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What should I discuss with my health care provider before receiving romiplostim (Nplate)?
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use romiplostim, tell your doctor if you have kidney or liver disease.
FDA pregnancy category C. It is not known whether romiplostim is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
Your name may need to be listed on a pregnancy registry if you become pregnant while receiving romiplostim. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether romiplostim had any effect on the baby
It is not known whether romiplostim passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Using romiplostim may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.
Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.
How is romiplostim given (Nplate)?
Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.
Romiplostim is given as an injection under the skin, usually once per week. Your doctor, nurse, or other healthcare provider will give you this injection.
It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. For best results, keep receiving the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.
After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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