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.
Prescribing Information & Medication Guide Indications Important Safety Information Healthcare Professionals QUESTIONS? CONTACT US

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Managing
platelet goals

 

Your healthcare team will help set goals

Manage itp with your doctor

It may help to set a goal for your
platelet counts that can be sustained
over time.

Because platelets can rise and fall even if your treatment is working, your healthcare team will try to keep your platelet count within a
certain range rather than at an exact number.

You and your doctor will set a target range for your platelet counts. Your doctor may prescribe platelet boosters, which are treatments that
aim to increase your platelet count, to reduce the risk of bleeding. Talk to your doctor about what’s right for you.

Remember that raising platelet counts above 50,000 per microliter may reduce your risk of bleeding.

Learn how Nplate® can help raise
platelet counts
Track platelet counts

The Nplate® Dose and Platelet Tracker can
help you track how your platelet counts are changing throughout your treatment.

 

How is Nplate® given?

Nplate® is a once-weekly injection given by a member of your healthcare team

Your weekly visits can help you stay on track to raise and sustain your platelet level.

When you receive your treatment is up to you. Many patients like to schedule their weekly Nplate® treatments at the same time and day each week.

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Treatment while
you
travel

If you’re planning to travel or relocate, ITP Specialist Finder can help you locate a doctor who may be able to administer your weekly Nplate® treatment.

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Personalized
treatment

Your doctor may increase or decrease the dose of your Nplate® injection to keep your platelet level stable.

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Track your
progress

Your healthcare team will measure your platelet count regularly to make sure you are responding to treatment.

If you miss a scheduled dose of Nplate®, make sure to schedule your next dose as soon as possible.

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Partner with your healthcare team

During your weekly visits, keep your healthcare team updated about any changes you experience or questions you have.

How long will I be on Nplate®?

Your doctor will help you understand how long you can expect to receive treatment for ITP. Without stable platelet counts above 50,000 per microliter, the risk of bleeding increases. Speak with your doctor about the importance of sticking with your Nplate® treatment without interruption.

Staying on Nplate® can help raise
and sustain platelet production
over time

Common side effects in Adult Patients

The most common side effect is a headache

Additional common side effects may include:

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

For people treated with Nplate® who experienced side effects, the side effects were mild to moderate and did not increase over time.

Ask your doctor if
Nplate® is right for you

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Download

the Nplate® Dose and
Platelet
Tracker to keep
track of platelet counts
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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.