Results With Nplate®

Nplate® raised and sustained platelet counts in medical studies1-3

Nplate® medical studies

  • Two 6-month key medical studies1,2
  • A 1-year open-label medical study that looked at how patients did on either Nplate® or on other ITP therapies3

Highlights from the Nplate® 6-month medical studies

  • In two 6-month medical studies, splenectomized and non-splenectomized patients who had at least one prior treatment were given 24 weeks of Nplate® or placebo. Doses were started at 1mcg/kg and were adjusted based on platelet counts.1,2
  • Some patients remained on their current ITP medicines while taking Nplate®. Most of these people were able to either reduce or discontinue these other medicines.1,2
  • The majority (61%) of non-splenectomized patients and more than a third (38%) of splenectomized patients achieved a durable response with Nplate® *,2
  • Within 3 weeks, the majority of patients on Nplate® in these studies reached at least 50,000 platelets per microliter. This is a level that is thought to help reduce the risk of bleeding.1,2

Highlights from the Nplate® 1-year open-label medical study

  • Incidence of treatment failure and splenectomy as well as safety were tested in a 1-year evaluation of Nplate® versus other ITP therapies‡,2
  • Nearly 9 out of 10 patients avoided treatment failures on Nplate®
  • The most common side effects in these 3 studies were mild to moderate.1-3
    —Headache was the most common side effect.

Individual results will vary. Discuss Nplate® with your doctor.
*Durable response was defined as at least 6 weeks with platelet counts of at least 50,000 per microliter during the last 8 weeks of treatment
Treatment failure = platelet count less than 20,000 per microliter for 4 consecutive weeks at the highest recommended dose, a major bleeding event, a change in treatment due to side effects or bleeding symptoms or study discontinuation before treatment failure.3
Other ITP therapies in the study included: steroids, immunoglobulins, rituximab, azathioprine, danazol, platelet transfusions, and other agents

How Nplate® Works: Video Transcript

Indication

Nplate® is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP), when certain other 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 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 18.

Not all patients will respond to Nplate®. Individual patient results may vary.

Hello! This video is designed to help you understand:

  • How platelets are naturally made in the body.
  • How immune thrombocytopenia (or ITP) causes low platelet counts.
  • How Nplate® works to help increase the number of platelets in adults with chronic ITP.
  • Nplate® Important Safety Information.

At any given time, trillions of blood cells are circulating in your body.

There are different types of cells in your blood, including red blood cells, white blood cells and platelets.

ITP is a condition that specifically affects your platelets. Let's take a look inside the body to learn more about platelets.

Platelets are small cells that are needed to help your blood form clots.

They are made by special cells in your bones, in the spongy core called bone marrow. Platelets are normally destroyed after 9 or 10 days and replaced with new platelets.

A protein called thrombopoietin, or TPO, controls how many platelets are made.

In the bone marrow, TPO attaches to the cells that make platelets. This triggers the cells to make platelets and release them into the blood. If the level of TPO in the blood is low, fewer platelets are made. If the level of TPO in the blood is high, more platelets are made.

Normally when there are adequate or high numbers of platelets in circulation, TPO levels are low. However, when platelet levels drop, TPO levels increase to help make more platelets.

Now let's discuss what happens to platelets in adults with chronic ITP.

In adults with chronic ITP, platelets are destroyed by antibodies.

In ITP, antibodies cause the destruction of TPO, the protein needed for platelet production. Since TPO naturally binds to platelets, it is destroyed along with the platelets.

Because TPO levels are low, there is not a strong enough signal for normal platelet production, and therefore, not enough platelets are being produced.

This means ITP involves both increased platelet destruction and lower-than-expected platelet production, which results in low platelet counts.

People with ITP who have lower-than-normal platelet counts have a condition called thrombocytopenia, which can cause bleeding, bruising, and other symptoms.

Now that we've discussed how platelets are formed, and what happens in adults with chronic ITP, let's discuss how Nplate® works to help increase platelet counts in adults with chronic ITP.

Nplate® is a type of medicine called a platelet booster.

Like TPO, Nplate® attaches to special cells in the bone marrow, triggering platelet production.

Nplate® increases platelet production at a rate that outpaces platelet destruction, which helps increase platelet counts in adults with chronic ITP.

It's important to know that not all patients will respond to Nplate®, and individual patient results may vary.

It's important to understand that Nplate® does not bring platelet counts to normal levels, but it can help raise them to a level high enough to help reduce symptoms of ITP.

Important Safety Information
What is the most important information I should know about Nplate®?

Nplate® can cause serious side effects:

  • 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.
  • Loss of response: If you do not experience results from Nplate®, your immune system may have created a response that is counteractive to Nplate®. Your healthcare provider will monitor your platelet counts and test your blood regularly to determine if this is an issue.
  • Blood test monitoring: 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 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 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®are:
      • 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
    • 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 them 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.

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).

Please see Prescribing Information and Medication Guide for more information about Nplate® (romiplostim).

For more information on Nplate®, please review the information on this web site and talk to your healthcare provider. To find a doctor, please use the physician locator tool located on this web site.

References:


  1. Nplate® (romiplostim) prescribing information, Amgen.
  2. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002;346:995-1008.
  3. Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005;115:3339-3347.
  4. Nichol JL. Endogenous TPO (eTPO) levels in health and disease: possible clues for therapeutic intervention. Stem Cells. 1998;16(suppl 2):165-175.
  5. Gernsheimer T. Pathophysiology and thrombokinetics in autoimmune thrombocytopenia. Blood Rev. 2002;16:7-8.

USA-531-107889(1)

Tracking your platelet counts is an important way to monitor whether you are meeting your ITP treatment goals. Use the Nplate® Dose and Platelet Tracker to keep a record of how your dosing affects your platelet counts and work closely with your doctor.

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