STABILITY AND REMISSION WITH NPLATE^® (romiplostim)

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 legs (Deep Vein Thrombosis), lungs (Pulmonary Embolism) or that cause heart attacks or strokes.
  • You may get blood clots in the veins of your liver (Portal Vein Thrombosis) with or without chronic liver disease that 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)
    • headache
  • 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.