Fragmin

Fragmin is a prescription medication used to treat and prevent blood clots from developing in patients with several different medical conditions. Fragmin is also used to prevent further blood clots from developing in cancer patients who have already had a blood clot.

Fragmin belongs to a group of drugs called low molecular weight heparins or "blood thinners". These work by blocking the effects of enzymes involved in making blood clots. 

This medication comes in an injectable form to be given under the skin (subcutaneously) and is typically injected once or twice daily for a duration that is dependent on several medical factors. If Fragmin is to prevent blood clots from developing after surgery, Fragmin will be injected under the skin (subcutaneously) before surgery. 

Common side effects of Fragmin include bleeding, pain at the injection site, and upset stomach.

Fragmin is a prescription medication used in the following situations:

• in hospitalized patients along with aspirin to prevent complications of chest pain (angina) and heart attacks including blood clots
• to prevent blood clots in hospitalized patients who are on bed rest for various conditions and/or surgeries
• to prevent blood clots in patients who are about to have hip replacement or abdominal surgeries
• to prevent recurrence of blood clots in patients with cancer who have already had blood clots
• in the extended treatment of blood clots in cancer patients

Fragmin is NOT for use in the acute treatment of blood clots.

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

• Eisai, Inc

Serious side effects have been reported with Fragmin. See the "Fragmin Precautions" section.

Common side effects of Fragmin include the following:

• bleeding
• upset stomach
• pain or irritation at the injection site

This is not a complete list of Fragmin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• abciximab (ReoPro)
• anagrelide (Agrylin)
• warfarin (Coumadin)
• dabigatran (Pradaxa)
• rivaroxaban (Xarelto)
• apixaban (Eliquis)
• aspirin
• ibuprofen (Advil, Motrin, or Nuprin)
• indomethacin (Indocin)
• heparin (Lovenox)
• ketoprofen (Actron, Orudis)
• naproxen (Aleve, Anaprox, Naprosyn), or other nonsteroidal anti-inflammatory drugs (NSAIDs)
• cilostazol (Pletal)
• clopidogrel (Plavix)
• dipyridamole (Persantine)
• eptifibatide (Integrilin)
• sulfinpyrazone (Anturane)
• ticlopidine (Ticlid)
• tirofiban (Aggrastat)

This is not a complete list of Fragmin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Fragmin including:

• Epidural or spinal hematomas. Tell your healthcare provider right away if you plan on receiving spinal or epidural anesthesia or having a spinal puncture performed.
• Heparin-induced thrombocytopenia. Tell your healthcare provider right away if you have had heparin-induced thrombocytopenia in the past. Your doctor may take blood samples to monitor your response to Fragmin.
• Gasping Syndrome in premature infants. Tell your healthcare provider right away if you are pregnant, as a preservative-free formulation of Fragmin may be required.
• Severe bleeding. Fragmin increases your risk of bleeding, and can cause bleeding in the brain, paralysis, and sometimes death.  Tell your healthcare provider right away if you have some or all of the following symptoms of bleeding:
  • easy bruising
  • black or bloody stools
  • blood in the urine
  • bloody vomit
  • a decrease in blood pressure (hypotension)

Fragmin should be used with caution in pregnant women with artificial heart valves. Clots could develop and possibly cause death to the pregnant woman and/or the developing child.

Fragmin can change results of liver tests.  Tell your doctor if you have a history of liver disease.

Do not take Fragmin if you:

• are actively bleeding
• have a decreased amount of platelets in the blood (thrombocytopenia) when exposed to Fragmin 
• are allergic to Fragmin, heparin, or pork products

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fragmin, there are no specific foods that you must exclude from your diet when receiving Fragmin.

Before taking Fragmin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of liver, kidney, or heart disease
• have a history of bleeding, ulcers, or high blood pressure
• have a history of retina damage (retinopathy) caused by diabetes
• have a history of spine problems
• are allergic to Fragmin, heparin, or pork products
• have a decreased amount of platelets in the blood (thrombocytopenia) when exposed to Fragmin
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fragmin falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby, and there are no well-controlled studies in pregnant women. Fragmin should be used only be used during pregnancy only if clearly needed. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Fragmin may cross into human milk. Because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Fragmin.

Use Fragmin exactly as prescribed.

Fragmin comes in an injectable form to be given under the skin (subcutaneously) and is typically injected once or twice daily for a duration that is dependent on several medical factors.  If Fragmin is to prevent blood clots from developing after surgery, Fragmin will be injected under the skin (subcutaneously) before surgery. 

You may receive Fragmin while you are still in the hospital and your healthcare provider will probably be giving you the injections. Before you leave the hospital, your healthcare provider will teach you to give yourself the injections or he or she may teach someone else to give you the injections. When you are injecting the medication at home, you will be injecting it just under the skin (subcutaneously). Fragmin should not be injected into the muscle.

Follow your physician's instructions to inject Fragmin. You may refer to the following instructions for additional information:

1. Inspect Fragmin prefilled syringes and vials visually for particles and discoloration prior to administration
2. Wash your hands
3. Clean the area of skin where you will give the shot
4. Make sure the drug is clear and colorless
5. Take the cap off the needle
6. To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection
7. Hold the syringe assembly by the open sides of the device and remove the needle shield
8. You should be sitting or lying down to inject Fragmin
9. Fragmin may be injected in a U-shape area around the navel, the upper outer side of the thigh, or the upper outer area of the buttock; the injection site should be varied daily
10. Pinch a fold of skin between your finger and thumb and insert the needle into the injection area; the entire length of the needle should be inserted at a 45 to 90 degree angle
11. Depress the plunger of the syringe while holding the finger flange until the entire dose has been given; the needle guard will not be activated unless the entire dose has been given 
12. Release the skin after Fragmin is injected
13. Remove needle and let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded; do not rub the area of the injection
14. Discard the syringe assembly in approved containers

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Fragmin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

Dosing for Fragmin is as follows:

• The recommended dose of Fragmin for the prevention of blood clots in patients with angina and/or heart attacks is 120 IU/kg of body weight, but not more than 10,000 IU, injected subcutaneously every 12 hours. The usual duration of administration is 5 to 8 days. 
• The recommended dose of Fragmin for the prevention of blood clots in patients following hip replacement surgery is 2,500 IU injected subcutaneously within 2 hours before surgery, 2,500 IU injected subcutaneously within 4 to 8 hours after surgery, and 5,000 IU injected subcutaneously once daily for 5 to 10 days after surgery. OR
• The recommended dose of Fragmin for the prevention of blood clots in patients undergoing hip replacement surgery is 5,000 IU injected subcutaneously evening before surgery, 5,000 IU injected subcutaneously within 4 to 8 hours after surgery, and 5,000 IU injected subcutaneously once daily for 5 to 10 days after surgery. 
• The recommended dose of Fragmin for the prevention of blood clots in patients following abdominal surgery is 2,500 IU injected subcutaneously within 2 hours before surgery and 2,500 IU injected subcutaneously once daily for 5 to 10 days after surgery.
  • In patients undergoing abdominal surgery associated with a high risk of thromboembolic complications, such as malignant disorder, the recommended dose is 5000 IU injected subcutaneously the evening before surgery, then 5000 IU injected subcutaneously once daily for 5 to 10 days after surgery.
  • In patients with malignancy, the recommended dose is 2500 IU  injected subcutaneously 1 to 2 hours before surgery followed by 2500 IU12 hours later, and then 5000 IU once daily for 5 to 10 days after surgery.
• The recommended dose of Fragmin for the prevention of blood clots in patients with severely restricted mobility during acute illness is 5,000 IU injected subcutaneously once daily. The usual duration of administration is 12 to 14 days.
• The recommended dose of Fragmin for the extended treatment of blood clots in patients with cancer is 200 IU/kg total body weight injected subcutaneously once daily for 30 days, then 150 IU/kg injected subcutaneously once daily for months 2 through 6.

If you take too much Fragmin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Fragmin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Fragmin at room temperature.
• After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks.
• Keep this and all medicines out of the reach of children.