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Frequently Asked Questions

What is Nplate®?

Nplate® is a man-made protein medicine used to treat low blood platelet countsA measure of how many platelets are in the blood, usually expressed in thousands per microliter (e.g., 50,000) or in 109 per liter (e.g., 50 x 109/L). A count of 50 x 109/L is equal to a count of 50,000 per microliter. in adults with chronic ITP.

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Who should receive 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.

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How does ITP result in low blood platelet counts?

ITP involves two processes: the destruction of existing plateletsSmall cells that are made in the bone marrow and circulate through the bloodstream. Whenever there is damage to a blood vessel, platelets stick to the area to stop or prevent bleeding. by the body’s immune system, and inadequate platelet production to make up for those being destroyed.2-4

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What kind of drug is Nplate®?

Nplate® is a platelet booster. Nplate® imitates TPO, or thrombopoietin, a protein that directs special cells in the bone marrowTissue inside the bones where blood cells are made. to produce platelets. By imitating the action of TPO, platelet boosters help increase platelet production.2

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Will Nplate® raise my platelet count to normal levels?

No, Nplate® is not intended to make your platelet count normal. Treatment with Nplate® is intended to keep your platelet count at about 50,000 per microliter, a level that lowers the risk for bleeding.

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Why do my platelet counts go up and down from one week to the next?

Even when you are on ITP therapy that works for you, platelet counts can vary slightly from week to week, which is why your healthcare provider may adjust your dose of Nplate® until your platelet count reaches at least 50,000 per microliter and stays at that level.

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How is Nplate® given?

Once-weekly Nplate® is given by a healthcare provider as an injection under the skin (also known as a subcutaneous injection).1

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How long has Nplate® been studied?

A study tracked patient experiences with Nplate® for over 5 years. The most common side effects were mild, including headache, nasopharyngitis (inflammation of the nasal passages and the throat), and fatigue. They did not occur more often with longer use of Nplate®.5 Please see Important Safety Information to learn more about additional side effects associated with Nplate®.

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Do I still need to be enrolled in the Nplate® NEXUS Program?

The Nplate® REMS has been changed to remove the Nplate® NEXUS Program. This means that doctors and patients will no longer have to be enrolled in the Nplate® NEXUS Program to prescribe or receive Nplate®. If you enrolled in the Nplate® NEXUS Program in the past, then:

  • There is no need to withdraw or cancel your Nplate® NEXUS Program enrollment
  • Your previously shared personally identifiable health information will remain confidential and protected, but may be used consistent with the terms of the originally signed authorization

If you have any additional questions please speak with your doctor.

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What side effects are associated with Nplate®?

Nplate® can cause serious side effects:

  • Worsening of a precancerous blood condition to a blood cancer (leukemia)
  • Higher risk for blood clots
  • Bone marrow changes (increased reticulin and possible bone marrow fibrosis)
  • Worsening low blood platelet count (thrombocytopeniaThe general term for having platelet counts lower than 100,000 per microliter. Thrombocytopenia can have a number of different causes. ITP is only one cause of thrombocytopenia.) and risk of bleeding shortly after stopping Nplate®
  • Lack or loss of response

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

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

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Do I need to be aware of any drug interactions with Nplate®?

No formal drug interaction studies have been conducted. When discussing treatment approaches with your healthcare provider, it is important to know if you can be on certain ITP treatments and continue to take any nutritional supplements or other medications you're taking. Different treatments for ITP have different benefits and risks. You should discuss all available options with your healthcare provider.

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Is financial assistance available to help pay for Nplate®?

Yes, patients may qualify for programs that provide financial assistance in connection with Nplate®. For more information, please call My Nplate Center® at 1-855-MYCENTER (1-855-692-3683). Learn more about Nplate® Financial Assistance.

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How will I know whether Nplate® is working?

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, based on your platelet counts, 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.

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What resources and patient support are available for people taking Nplate®?

While your doctor and healthcare team are your primary sources of information about ITP and Nplate®, you can also turn to My Nplate® Center for live patient support and personalized services.

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Can I receive Nplate® treatment when I am traveling?

Yes. Through My Nplate® Center, you can receive assistance in locating a physician who can give you your Nplate® injection while you’re away from home.

You or your healthcare provider can call My Nplate® Center at 1-855-MYCENTER (1-855-692-3683) and speak to a patient support specialist to help locate a physician.

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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.

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.

Bone marrow changes (increased reticulin and possible bone marrow fibrosis): Nplate® may cause changes in your bone marrow, but these changes may improve if you stop taking Nplate®. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called "increased reticulin." It is not known if this may progress to a more severe form called "fibrosis." The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormalities in your blood tests. Your healthcare provider will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate®.

Worsening low blood platelet count (thrombocytopenia) and risk of bleeding shortly after stopping Nplate®: When you stop receiving Nplate®, your low blood platelet count (thrombocytopenia) may become worse than before you started receiving Nplate®. These effects are most likely to happen shortly after stopping Nplate® and may last about 2 weeks. The lower platelet counts during this time period may increase your risk of bleeding, especially if you are taking a blood thinner or other medicine that affects platelets. Your healthcare provider will check your blood platelet counts for at least two weeks after you stop taking Nplate®. Call your healthcare provider right away to report any bruising or bleeding.

Lack or loss of response: If you do not experience results from Nplate®, your body may have created cells that are 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
  • 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. V2 Issue Date: 1/2011.
  2. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115:168-186.
  3. Emmons RV, Reid DM, Cohen RL, et al. Human thrombopoietin levels are high when thrombocytopenia is due to megakaryocyte deficiency and low when due to increased platelet destruction. Blood. 1996;87:4068-4071.
  4. Nichol JL. Endogenous TPO (eTPO) levels in health and disease: possible clues for therapeutic intervention. Stem Cells. 1998;16(suppl 2):165-175.
  5. Kuter DJ, Bussel JB, Newland A, et al. Long-term efficacy and safety of romiplostim treatment of adult patients with chronic immune thrombocytopenia (ITP): final report from an open-label extension study. Blood. 2010;116:Abstract 68. Abstract and poster presented at 52nd American Society of Hematology Annual Meeting and Exposition; Orlando, FL.