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Manufacturer Warnings

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FDA Labeling Changes

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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 Cancer

FRAGMIN 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.


There is currently no drug history available for this drug.

Other Information

FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500, 5,000, 7,500, 10,000, 12,500, 15,000 or 18,000 anti-Factor Xa international units (IU), equivalent to 16, 32, 48, 64, 80, 96 or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains either 10,000 or 25,000 anti-Factor Xa IU per 1 mL (equivalent to 64 or 160 mg dalteparin sodium, respectively), for a total of 95,000 anti-Factor Xa IU per vial.

Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5 [see Dosage and Administration (2) and How Supplied (16)].

Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is:

< 3000 daltons 3.0–15%
3,000 to 8,000 daltons 65.0–78.0%
> 8,000 daltons 14.0–26.0%


Chemical Structure

Fragmin Manufacturers

  • Pfizer Laboratories Div Pfizer Inc
    Fragmin (Dalteparin Sodium) Injection [Pfizer Laboratories Div Pfizer Inc]
  • Pfizer, Inc.
    Fragmin (Dalteparin Sodium) Injection, Solution [Pfizer, Inc.]
  • Eisai Inc.
    Fragmin (Dalteparin Sodium) Injection [Eisai Inc.]

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