Romiplostim

What it is used for

Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP.

Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. 1.1 Patients with Immune Thrombocytopenia (ITP) Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 1.2 Patients with Hematopoietic Syndrome of Acute Radiation Syndrome Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation.

Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.

The most important thing to know

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. Blood clots in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), heart attack and strokes have happened in people with ITP during treatment with Nplate.

You may get blood clots in the veins of your liver (portal vein thrombosis) with or without chronic liver disease. This may affect your liver function. 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 “How will I receive Nplate?” ). See “

Side effects, and when to stop

” for other side effects of Nplate. What is Nplate? 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 a prescription medicine also used to treat people including newborns who have been exposed to high levels of radiation (acute radiation syndrome). The effectiveness of Nplate for this use was only studied in animals, because it could not be studied in people. 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 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 is safe and effective in children under the age of 1.

Before receiving Nplate, first speak to your healthcare provider and understand the benefits and risks of Nplate. Be sure to tell your healthcare provider about all of your medical conditions, including if you: have had surgery to remove your spleen (splenectomy) have a bone marrow problem, including a blood cancer or MDS have or had a blood clot have chronic liver disease.

have bleeding problems are pregnant or plan to become pregnant. Nplate may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with Nplate. are breastfeeding or plan to breastfeed. Nplate may pass into your breast milk and harm your baby. Do not breastfeed during treatment with Nplate.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine. How will I receive Nplate? Nplate for ITP is given by your healthcare provider as an injection under the skin (subcutaneous) one time each week.

Nplate is given by your healthcare provider as an injection under the skin once for exposure to high levels of radiation. During treatment for ITP, your healthcare provider will closely monitor your Nplate dose and platelet counts. ○ 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. ○ Tell your healthcare provider about any bruising or bleeding that occurs during treatment with Nplate.

If you miss a scheduled dose of Nplate, call your healthcare provider to schedule your next dose as soon as possible.

What to avoid

Avoid situations or medicines that may increase your risk of bleeding. What are the possible side effects of Nplate? Nplate may cause serious side effects. The most common side effects of Nplate in adults include: headache tingling or numbness in hands and feet joint pain bronchitis dizziness inflammation of the sinuses (sinusitis) trouble sleeping vomiting muscle tenderness or weakness pain in the arms and legs stomach (abdomen) pain shoulder pain indigestion 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 of the possible side effects of Nplate. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).