ith Cancer and Acute Symptomatic VTE 2.3 Dose Reductions for Renal Insufficiency in Extended Treatment of Acute Symptomatic Venous Thromboembolism in Patients with Cancer 2.4 Administration 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Hemorrhage including Spinal / Epidural Hematoma 5.2 Thrombocytopenia 5.3 Benzyl Alcohol 5.4 Laboratory Tests 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Post-Marketing Experience 7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 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 14 CLINICAL STUDIES
14.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction 14.2 Prophylaxis of Deep Vein Thrombosis in Patients Following Hip Replacement Surgery 14.3 Prophylaxis of Deep Vein Thrombosis Following Abdominal Surgery in Patients at Risk for Thromboembolic Complications 14.4 Prophylaxis of Deep Vein Thrombosis in Medical Patients at Risk for Thromboembolic Complications Due to Severely Restricted Mobility During Acute Illness 14.5 Patients with Cancer and Acute Symptomatic Venous Thromboembolism 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN® Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1)].
1.2 Prophylaxis of Deep Vein Thrombosis FRAGMIN is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
In patients undergoing hip replacement surgery [see Clinical Studies (14.2)];
In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.3)];
In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness [see Clinical Studies (14.4)].
1.3 Extended Treatment of Symptomatic Venous Thromboembolism in Patients with CancerFRAGMIN is also indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies (14.5)].
Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE.
2 DOSAGE AND ADMINISTRATION
FRAGMIN is administered by subcutaneous injection. It must not be administered by intramuscular injection.
FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.
Routine coagulation tests such as Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) are relatively insensitive measures of FRAGMIN activity and, therefore, unsuitable for monitoring the anticoagulant effect of FRAGMIN. [see W |
