Fragmin injection/adult indications and dosage

# FDA-Labeled Indications and Dosage (Adult)

## Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction
In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Fragmin Injection is 120 IU/kg of body weight, but not more than 10,000 IU, subcutaneously (s.c.) every 12 hours with concurrent oral aspirin (75 to 165 mg once daily) therapy. Treatment should be continued until the patient is clinically stabilized. The usual duration of administration is 5 to 8 days. Concurrent aspirin therapy is recommended except when contraindicated.
The table lists the volume of Fragmin, based on the 9.5 mL multiple-dose vial (10,000 IU/mL), to be administered for a range of patient weights.

## Prophylaxis of Venous Thromboembolism Following Hip Replacement Surgery
This table presents the dosing options for patients undergoing hip replacement surgery. The usual duration of administration is 5 to 10 days after surgery; up to 14 days of treatment with Fragmin have been well tolerated in clinical trials.

## Prophylaxis of Venous Thromboembolism Following Abdominal Surgery
In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of Fragmin is 2500 IU administered by s.c. injection once daily, starting 1 to 2 hours prior to surgery and repeated once daily postoperatively. The usual duration of administration is 5 to 10 days.
In patients undergoing abdominal surgery associated with a high risk of thromboembolic complications, such as malignant disorder, the recommended dose of Fragmin is 5000 IU s.c. the evening before surgery, then once daily postoperatively. The usual duration of administration is 5 to 10 days. Alternatively, in patients with malignancy, 2500 IU of Fragmin can be administered s.c. 1 to 2 hours before surgery followed by 2500 IU s.c. 12 hours later, and then 5000 IU once daily postoperatively. The usual duration of administration is 5 to 10 days.
Dosage adjustment and routine monitoring of coagulation parameters are not required if the dosage and administration recommendations specified above are followed.

## Medical Patients with Severely Restricted Mobility During Acute Illness
In medical patients with severely restricted mobility during acute illness, the recommended dose of Fragmin is 5000 IU administered by s.c. injection once daily. In clinical trials, the usual duration of administration was 12 to 14 days.

## Extended Treatment of Symptomatic Venous Thromboembolism in Patients with Cancer
In patients with cancer and symptomatic venous thromboembolism, the recommended dosing of Fragmin is as follows: for the first 30 days of treatment administer Fragmin 200 IU/kg total body weight subcutaneously (s.c.) once daily. The total daily dose should not exceed 18,000 IU. Table 15 lists the dose of Fragmin to be administered once daily during the first month for a range of patient weights.
Administer Fragmin at a dose of approximately 150 IU/kg, s.c. once daily during Months 2 through 6. The total daily dose should not exceed 18,000 IU. Table 16 lists the dose of Fragmin to be administered once daily for a range of patient weights during months 26.
Safety and efficacy beyond six months have not been evaluated in patients with cancer and acute symptomatic VTE (see WARNINGS, Thrombocytopenia and ADVERSE REACTIONS, Patients with Cancer and Acute Symptomatic VTE).
Dose reductions for thrombocytopenia in patients with cancer and acute symptomatic VTE
In patients receiving FRAGMIN who experience platelet counts between 50,000 and 100,000/mm3, reduce the daily dose of FRAGMIN by 2,500 IU until the platelet count recovers to 100,000/mm3. In patients receiving FRAGMIN who experience platelet counts < 50,000/mm3, FRAGMIN should be discontinued until the platelet count recovers above 50,000/mm3.
Dose reductions for renal insufficiency in extended treatment of acute symptomatic venous thromboembolism in patients with cancer
In patients with severely impaired renal function (CrCl < 30 mL/min), monitoring for anti-Xa levels is recommended to determine the appropriate FRAGMIN dose. Target anti-Xa range is 0.51.5 IU/mL. When monitoring anti-Xa in these patients, sampling should be performed 46 hrs after FRAGMIN dosing and only after the patient has received 34 doses.

# Off-Label Use and Dosage (Adult)