Luspatercept

Luspatercept is a prescription medication used for the treatment of  Anemia related Beta-Thalassemia and  Anemia-related Myelodysplastic Syndromes. 

• Luspatercept is available under the following different brand names: Reblozyl, luspatercept-aamt

Common side effects of Luspatercept include:

• Stomach pain,
• Diarrhea,
• Headache,
• Dizziness,
• Tiredness,
• Cough,
• Bone pain, and
• Joint pain

Serious side effects of Luspatercept include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Severe headache,
• Blurred vision,
• Pounding in the neck or ears,
• Sudden numbness or weakness (especially on one side of the body),
• Slurred speech,
• Balance problems,
• Chest pain,
• Sudden cough,
• Wheezing,
• Rapid breathing,
• Coughing up blood, and
• Swelling, warmth, or redness in an arm or leg

Rare side effects of Luspatercept include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, of lyophilized powder for reconstitution

• 25 mg/vial (single dose)
• 75 mg/vial (single dose)

Anemia Related Beta-Thalassemia

Adult dosage

• Initial dose: 1 mg/kg once Subcutaneous every 3 weeks
• Do not increase the dose if an adverse reaction occurs
• Titrate dose based on insufficient response
• No reduction in RBC transfusion burden after at least 2 consecutive doses (6 weeks) at 1 mg/kg: Increase to 1.25 mg/kg every 3 weeks
• No reduction in RBC transfusion burden after 3 consecutive doses (9 weeks) at 1.25 mg/kg: Discontinue treatment

Anemia-related Myelodysplastic Syndromes

Adult dosage

• Do not increase the dose if an adverse reaction occurs
• Titrate dose based on insufficient response
• No reduction in RBC transfusion-free after at least 2 consecutive doses (6 weeks) at 1 mg/kg: Increase to 1.33 mg/kg every 3 weeks
• No reduction in RBC transfusion-free after at least 2 consecutive doses (6 weeks) at 1.33 mg/kg: Increase to 1.75 mg/kg every 3 weeks
• No reduction in RBC transfusion burden after 3 consecutive doses (9 weeks) at 1.75 mg/kg: Discontinue treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Luspatercept has severe interactions with no other drugs.
• Luspatercept has serious interactions with no other drugs.
• Luspatercept has moderate interactions with no other drugs.
• Luspatercept has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Luspatercept?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Luspatercept?”

Cautions

• Increased risk of thrombosis/thromboembolism in patients with beta-thalassemia; patients with known risk factors for thromboembolism, g, splenectomy, or concomitant use of hormone replacement therapy, maybe at further increased risk; consider thromboprophylaxis in patients with beta-thalassemia at increased risk; Monitor for signs and symptoms of and institute treatment promptly
• Monitor for hypertension; monitor blood pressure before each administration; manage new-onset hypertension or exacerbations of preexisting hypertension using anti-hypertensive agents
• May cause fetal harm; advise females of reproductive potential of the potential risk to the fetus and use of effective contraception
• Extramedullary hematopoietic masses (EMH)
• EMH observed in treated patients with transfusion-dependent beta-thalassemia
• Incidence of EMH was higher in non-transfusion dependent beta-thalassemia compared to placebo
• Spinal cord compression symptoms due to EMH masses reported
• Possible risk factors for developing EMH a include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (below 8.5 g/dL)
• Monitor at initiation and during treatment for symptoms and signs or complications resulting from EMH masses and treat accordingly
• Discontinue therapy in case of serious complications due to EMH masses
• Avoid use in patients requiring treatment to control the growth of EMH masses

Pregnancy and Lactation

• There are no available data on drug use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Pregnancy testing is recommended for females of reproductive potential before starting treatment

Contraception

• Females of reproductive potential: Use effective contraception during treatment and for at least 3 months after the last dose; may cause embryofetal harm when administered to pregnant women

Infertility

• Females: Based on findings in animals, therapy may impair female fertility; adverse effects on fertility in female rats were reversible after a 14-week recovery period

Lactation

• Luspatercept-aamt was detected in the milk of lactating rats
• When a drug is present in animal milk, it is likely the drug will be present in human milk
• There are no data on the presence of luspatercept in human milk, the effects on the breastfed child, or the effects on milk production
• Owing to the potential for serious adverse reactions in the breastfed child, advise that breastfeeding is not recommended during treatment and for 3 months after the last dose