How Nplate® May Help

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Nplate® Side Effects

Multiple medical studies confirm the safety profile of Nplate®, including a long-term follow-up1-3

  • The most common side effects were mild to moderate and did not increase over time.
  • Headache was the most common side effect.

Not all patients will respond to Nplate®. Individual patient results may vary. Discuss Nplate® with your doctor.

Please see Important Safety Information to learn about additional side effects associated with Nplate®.

Indication

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® works or if it is safe in people under the age of 18.

Important Safety Information

What is the most important information I should know about Nplate®?

Nplate® can cause serious side effects:

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 leukemia you may die sooner from the acute leukemia.

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.

Loss of response: If you do not experience results from Nplate®, your immune system may have created a response that is counteractive to Nplate®. Your healthcare provider will monitor your platelet counts and test your blood regularly to determine if this is an issue.

Blood test monitoring: 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.

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
    • 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
  • 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®.
  • These are not all the possible side effects of Nplate®. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.
  • If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Prescribing Information and Medication Guide for more information about Nplate®.

References:

  1. Nplate® (romiplostim) prescribing information, Amgen.
  2. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371:395-403.
  3. Kuter DJ, Rummel M, Boccia R, et al. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010;363:1889-1899.