(dal te pa' rin)

Brand Name(s): Fragmin^®

IMPORTANT WARNING:

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); apixaban (Eliquis); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others); cilostazol; clopidogrel (Plavix); dabigatran (Pradaxa); dipyridamole (Persantine, in Aggrenox); edoxaban (Savaysa); heparin; prasugrel (Effient); rivaroxaban (Xarelto); ticagrelor (Brilinta); ticlopidine; 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.

WHY is this medicine prescribed?

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 or abdominal surgery. It is also used treat DVT or PE and prevent it from happening again in children one month of age and older, and in adults with DVT or PE who have cancer. Dalteparin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.

Are there OTHER USES for this medicine?

Dalteparin is also sometimes used to help prevent strokes or blood clots in people who have atrial fibrillation or flutter (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) who are undergoing cardioversion (a procedure to normalize the heart rhythm). It is also sometimes used to prevent clots in people with prosthetic (surgically inserted) heart valves, or other conditions, when their warfarin (Coumadin) therapy has just been started or has been interrupted. It is also sometimes used to prevent blood clots in certain pregnant women and in people who are having total knee replacement, hip fracture surgery, or other surgeries. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dalteparin comes as a solution (liquid) in vials and prefilled syringes to inject subcutaneously (under the skin). When used for adults, it is usually given once a day, but may be given twice a day for certain conditions. When used for children, it is usually given twice a day. 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 complications from angina and heart attacks it is usually given for 5 to 8 days. If you are using dalteparin to prevent DVT after surgery, it is usually given on the day of surgery, and for 5 to 10 days after surgery. . If you are using dalteparin to prevent DVT in people who are on bedrest, it is usually given 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 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. 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

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 reaction to heparin that caused 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 or delicate, swollen blood vessels in your stomach or intestines, high blood pressure, endocarditis (an infection in the heart), a stroke or ministroke (TIA), eye disease due to high blood pressure or diabetes, or liver or kidney disease. Also tell your doctor if you have recently had brain, spine, or eye surgery, or if you recently had bleeding from your stomach or intestines.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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

• nosebleeds
• 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, rash
• 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.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of 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. Dispose of vials of dalteparin injection 2 weeks after opening.

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.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include:

• unusual bleeding
• blood in urine
• black, tarry stools
• easy bruising
• red blood in stools
• vomit that is bloody or looks like coffee grounds

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2019.