bsp; Dosing Regimen
Unstable angina and
non-Q-wave MI 120 IU/kg subcutaneous every 12 hours (with aspirin) (2.1)
DVT prophylaxis in
abdominal surgery 2500 IU subcutaneous once daily or 5000 IU subcutaneous once daily or 2500 IU subcutaneous followed by 2500 IU subcutaneous 12 hours later and then 5000 IU subcutaneous once daily (2.1)
DVT prophylaxis in
hip replacement
surgery Postoperative start - 2500 IU subcutaneous 4 to 8 hours after surgery, then 5000 IU subcutaneous once daily or Preoperative start - day of surgery 2500 IU subcutaneous 2 hours before surgery followed by 2500 IU subcutaneous 4 to 8 hours after surgery, then 5000 IU subcutaneous once daily (2.1)
Preoperative start - Evening Before Surgery 5000 IU subcutaneous followed by 5000 IU subcutaneous 4 to 8 hours after surgery (2.1)
DVT prophylaxis in
medical patients 5000 IU subcutaneous once daily (2.1)
Extended treatment of
VTE in patients with
cancer Month 1 - 200 IU/kg subcutaneous once daily (2.1)
Months 2 - 6 150 IU/kg subcutaneous once daily (2.1)
Do not use as intramuscular injection. FRAGMIN should not be mixed with other injections or infusions. (2)
DOSAGE FORMS AND STRENGTHS
Single-dose prefilled syringe: 2,500 IU/ 0.2 mL, 5,000 IU/ 0.2 mL. 7500 IU/ 0.3 mL, 10,000 IU/ 0.4 mL, 12,500 IU/ 0.5 mL, 15,000 IU/ 0.6 mL, 18,000 IU/ 0.72 mL (3)
Single-dose graduated syringe: 10,000 IU/ 1 mL (3)
Multiple dose vial: 95,000 IU/ 9.5 mL, 95,000/ 3.8 mL (3)
CONTRAINDICATIONS
Active major bleeding (4)
History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. (4)
Hypersensitivity to dalteparin sodium (4, 6.1)
In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN [see Boxed Warning, (4)];
As a treatment for unstable angina and non-Q-wave MI
For prolonged VTE prophylaxis (4)
Hypersensitivity to heparin or pork products (4)
WARNINGS AND PRECAUTIONS
Use caution in conditions with increased risk of hemorrhage (5.1)
Monitor thrombocytopenia of any degree closely (5.2)
Multiple-dose formulations contain benzyl alcohol (5.3)
Periodic blood counts recommended (5.4)
ADVERSE REACTIONS
Most common adverse reaction is hematoma at the injection site. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai at (1-888-274-2378) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Use FRAGMIN with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents (7)
USE IN SPECIFIC POPULATIONS
Safety and effectiveness in pediatric patients have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SPINAL/EPIDURAL HEMATOMAS
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction 1.2 Prophylaxis of Deep Vein Thrombosis 1.3 Extended Treatment of Symptomatic Venous Thromboembolism in Patients with Cancer 2 DOSAGE AND ADMINISTRATION
2.1 Adult Dosage 2.2 Dose Reductions for Thrombocytopenia in Patients w |
