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Frequently Asked Questions About FRAGMIN®
Below are answers to some common questions about FRAGMIN®. Be sure to talk to your health care professional about your specific concerns and questions.
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What is FRAGMIN® used for?
FRAGMIN® is a low–molecular-weight heparin used to help prevent DVT,* which may lead to PE,† in patients who are immobile due to severe illness, have had hip-replacement surgery, or have had abdominal surgery and are at risk for DVT. FRAGMIN® is also used for extended treatment of symptomatic VTE‡ (DVT and/or PE) to lower the chance of VTE happening again in patients with cancer.
Where should I inject FRAGMIN®?
FRAGMIN® is injected under the skin and only into fatty areas of the body. The best areas for injection are the U-shaped area around the belly button, the upper outer side of the thigh, and the upper outer part of the buttock. The injection site should be varied daily. If you’ve had surgery, avoid areas close to your surgical incisions or bandages. FRAGMIN® must not be injected into the muscle.
How should I inject FRAGMIN®?
Please note—These instructions are for syringes with the following fixed doses: 2500 IU, 5000 IU, 7500 IU, 10,000 IU§, 12,500 IU, 15,000 IU, and 18,000 IU.
To inject FRAGMIN®, please follow these steps:
1. Open the pack and remove the syringe. Hold it by the open sides. (Do not press the plunger down.) Pull the needle guard straight off so the needle does not bend. Be sure the medicine is clear and has nothing floating in it. If you see anything in it, talk to your health care professional.
To ensure delivery of the full dose, do not remove the air bubble from the syringe.
2. To be sure that you are injecting FRAGMIN® into fatty tissue, pinch (between the thumb and fingers of one hand) a fold of skin on the abdomen (while sitting) or outer thigh (sitting or lying down). Because there is enough fatty tissue in the buttock, pinching a fold of skin is not needed. FRAGMIN® must not be inserted into the muscle.
3. Hold the syringe with your other hand. Insert the entire needle into the fold of skin at a 45- to 90-degree angle. Then, slowly press the plunger down until the full dose of FRAGMIN® has been given.
4. With your finger still on the plunger, remove the needle while letting go of the fold of skin. Remove your finger from the plunger. The safety guard will slide over the needle.
How should I store FRAGMIN®?
FRAGMIN® must be stored at room temperature [between 68°F and 77°F (20°C to 25°C)] and must not be used after the expiration date. Store out of reach of children. Dispose in approved containers.
How should I dispose of my syringes?
Discard the syringe assembly in an approved container (eg, SHARPS container). The container should be kept stored away from children. Ask your health care professional how you should safely dispose of your container when it is full.
What are possible side effects of FRAGMIN®?
The most common side effects of FRAGMIN® are swelling, bruising, and/or an occasional drop of blood at the site of injection. If bleeding continues or if you have a surgical incision that is oozing or bleeding, call or see your health care professional immediately.
Allergic reactions (ie, itching, rash, fever, injection site reaction, and blistering) have occurred rarely. A few cases of serious allergic reactions have been reported.
Symptoms of a serious allergic reaction include:
Hives
Swelling of your face, eyelids, lips, tongue, or throat, and trouble swallowing
Asthma (wheezing) or other breathing problems such as chest tightness or shortness of breath
Shock (loss of blood pressure and consciousness)
Get emergency help immediately if you have any of these symptoms.
These are not all of the side effects of FRAGMIN®. If you think you are experiencing a side effect, please contact your health care provider.
What should I do if I experience a side effect?
It is important to contact your health care professional immediately to determine the best course of action.
What should I do if I have more questions about FRAGMIN®?
Contact your health care professional if you have questions about FRAGMIN®. For additional information, you can also call the FRAGMIN® hotline at 1-866-272-8804.
* DVT, or deep vein thrombosis, is a blood clot that forms in a leg or pelvic vein.
† PE, or pulmonary embolism, is what happens when a clot breaks off and travels to your lungs.
‡ Symptomatic is when you have symptoms; VTE, or venous thromboembolism, is a general term used to describe the process of blood clots forming and traveling through your veins.
§ For instructions on how to administer the 10,000 IU graduated syringe, please see the accompanying full prescribing information (ADMINISTRATION section) for FRAGMIN®.
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IMPORTANT SAFETY INFORMATION
  Tell your doctor you are using FRAGMIN® (dalteparin sodium injection) before having certain spinal procedures (spinal puncture or spinal/epidural anesthesia). Use of this medication before these procedures may put you at risk of blood clots in or around the spine. This risk is increased by drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors such as aspirin, and other drugs that prevent clots, when used together with FRAGMIN®. These blood clots around the spine may cause paralysis that may be permanent. Discuss the risks and benefits of treatment with your doctor.

Do not use FRAGMIN® (dalteparin sodium injection) and tell your doctor if you have active major bleeding (bleeding into major organs), an increased risk of bleeding, drop in platelet count known as "thrombocytopenia" or history of "heparin-induced thrombocytopenia."

FRAGMIN® may cause thrombocytopenia (drop in platelet count). Thrombocytopenia needs to be monitored by a doctor.

Do not use FRAGMIN® and tell your doctor if you are allergic or sensitive to the active ingredient called "dalteparin" or "dalteparin sodium," or heparin, or pork products.

In certain situations, FRAGMIN® should not be used with a procedure numbing part of your body (known as regional anesthesia). Tell your doctor you are using FRAGMIN® if you are about to have regional anesthesia. This situation can put you at risk for bleeding, even when the recommended dose of FRAGMIN® is used.

Tell your doctor immediately if you have any bleeding while using FRAGMIN®. This risk is increased when used with other "blood thinning" medications (eg, aspirin, clopidogrel) or NSAIDs (eg, ibuprofen, ketorolac, naproxen).

Tell your doctor if you have any bleeding problems, liver or kidney disease, or eye problems caused by high blood pressure or diabetes. FRAGMIN® should be used with caution in these situations.

Tell your doctor if you are or may be pregnant, or if you become pregnant while taking FRAGMIN® (dalteparin sodium injection). FRAGMIN® multiple-dose vials contain a preservative that may harm the fetus.

FRAGMIN® must not be injected into the muscle and cannot be substituted with other types of heparins.

Allergic reactions (ie, itching, rash, fever, injection site reaction, and blistering) have occurred rarely. A few cases of serious allergic reactions have been reported. Symptoms of a serious allergic reaction include:
• hives
• swelling of your face, eyelids, lips, tongue, or throat, and trouble swallowing
• asthma (wheezing) or other breathing problems such as chest tightness or shortness of breath
• shock (loss of blood pressure and consciousness)
Get emergency help immediately if you have any of these symptoms.

The most common side effects of FRAGMIN® are swelling and bruising at the site of injection.
   
 
 
 
This Web site contains information relating to various medical conditions and their treatment. Such information is provided for educational purposes only and is not meant to substitute the advice of a physician or other health care professional.

You should not use this information for diagnosing a health problem or disease. Only your doctor can assess the benefits and risks of therapy to determine whether a medication is right for you. You should discuss any questions about you or your loved one’s personal medical needs with your doctor.

The laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country.

The information provided in this Web site is intended for residents of the United States only. The products discussed herein may have different product labeling in different countries.

FRAGMIN® is a registered trademark of Pfizer Health AB and is licensed to Eisai Inc.
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