reatment of 60 weeks and a maximum duration of 96 weeks.
16 HOW SUPPLIED/STORAGE AND HANDLING
Nplate is supplied in single-use vials containing 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) deliverable romiplostim.
Store Nplate vials in their carton to protect from light until time of use. Keep Nplate vials refrigerated at 2° to 8°C (36° to 46°F). Do not freeze.
17 Patient Counseling Information
See FDA-Approved Medication Guide.
17.1 Information for Patients
Prior to treatment, patients should fully understand the risks and benefits of Nplate. Inform patients that the risks associated with long-term administration of Nplate are unknown and that they must enroll in the Nplate NEXUS Program, which provides for the proper use of Nplate in ITP patients.
Inform patients of the following risks and considerations for Nplate:
Nplate can only be administered by a healthcare provider who is enrolled in the Nplate NEXUS Program or a healthcare provider under their direction.
Nplate therapy is administered to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding; Nplate is not used to normalize platelet counts.
Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy.
Nplate therapy increases the risk of reticulin fiber formation within the bone marrow, and further fiber formation may progress to marrow fibrosis. Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination.
Too much Nplate may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications.
Nplate stimulates certain bone marrow cells to make platelets and may increase the risk for progression of underlying MDS or hematological malignancies.
Platelet counts and CBCs, including peripheral blood smears, must be performed weekly until a stable Nplate dose has been achieved; thereafter, platelet counts and CBCs, including peripheral blood smears, must be performed monthly while taking Nplate.
Patients must be closely monitored with weekly platelet counts and CBCs for at least 2 weeks following Nplate discontinuation.
Even with Nplate therapy, patients should continue to avoid situations or medications that may increase the risk for bleeding.
(Amgen Logo)
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)
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v2
Issue Date: 01/2011
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 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 cel |
