Romiplostim

Generic Name: romiplostim (roe-mi-PLOE-stim)
Brand Name: NPlate

Romiplostim is used for:

Treating low platelets (thrombocytopenia) in certain patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP).

Romiplostim is a thrombopoietin (TPO) mimetic protein. It works by helping the bone marrow to increase the number of clot-forming cells (platelets) in the blood. This helps the blood to clot more normally and reduce your risk for excessive or severe bleeding.

Do NOT use romiplostim if:

  • you are allergic to any ingredient in romiplostim
  • you have low blood platelets caused by a certain precancerous blood condition (myelodysplastic syndrome [MDS]) or a condition other than chronic ITP

Contact your doctor or health care provider right away if any of these apply to you.

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Before using romiplostim:

Some medical conditions may interact with romiplostim. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had your spleen removed (splenectomy)
  • if you have or have had a blood clot
  • if you have a history of kidney problems, liver problems, bone marrow problems (eg, myelodysplastic syndrome [MDS]), blood cancer), bleeding problems, heart attack, or stroke
  • if you are also taking an anticoagulant (eg, warfarin) or antiplatelet medicine (eg, clopidogrel)

Some MEDICINES MAY INTERACT with romiplostim. However, no specific interactions with romiplostim are known at this time.

Ask your health care provider if romiplostim may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use romiplostim:

Use romiplostim as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Romiplostim comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again before each time you use romiplostim.
  • Romiplostim is given as an injection at your doctor's office, hospital, or clinic. You should receive romiplostim only under direct medical supervision by a doctor experienced in the use of romiplostim.
  • If you miss a dose of romiplostim, contact your doctor right away.

Ask your health care provider any questions you may have about how to use romiplostim.

Important safety information:

  • Romiplostim may cause dizziness. Use romiplostim with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Romiplostim may worsen a certain precancerous blood condition (MDS) and become a certain type of blood cancer (leukemia). Tell your doctor if you have any of these conditions before you use romiplostim.
  • Romiplostim may increase the risk of high platelet counts and serious, and sometimes fatal, blood clots. Your doctor will check your blood platelet counts while you are taking romiplostim. Discuss any questions or concerns with your doctor.
  • You may be at greater risk for low platelet counts and bleeding after you stop romiplostim. These effects are most likely to occur soon after stopping romiplostim and may last about 2 weeks. Check with your doctor right away if you notice any unusual bleeding or bruising.
  • Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take romiplostim before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts and bone marrow tests, may be performed while you use romiplostim and for at least 2 weeks after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Romiplostim should be used with extreme caution in CHILDREN; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY AND BREAST-FEEDING: It is not known if romiplostim can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using romiplostim while you are pregnant. It is not known if romiplostim is found in breast milk. Do not breast-feed while taking romiplostim.

Possible side effects of romiplostim:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; indigestion; joint pain; mild stomach pain or upset; muscle tenderness or weakness; shoulder pain; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; calf or leg pain, swelling, redness, or tenderness; chest, jaw, or arm pain; confusion; coughing up blood; fainting; numbness or tingling of the hands and feet; one-sided weakness; severe or persistent dizziness or headache; severe or persistent stomach pain; shortness of breath; slurred speech; sudden, severe nausea or vomiting; unusual bruising or bleeding; unusual sweating; unusual weakness or tiredness; vision problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include calf or leg pain, redness, swelling, or tenderness; chest, jaw, or arm pain; confusion; coughing up blood; fainting; one-sided weakness; shortness of breath; slurred speech; sudden, severe nausea or vomiting; unusual sweating or weakness; vision problems.

Proper storage of romiplostim:

Romiplostim is handled and stored by a health care provider. Keep romiplostim out of the reach of children and away from pets.

General information:

  • If you have any questions about romiplostim, please talk with your doctor, pharmacist, or other health care provider.
  • Romiplostim is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take romiplostim or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about romiplostim. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to romiplostim. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using romiplostim.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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