masses.

Pregnancy

Tell your doctor if you are pregnant or could become pregnant. Reblozyl may harm an unborn baby. If you are able to become pregnant, your healthcare provider should ask you to do a pregnancy test before you start treatment. You should use effective birth control to prevent pregnancy while you are using Reblozyl and for at least 3 months after your last dose.

Reblozyl may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 3 months after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

How is Reblozyl given?

Reblozyl is injected under the skin (subcutaneous injection), in the upper arm, thigh, or stomach (abdomen) by your healthcare provider, usually once every 3 weeks.

Before each injection, your will need a blood test to check your hemoglobin levels. Be sure to tell your healthcare provider when you last had a blood transfusion.

Reblozyl doses are based on weight. Your dose needs may change if you gain or lose weight.

Your blood pressure will need to be checked often.

You may be given other medications to help control your blood pressure. Keep using this medicine for as long as your doctor has prescribed.

Reblozyl Dosing information

Usual Adult Reblozyl Dose for Anemia in beta thalassemia:

Reblozyl Initial dose: 1 mg/kg subcutaneously once every 3 weeks

If there is no reduction in red blood cell transfusions after 2 doses (6 weeks), increase to 1.25 mg/kg.

If there is no reduction in RBC transfusion burden after 3 consecutive doses (9 weeks) at 1.25 mg/kg treatment should be discontinued.

Maximum dose: 1.25 mg/kg

Comments:

• This drug is not a substitute for red blood cell transfusions in the immediate correction of anemia.
• Assess and review hemoglobin prior to each administration; if a red blood cell transfusion occurred prior to dosing, use pretransfusion hemoglobin for dosing purposes.
• Do not increase the dose if the patient is experiencing an adverse reaction.
• If pre-dose hemoglobin is 11.5 g/dL or higher (not related to recent transfusion), delay dose until hemoglobin is 11 g/dL or less.
• If treatment response is lost, search for causative factors (e.g. bleeding event); if typical causes are excluded, increase dose to 1.25 mg.
• If the increase in hemoglobin is greater than 2 g/dL within 3 weeks in the absence of transfusions requires a dose reduction or treatment discontinuation. See more detailed dosing information.
• Discontinue therapy if no decrease in transfusions is seen after 9 weeks (3 doses) at the maximum dose or unacceptable toxicity occurs (at any time).

Recommended Adult Reblozyl Dosage for Myelodysplastic Syndromes Associated Anemia

Reblozyl Initial dose: 1 mg/kg subcutaneously once every 3 weeks

If not RBC transfusion-free after at least 2 consecutive doses (6 weeks) at the 1 mg/kg starting dose then dose increase to increase the dose to 1.33 mg/kg every 3 weeks.

If not RBC transfusion-free after at least 2 consecutive doses (6 weeks) at 1.33 mg/kg then increase the dose to 1.75 mg/kg every 3 weeks.

If there is no reduction in RBC transfusion burden including no increase from baseline hemoglobin after at least 3 consecutive doses (9 weeks) at 1.75 mg/kg then treatment should be discontinued.

Comments:

• Prior to each dose, review the patient’s hemoglobin and transfusion record. Titrate the dose based on responses.
• Interrupt treatment for adverse reactions.
• Do not increase the dose if the patient is experiencing an adverse reaction.
• Discontinue Rebozyl if a patient does not experience a decrease in transfusion burden after 9 weeks of treatment (administration of 3 doses) at the maximum dose level or if unacceptable toxicity occurs at any time.

For more detailed information on Rebozyl dosing and information about Dose Titration for Response, Dosing Modifications for Adverse Reactions etc, click on the link below.

Reblozyl Dosage Forms and Strengths

Reblozyl 25 mg lyophilized powder in a single-dose vial for reconstitution

Reblozyl 75 mg lyophilized powder in a single-dose vial for reconstitution

Reblozyl J Code is J0896

What happens if I miss a dose?

You should receive an injection as soon as you can, and then go back to your regular schedule. At least 3 weeks should pass between each injection.

What happens if I overdose?

Since Reblozyl is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Reblozyl Package Insert

Review the Reblozyl Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

What other drugs will affect Reblozyl?

Other drugs may affect Reblozyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Not all possible drug interactions are listed here. To check for interactions, click on the link below.

Ingredients

Active ingredient: luspatercept-aamt

Inactive ingredients: citric acid monohydrate, polysorbate 80, sucrose, and tri-sodium citrate dihydrate.

Storage

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.

Storage of 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 15-30 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.

Manufacturer

Celgene Corporation, a Bristol-Myers Squibb Company, 86 Morris Avenue, Summit, NJ 07901.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2024 Cerner Multum, Inc. Version: 1.01.