Pronunciation:

lus-PAT-er-sept - aamt

Uses of This Medicine:

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 has received ESA but did not work well.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of luspatercept-aamt injection in the pediatric population. Use in children is not recommended.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of luspatercept-aamt injection in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 keep from getting pregnant 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 (eg, 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 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 the medicine. Also, your health care professional may be able to tell you about ways 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.