Luspatercept-aamt (Injection)

Luspatercept-aamt (Injection) is used to treat anemia in patients with beta thalassemia who need regular red blood cell (RBC) transfusions.

Luspatercept-aamt (Injection) is also used to treat anemia in patients with myelodysplastic syndromes who need regular red blood cell (RBC) transfusions and have never received an erythropoiesis stimulating agent (ESA).

Luspatercept-aamt (Injection) is also used to treat anemia in patients with myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need regular red blood cell (RBC) transfusions. This medicine is given to patients who cannot receive erythropoiesis stimulating agent (ESA) or have received ESA but did not work well.

This medicine is to be given only by or under the immediate supervision of your doctor.

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may increase your risk of having blood clots (for example, deep vein thrombosis, ischemic strokes, portal vein thrombosis, pulmonary embolus). Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, trouble breathing, severe sudden headache, slurred speech, sudden loss of coordination, sudden severe weakness or numbness in the arm or leg, or vision changes.

Call your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat. These may be symptoms of high blood pressure.

This medicine may cause blood problems, including extramedullary hematopoietic masses (EMH). Check with your doctor right away if you have severe back pain, numbness, weakness, or loss of voluntary movement in the feet, legs, hands, or arms, or loss of bowel or bladder control.

Some women who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how luspatercept-aamt (Injection) affects children. It is not recommended for use in children.

Geriatric

Appropriate studies have not been done on how luspatercept-aamt (Injection) affects older adults.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In such cases, your doctor may need to change the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Blood clots, history of or
• Blood problems (e.g., extramedullary hematopoietic masses), history of or
• Hypertension (high blood pressure)—Use with caution. May worsen these conditions.

• Smoking or
• Splenectomy (surgery to remove the spleen), history of—May increase the risk of more serious side effects.

Along with its needed effects, Luspatercept-aamt (Injection) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Black, tarry stools
• Bladder pain
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blood in the urine or stools
• Bloody or cloudy urine
• Blurred vision
• Bone pain
• Chills
• Cough
• Difficult, burning, or painful urination
• Dizziness
• Fever
• Frequent urge to urinate
• Headache
• Loss of taste or smell
• Lower back or side pain
• Nervousness
• Pale skin
• Pinpoint red spots on the skin
• Pounding in the ears
• Rapid weight gain
• Slow or fast heartbeat
• Sore throat
• Tingling of the hands or feet
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss

Less common

• Chest pain or tightness
• Hives, itching, or skin rash
• Hoarseness
• Inability to speak
• Irritation
• Joint pain, stiffness, or swelling
• Lightheadedness or fainting
• Loss of bowel or bladder control
• Numbness, weakness, or loss of voluntary movement in the feet, legs, hands, or arms
• Pain, redness, or swelling in the arm or leg
• Redness of the skin
• Seizures
• Severe back pain
• Severe or sudden headache
• Slurred speech
• Swelling of the eyelids, face, lips, hands, or feet
• Temporary blindness
• Trouble breathing or swallowing
• Weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Luspatercept-aamt. Also, your health care professional may know how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• Diarrhea
• Difficulty in moving
• Ear congestion
• General feeling of discomfort or illness
• Loss of appetite
• Loss of voice
• Lower back, side, or stomach pain
• Muscle pain or stiffness
• Nausea or vomiting
• Runny or stuffy nose
• Shivering
• Sneezing
• Sore throat
• Stomach pain
• Sweating
• Trouble sleeping

Less common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Feeling of constant movement of self or surroundings
• Sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Find detailed information on biosimilars for this medication.

A doctor or other trained health professional will give you this medicine in a hospital. It is given as a shot under your skin once every 3 weeks.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed Dose

Call your doctor or pharmacist for instructions.