dalteparin

What is the most important information I should know about dalteparin?

You should not use this medication if you are allergic to dalteparin, heparin, or pork products, or if you have active bleeding, or a low level of platelets in your blood after testing positive for a certain antibody while using dalteparin.

If you need anesthesia for a medical procedure or surgery, tell the doctor ahead of time that you are using dalteparin. You may need to stop using the medicine for a short time.

Dalteparin may cause you to bleed more easily, especially if you have: a bleeding disorder, hemorrhagic stroke, an infection in the lining of your heart, uncontrolled high blood pressure, stomach or intestinal bleeding or ulcer, or if you have had recent brain, spine, or eye surgery.

Dalteparin can cause a very serious blood clot around your brain or 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 medications to treat or prevent blood clots. Symptoms of this type of blood clot include numbness, tingling, muscle weakness, or loss of movement. Tell any doctor who treats you that you are using dalteparin.

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding or life-threatening blood clots, and it is very important to tell your doctor about all medicines you have recently used.

Blood clots around the brain or spinal cord may occur if you use dalteparin with other drugs that can affect blood clotting, including aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as Advil or Motrin, and any other medications to treat or prevent blood clots.

Avoid taking aspirin unless your doctor recommends it as part of your treatment. Aspirin can increase your risk of bleeding.

Tell your caregivers at once if you have signs of bleeding such as black or bloody stools, coughing up blood, confusion, feeling like you might pass out, or any bleeding that will not stop.

What is dalteparin?

Dalteparin is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Dalteparin is used together with aspirin to prevent blood vessel complications in people with certain types of 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 who are bed-ridden 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 other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using dalteparin?

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

• active or uncontrolled bleeding; or
• or a low level of platelets in your blood after testing positive for a certain antibody while using dalteparin.

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 very serious blood clot around your brain or spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if you have:

• a genetic spinal defect;
• a history of spinal surgery or repeated spinal taps; or
• if you are using other medications to treat or prevent blood clots.

If you have any of these other conditions, you may need a dalteparin dose adjustment or special tests:

• eye problems caused by diabetes or high blood pressure;
• severe liver or kidney disease;
• recent stomach bleeding; or
• low levels of platelets in your blood.

FDA pregnancy category B. Dalteparin is not expected to harm an unborn baby. However, some forms of this medication contain a preservative that may be harmful to a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether dalteparin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use dalteparin?

Dalteparin is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

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

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

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.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

When used for DVT or blood vessel complications, dalteparin is usually given every day until your bleeding condition improves. When used for VTE, dalteparin is often used for several months. Follow your doctor's instructions.

To be sure this medication is not causing harmful effects, your blood and your stool (bowel movement) may need to be tested often. Your nerve and muscle function may also need to be tested. Visit your doctor regularly.

Tell any doctor who treats you that you are using dalteparin. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication. If you need anesthesia for a medical procedure or surgery, you may need to stop using dalteparin for a short time.

Store dalteparin vials (bottles) at room temperature away from moisture and heat. Once you have used a vial for the first time, the medicine will keep at room temperature for up to 2 weeks. Throw away the vial after 2 weeks have passed since you first used the vial, even if there is still medicine left in it.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause excessive bleeding.

What should I avoid while using dalteparin?

Avoid taking aspirin unless your doctor recommends it as part of your treatment. Aspirin can increase your risk of bleeding.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of dalteparin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dalteparin and call your doctor at once if you have a serious side effect such as:

• unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
• easy bruising, purple or red pinpoint spots under your skin;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
• numbness, tingling, or muscle weakness (especially in your legs and feet);
• loss of movement in any part of your body;
• sudden weakness, severe headache, confusion, or problems with speech, vision, or balance; or
• trouble breathing.

Less serious side effects include pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect dalteparin?

Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding, and it is very important to tell your doctor about all medicines you have recently used. Bleeding or blood clots around the brain or spinal cord may occur if you use dalteparin with other drugs that can affect blood clotting, such as:

• dextran (Gentran, Hyskon);
• heparin, warfarin (Coumadin);
• abciximab (ReoPro), eptifibatide (Integrelin), tirofiban (Aggrastat);
• cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), prasugrel (Effient), ticlopidine (Ticlid);
• enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep);
• argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);
• alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);
• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
• salicylates such as Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others.

This list is not complete and other drugs may interact with dalteparin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about dalteparin.