Fragmin (Dalteparin Sodium)

(dal te pa' rin)

If you have an epidural or spinal anesthesia or a spinal puncture while using a 'blood thinner' such as dalteparin injection, you are at risk for having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you have an epidural catheter that is left in your body, if you recently had spinal anesthesia (administration of pain medication in the area around the spine), or have or have ever had repeated epidural or spinal punctures or problems with these procedures, spinal deformity, or spinal surgery. Tell your doctor and pharmacist if you are taking any of the following: anagrelide (Agrylin); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); heparin; prasugrel (Effient); ticagrelor (Brilinta); ticlopidine; tirofiban (Aggrastat), and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: muscle weakness (especially in your legs and feet), numbness or tingling (especially in your legs), back pain, or loss of control of your bowels or bladder. Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to dalteparin injection. Talk to your doctor about the risk of using dalteparin injection.

Dalteparin is used in combination with aspirin to prevent serious or life-threatening complications from angina (chest pain) and heart attacks. Dalteparin is also used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg), which can lead to pulmonary embolism (PE; a blood clot in the lung), in people who are on bedrest or who are having hip replacement, knee replacement, or abdominal surgery. It is also used treat or prevent DVT and PE in people who have cancer. Dalteparin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.

Dalteparin comes as as a solution (liquid) in vials and prefilled syringes to inject subcutaneously (under the skin). It is usually given once a day, but may be given twice a day for certain conditions. The length of your treatment depends on the condition that you have and how well your body responds to the medication. If you are using dalteparin to prevent DVT after surgery, it is usually given for 5 to 10 days or sometimes for up to about 1 month. If you are using dalteparin is used to prevent DVT in people who are on bedrest, you will receive the medication for 12 to 14 days. If you have cancer and dalteparin is used to treat and prevent DVT, you may need to use the medication for up to 6 months. Dalteparin may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication at home. If you will be injecting dalteparin at home, inject the medication at about the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use dalteparin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. If you will be using dalteparin at home, a healthcare provider will show you how to inject the medication. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about where on your body you should inject dalteparin, how to give the injection, what type of syringe to use, or how to dispose of used needles and syringes after you inject the medication. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using dalteparin injection,
• tell your doctor and pharmacist if you are allergic to dalteparin, heparin, pork products, any other medications, or any of the ingredients in dalteparin injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have heavy bleeding anywhere in your body that cannot be stopped or if you have or have ever had a low level of platelets (type of blood cells needed for normal clotting) in your blood. Your doctor may tell you not to use dalteparin.
• tell your doctor if you have or have ever had a bleeding disorder such as hemophilia (condition in which the blood does not clot normally), ulcers in your stomach or intestines, high blood pressure, endocarditis (an infection in the heart), a stroke or ministroke (TIA), eye disease due to diabetes, or liver or kidney disease. Also tell your doctor if you have recently had brain or eye surgery.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using dalteparin injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using dalteparin injection.

Unless your doctor tells you otherwise, continue your normal diet.

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

Dalteparin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, pain, bruising, or sores at the injection site

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• unusual bleeding or bruising
• dark red spots under the skin or in the mouth
• vomiting or spitting up blood or brown material that resembles coffee grounds
• bloody or black, tarry stools
• blood in urine
• red or dark-brown urine
• excessive menstrual bleeding
• dizziness or lightheadedness
• hives
• swelling of the face, throat, tongue, lips, or eyes
• difficulty swallowing or breathing

Dalteparin injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Your healthcare provider will tell you how to store your medication. Store your medication as directed at room temperature. Make sure you understand how to store your medication properly. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving dalteparin injection. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.