| Pharmacy Drug Brand Name: | Refludan® |
| Active Ingredient(s): | lepirudin (rDNA) |
| Strength(s) / Dose(s): | 50mg/vial |
| Delivery / Dosage Form(s): | Injection |
| Company Manufacturer Name: | Hoechst Marion Roussel, Inc. |
| Availability / Prescription: | Prescription only |
| Date Approved by FDA *: | March 6, 1998 |
* Approval by the FDA does not necessarily mean that this 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 or damage.
What should I tell my doctor or health care (healthcare) 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 (healthcare) 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 comprehensive list of possible side effects assosciated with Refludan. Your doctor or pharmacist can provide expert advice on the possible side effects of this drug.)
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