Indications

Nplate® is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in:

  • adults with chronic 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 the 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 1.

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NOW APPROVED for children with ITP when other ITP treatments have not worked well enough.*

NPLATE®
FOR CHILDREN

THE ONLY ONCE-WEEKLY PLATELET BOOSTER

NPLATE® BOOSTS PLATELETS TO LOWER THE RISK OF BLEEDING IN CHILDREN

  • Children with immune thrombocytopenia (ITP) may have tried other treatments and experienced mixed results.
  • Living with ITP can feel like a roller coaster ride. If you have been disappointed with your child’s treatments so far, you may be looking for more stability.

WHY NPLATE® (ROMIPLOSTIM) for children?

Stable platelet counts

The effectiveness and safety of Nplate® in children with ITP

have been studied in 3 medical studies

  • 2 studies looked at how pediatric patients responded to Nplate® compared to a placebo
  • 1 study looked at the long-term safety profile of Nplate® in pediatric patients
Majority of patients

7 OUT OF 10 PATIENTS

were able to raise their platelet counts to 50,000 platelets per microliter or higher

NPLATE® HAS NO DIETARY RESTRICTIONS
or known drug interactions

While other ITP treatments may require you to plan meals around a pill schedule or stop taking other medicines, Nplate® does not.

Your child can enjoy the calcium-rich foods they love:

Calcium-rich foods

Milk and cereal

Calcium-rich foods

Bread

Calcium-rich foods

Cheese

Calcium-rich foods

Leafy green vegetables

Calcium-rich foods

Pizza

Calcium-rich foods

Ice cream

HOW IS NPLATE® GIVEN?

Nplate® is given once a week as an injection under the skin by a member of your child’s healthcare team.

These weekly visits can help with staying on track to raise and sustain platelet counts. If your child misses a scheduled dose of Nplate®, make sure to schedule the next dose as soon as possible.

Once-weekly

ONCE-WEEKLY NPLATE®

Means you don't have to remind your child to take medicine every day

Personalized treatment

PERSONALIZED TREATMENT

Your child's doctor can increase or decrease the amount of Nplate® given to find the right dose to keep platelet levels stable

WHAT ARE THE POSSIBLE SIDE EFFECTS OF NPLATE®?

The most common side effects of Nplate® in children 1 year of age and older include:

  • inflammation of the passages in the nose and throat
  • upper respiratory tract infection
  • itchy, runny, or blocked nose
  • sore throat and discomfort with swallowing
  • inflammation of the eye
  • ear infection
  • inflammation in the lining of the intestines
  • inflammation of the sinuses
  • cough
  • pain in mouth and throat
  • upper stomach (abdomen) pain
  • diarrhea
  • rash
  • bleeding beneath the surface of the skin or bruising under the skin
  • itchy rash
  • fever
  • swelling in the limbs/hands/feet
  • bruising

Ask a doctor if
Nplate® could be right for your child

Important Safety Information

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

  • 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 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.
    • If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.
  • 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® in adults include:
      • 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
    • The most common side effects of Nplate® in children 1 year of age and older include:
      • inflammation of the passages in the nose and throat
      • upper respiratory tract infection
      • itchy, runny, or blocked nose
      • sore throat and discomfort with swallowing
      • inflammation of the eye
      • ear infection
      • inflammation in the lining of the intestines
      • inflammation of the sinuses
      • cough
      • pain in mouth and throat
      • upper stomach (abdomen) pain
      • diarrhea
      • rash
      • bleeding beneath the surface of the skin or bruising under the skin
      • itchy rash
      • fever
      • swelling in the limbs/hands/feet
      • bruising
    • 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 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.

How will I receive Nplate®?

Nplate® is given under the skin (subcutaneous injection) one time each week by your healthcare provider. 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.

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).

Indications

Nplate® is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in:

  • adults with chronic 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 the 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 1.

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

REFERENCES

1. Nplate® (romiplostim) prescribing information, Amgen. 2. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115:168-186. 3. Data on file, Amgen; Pediatric Long-term Trial CSR; 2017.

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