Fragmin (dalteparin sodium)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved March 1999

Specific Treatments:

prophylaxis of deep vein thrombosis and symptomatic venous thromboembolism in pediatrics

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General Information

Fragmin (dalteparin sodium) is a low molecular weight heparin.

Fragmin is specifically indicated for the following:

  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
  • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
  • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months
  • To reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.

Fragmin is supplied as an injection for subcutaneous administration. The recommended dose is weight based. Please see drug label.

Clinical Results

FDA Approval

In adults, the efficacy of Fragmin was assessed in adults for the following:

Prophylaxis of deep vein thrombosis in patients following hip replacement surgery, where Fragmin was compared with warfarin sodium and heparin. The incidence of deep vein thrombosis (DVT), as determined by evaluable venography, was significantly lower for the group treated with Fragmin compared with patients treated with warfarin sodium (two studies) and patients treated with heparin (1 study).

Prophylaxis of Deep Vein Thrombosis following abdominal surgery in patients at risk for thromboembolic complications, where Fragmin was superior to placebo and similar to heparin in reducing the risk of DVT.

Prophylaxis of Deep Vein Thrombosis in medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, where Fragmin significantly reduced the incidence of thromboembolic reactions including verified DVT by Day 21 versus placebo.

The efficacy of Fragmin in children was based on a single trial with 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.

Side Effects

Adverse effects associated with the use of Fragmin may include, but are not limited to, the following:

hemorrhage

thrombocytopenia (Type I)

hematoma at the injection site

pain at the injection site

transient elevation of transaminases

The label for Fragmin contains a boxed warning to alert health care professionals and patients that epidural or spinal hematomas (accumulation of blood that can mechanically compress the spinal cord) may occur in patients who are anticoagulated due to taking certain medications called low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia (injection near the spine) or undergoing spinal puncture (removing spinal fluid for testing). These hematomas may result in long-term or permanent paralysis. Health care professionals are advised to consider these risks when scheduling patients for spinal procedures as patients may be at a higher risk of developing VTE.

Mechanism of Action

Fragmin (dalteparin sodium) is a low molecular weight heparin.

Additional Information

For additional information regarding Fragmin or deep vein thrombosis and symptomatic venous thromboembolism, please visit the Fragmin drug label