Dalteparin Sodium, Injection

What are other names for this medicine?

Type of medicine: anticoagulant (medicine that reduces the chance of blood clots forming); low molecular weight heparin

Generic and brand names: dalteparin sodium, injection; Fragmin

What is this medicine used for?

This medicine is known as a low molecular weight heparin. It is given by injection (shot) to treat or prevent deep vein thrombosis (blood clots). It is also used to treat blood clots in the lungs (pulmonary embolisms).

This medicine may given along with warfarin (Coumadin).

This medicine is used to reduce the risk of blood clots in people who:

• are having abdominal surgery or knee or hip replacement surgery
• are bedridden
• have cancer, unstable angina (chest pain), or a heart attack.

This medicine may also be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have:

• an allergic reaction to any medicine or to pork products
• a history of bleeding problems or blood disorders
• eye problems due to diabetes
• high blood pressure
• kidney or liver problems
• recently had brain, eye, or spinal surgery, or a spinal tap
• recently had a stroke, heart infection, or an ulcer

Tell your healthcare provider if you have had any reaction to heparin in the past.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

You will be given these shots by your healthcare provider while you are in the hospital. You will be closely watched to be sure that you do not bleed too much or develop any serious side effects.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. Use sterile, disposable syringes and needles. Use each syringe and needle only once and dispose of them safely, following your healthcare provider's instructions. This medicine may also be available in prefilled, disposable syringes. Carefully read and follow the directions that come in the package of medicine for preparing the shots. Wash your hands before using this medicine. Follow these steps to give yourself the shots:

1. Your healthcare provider will tell you where you can give yourself the shots (abdomen, thigh, upper arm, or other sites). If you are giving the shot in your abdomen, choose a site around the belly button but not in the belly button. Each day, choose a different spot for the shot to lessen irritation.
2. Use an alcohol swab to clean the skin where you will give yourself the shot.
3. Gently pinch up the skin and insert the needle into the skin at a 45° angle. After you insert the needle completely, release your grasp of the skin.
4. Inject all of the solution by gently and steadily pushing down the plunger.
5. After you have given yourself the shot, withdraw the needle and syringe and gently press an alcohol swab on the spot where the shot was given. Do not rub the injection site.
6. Discard the syringe, needle, and drug vial. Use the syringes and needles ONLY ONCE. Throw them away after use. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.

If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nosebleeds, blood in your urine or stools, unusual bruising or bleeding, bleeding that won't stop.

What should I watch out for?

If you have epidural or spinal anesthesia or a spinal puncture while taking this medicine, you are at risk for internal bleeding that could cause you to become paralyzed.

Contact your healthcare provider right away if you notice numbness, tingling, leg weakness or paralysis, and loss of control over your bladder or bowels.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

You may bleed easily while taking this medicine. Be careful to avoid falls or injury while you are taking this medicine. Use a soft brush to brush your teeth. Avoid injury while shaving, cutting fingernails or toenails, or when using sharp objects. To avoid bruising, do not rub the skin where the shot is given.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Your healthcare provider will watch you closely to make sure the medicine is working and is not causing unwanted side effects. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Unusual bleeding or bruising (bloody or black tarry stools, bloody urine, nosebleeds, coughing or vomiting blood, unusually heavy menstrual period, injection site bleeding or bruising); chest pain; unexplained fever, chills, or sore throat; lightheadedness or fainting; sudden back pain; unusual weakness or tiredness; severe or sudden headache; sudden confusion; sudden vision, speech, or balance problems; numbness or tingling.

Other: Irritation at injection site, urinary tract infection, headache, diarrhea, constipation, nausea, vomiting, trouble sleeping, dizziness, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• medicine that reduces the chance of blood clots forming such as warfarin (Coumadin), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), clopidogrel (Plavix), dipyridamole (Persantine), and ticlopidine (Ticlid)
• aspirin or other salicylates
• natural remedies such as cat's claw, dong quai, evening primrose, feverfew, red clover, horse chestnut, garlic, green tea, ginseng, and ginkgo
• medicines to treat cancer such as dasatinib (Sprycel) and ibritumomab (Zevalin)
• medicines to treat pulmonary hypertension such as treprostinil (Remodulin), iloprost (Ventavis), and epoprostenol (Flolan)
• NSAIDS such as ibuprofen (Motrin, Motrin IB, Advil, Nuprin), naproxen (Aleve, Naprosyn, Naprelan, Anaprox), ketorolac (Toradol), ketoprofen (Oruvail), indomethacin (Indocin), celecoxib (Celebrex), sulindac (Clinoril), nabumetone (Relafen), and oxaprozin (Daypro)
• sulfinpyrazone (Anturane)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.