Nplate® (N-plāt) (Romiplostim)
Learn about this cancer-treatment related side effect, practical management information and when to seek medical attention.
What is NPLATE (Romiplostim)?
Nplate is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP), when certain other medicines, or surgery to remove your spleen, have not worked well enough.
- Nplate is not for use in people with a precancerous condition called myelodysplastic syndrome (MDS) or low platelet count caused by any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP).
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- Nplate is only used if your low platelet count and medical condition increase your risk of bleeding.
- Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Nplate is not used to make your platelet count normal.
It is not known if Nplate works or if it is safe in people under the age of 18.
What is the most important information I should know about NPLATE?
NPLATE can cause serious side effects. These serious side effects include:
- Worsening of a precancerous blood condition to a blood cancer (leukemia). Nplate is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS) or for any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP). If you have MDS and receive Nplate, your MDS condition may worsen and become an acute leukemia. If MDS worsens to become acute leuke mia you may die sooner from the acute leukemia.
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Higher risk for blood clots- You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. You may have severe complications or die from some forms of blood clots, such as clots that spread to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts and change your dose or stop Nplate if your platelet counts get high.
If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function. - Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects
- During Nplate therapy, your healthcare provider may change your Nplate dose, depending upon the change in your blood platelet count. You must have blood platelet counts done before you start Nplate, during Nplate therapy, and after Nplate therapy is stopped.
- People who take Nplate may have an increased risk of developing new or worsening changes in the bone marrow called “increased reticulin.” These changes may improve if you stop taking Nplate. Your healthcare provider may need to check your bone marrow for this problem during treatment with Nplate.
- The most common side effects of Nplate are:
- Headache
- Joint pain
- Dizziness
- Trouble sleeping
- Muscle tenderness or weakness
- Pain in arms and legs
- Abdominal pain
- Shoulder pain
- Indigestion
- Tingling or numbness in hands and feet
How should I take NPLATE?
- Before you receive Nplate you should first talk with your healthcare provider and understand the benefits and risks of Nplate.
- Nplate is given as a subcutaneous (SC) injection under the skin one time each week. You may not give Nplate injections to yourself.
- Your healthcare provider will check your platelet count every week and change your dose of Nplate as needed. This will continue until your healthcare provider decides that your dose of Nplate can stay the same. After that, you will need to have blood tests every month. When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.
- Tell your healthcare provider about any bruising or bleeding that occurs while you are receiving Nplate.
- If you miss a scheduled dose of Nplate, call your healthcare provider to arrange for your next dose as soon as possible.
Important Safety Information
- Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of Nplate. You should arrange for your next dose as soon as possible and call your healthcare provider.
- Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
- Tell your Doctor if you are pregnant, or plan to become pregnant. It is not known if Nplate will harm your unborn baby
- Ask your Doctor if you are breast-feeding or plan to breast-feed. It is not known if Nplate passes into your breast milk.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking NPLATE?
Tell your healthcare provider about all your medical conditions, including if you:
- Have had surgery to remove your spleen (splenectomy).
- Have a bone marrow problem, including a blood cancer or MDS.
- Have or had a blood clot.
- Have chronic liver disease.
- Have bleeding problems.
- Have any other medical condition.
- Are pregnant, or plan to become pregnant. It is not known if Nplate will harm your unborn baby.
- Are breast-feeding or plan to breast-feed. It is not known if Nplate passes into your breast milk. You and your healthcare provider should decide whether you will take Nplate or breast-feed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.
General information about NPLATE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Nplate. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Nplate that is written for health professionals.
What are the ingredients in NPLATE?
Active ingredient: Romiplostim
Other ingredient: L-histidine, sucrose, mannitol, polysorbate 20, and hydrochloric acid
