Drug Insights

Is Reblozyl approved by the FDA?

26 June 2024
4 min read

Yes, Reblozyl (generic name: luspatercept-aamt) is FDA approved. The U.S. Food and Drug Administration (FDA) approved Reblozyl on November 8, 2019, for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

What is Reblozyl?

Reblozyl is a subcutaneous injection that comes in two dosage forms: 25 mg/vial and 75 mg/vial. It belongs to the drug class of miscellaneous erythropoiesis agents. Reblozyl is used to treat anemia by increasing the number of mature red blood cells (RBCs) in the bloodstream, thus reducing the need for blood transfusions. It is specifically indicated for:

  • Beta Thalassemia: A rare inherited blood disorder causing ineffective red blood cell production, leading to anemia.
  • Myelodysplastic Syndromes (MDS): A group of blood cancers where the body cannot produce healthy red blood cells, white blood cells, and platelets properly, resulting in anemia and the need for blood transfusions.

Indications and Usage

Reblozyl is FDA-approved to treat anemia in adult patients with:

  • Beta Thalassemia: Patients requiring regular RBC transfusions.
  • Very Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS): Patients with anemia who have not previously used erythropoiesis-stimulating agents (ESA-naïve) and may require regular RBC transfusions.
  • MDS with Ring Sideroblasts (MDS-RS) or Myelodysplastic/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): Patients who need regular RBC transfusions (two or more RBC units over eight weeks) and have not responded well to or cannot receive an erythropoiesis-stimulating agent (ESA).

Dosage and Administration

Reblozyl is administered as a subcutaneous injection, typically given once every three weeks. The dosage is based on the patient's weight, with initial dosing for anemia in beta thalassemia patients set at 1 mg/kg. If there is no reduction in RBC transfusions after two doses, the dose may be increased to a maximum of 1.25 mg/kg.

Side Effects

Common Side Effects

  • Stomach pain, diarrhea, nausea
  • Headache, dizziness
  • Fatigue
  • Cough, trouble breathing
  • Muscle, bone, and joint pain
  • Allergic reactions

Serious Side Effects

  • Severe headache, blurred vision, pounding in the neck or ears
  • Stroke symptoms: sudden numbness or weakness, severe headache, slurred speech, balance problems
  • Blood clot symptoms: chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; swelling, warmth, or redness in an arm or leg

Reblozyl may also cause fertility problems in females, potentially affecting their ability to become pregnant.

Warnings and Precautions

Patients should inform their doctor about all medical conditions, including:

  • Spleen removal surgery or a history of enlarged spleen or liver
  • History of stroke or blood clot
  • High blood pressure, cholesterol, or diabetes
  • Use of birth control pills or hormone replacement therapy
  • History of extramedullary hematopoietic (EMH) masses

Pregnancy and Breastfeeding

Reblozyl may harm an unborn baby, so it is important for women who can become pregnant to use effective contraception during treatment and for at least three months after the last dose. Breastfeeding should be avoided while using Reblozyl and for at least three months after the last dose.

Conclusion

Reblozyl, approved by the FDA on November 8, 2019, provides a significant therapeutic option for managing anemia in patients with beta thalassemia and certain myelodysplastic syndromes. By increasing the production of mature red blood cells, it helps reduce the need for frequent blood transfusions, thereby improving the quality of life for these patients. As with any medication, patients should discuss potential side effects and interactions with their healthcare provider to ensure safe and effective use.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

The Latest Review Provides Detailed Analysis of CAR-NK and CAR-T Cell Therapies
Hot Spotlight
8 min read
The Latest Review Provides Detailed Analysis of CAR-NK and CAR-T Cell Therapies
26 June 2024
The improved version of CAR-T therapy, CAR-NK therapy, has recently attracted considerable attention from the academic and pharmaceutical sectors due to its increased tumor-specific targeting and cytotoxicity, cost-effectiveness and easier availability of NK cells, shorter large-scale production cycles, and enhanced efficacy in treating solid tumors.
Read →
Chugai collaborates with Helsinn to promote the antiemetic drug AKYNZEO
Hot Spotlight
6 min read
Chugai collaborates with Helsinn to promote the antiemetic drug AKYNZEO
25 June 2024
On June 12, Helsinn Healthcare announced the renewal of its distribution and licensing agreement with Chugai Pharma Europe to promote AKYNZEO® (a combination drug containing netupitant and palonosetron) in the UK and Ireland.
Read →
Pharma Frontiers: Daily Digest of Global Pharmaceutical News - Jun 25
Pharma Frontiers
12 min read
Pharma Frontiers: Daily Digest of Global Pharmaceutical News - Jun 25
25 June 2024
Jun 25th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.
Read →
FDA Approves KEYTRUDA® Combo for Advanced Endometrial Cancer Treatment
Latest Hotspot
4 min read
FDA Approves KEYTRUDA® Combo for Advanced Endometrial Cancer Treatment
24 June 2024
FDA Greenlights Merck’s KEYTRUDA® (pembrolizumab) Combined with Carboplatin and Paclitaxel for Treating Adults with Advanced or Recurrent Endometrial Cancer.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.