NPLATE- romiplostim injection, powder, lyophilized, for solution 
Amgen Inc

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MEDICATION GUIDE

Nplate®(N-plāt)
(romiplostim)

Read this Medication Guide before you start Nplate and before each Nplate injection. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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

Nplate can cause serious side effects:

When you are being treated with Nplate, your healthcare provider will closely monitor your Nplate dose and blood tests, including platelet counts.

See “What are the possible side effects of Nplate?” for other side effects of Nplate.

What is Nplate?

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.

What should I tell my healthcare provider before taking Nplate?

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Nplate?

Before you receive Nplate you should first talk with your healthcare provider and understand the benefits and risks of Nplate.

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.

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. 

What should I avoid while receiving Nplate?

Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of Nplate.  You should arrange for your next dose as soon as possible and call your healthcare provider.

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.

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). 

General information about the safe and effective use of Nplate.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Nplate.  If you would like more information, talk with your healthcare provider.  You can ask your healthcare provider or pharmacist for information about Nplate that is written for health professionals.

What are the ingredients in Nplate?

Active ingredient: romiplostim

Inactive ingredients: L-histidine, sucrose, mannitol, polysorbate 20, and hydrochloric acid

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Nplate® (romiplostim)

Manufactured by:

Amgen Inc.

One Amgen Center Drive  

Thousand Oaks, California 91320-1799

Revised: 12/2011

This product, its production, and/or its use may be covered by one or more U.S. Patents, including U.S. Patent Nos. 6,835,809, 7,189,827, 7,994,117 and 8,044,174, as well as other patents or patents pending.

© 2008-2011 Amgen Inc.  All rights reserved.
www.nplate.com

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Revised: 05/2013
 
Amgen Inc