IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DALTEPARIN - INJECTION

(DAL-te-PAR-in)

COMMON BRAND NAME(S): Fragmin

WARNING: Tell your doctor you are using dalteparin before having certain spinal procedures (spinal puncture or spinal/epidural anesthesia). Use of this medication before these procedures has rarely caused major bleeding or blood clots in or around the spine. This effect may cause paralysis that may be permanent. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you have any of these serious side effects: tingling, weakness, numbness, trouble urinating, or pain.

This risk is increased when you use other "blood thinning" medications (e.g., aspirin, clopidogrel, warfarin) or NSAIDs (e.g., ibuprofen, ketorolac, naproxen), or when certain medication delivery devices (indwelling epidural catheters) are used. Do not stop taking any prescribed medication without first talking to your doctor.

You will be monitored closely while you are on this medication.

USES: Dalteparin is used to treat or prevent harmful blood clots. Preventing harmful blood clots helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of clotting proteins in the blood. Dalteparin is a type of heparin, and works as an anticoagulant (commonly called a "blood thinner").

Conditions that increase your risk of developing blood clots include certain types of surgeries (e.g., hip replacement or abdominal), long periods of being in one position (immobile), certain types of heart attack, and a certain type of chest pain called unstable angina. For some medical conditions, dalteparin may be used in combination with other "blood thinners."

HOW TO USE: This medication is injected under the skin (subcutaneously) by a healthcare professional. Follow your doctor's directions for using dalteparin. Do not inject into a muscle (intramuscularly). Dosage and length of treatment are based on your medical condition and response to therapy. Dosage may also be based on your weight for some conditions.

If you are giving yourself injections at home, make sure you learn how to prepare and inject this medication properly. Select a different site for each injection. Ask your doctor, pharmacist, or nurse any questions you may have about how to give yourself dalteparin. Learn how to properly dispose of used syringes, needles, and any unused medication. Never reuse needles or syringes.

If you are uncertain how this medication should be used, ask your doctor or pharmacist to explain it to you.

This medication should not be mixed with or added to any other medication in the same syringe. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Take this medication exactly as prescribed by your doctor. Do not skip any doses. It is very important to continue taking this medication even if you feel well. Do not stop taking dalteparin without first talking with your doctor.

SIDE EFFECTS: See also Warning section.

Irritation, bruising, or pain at the injection site may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause bleeding if its effect on your blood clotting proteins is too strong. Tell your doctor immediately if any of these unlikely but serious signs of bleeding occur: unusual pain/swelling/discomfort, unusual or prolonged bleeding, unusual or easy bruising.

Tell your doctor immediately if any of these rare but very serious signs of bleeding occur: dark urine, black stools, severe headache, confusion, vision changes, unusual dizziness, fainting, seizures, weakness, numbness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using dalteparin, tell your doctor or pharmacist if you are allergic to it; or to heparins or pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious active bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: artificial heart valves, bleeding or blood disorders (low platelet counts), certain eye problems (hypertensive or diabetic retinopathy), uncontrolled severe high blood pressure, infection of the heart, kidney disease, liver disease, low platelet counts after previous heparin treatment, certain stomach/intestinal problems (e.g., active or recent ulcers), stroke, recent spinal procedures or puncture, spine problems (such as spinal deformity), recent eye/brain/spinal cord surgery.

Limit alcohol while taking this drug because it may increase the risk of stomach bleeding.

Before having surgery, tell your doctor or dentist that you are using dalteparin.

This medication can infrequently cause heavy bleeding. Be extra careful to avoid injuries (e.g., contact sports). Use an electric razor when shaving and a soft toothbrush when brushing your teeth.

The elderly may be at greater risk for bleeding while using this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Pregnant women with artificial heart valves need close monitoring (see Notes).

It is unknown if this medication passes into breast milk. Consult with your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: mifepristone.

If you are currently using this medication, tell your doctor or pharmacist before starting dalteparin.

Before using dalteparin, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This medication is sometimes used together with other drugs that have "blood thinning" or anti-platelet effects such as aspirin, clopidogrel, or warfarin. When these combinations are prescribed by your doctor, you will require closer monitoring to minimize your risk of bleeding. Keep all medical and laboratory appointments.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) which can increase the risk of bleeding/anti-platelet effect when used with dalteparin. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention or to prevent clotting of artificial heart valves (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This product may affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include excessive bleeding and bruising.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts including hemoglobin, hematocrit and platelets, checking stool for blood) should be performed periodically to monitor your progress or check for side effects. Additional lab tests (anti-factor Xa blood levels) should be performed in certain cases, especially if you have severe kidney disease, are pregnant with artificial heart valves, or if the dalteparin does not appear to be working properly. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C).

Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C).

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2010 Copyright(c) 2010 First DataBank, Inc.