Romiplostim Injection

Romiplostim injection is used to treat immune thrombocytopenia (ITP; a condition that causes an abnormally low number of platelets in the blood) and Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS; a syndrome that occurs when the bone marrow is damaged by radiation exposure). and in people that have been exposed to high levels of radiation (acute radiation syndrome). Romiplostim is in a class of medications called thrombopoietin receptor agonists. It works by causing the bone marrow to produce more platelets.

Romiplostim injection comes as a powder to be mixed with liquid to be injected subcutaneously (under the skin) by a doctor or nurse in a medical office. It is injected once a week in people with ITP. It is given as single dose in people who have been exposed to high levels of radiation.

Your doctor will probably start you on a low dose of romiplostim injection and adjust your dose, not more than once every week. At the beginning of your treatment, your doctor will order a blood test to check your platelet level once every week. Your doctor may increase your dose if your platelet level is too low. If your platelet level is too high, your doctor may decrease your dose or may not give you the medication at all. After your doctor has found the dose that works for you, your platelet level will be checked once every month. Your platelet level will also be checked for at least 2 weeks after you finish your treatment.

Romiplostim injection does not work for everybody. If your platelet level does not increase enough after you have received romiplostim injection for some time, your doctor will stop giving you the medication. Your doctor may also order blood tests to find out why romiplostim injection did not work for you.

Romiplostim injection controls ITP but does not cure it. Continue to keep appointments to receive romiplostim injection even if you feel well.

Your doctor or pharmacist will give you the Medication Guide when you begin treatment with romiplostim injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving romiplostim injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving romiplostim injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had a blood clot, bleeding problems, any type of cancer that affects your blood cells, myelodysplastic syndrome (a condition in which the bone marrow produces abnormal blood cells and there is a risk that cancer of the blood cells may develop), any other condition that affects your bone marrow, or liver disease. Also tell your doctor if you have had your spleen removed.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while receiving romiplostim injection, call your doctor.
• tell your doctor if you are breast-feeding. You should not breast-feed during your treatment with romiplostim injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving romiplostim injection.
• avoid activities that may cause injury and bleeding during your treatment. Romiplostim injection is given to decrease the risk severe bleeding, but there is still a risk that bleeding may occur.

Unless your doctor tells you otherwise, continue your normal diet.

Call your doctor right away if you are unable to keep an appointment to receive a dose of romiplostim injection.

Romiplostim injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• joint or muscle pain
• pain in the arms, legs, or shoulders
• numbness, burning, or tingling in the arms or legs
• nausea, vomiting, heartburn, diarrhea, or stomach pain
• difficulty falling asleep or staying asleep
• runny nose, congestion, cough, or other cold symptoms
• mouth or throat pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• unusual bleeding or bruising
• swelling, pain, tenderness, warmth or redness in one leg
• shortness of breath, fast breathing, pain when breathing deeply, coughing up blood, or fast heartbeat
• chest pain or discomfort; pain in arms, back, neck, jaw, or stomach; shortness of breath; breaking out in cold sweat; nausea; lightheadedness; or dizziness or fainting
• trouble speaking or understanding; weakness or numbness of face, arm, or leg (especially on one side of the body); trouble seeing or loss of vision; trouble walking; or sudden severe headache
• itching; hives difficulty breathing or swallowing; swelling of the face, eyes, lips, or mouth

Romiplostim injection may cause changes in your bone marrow. These changes may cause your bone marrow to make fewer blood cells or to make abnormal blood cells. These blood problems may be life-threatening.

Romiplostim injection may cause your platelet level to increase too much. This may increase the risk that you will develop a blood clot, which may spread to the lungs, or cause a heart attack or a stroke. Your doctor will monitor your platelet level carefully during your treatment with romiplostim injection.

After your treatment with romiplostim injection ends, your platelet level may drop lower than it was before you began your treatment with romiplostim injection. This increases the risk that you will experience bleeding problems. Your doctor will monitor you carefully for 2 weeks after your treatment ends. If you have any unusual bruising or bleeding, tell your doctor immediately.

Talk to your doctor about the risks of receiving romiplostim injection.

Romiplostim injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to romiplostim injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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