INDICATIONS

Nplate® is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in:

  • adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough. Read More
  • children 1 year of age and older with ITP for at least 6 months when certain medicines or surgery to remove your spleen have not worked well enough.
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Frequently Asked Questions

What is Nplate®?

Nplate® is a treatment for low blood platelet counts in adults with chronic immune thrombocytopenia (ITP). Nplate® is used when certain other medicines, or surgery to remove the spleen, have not worked well enough.

How could Nplate® help me?

  • Once-weekly Nplate® has been proven to boost and sustain platelets to lower the risk of bleeding, so there may be one less thing to keep you from doing what you love.
  • Nplate® restores platelet stability for 8 out of 10 patients.*
  • Within 1-3 weeks, the majority of patients on Nplate® reached at least 50,000 platelets per microliter. This is a level thought to help reduce the risk of bleeding.

*Based on overall platelet response.

What can I expect with Nplate®?

Nplate® is an injection given by your doctor or nurse once a week. Nplate® has no dietary restrictions and no known drug interactions. This means you won't have to change your meal schedule or other medicines.

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

Nplate® can cause serious side effects, including:

  • 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.
    • If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.

Your healthcare provider will closely monitor your Nplate® dose and blood tests, including platelet counts during treatment.

  • Injection of too much Nplate® may cause a dangerous increase in your blood platelet count and serious side effects.
  • Your healthcare provider may change your dose or stop Nplate®, depending upon the change in your blood platelet count. You must have blood platelet counts done before you start, during, and after Nplate® therapy is stopped.

See “What are the possible side effects of Nplate®?” for other side effects of Nplate®.

What are the possible side effects of Nplate®?

Nplate® may cause serious side effects.

The most common side effects of Nplate® are:

  • Headache
  • Joint pain
  • Dizziness
  • Trouble sleeping
  • Muscle tenderness or weakness
  • Pain in the arms and legs
  • Stomach (abdomen) pain
  • Indigestion
  • Tingling or numbness in hands and feet

Is there information on long-term safety for Nplate®?

The long-term safety data for Nplate® illustrated that adverse events did not increase in frequency with longer drug exposure. The study looked at some patients from previous Nplate® studies. Other safety data can be found in the Prescribing Information and the Important Safety Information.

Can I find financial resources at Nplate® Navigator?

Whatever type of insurance you have–even if you have none–Nplate® Navigator can help you understand how your Nplate® medicine may be covered, and refer you to programs that may be able to help you afford it, such as Nplate® Amgen FIRST STEP™.

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

If you’ve been prescribed Nplate®, you might have questions about your medicine, how it may be covered by your insurance, or resources within your community. That’s why we created Nplate® Navigator—so you have a single place to go to find the support, tools, and resources* most important to you.

*Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

Call Nplate® Navigator to find out more: 1-855-7Nplate (1-855-767-5283)

Ask your doctor if Nplate® is right for you

Important Safety Information

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

  • Nplate® can cause serious side effects, including:

  • 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 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.
    • If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.

  • 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® in adults include:
      • headache
      • joint pain
      • dizziness
      • trouble sleeping
      • muscle tenderness or weakness
      • pain in arms and legs
      • stomach (abdomen) pain
      • shoulder pain
      • indigestion
      • tingling or numbness in hands and feet
      • bronchitis
      • inflammation of the sinuses (sinusitis)
      • vomiting
      • diarrhea
      • upper respiratory tract infection
      • cough
      • nausea
      • pain in mouth and throat (oropharyngeal pain)
    • The most common side effects of Nplate® in children 1 year of age and older include:
      • bruising
      • upper respiratory tract infection
      • pain in mouth and throat (oropharyngeal pain)
    • 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 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.

How will I receive Nplate®?

Nplate® is given as an injection under the skin (subcutaneous) one time each week by your healthcare provider. 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 get 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.

APPROVED USES

Nplate® is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in:

  • adults with immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough.
  • children 1 year of age and older with ITP for at least 6 months when certain 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 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 1.

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

Important Safety Information

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

  • Nplate® can cause serious side effects, including:

  • 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 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.

References

1. Data on file, Amgen; Onset of response; 2018. 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. Nplate® (romiplostim) prescribing information, Amgen.

1. Nplate® (romiplostim) prescribing information, Amgen. 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. Data on file, Amgen; Pediatric Long-term Trial CSR; 2017.

1. Arnold DM. Bleeding complications in immune thrombocytopenia. Hematology Am Soc Hematol Educ Program. 2015;2015:237-242. 2. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002;346:995-1008. 3. Cines DB, McMillan R. Management of adult idiopathic thrombocytopenic purpura. Annu Rev Med. 2005;56:425-442. 4. Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005;115:3339-3347. 5. 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. 6. 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. 7. Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017; 129:2829-2835. 8. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117:4190-4207. 9. Nplate® (romiplostim) prescribing information, Amgen. 10. 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. 11. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criter ia in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113:2386-2393. 12. Thrombocytopenia (low platelet count). Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/thrombocytopenia/symptoms-causes/syc-20378293. Accessed November 8, 2018.

1. Arnold DM. Bleeding complications in immune thrombocytopenia. Hematology Am Soc Hematol Educ Program. 2015;2015:237-242. 2. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002;346:995-1008. 3. Cines DB, McMillan R. Management of adult idiopathic thrombocytopenic purpura. Annu Rev Med. 2005;56:425-442. 4. 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. 5. Nplate® (romiplostim) prescribing information, Amgen. 6. 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.

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. Data on file, Amgen; Onset of response; 2018.