FRAGMIN (DALTEPARIN)

FRAGMIN (DALTEPARIN) prevents and treats blood clots. It belongs to a group of medications called blood thinners.

What is dalteparin?

Dalteparin is an anticoagulant that helps prevent the formation of blood clots.

Dalteparin is used with aspirin to prevent blood vessel complications in people with certain angina (chest pain) or heart attack.

Dalteparin is also used to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery or in people bedridden due to a prolonged illness.

Dalteparin is also used long-term to treat a type of blood clot called venous thromboembolism (VTE) in people with cancer.

Dalteparin may also be used for purposes not listed in this medication guide.

Warnings
You should not use dalteparin if you have active bleeding or a low level of platelets in your blood after testing positive for a certain antibody while using dalteparin.

Dalteparin can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, a history of spinal surgery or repeated spinal taps, or if you are using other drugs that can affect blood clotting, including blood thinners or NSAIDs (ibuprofen, Advil, Aleve, and others). This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot, such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Before taking this medicine

You should not use this medicine if you are allergic to dalteparin, heparin, or pork products, or if you have:

active or uncontrolled bleeding; or
a history of blood clot or low levels of platelets in your blood while using heparin.
Dalteparin may cause you to bleed more easily, especially if you have:

• a bleeding disorder that is inherited or caused by disease;
• hemorrhagic stroke;
• an infection of the lining of your heart (also called bacterial endocarditis);
• uncontrolled high blood pressure;
• stomach or intestinal bleeding or ulcer; or
• recent brain, spine, or eye surgery.Dalteparin can cause a serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term or permanent paralysis and may be more likely to occur if:
• you have a genetic spinal defect;
• you have a spinal cord injury;
• you have a spinal catheter in place or if a catheter has been recently removed;
• you have a history of spinal surgery or repeated spinal taps;
• you have recently had a spinal tap or epidural anesthesia;
• you take an NSAID (nonsteroidal anti-inflammatory drug)–ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
• you take a blood thinner (warfarin, Coumadin) or other medicines to treat or prevent blood clots.

Tell your doctor if you have ever had:

• eye problems caused by diabetes or high blood pressure;
• severe liver or kidney disease;
• recent stomach bleeding;
• low levels of platelets in your blood; or
• if you have recently had a spinal tap or epidural anesthesia.
• It is not known whether this medicine will harm an unborn baby. However, some forms of dalteparin contain a preservative that may harm a newborn.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How should I use dalteparin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Dalteparin is usually given daily for DVT or blood vessel complications until your bleeding condition improves. When used for VTE, dalteparin is often used for several months.

Dalteparin is injected under the skin. A healthcare provider may teach you how to use the medication by yourself properly.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colours or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject dalteparin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You should be sitting or lying down during the injection. Do not inject dalteparin into a muscle.

Do not mix dalteparin with other medications in the same syringe unless your doctor tells you to.

If you use a single-dose prefilled syringe, follow the injection instructions closely. Single-dose syringes come in two different types, and the directions for use are not the same for each type.

If you need surgery or dental work, tell your surgeon or dentist you currently use dalteparin. If you need anesthesia for a medical procedure or surgery, you may need to stop using dalteparin for a short time.

You will need frequent medical tests.

Store at room temperature, away from moisture and heat.

Once you have used a dalteparin vial (bottle) for the first time, you may use that vial for up to 2 weeks. Throw the vial away after 2 weeks, even if there is still medicine left inside.

Use a needle and syringe only once, then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.