NPLATE - romiplostim injection, powder, lyophilized, for solution 
Amgen, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Nplate safely and effectively. See full prescribing information for Nplate.
Nplate™ (romiplostim
For subcutaneous injection
Initial U.S. Approval: 2008
INDICATIONS AND USAGE
Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. (1)
DOSAGE AND ADMINISTRATION
Initial dose of 1 mcg/kg once weekly as a subcutaneous injection. (2.1)
Adjust weekly dose by increments of 1 mcg/kg to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding. (2.1)
Do not exceed the maximum weekly dose of 10 mcg/kg. Do not dose if platelet count is > 400 x 109/L. (2.1)
Discontinue Nplate if platelet count does not increase after 4 weeks at the maximum dose. (2.1)
Do not shake during reconstitution; protect reconstituted Nplate from light; administer reconstituted Nplate within 24 hours. (2.2)
The injection volume may be very small. Use a syringe with gradations to 0.01 mL. (2.2)
Discard any unused portion of the single-use vial. (2.2)
DOSAGE FORMS AND STRENGTHS
250 mcg or 500 mcg of deliverable romiplostim in single-use vials (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Nplate increases the risk for reticulin deposition within the bone marrow; clinical studies have not ruled out the possibility that reticulin and other fiber deposition may result in bone marrow fibrosis with cytopenias. Monitor peripheral blood for signs of marrow fibrosis. (5.1)
Discontinuation of Nplate may result in worsened thrombocytopenia than was present prior to Nplate therapy. Monitor complete blood counts (CBCs), including platelet counts, for at least 2 weeks following Nplate discontinuation. (5.2)
Excessive Nplate doses may increase platelet counts to a level that produces thrombotic/thromboembolic complications. (5.3)
Assess patients for the formation of neutralizing antibodies if platelet counts importantly decrease following an initial Nplate response. (5.4)
Nplate may increase the risk for hematological malignancies, especially in patients with myelodysplastic syndrome. (5.5)
Monitor CBCs, including platelet counts and peripheral blood smears, weekly until a stable Nplate dose has been achieved. Thereafter, monitor CBCs, including platelet counts and peripheral blood smears, at least monthly. (5.6)
Nplate is available only through a restricted distribution program called the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program. Under the Nplate NEXUS Program, only prescribers and patients registered with the program are able to prescribe, administer, and receive product. To enroll in the Nplate NEXUS Program, call 1-877-Nplate1 (1-877-675-2831). (5.7)
ADVERSE REACTIONS
The most common adverse reactions (≥ 5% higher patient incidence in Nplate versus placebo) are arthralgi