Nplate® Side Effects

Medical studies have looked at the safety profile of Nplate®, including a long-term follow-up1-4

Patients from previous Nplate® medical studies were enrolled in a long-term follow-up study looking at the safety of Nplate®.

In this long-term study, common side effects reported with Nplate®1,4:

  • were generally mild to moderate, although severe side effects were observed
  • did not get worse with longer treatment
  • occurred at similar rate as in other Nplate® studies.

The most common side effects were headache, nasopharyngitis (inflammation of the nasal passages and the throat), fatigue (feeling tired), contusion (bruising), upper respiratory tract infection, diarrhea, and nose bleeds.4

*The average treatment time with Nplate® in the study was 110 weeks (range 1 to 277 weeks).4

Understanding the Long-Term Nplate® Study4

In the long-term follow-up study, the length of time patients received Nplate® varied (see table). A total of 292 patients from the US, Canada, Europe, and Australia were enrolled. 291 of these patients received at least one dose of Nplate®.

A total of 200 patients completed the long-term study. This means they were followed through the last study visit, regardless of whether or not they were still taking Nplate®.

  • The average time on Nplate® treatment was just over two years.
  • Almost all patients (93%) received Nplate® for at least 24 weeks (approximately 6 months). A total of 23 patients (8%) completed over 240 weeks of treatment.
  • The longest continuous treatment duration studied was approximately 5 years.

For more information, be sure to discuss these results with your healthcare provider.

Length of Time on Nplate®1,4

Treatment period # of patients (%)
> 24 weeks 271 patients (93%)
> 48 weeks 242 patients (83%)
> 96 weeks 117 patients (40%)
> 144 weeks 93 patients (32%)
> 192 weeks 53 patients (18%)
> 240 weeks 23 patients (8%)
  • The most common side effects were mild to moderate and did not increase over time.
  • Headache was the most common side effect.

Not all patients will respond to Nplate®. Individual patient results may vary. Discuss Nplate® with your doctor.

Before taking Nplate®, tell your doctor 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.
  • Have any other medical condition.
  • Are pregnant, or plan to become pregnant. It is not known if Nplate® will harm your unborn baby.
    • Pregnancy Registry: There is a registry for women who become pregnant during treatment with Nplate®. If you become pregnant, consider this registry. The purpose of the registry is to collect safety information about the health of you and your baby. Contact the registry as soon as you become aware of the pregnancy, or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll in the registry by calling 1-800-77-AMGEN (1-800-772-6436).
  • Are breast-feeding or plan to breast-feed. It is not known if Nplate® passes into your breast milk. You and your healthcare provider should decide whether you will take Nplate® or breast-feed. You should not do both.
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