Nplate® romiplostim
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Prescribing Information &
Medication Guide		 Important Safety
Information		 The Nplate® NEXUS
Program

Currently on Nplate ®?

If you are currently on Nplate®, then you may be aware of its benefits and risks and how it is different from traditional treatment options.

Durable platelet response

In the two 6-month trials, the primary goal of treatment with Nplate® was "durable platelet response." This was defined as keeping platelet counts greater than or equal to 50,000 per microliter for at least 6 of the last 8 weeks of the 6-month study, even after other ITP treatments were adjusted or taken away. Also, those patients who received rescue therapies at any time during the 6-month trial could not be considered as having a durable platelet response. Studying Nplate® this way helped show how well Nplate® worked by taking the effects of other ITP medications into account.1,2 In the two trials:

  • 61% (25/41) of Nplate® patients who did not have a splenectomy met the durable platelet response, versus 5% (1/21) of placebo patients.1,2
  • 38% (16/42) of Nplate® patients who have had a splenectomy met the durable platelet response, versus 0% (0/21) of placebo patients.1,2

In the trials, if a patient in any given week had a platelet count of 50,000 per microliter or greater, that was called a "weekly platelet response." Platelet counts within 8 weeks of rescue medication were not included. If a patient had four or more weekly platelet responses, that patient was considered to have a "transient platelet response."

All the patients who had transient platelet responses and durable platelet responses were added together to obtain the "overall platelet response"1:

  • 88% (36/41) of Nplate® patients, versus 14% (3/21) of placebo patients who did not have a splenectomy had an overall platelet response.1,2
  • 79% (33/42) of Nplate® patients, versus 0% (0/21) of placebo patients who had a splenectomy had an overall platelet response.1,2

It's important to remember that no other treatment has been studied this way. Discuss with your doctor the risks and benefits of staying on weekly Nplate® therapy. Individual patient results may vary.

You should talk to your healthcare provider about any questions or concerns you have about your disease or your treatment.

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Indication

Nplate® is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) when other medicine to treat your ITP is not the best choice for you or surgery to remove the spleen has not worked well enough. 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.

Important Safety Information

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

Nplate® can cause uncommon but serious side effects:

Bone marrow changes (increased reticulin and possible bone marrow fibrosis). Long-term use of Nplate® may cause changes in your bone marrow. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called "increased reticulin." It is not known if this may progress to a more severe form called "fibrosis." The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormalities in your blood tests. Your healthcare provider will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate®.

Worsening low blood platelet count (thrombocytopenia) and risk of bleeding shortly after stopping Nplate®. When you stop receiving Nplate®, your low blood platelet count (thrombocytopenia) may become worse than before you started receiving Nplate®. These effects are most likely to happen shortly after stopping Nplate® and may last about 2 weeks. The lower platelet counts during this time period may increase your risk of bleeding, especially if you are taking a blood thinner or other medicine that affects platelets. Your healthcare provider will check your blood platelet counts for at least two weeks after you stop taking Nplate®. Call your healthcare provider right away to report any bruising or bleeding.

High platelet counts and higher chance for blood clots. You have a higher chance of getting a blood clot if your platelet count is too 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 too high.

Worsening of blood cancers. Nplate® is not for use in patients with blood cancer or a precancerous condition called myelodysplastic syndrome (MDS). If you have one of these conditions, Nplate® may worsen your cancer or condition and may cause you to die sooner.

Lack or loss of response: If you do not experience results from Nplate® your body may have created cells that are counteractive to Nplate®. Your healthcare provider will monitor your platelet counts and test your blood regularly to determine if this is an issue. 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.

Nplate® is only:
Prescribed by healthcare providers who are enrolled in the Nplate® NEXUS Program.
Given to patients who are enrolled in the Nplate® NEXUS Program.
Given by the enrolled healthcare provider or a provider under their direction. You may not give Nplate® injections to yourself.
Nplate® is for treatment of certain people with low blood platelet counts caused by chronic ITP, not low platelet counts caused by other conditions or diseases.

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
  • Abdominal pain
  • Shoulder pain
  • Indigestion
  • Tingling or numbness in hands and feet
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.You may also report side effects to the Nplate® NEXUS Program at 1-877-NPLATE1 (1-877-675-2831).

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

1. Nplate® (romiplostim) [prescribing information].Thousand Oaks, CA: Amgen Inc; 2008. 2. 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.
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