Fragmin contains dalteparin sodium in a low molecular weight heparin form. It is a sterile injection available in single-dose prefilled syringes and multi-dose vials. The syringes contain varying strengths ranging from 2,500 to 18,000 anti-Xa units, and the vials provide up to 95,000 anti-Xa units per vial. Key inactive ingredients include Water for Injection and, in the multi-dose vials, benzyl alcohol as a preservative. The drug is designed to affect blood clotting mechanisms due to its classification as a low molecular weight heparin.

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses or stopping medication can increase your risk of a blood clot or stroke. Keep taking this medication unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medications to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on the skin, unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Pain, redness, or irritation at the injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorders
• Having surgery
• High blood pressure
• History of stomach bleeding
• History of stroke
• Infection of the heart or heart valves
• Kidney disease
• Liver disease
• Low blood counts, like white cells, platelets, or red blood cells
• An unusual or allergic reaction to dalteparin, heparin, pork or pork products, latex, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Aspirin and aspirin-like medications
• Certain medications that prevent or treat blood clots
• Dipyridamole
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

If you are going to need surgery or a procedure, tell your care team that you are taking this medication.

Avoid sports and activities that may cause injury while you are taking this medication. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your care team.

Avoid taking medications that contain aspirin, ibuprofen, or naproxen. These medications may increase your risk of bleeding. Your care team may recommend acetaminophen for mild pain or fever.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What are the most serious risks of this medication?

People who take this medication and have a spinal procedure are at risk of forming a blood clot in the space around the brain or spinal cord. This could cause paralysis (not being able to move). The risk is higher in people who have spinal problems or injuries, have had spinal surgery in the past, and for those with a tube (catheter) in their back. Taking other medications that also affect bleeding, such as NSAIDs or other blood thinners, can also increase the risk. Your care team will watch you closely. Let them know right away if you feel pain, tingling, or numbness in your legs or feet.