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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Support and resources

Support from every angle

ITP can feel overwhelming. We understand.

Nplate Navigator Program

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.

Sign up for Nplate® Navigator
Nplate Navigator Program
Downloads
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Nurse Ambassadors†

Call toll-free: 1-855-7Nplate
(1-855-767-5283)
 Monday - Friday, 9AM - 8PM EST

Sign up now
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Co-pay and reimbursement resources*

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 Amgen FIRST STEP™. See below for more information.

*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.

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Medication answers

Your Nplate® Navigator Nurse Ambassador† may help you find answers to questions about Nplate®.

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Find an ITP specialist
near you

If you are planning to travel or relocate, the
ITP Specialist Finder
can help you locate a doctor who may be able to administer your weekly Nplate® treatment. And if you prefer,
you can also call
Nplate® Navigator to get help finding an ITP specialist near your location.

†Nplate® Navigator Nurse Ambassadors are only available to patients that are prescribed certain products. Nurses are there to support, not replace, your treatment plan and do not provide medical advice or case management services. Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.

Learn about a co-pay program

Amgen FIRST STEP™ Program

The Amgen FIRST STEP™ program can help eligible‡ commercially insured patients cover their out-of-pocket prescription costs, including deductible, co-insurance, and co-payment.

For more information, call Nplate® Navigator or call Amgen FIRST STEP™ Program directly.

1-888-65-STEP1 (1-888-657-8371),
Monday - Friday, 9AM - 8PM EST
or visit amgenfirststep.com

Amgen First Step Program

‡Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law.

 

ITP community websites

Below you'll find a few helpful support groups and national organizations that provide information about ITP and patient support. When using any of these resources, look over the information you receive carefully so that you can understand how it may apply to your specific support needs. Always consult your doctor if you have specific questions about your ITP treatment.

Platelet Disorder Support Association (PDSA)

A nonprofit organization dedicated
to enhancing the lives of people
with ITP and other platelet
disorders through education,
advocacy, research, and support.

pdsa.org

Health Monitor Guide
to ITP

An ITP-focused partner site of
Health Monitor, a leading online
destination for those seeking
trusted, user-friendly information
about various health-related topics.

guide2itp.com

ITP Support
Association

A UK-registered charity that aims to promote and improve the general welfare of people with ITP.

itpsupport.org.uk

National Heart, Lung, and
Blood Institute

A globally led institute that supports and conducts heart, lung, and
blood disease research on behalf
of the federal government at the
National Institutes of Health (NIH).

nhlbi.nih.gov

American Society of
Hematology

The world’s largest professional
society working to conquer blood
diseases.

hematology.org

Platelets on
the Web

Useful information for physicians, patients, and caregivers about idiopathic thrombocytopenic
purpura (ITP).

ouhsc.edu/platelets

These third-party resources are for your information only. Amgen does not endorse and is not responsible for the content included in these resources.

 

Downloadable education and resources

You can download and use these Nplate® resources to answer questions about your ITP, record your medical history and symptoms, and guide your discussion with your healthcare team.

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Summary of Symptoms
and Medical History

Helps you keep your symptoms
and medical history in one
convenient place to share with your
healthcare team
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Conversation Starter

Provides sample questions to help
you talk with your doctor during your
next visit
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Nplate® Dose and
Platelet Tracker

Track the changes to your platelet
counts and your dose each week
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Nplate® Patient Brochure

Can help you understand ITP and
how Nplate® could help
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Nplate® Pediatric Patient &
Caregiver Brochure

Learn about ITP in children and
how Nplate® could help

Call Nplate® navigator to talk to a registered nurse

Call Nplate® navigator to talk to a registered nurse

nplate-navigator-logo-svgnplate-navigator-logo-svg

1-855-7Nplate
(1-855-767-5283)

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Next

Nplate® Navigator
Sign-up

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.