a, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia. Headache was the most commonly reported adverse reaction that did not occur at ≥ 5% higher patient incidence in Nplate versus placebo. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-877-Nplate1 (1-877-675-2831) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, Nplate may cause fetal harm. Enroll pregnant patients in the Nplate pregnancy registry by calling 1-877-Nplate1 (1-877-675-2831). (8.1)
Nursing Mothers: A decision should be made to discontinue Nplate or nursing, taking into account the importance of Nplate to the mother. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
Revised: 01/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage Regimen
2.2 Preparation and Administration
2.3 Use of Nplate With Concomitant Medical ITP Therapies
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
5.2 Worsened Thrombocytopenia After Cessation of Nplate
5.3 Thrombotic/Thromboembolic Complications
5.4 Lack or Loss of Response to Nplate
5.5 Malignancies and Progression of Malignancies
5.6 Laboratory Monitoring
5.7 Nplate Distribution Program
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Immunogenicity
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Chronic ITP
16 HOW SUPPLIED/STORAGE AND HANDLING
17 Patient Counseling Information
17.1 Information for Patients
MEDICATION GUIDE
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL, 250 MCG
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL, 500 MCG
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Nplate is 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 increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.
2 DOSAGE AND ADMINISTRATION
Only prescribers enrolled in the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program may prescribe Nplate [see Warnings and Precautions (5.7)]. Nplate must be administered by the enrolled prescribers or healthcare pro |
