Luspatercept is for use in adults with a blood disorder called beta thalassemia, in which the body does not produce enough hemoglobin (HEEM o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs.

Luspatercept is used to treat anemia (lack of red blood cells) in adults with beta thalassemia who need to have regular red blood cell transfusions.

Luspatercept may also be used for purposes not listed in this medication guide.

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

Luspatercept is injected under the skin, usually once every 3 weeks.

A healthcare provider will give you this injection.

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.

Luspatercept 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.

Usual Adult Dose for Anemia:

Initial dose: 1 mg/kg subcutaneously once every 3 weeks
-If no reduction in red blood cell transfusions after 2 doses (6 weeks), increase to 1.25 mg/kg.
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 (Hgb) prior to each administration; if a red blood cell transfusion occurred prior to dosing, use pretransfusion Hgb for dosing purposes.
-If pre-dose Hgb is 11.5 g/dL or higher (not related to recent transfusion), delay dose until Hgb 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.
-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).

Use: Treatment of anemia in beta thalassemia patients who require regular red blood cell transfusions.

Usual Adult Dose for Thalassemia:

Initial dose: 1 mg/kg subcutaneously once every 3 weeks
-If no reduction in red blood cell transfusions after 2 doses (6 weeks), increase to 1.25 mg/kg.
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 (Hgb) prior to each administration; if a red blood cell transfusion occurred prior to dosing, use pretransfusion Hgb for dosing purposes.
-If pre-dose Hgb is 11.5 g/dL or higher (not related to recent transfusion), delay dose until Hgb 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.
-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).

Use: Treatment of anemia in beta thalassemia patients who require regular red blood cell transfusions.

Tell your doctor if you have ever had:

• spleen removal surgery;

• a stroke or blood clot;

• high blood pressure;

• high cholesterol;

• diabetes;

• if you smoke; or

• if you use birth control pills or hormone replacement therapy.

Tell your doctor if you are pregnant or could become pregnant. Luspatercept may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using luspatercept and for at least 3 months after your last dose.

Do not breastfeed while using this medicine, and for at least 3 months after your last 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.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Common side effects of luspatercept may include:

• stomach pain, diarrhea;

• headache, dizziness;

• feeling tired;

• cough; or

• bone pain, joint pain.

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.

Other drugs may affect luspatercept, 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.