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Fragmin

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Fragmin

Fragmin

INDICATIONS

Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction

FRAGMIN (dalteparin) ® 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].

Prophylaxis of Deep Vein Thrombosis

FRAGMIN (dalteparin) 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];
  • In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies];
  • In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness [see Clinical Studies].

Extended Treatment of Symptomatic Venous Thromboembolism in Patients with Cancer

FRAGMIN (dalteparin) 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 (dalteparin) therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies].

Limitations of Use

FRAGMIN (dalteparin) is not indicated for the acute treatment of VTE.

DOSAGE AND ADMINISTRATION

FRAGMIN (dalteparin) is administered by subcutaneous injection. It must not be administered by intramuscular injection.

FRAGMIN (dalteparin) 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 (dalteparin) activity and, therefore, unsuitable for monitoring the anticoagulant effect of FRAGMIN. [See WARNINGS AND PRECAUTIONS].

Adult Dosage

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 (dalteparin) 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 (dalteparin) , based on the 9.5 mL multiple-dose vial (10,000 IU/mL), to be administered for a range of patient weights.

Table 1 : Volume of FRAGMIN (dalteparin) to be Administered by Patient Weight, Based on 9.5 mL Vial (10,000 IU/mL)

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
Volume of FRAGMIN (mL) 0.55 0.65 0.75 0.90 1.0 1.0

Prophylaxis of Venous Thromboembolism 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 (dalteparin) 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 Surgery1 Postoperative Period2
Postoperative Start     2500 IU3 5000 IU once daily
Preoperative Start - Day of Surgery   2500 IU 2500 IU3 5000 IU once daily
Preoperative Start - Evening Before Surgery4 5000 IU   5000 IU 5000 IU once daily
1 Or later, if hemostasis has not been achieved.
2 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.
3 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.
4 Allow approximately 24 hours between doses.

Abdominal Surgery

In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of FRAGMIN (dalteparin) is 2500 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 (dalteparin) is 5000 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, 2500 IU of FRAGMIN (dalteparin) can be administered subcutaneously 1 to 2 hours before surgery followed by 2500 IU subcutaneously 12 hours later, and then 5000 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 (dalteparin) is 5000 IU administered by subcutaneous 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 (dalteparin) is as follows: for the first 30 days of treatment administer FRAGMIN (dalteparin) 200 IU/kg total body weight subcutaneously once daily. The total daily dose should not exceed 18,000 IU. Table 3 lists the dose of FRAGMIN (dalteparin) to be administered once daily during the first month for a range of patient weights

Month 1

Table 3 : Dose of FRAGMIN (dalteparin) to be Administered Subcutaneously by Patient Weight during the First Month

Body Weight (lbs) Body Weight (kg) FRAGMIN (dalteparin) Dose
(IU) (prefilled syringe)
once daily
≤ 124 ≤ 56 10,000
125 to 150 57 to 68 12,500
151 to 181 69 to 82 15,000
182 to 216 83 to 98 18,000
≥ 217 &gle; 99 18,000

Months 2 to 6

Administer FRAGMIN (dalteparin) at a dose of approximately 150 IU/kg, subcutaneously once daily during Months 2 through 6. The total daily dose should not exceed 18,000 IU. Table 4 lists the dose of FRAGMIN (dalteparin) to be administered once daily for a range of patient weights during months 2-6.

Table 4 : Dose of FRAGMIN (dalteparin) to be Administered Subcutaneously by Patient Weight during Months 2-6

Body Weight (lbs) Body Weight (kg) FRAGMIN (dalteparin) Dose
(IU) (prefilled syringe)
once daily
≤ 124 ≤ 56 7,500
125 to 150 57 to 68 10,000
151 to 181 69 to 82 12,500
182 to 216 83 to 98 15,000
≥ 217 ≥ 99 18,000

Safety and efficacy beyond six months have not been evaluated in patients with cancer and acute symptomatic VTE [see WARNINGS AND PRECAUTION and ADVERSE REACTIONS].

Dose reductions for thrombocytopenia in patients with cancer and acute symptomatic VTE

In patients receiving FRAGMIN (dalteparin) who experience platelet counts between 50,000 and 100,000/mm³, reduce the daily dose of FRAGMIN (dalteparin) by 2,500 IU until the platelet count recovers to ≥ 100,000/mm³. In patients receiving FRAGMIN (dalteparin) who experience platelet counts < 50,000/mm³, discontinue FRAGMIN (dalteparin) 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), monitor anti-Xa levels to determine the appropriate FRAGMIN (dalteparin) dose. Target anti-Xa range is 0.5-1.5 IU/mL. When monitoring anti-Xa in these patients, perform sampling 4-6 hrs after FRAGMIN (dalteparin) dosing and only after the patient has received 3-4 doses.

Administration

Subcutaneous injection technique: Patients should be sitting or lying down and FRAGMIN (dalteparin) administered by deep subcutaneous injection. FRAGMIN (dalteparin) may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock. The injection site should be varied daily. When the area around the navel or the thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection. The entire length of the needle should be inserted at a 45 to 90 degree angle.

Inspect FRAGMIN (dalteparin) prefilled syringes and vials visually for particulate matter and discoloration prior to administration

After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks. Discard any unused solution after 2 weeks.

Instructions for using the prefilled single-dose syringes preassembled with needle guard devices

Prefilled single-dose syringe - Illustration

Fixed dose syringes

To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose has been given. The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.

Graduated syringes

Hold the syringe assembly by the open sides of the device. Remove the needle shield. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.

HOW SUPPLIED

Dosage Forms And Strengths

2,500 IU / 0.2 mL single-dose prefilled syringe
5,000 IU / 0.2 mL single-dose prefilled syringe
7,500 IU / 0.3 mL single-dose prefilled syringe
10,000 IU / 0.4 mL single-dose prefilled syringe
10,000 IU / 1 mL single-dose graduated syringe
12,500 IU / 0.5 mL single-dose prefilled syringe
15,000 IU / 0.6 mL single-dose prefilled syringe
18,000 IU / 0.72 mL single-dose prefilled syringe
95,000 IU / 3.8 mL multiple-dose vial
95,000 IU / 9.5 mL multiple-dose vial

Storage And Handling

After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks.

Dosage Form Strength Package Size NDC Number
Single-dose prefilled syringe1 2,500 IU / 0.2 mL 10 Syringes 62856-250-10
5,000 IU / 0.2 mL 10 Syringes 62856-500-10
7,500 IU / 0.3 mL 10 Syringes 62856-750-10
10,000 IU / 0.4 mL 10 Syringes 62856-100-10
Single-dose graduated syringe2 10,000 IU / 1 mL 10 Syringes 62856-101-10
Single-dose prefilled syringe1 12,500 IU / 0.5 mL 10 Syringes 62856-125-10
15,000 IU / 0.6 mL 10 Syringes 62856-150-10
18,000 IU / 0.72 mL 10 Syringes 62856-180-10
Multiple dose vial 95,000 IU / 3.8 mL 3.8 mL vial 62856-251-01
Multiple dose vial 95,000 IU / 9.5 mL 9.5 mL Vial 62856-102-01
1 Single-dose prefilled syringe, affixed with a 27-gauge x ½ inch needle and preassembled with UltraSafe Passive™ Needle Guard devices.
2 Single-dose graduated syringe, affixed with a 27-gauge x ½ inch needle and preassembled with UltraSafe Passive™ Needle Guard devices. UltraSafe Passive™ Needle Guard is a trademark of Safety Syringes, Inc.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Manufactured for : Eisai Inc., Woodcliff Lake, NJ 07677. Manufactured by : Pfizer Inc New York, NY 10017. Made in Belgium, (multiple-dose vials), Jointly. manufactured by : Pfizer Inc, New York, NY 10017 and Vetter Pharma-Fertigung, GmbH & Co. KG, Ravensburg, Germany (prefilled syringes)

Last reviewed on RxList: 12/2/2010
This monograph has been modified to include the generic and brand name in many instances.

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