NPLATE- romiplostim injection, powder, lyophilized, for solution
What is the most important information I should know about Nplate?
Nplate can cause serious side effects, including:
Your healthcare provider will closely monitor your Nplate dose and blood tests, including platelet counts during treatment.
See “What are the possible side effects of Nplate?” for other side effects of Nplate.
What is Nplate?
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).
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 is safe and effective in children under the age of 18.
Before receiving Nplate, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How will I receive Nplate?
Before you receive Nplate you should first talk with your healthcare provider and understand the benefits and risks of Nplate.
What should I avoid while receiving Nplate?
Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of Nplate. You should schedule your next dose as soon as possible and call your healthcare provider.
What are the possible side effects of Nplate?
Nplate may cause serious side effects. See “What is the most important information I should know about Nplate?”
The most common side effects of Nplate are:
|• Headache||• Pain in arms and legs|
|• Joint pain||• Stomach (abdomen) pain|
|• Dizziness||• Shoulder pain|
|• Trouble sleeping||• Indigestion|
|• Muscle tenderness or weakness||• Tingling or numbness in hands and fee|
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).
General information about the safe and effective use of 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
Inactive ingredients: L-histidine, sucrose, mannitol, polysorbate 20, and hydrochloric acid
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This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2016