What is Nplate® and who should receive it?
Nplate® is a man-made protein medicine used to treat low blood platelet counts in adults with chronic (lasting a long time) immune thrombocytopenia (ITP), when certain other medicines, or surgery to remove your spleen, have not worked well enough.1
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 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 between 50,000 and 200,000 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 18.1
How does ITP result in low blood platelet counts?
ITP involves two processes: the destruction of existing platelets by the body’s immune system, and inadequate platelet production.2-4
What kind of drug is Nplate®?
Nplate® is a platelet booster. Nplate® imitates TPO, or thrombopoietin, a protein in the body that signals special cells in the bone marrow to make platelets. By imitating the action of TPO, platelet boosters help increase platelet production.1,3
Will Nplate® raise my platelet count to normal levels?
No, Nplate® is not intended to make your platelet count normal. Treatment with Nplate® is intended to keep your platelet count at about 50,000 per microliter in order to lower the risk for bleeding.1
Why do my platelet counts go up and down from one week to the next?
Platelet counts can vary from week to week, which is why your healthcare provider may adjust your dose of Nplate® until your platelet count reaches at least 50,000 per microliter to reduce the risk of bleeding. Your doctor may also adjust your dose if your platelet count is above 200,000 per microliter for two weeks in a row or temporarily stop your dose if your platelets are above 400,000 per microliter.1
How is Nplate® given?
Before you receive Nplate® you should first talk with your healthcare provider and understand the benefits and risks of Nplate®. Once-weekly Nplate® is given by a healthcare provider as an injection under the skin (also known as a subcutaneous injection). You may not give Nplate® injections to yourself. Your doctor will check your platelet count every week and change your dose of Nplate® as needed. This will continue until your doctor decides that your dose of Nplate® can stay the same. After that, you will need to have 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.1
Tell your healthcare provider about any bruising or bleeding that occurs while you are receiving Nplate®.
If you miss a scheduled dose of Nplate, call your healthcare provider to arrange for your next dose as soon as possible.1
What safety data is available for Nplate®?
What are possible side effects associated with 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® are:1
- Joint pain
- Trouble sleeping
- Muscle tenderness or weakness
- Pain in arms and legs
- Abdominal pain
- Shoulder pain
- Tingling or numbness in hands and feet
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.
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).
Please see Important Safety Information to learn more about side effects associated with Nplate®.
What is the most important information I should know about Nplate®?
Nplate® can cause serious side effects, including1:
- 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. Your healthcare provider will check your blood platelet counts and change your dose or stop Nplate® if your platelet counts get high.
- If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.
When you are being treated with Nplate®, your healthcare provider will closely monitor your Nplate® dose and blood tests, including platelet counts.
- Injection of too much Nplate® may cause a dangerous increase in your blood platelet count and serious side effects.
- During Nplate® therapy, your healthcare provider may change your Nplate® dose, depending upon the change in your blood platelet count. You must have blood platelet counts done before you start Nplate®, during Nplate® therapy, and after Nplate® therapy is stopped.
Is financial assistance available to help pay for Nplate®?
Yes, patients may be eligible for programs that provide financial assistance in connection with Nplate®. For more information, please call Nplate®
(1-855-767-5283) Monday–Friday, 9:00 AM–9:00 PM Eastern Time. Learn more about financial assistance for Nplate®
How will I know whether Nplate® is working?
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, based on your platelet counts, that your dose of Nplate® can stay the same. After that, you will need to have 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.
What resources and patient support are available for people taking Nplate®?
While your doctor and healthcare team are your primary sources of information about ITP and Nplate®, you can also turn to
Nplate® Navigator for live patient support and personalized services.
Can I receive Nplate® treatment when I am traveling?
Through Nplate® Navigator, you can receive assistance in locating a physician who may be able to give you your Nplate® injection while you’re away from home.
You or your healthcare provider can call Nplate® Navigator at
1-855-7Nplate (1-855-767-5283) Monday–Friday, 9:00 AM–9:00 PM Eastern Time, and speak to a registered nurse to help locate a physician.