Indications

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

  • adults with chronic 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 the 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 1.

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NOW APPROVED for children with ITP when other ITP treatments have not worked well enough.*

Normal platelet counts | Low platelet countsNormal platelet counts | Low platelet counts

About ITP

Immune Thrombocytopenia (ITP)

ITP is an autoimmune disease,
also called idiopathic
thrombocytopenia, that
attacks the
body’s platelets, so you don’t have
enough platelets in your blood.
The cause of ITP is not known.

Platelets help your blood to clot, which helps to stop bleeding.

Platelet destruction in ITP causes your normal platelet count to drop below what it should be. Depending on how
low your platelet count is, bruising and bleeding may occur.

Nplate® has been proven to boost and sustain platelets to lower the risk of bleeding.

What are some ITP Symptoms?

The symptoms of ITP may be similar to those of other diseases that can cause
platelet counts to drop, which can sometimes make the journey to an ITP diagnosis difficult. ITP symptoms may include:

  • Small red dots on the skin caused by broken blood vessels (petechiae)
  • Purple spots on the skin (purpura)
  • Brusing on the arms and legs resulting from seemingly minor
    bumps (ecchymosis)
  • Frequent or heavy nosebleeds (epistaxis)
  • Heavy bleeding during menstruation (menorrhagia)
  • Bleeding from the gums (gingival bleeding)
  • Blood in the urine (hematuria)

If a person with ITP has very low platelet counts, it is possible to have internal bleeding or, in rare cases, bleeding in the brain. Severe bleeding is rare in ITP.

It’s important to tell your doctor about any symptoms you are experiencing and your complete medical history.

It’s Important to Keep Your Platelet Counts at a Target Range

As you manage your chronic ITP with your doctor, it may help to set a goal for your platelet counts that can be sustained over time. Platelet counts can rise and fall even if your treatment is working, so your healthcare team will try to keep your count within a certain range rather than at an exact number. Talk to your doctor about what's right for you.

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

Normal platelet count range | Low platelet count range

Boosting Platelet Counts

Your doctor may prescribe platelet boosters, which are treatments that aim to increase your platelet count, to reduce the risk of bleeding.

Stable platelet counts

It’s time for the
power of
stable
platelets

You may have experienced mixed results or side effects from other treatments. ln fact, living with ITP can sometimes feel like a roller coaster. If you’ve felt disappointed with your treatments so far, you may be looking for more stability.

Once-weekly Nplate® could help.

How does Nplate® work to boost and sustain platelet counts?

Watch the video to see Nplate® in action

Video: How Nplate works
How Nplate® works

Platelets are made by cells in the bone marrow. The amount of platelets your body makes is controlled by a protein called thrombopoietin (TPO). In people with ITP, the amount of TPO is not high enough to keep platelet production up sufficiently to overcome the platelet destruction.

Nplate® works like TPO, telling the bone marrow to make more platelets, which can help reduce the
risk of bleeding in people with ITP.

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 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.
  • 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
    • The most common side effects of Nplate® in children 1 year of age and older include:
      • inflammation of the passages in the nose and throat
      • upper respiratory tract infection
      • itchy, runny, or blocked nose
      • sore throat and discomfort with swallowing
      • inflammation of the eye
      • ear infection
      • inflammation in the lining of the intestines
      • inflammation of the sinuses
      • cough
      • pain in mouth and throat
      • upper stomach (abdomen) pain
      • diarrhea
      • rash
      • bleeding beneath the surface of the skin or bruising under the skin
      • itchy rash
      • fever
      • swelling in the limbs/hands/feet
      • bruising
    • 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 under the skin (subcutaneous injection) 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.

Pregnancy Surveillance Program: Women who become pregnant during Nplate® treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. The purpose of this program is to collect safety information about the health of you and your baby. Contact the program as soon as you become aware of the pregnancy, or ask your healthcare provider to contact the program for you. You or your healthcare provider can get information and enroll in the program by calling 1-800-77-AMGEN (1-800-772-6436).

Indications

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

  • adults with chronic 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 the 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 1.

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

References

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 criteria 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.

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