Romiplostim (Injection)

Introduction

Romiplostim (roe-mi-PLOE-stim)

Treats low blood platelet counts and helps prevent bleeding in patients with a blood disorder called idiopathic thrombocytopenic purpura (ITP). This medicine is only used when surgery and other medicines have not worked well enough.

Brand Name(s)

Nplate

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• A doctor or other trained health professional will give you this medicine. This medicine is given as a shot under your skin.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including cirrhosis), bleeding problems, bone marrow problems, a blood cancer, myelodysplastic syndrome (MDS), or a history of blood clots. Also tell your doctor if you have already had surgery to remove your spleen.
• It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving this medicine.
• Using this medicine for a long time may cause changes in your bone marrow. These changes may lead to a serious condition called bone marrow fibrosis, where your body produces less blood cells. Your doctor will check for this unwanted effect.
• Blood clotting problems may occur while you are receiving this medicine. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or shortness of breath and pain in your chest.
• Do not stop receiving this medicine without checking first with your doctor. Stopping this medicine suddenly may cause the number of platelets to go lower than the number you had before you started receiving the medicine. This will increase your risk for bleeding. Your doctor will check your platelet levels and progress when you stop receiving the medicine.
• Portal vein thrombosis (a blood clotting problem) occurs in patients receiving this medicine. It usually occurs in patients with low platelet counts caused by liver problems (including cirrhosis). Check with your doctor right away if you have abdominal or stomach pain, blood in the stool, or if you are vomiting blood.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, shortness of breath, or coughing up blood.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Pain in your lower leg (calf).
• Pinpoint red spots on the skin.
• Sudden or severe headache, problems with vision, speech, or walking.
• Unusual bleeding or bruising, or blood in the urine or stools.
• Weakness in your arm or leg, or on one side of your body.

If you notice these less serious side effects, talk with your doctor:

• Headache or dizziness.
• Muscle or joint pain, or pain in your shoulders, arms, or legs.
• Redness, pain, swelling, itching, blistering, or rash where the shot was given.
• Stomach pain or upset.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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