Fragmin (Dalteparin)
Fragmin
Dalteparin Sodium
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Product of Canada.

Express Ships from Canada.

Prescription Required.
Product of Canada.
Express Ships from Canada.

Fragmin (dalteparin)

What is Fragmin (dalteparin)?

Fragmin, also known as dalteparin, is a low molecular weight heparin used prophylactically and in the treatment of deep vein thrombosis (DVT) and certain ischemic complications of unstable angina and myocardial infarction. Fragmin is also used for the extended treatment of venous thromboembolism (VTE).

How does Fragmin work?

Fragmin (dalteparin) is a low molecular weight heparin that acts as an anticoagulant by inhibiting clotting factor Xa and binding to antithrombin III (AT-III). The dalteparin-AT-III complex irreversibly inhibits factor IIa (thrombin). Dalteparin preferentially inhibits factor Xa.

Dosage and How to Use

Fragmin is available in the following strengths and dosage forms:

  • Single-dose prefilled syringe
    • 2,500 IU / 0.2 mL
    • 5,000 IU / 0.2 mL
    • 7,500 IU / 0.3 mL
  • Single-dose graduated syringe
    • 10,000 IU / 1 mL
  • Single-dose prefilled syringe
    • 12,500 IU / 0.5 mL
    • 15,000 IU / 0.6 mL
    • 18,000 IU / 0.72 mL
  • Multiple-dose vial
    • 95,000 IU / 3.8 mL (25,000 IU / mL)

The dosing for Fragmin varies greatly and depends on the indication that it is being used for. Make sure to take the medication exactly as directed by your doctor.

For DVT prophylaxis in medical patients, the dose is 5,000 IU subcutaneous injection once daily. For most other indications, the dose of Fragmin is determined using a patient’s weight and must be given at specific timeframes around surgery.

Fragmin is given as a subcutaneous injection and cannot be given intramuscularly.

Subcutaneous injection

  • Patients should be lying or sitting down, and Fragmin is given as a deep subcutaneous injection.
  • Acceptable injection sites include a U-shape around the navel, the upper outer side of the thigh, or the buttock.
  • When injecting near the navel or in the thigh, a thumb and forefinger must be used to lift a skin fold to insert the entire needle at a 45 to 90-degree angle.
  • The injection site should change daily.

For detailed instructions on injection technique, please consult your pharmacist or doctor.

Storage

Store at 20° to 25°C (68° to 77°F). Temperature excursions are permitted between 15°C to 30°C (59°F to 86°F). Multiple-dose vials can be stored at room temperature for up to 2 weeks after the first puncture.

Overdosage

If there has been an overdose of Fragmin, seek medical attention due to the risk of hemorrhagic complications. Protamine sulfate is an antidote for Fragmin and other low molecular weight heparins that must be given through intravenous infusion under medical care. It is important to know the amount of Fragmin and when it was injected because that will help medical providers determine how much protamine sulfate will be needed.

Side Effects

The common side effects of Fragmin can include:

  • Redness, pain, or irritation around the injection site

Serious side effects are possible with Fragmin. Contact your doctor immediately if you experience one of the following symptoms of a serious side effect.

  • Bleeding problems such as vomiting or coughing up blood, blood in the urine, abnormal vaginal bleeding, red or tarry stools, unusual bruising
  • Back pain
  • Paralysis
  • Leaking of urine or stool
  • Severe dizziness, confusion, or passing out
  • Severe headache
  • Burning or numbness feeling
  • Muscle weakness
  • Signs of a severe allergic reaction such as hives, itching, red skin, trouble breathing, or swelling of the face or lips

This is not a comprehensive list of all the possible side effects of Fragmin. Reach out to your pharmacist or doctor for more information.

Warnings & Precautions

Boxed Warning

Risk of Hemorrhage, including Spinal/Epidural Hematomas

  • Spinal or epidural hemorrhage and subsequent hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture.
  • Use Fragmin with extreme caution in patients with an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration, angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal or ophthalmological surgery.

Other Warnings & Precautions

Thrombocytopenia

  • Heparin-induced thrombocytopenia (HIT) can occur with the administration of Fragmin. The incidence of this complication is currently unknown. In clinical practice, cases of thrombocytopenia with thrombosis, amputation, and death have been observed.

Risk of Serious Adverse Reactions in Neonates and Infants due to Benzyl Alcohol Preservative

  • Use preservative-free Fragmin in neonates and infants. Serious and fatal adverse reactions, including gasping syndrome, can occur in neonates and low birth-weight infants treated with medications containing benzyl alcohol. Benzyl alcohol is used in multiple-dose vials of Fragmin.

Laboratory Tests

  • Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during treatment with Fragmin.

Drug Interactions and Other Interactions

Using Fragmin in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding.

Contraindications

Fragmin is contraindicated in patients with any of the following:

  • Active major bleeding
  • History of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia with thrombosis
  • Prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions)
  • Patients undergoing Epidural/Neuraxial anesthesia, do not administer Fragmin for the following:
    • As a treatment for unstable angina and non-Q-wave MI
    • For prolonged VTE prophylaxis
  • Patients with prior hypersensitivity to heparin or pork products

Frequently Asked Questions

Fragmin is used to prevent and treat certain types of blood clots, often in the legs or other blood clots that can lead to heart attacks.

Fragmin is a low molecular weight heparin (LMWH) that works by inhibiting certain clotting factors (factor Xa and IIa) to stop blood clots from forming.

You should take Fragmin as a subcutaneous injection. The correct dose will be determined by your doctor and can change depending on what the medication is being used for. Make sure to take Fragmin exactly as directed by your doctor.

Subcutaneous injection

  • Patients should be lying or sitting down, and Fragmin is given as a deep subcutaneous injection.
  • Acceptable injection sites include a U-shape around the navel, the upper outer side of the thigh, or the buttock.
  • When injecting near the navel or in the thigh, a thumb and forefinger must be used to lift a skin fold to insert the entire needle at a 45 to 90-degree angle.
  • The injection site should change daily.

For detailed instructions on injection technique, please consult your pharmacist or doctor.

Patients who have any of the following should not take Fragmin:

  • Active major bleeding
  • History of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia with thrombosis
  • Prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions)
  • Patients undergoing Epidural/Neuraxial anesthesia, do not administer Fragmin for the following:
    • As a treatment for unstable angina and non-Q-wave MI
    • For prolonged VTE prophylaxis
  • Patients with prior hypersensitivity to heparin or pork products

Fragmin (dalteparin) is an anticoagulant known as a low molecular weight heparin. Fragmin and heparin work in similar ways, but Fragmin targets a more specific clotting factor. Fragmin is generally better tolerated by patients and requires fewer injections than heparin.

The common side effects of Fragmin are discomfort or itching around the injection site. This is not the only side effect that may occur. Reach out to your doctor or pharmacist for more information.

Serious side effects with Fragmin are possible. Reach out to your doctor immediately if you experience any of the following symptoms of a serious side effect.

  • Signs of bleeding, such as coughing or throwing up blood, dark or tarry stools, abnormal vaginal bleeding, or unusual bruising
  • Signs of an allergic reaction like rash, hives, red or swollen skin, trouble breathing, or swelling of the mouth and lips
  • Dizziness or passing out
  • Confusion
  • Severe headache
  • Muscle weakness
  • Abnormal burning feeling, numbness, or weakness

The active ingredient in all Fragmin products is dalteparin sodium. Inactive ingredients of Fragmin are water and normal saline or water and benzyl alcohol (multiple-dose vials).

Store Fragmin at 20° to 25°C (68° to 77°F). Temperature excursions are permitted between 15°C to 30°C (59°F to 86°F). Multiple-dose vials can be stored at room temperature for up to 2 weeks after the first puncture.

Take the missed dose as soon as you remember. If it is close to your next dose, skip the missed dose and resume your regular dosing schedule. Never take 2 doses at the same time.

Fragmin is not known to interact with any foods, so there is no need to change your diet when starting the medication.

Fragmin can increase your risk for bleeding, especially when used in combination with other medications that also increase bleeding risk. Make sure your doctor knows about all the medications that you are taking, including prescription, over the counter, and natural supplements. Talk to your doctor or pharmacist before taking any new medications.

Seek medical attention due to the risk of bleeding complications. There is an antidote for Fragmin that must be given under medical care. If possible, keep track of the amount of Fragmin that was injected and at what time it was injected because that will help medical providers determine how much of the antidote will be needed.

If possible, avoid activities that increase your risk of bleeding, bruising, or injury. Use extra caution while shaving and brushing your teeth.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving a dalteparin injection