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Refludan®

Brand Name: Refludan®
Active Ingredient:   lepirudin (rDNA)
Strength(s): 50mg/vial
Dosage Form(s):   Injection
Company Name:    Hoechst Marion Roussel, Inc.
Availability:         Prescription only
*Date Approved by FDA:   March 6, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Refludan used for? Refludan is indicated for patients who have had a reaction to heparin that resulted in reduced platelets and associated blood clots, in order to prevent more clotting complications

Who should not be treated with Refludan? You should not be given Refludan if you are allergic to this drug or similar drugs.

Special Warnings for Refludan:

Bleeding is the most common complication of Refludan. If you have the following conditions, your risk of bleeding may be increased:

  • Recent puncture of large vessels or organ biopsy
  • Abnormality of blood vessels or organs
  • Recent "mini-stroke," stroke, brain surgery, or other central nervous system procedure
  • Uncontrolled severe high blood pressure
  • Infection of the heart lining (endocarditis)
  • Advanced kidney damage
  • Tendency to bleed
  • Recent major surgery
  • Recent major bleeding

General Precautions with Refludan:

  • Your doctor will monitor your treatment by using a test that measures the clotting time of your blood.
  • The dosage of Refludan may be decreased if you have liver or kidney disease.

What should I tell my doctor or health care provider?

Because certain other medications can interact with Refludan, and increase the risk of bleeding, review all medications that you are taking with your health care provider, including those that you take without a prescription. Other drugs that break up or dissolve clots, such as (rt-PA) or streptokinase, or drugs that prevent clots such as Coumadin, warfarin, or aspirin, can increase your risk of bleeding.

What are some possible side effects of Refludan? (This is NOT a complete list of side effects reported with Refludan. Your health care provider can discuss with you a more complete list of side effects.)

Bleeding was the most common adverse event reported during testing of the product. Bleeding can be severe.

Other side effects occurring in at least 2% of the people studied:

  • Abnormal liver function
  • Allergic skin reactions

For more detailed information about Refludan, ask your health care provider.

Revised: 7/25/00

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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