What is Luspatercept?
Luspatercept can be used in adults who have a blood disorder known as beta thalassemia, in which there is not enough haemoglobin produced by the ody. Haemoglobin is a substance that carries oxygen from your bloodstream to tissues and organs.Luspatercept treats anaemia in adults who have beta-thalassemia and need regular red blood cell blood transfusions.This medication guide does not list all possible uses of Luspatercept.
Side effects of Luspatercept
When experiencing signs and symptoms of an allergic reaction, such as hives, difficulty breathing or facial, lip or throat swelling - seek medical help immediately!
If you:
- Severe headache; blurred vision; or a pounding sensation in the neck or ears
- Signs of a stroke include sudden numbness, weakness, or slurred speech (especially on one side) and balance problems.
- Signs of a blood clot in the lungs: chest pain, sudden hack or wheezing; rapid breathing and coughing blood
- Signs of a deep blood clot: swelling, warmth, or redness on an arm or limb
If you experience certain side effects, your luspatercept may be discontinued or delayed.
Some of the most common side effects associated with luspatercept include:
- Stomach pain, diarrhoea;
- Headache, dizziness;
- Feeling tired
- Cough;
- Joint pain.
There may be other side effects. For medical advice on side effects, call your doctor. Reaching out to the FDA with any side effect information can be done at 1-800-FDA-1088.
Warnings
Tell your doctor if you have any medical conditions, allergies, or medicines that you take. Also, tell him if you're pregnant or nursing.
Before you take this drug
Inform your physician immediately of any of the following conditions:
- Spleen surgery;
- A stroke or blood clot
- High blood pressure
- High-cholesterol
- Diabetes;
- If you smoke;
- If you are using birth control pills or hormone replacement therapy,
Inform your doctor immediately if you think you might be pregnant. Luspatercept can harm an unborn child. Use effective contraception during treatment with luspatercept and for 3 months following your last dose.Do not breastfeed for 3 months after the last dose of this medication.
How to take Luspatercept?
In general, Luspatercept injections are given under the skin once every three weeks.This injection will be administered by a healthcare provider.You will need to have a blood test done before each injection. This is to determine your haemoglobin level. Tell your healthcare provider if you have had a transfusion.The dose of Luspatercept is based on your weight.As your weight fluctuates, your dosing requirements may adjust accordingly.Your blood pressure must be regularly checked.Other medications may be prescribed to control your blood pressure. Continue to use this medication as prescribed by your doctor.
Details on dosage
Adult dose for anaemia:
Initial dose: 1 mg/kg once subcutaneously every 3 weeks
If there is no reduction in the number of red blood cells transfused after two doses (six weeks), then increase to 1.25 mg/kg.
Maximum dose: 1.25 mg/kg
Comments:
This drug does not replace red blood cell transfusions for the immediate correction of anaemia.
Use pretransfusion haemoglobin for dosing if there has been a transfusion of red blood cells prior to the administration.
If Hgb at pre-dose is higher than 11.5 g/dL (not due to a recent transfusion), defer the dose until Hgb reaches 11 g/dL.
If treatment does not work, look for the cause (e.g., if bleeding occurs, increase the dose to 1.25 mg).
Discontinue treatment if there is no reduction in transfusions after 3 doses at the maximum dose for 9 weeks or if unacceptable toxicity occurs.
Use: Treat anaemia in beta-thalassemia patients requiring regular red blood cell transfusions.
Adult dose for Thalassemia:
Initial dose: 1 mg/kg once subcutaneously every 3 weeks
If there is no reduction in the number of red blood cells transfused after two doses (six weeks), then increase to 1.25 mg/kg.
Maximum dose: 1.25 mg/kg
Comments:
This drug does not replace red blood cell transfusions for the immediate correction of anaemia.
Use pretransfusion haemoglobin for dosing if there has been a transfusion of red blood cells prior to the administration.
If Hgb at pre-dose is higher than 11.5 g/dL (not due to a recent transfusion), defer the dose until Hgb reaches 11 g/dL.
If treatment does not work, look for the cause (e.g., if bleeding occurs, increase the dose to 1.25 mg).
Discontinue treatment if there is no reduction in transfusions after 3 doses at the maximum dose for 9 weeks or if unacceptable toxicity occurs.
Use: Treat anaemia in beta-thalassemia patients requiring regular red blood cell transfusions.
What happens if I miss the dose?
After receiving an injection, you should return to your normal schedule. Each injection should be separated by at least three weeks.
What happens if I overdose?
Overdoses are unlikely because luspatercept will be administered by a healthcare provider in a medical environment.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
Other drugs, such as vitamins and herbal products, may also affect luspatercept. Informing your physician of all the medicines you are currently taking and any you start or stop taking can prevent misunderstanding.
