Fragmin

FRAGMIN- dalteparin sodium injection
Pfizer Laboratories Div Pfizer Inc

WARNING: SPINAL/EPIDURAL HEMATOMAS

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
  • A history of traumatic or repeated epidural or spinal punctures
  • A history of spinal deformity or spinal surgery
  • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7)].

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 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 (VTE) in Adult Patients with Cancer

FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult 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)].

1.4 Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients

FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients 1 month of age and older.

1.5 Limitations of Use

FRAGMIN is not indicated for the acute treatment of VTE.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for 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 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.

Table 1 lists the volume of FRAGMIN in mL (based on the 3.8 mL multiple-dose vial 25,000 IU/ mL) and quantity of FRAGMIN in IU, to be administered for a range of patient weights.

Table 1 Quantity and Volume of FRAGMIN to be Administered by Patient Weight
Patient weight (lb) <110 110 to 131 132 to 153 154 to 175 176 to 197 ≥198
Patient weight (kg) <50 50 to 59 60 to 69 70 to 79 80 to 89 ≥90
Quantity of FRAGMIN (IU) 5,500 IU 6,500 IU 7,500 IU 9,000 IU 10,000 IU 10,000 IU
Volume of FRAGMIN (mL)95,000 IU / 3.8 mL 0.22 0.26 0.30 0.36 0.40 0.40

2.2 Prophylaxis of Deep Vein Thrombosis

Prophylaxis of VTE Following Hip Replacement Surgery: Table 2 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.

Table 2 Dosing Options for Patients Undergoing Hip Replacement Surgery
Timing of First Dose of FRAGMIN Dose of FRAGMIN to be Given Subcutaneously
10 to 14 Hours Before Surgery Within 2 Hours Before Surgery 4 to 8 Hours After Surgery * Postoperative Period
*
Or later, if hemostasis has not been achieved.
Up to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 to 10 days postoperatively.
Allow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.
§
Allow approximately 24 hours between doses.
Postoperative Start 2,500 IU 5,000 IU once daily
Preoperative Start — Day of Surgery 2,500 IU 2,500 IU 5,000 IU once daily
Preoperative Start — Evening Before Surgery § 5,000 IU 5,000 IU 5,000 IU once daily

Abdominal Surgery: In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of FRAGMIN is 2,500 IU administered by subcutaneous 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 5,000 IU subcutaneously the evening before surgery, then once daily postoperatively. The usual duration of administration is 5 to 10 days. Alternatively, in patients with malignancy, 2,500 IU of FRAGMIN can be administered subcutaneously 1 to 2 hours before surgery followed by 2,500 IU subcutaneously 12 hours later, and then 5,000 IU once daily postoperatively. The usual duration of administration is 5 to 10 days.

Medical Patients During Acute Illness: In medical patients with severely restricted mobility during acute illness, the recommended dose of FRAGMIN is 5,000 IU administered by subcutaneous injection once daily. In clinical trials, the usual duration of administration was 12 to 14 days.

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