ss
Trouble sleeping
Muscle tenderness or weakness
Pain in hands and feet
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 the Nplate NEXUS Program at 1-877-Nplate1 (1-877-675-2831) or FDA at 1-800-FDA-1088.
General information about the safe and effective use of Nplate
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 dilute hydrochloric acid
Nplate™ (romiplostim)
Manufactured by:
Amgen Inc..
One Amgen Center Drive
Thousand Oaks, California 91320-1799
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 and 7,189,827, as well as other patents or patents pending.
© 2008 Amgen Inc. All rights reserved.
www.Nplate.com
1-877-Nplate1 (1-877-675-2831)
3xxxxxx
v1 Issue Date: 08/2008
This Medication Guide has been approved by the U.S. Food and Drug Administration.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL, 250 MCG
Single Use Vial
1 x 250 mcg/0.5 mL Single Use Vial
NDC 55513-221-01
Amgen®
NplateTM
(romiplostim)
250 mcg
Delivers 250 mcg in 0.5 mL
For Subcutaneous Use Only
Store at 2° to 8°C (36° to 46°F).
No Preservative
Protect from light. Do not freeze.
Rx Only
Reconstitute with 0.72 mL Sterile
Water for Injection, USP.
Do Not Shake reconstituted
solution.
Discard unused portion
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL, 500 MCG
Single Use Vial
1 x 500 mcg/1 mL Single Use Vial
NDC 55513-222-01
Amgen®
NplateTM
(romiplostim)
500 mcg
Delivers 500 mcg in 1 mL
For Subcutaneous Use Only
Store at 2° to 8°C (36° to 46°F).
No Preservative
Protect from light. Do not freeze.
Rx Only
Reconstitute with 1.2 mL Sterile
Water for Injection, USP.
Do Not Shake reconstituted
solution.
Discard unused portion
NPLATE
romiplostim injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 55513-221
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
romiplostim (romiplostim) romiplostim 250 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
hydrochloric acid
HISTIDINE 10 mmol in 1 mL
MANNITOL 40 mg in 1 mL
POLYSORBATE 20 0.04 mg in 1 mL
sucrose 20 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor |
