Fragmin Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Fragmin Injection (dalteparin sodium) is a low molecular weight heparin (LMWH) belonging to the anticoagulant-antithrombotic class of medicines. It is given by injection to help prevent blood clots from forming or stop existing clots from growing larger. Fragmin is used in situations such as surgery, deep vein thrombosis, unstable heart disease, dialysis, and in people with cancer at risk of blood clots.

What is Fragmin Injection

FRAGMIN is a low molecular weight heparin (LMWH) given by injection. It is derived from pig intestines and helps stop blood from clotting or keep an existing clot from getting bigger.

Fragmin Injection uses

• Prevention of blood clots in connection with surgery
• Treatment of acute deep vein thrombosis (DVT)
• Treatment of unstable coronary artery disease (unstable angina and non-Q-wave heart attack)
• Preventing clotting in the dialysis machine during hemodialysis or hemofiltration for kidney failure
• Extended treatment to prevent recurrence of blood clots in people with cancer
• Reducing deep vein thrombosis risk in hospitalized patients with severely restricted mobility during acute illness

Benefits of Fragmin Injection

• Helps prevent new blood clots from forming
• Helps stop existing blood clots from growing larger
• Can reduce the risk of complications from unstable heart disease when used with aspirin
• Treats venous thromboembolism (VTE)
• Helps prevent deep vein thrombosis (DVT)
• Helps reduce recurrence of VTE in certain patients with cancer

How Fragmin Injection works

FRAGMIN works by making thrombin, a substance involved in blood clotting, inactive, which helps stop blood clots from forming or growing.

Fragmin Injection dosage

FRAGMIN is given as an injection under the skin (subcutaneous), or sometimes as a drip or injection into a vein, depending on your condition. It must NOT be injected into a muscle. Do not remove small air bubbles from the prefilled syringe before injecting, to make sure you get the full dose.

Inject into the stomach area (lower abdomen) or the outer thigh or upper buttock, lifting a fold of skin for the stomach or thigh area. Use a different injection site each time to avoid soreness, and clean the injection site with an alcohol swab or soap and water before injecting.

If you are being treated for deep vein thrombosis, your doctor may also start you on a separate blood-thinning tablet. If being treated for unstable heart disease, you may also be told to take aspirin at the same time. Follow your doctor's or nurse's instructions exactly if you are shown how to self-inject at home.

If you miss a twice-daily dose, inject as soon as possible if it has been less than 6 hours since the missed dose; otherwise wait and take the next scheduled dose. If you miss a once-daily dose, inject as soon as possible if it has been less than 12 hours since the missed dose; otherwise wait and take the next scheduled dose. Do not take two doses at the next dosage time to make up for a missed dose.

Available forms and strengths

• Solution for injection in ampoules
• Solution for injection in multi-dose vials (25,000 IU/mL)
• Solution for injection in prefilled syringes with safety needle device
• Solution for injection in single-dose graduated syringes

Side effects of Fragmin Injection

Common

• Pain, bruising, or a hard lump at the injection site
• Change in skin colour at the injection site
• Hair loss
• Easy bruising or bruising without apparent cause
• Nosebleed

Serious

• Allergic reactions (rash, itching, hives, swelling of face/lips/tongue, trouble breathing)
• Unusual or heavy bleeding at any site, including surgical sites
• Blood in urine
• Bleeding from the gums, mouth, anus, or vagina
• Bleeding inside the abdomen
• Severe back pain, numbness or weakness in the legs, or loss of bladder or bowel control (possible signs of spinal or epidural bleeding)
• Signs of stroke or bleeding in the brain (severe headache, confusion, difficulty speaking or seeing, weakness or numbness on one side of the body)
• Signs of high blood potassium (muscle weakness, numbness or tingling, nausea or vomiting, irregular heartbeat)
• Signs of low platelet count (unusual bruising, rash of dark red spots under the skin)
• Chest pain, fainting, or sudden shortness of breath

Warnings and precautions

• People who have a spinal or epidural anesthetic procedure while on FRAGMIN are at risk of bleeding around the spinal cord, which can cause long-term or permanent paralysis. Tell your doctor if you are scheduled for this type of procedure.
• Do not inject FRAGMIN into a muscle, as this is not how it should be given.
• FRAGMIN cannot be swapped unit-for-unit with regular heparin or other low molecular weight heparins, since they differ in how they are made and how they work.
• The multi-dose vial form contains a preservative called benzyl alcohol, which can be dangerous and potentially fatal for newborn babies, causing a condition called 'Gasping Syndrome.' It should not be used in pregnant women, premature babies, or newborns.
• This medicine can cause a drop in platelet count (thrombocytopenia), which needs to be monitored closely, especially early in treatment and long term.
• People with artificial heart valves, especially pregnant women, have had serious clotting problems on this type of medicine, sometimes leading to death.
• Long-term use of this type of medicine has been linked to a risk of thinning bones (osteoporosis).
• If you have an allergy to natural rubber latex, be aware the needle shield on the prefilled syringe may contain latex.
• FRAGMIN is not generally recommended during pregnancy, and the multi-dose vial form must not be used in pregnant women because it contains a preservative that can harm the baby. Tell your doctor if you are pregnant or planning to become pregnant.
• FRAGMIN is not generally recommended while breastfeeding, as small amounts may pass into breast milk. Talk to your doctor if you are breastfeeding.
• FRAGMIN should be used carefully in people with kidney problems, especially severe kidney impairment, because the drug can build up and increase bleeding risk. Your doctor may need to adjust your dose and monitor you closely.
• FRAGMIN should be used carefully in people with liver problems, as they may have a higher risk of bleeding.
• There is no specific information on alcohol and FRAGMIN. If you drink alcohol, discuss this with your doctor.
• FRAGMIN is not expected to affect your ability to drive or use machines, but be cautious until you know how it affects you.

Storage

• Store at room temperature (15-30ºC)
• The 25,000 IU/mL multi-dose vial must be used within 2 weeks after initial penetration
• Keep the prefilled syringes in their pack until you are ready to use them
• Keep in a cool, dry place away from moisture, heat, and sunlight
• Do not store in the bathroom, near a sink, in the car, or on window sills
• Keep out of reach of children
• Dispose of used syringes and needles safely in an approved sharps or puncture-proof container

When to see a doctor

• Get medical help right away if you have signs of spinal bleeding such as back pain, numbness, weakness in your legs, or loss of bladder or bowel control.
• Seek urgent care for any sign of serious bleeding, such as unexplained drop in blood pressure, blood in urine or stool, or unusual bruising.
• If you think you have used too much FRAGMIN, get urgent medical attention right away, even if you feel fine.
• Seek medical attention if you experience chest pain, a fast or irregular heartbeat, or sudden shortness of breath.
• Tell your doctor right away if you develop a severe headache with vomiting, dizziness, confusion, trouble speaking or seeing, or weakness/numbness on one side of your body, as this could be a sign of bleeding in the brain.

Alternatives

• Enoxaparin
• Unfractionated heparin
• Fondaparinux