AcuTect is a radioactive imaging test used to diagnose acute venous thrombosis (sudden blood clots) in the legs. AcuTect appears to detect acute and not chronic venous thrombosis.

Special Warning(s) with AcuTect:

If you are experiencing the signs and symptoms of acute venous thrombosis, your doctor will determine whether or not to withhold any anticoagulant drugs (drugs used to thin the blood) that you may be taking. This decision should not be based on a negative AcuTect study alone.

If you have a history of drug reactions, other allergies, or immune system disorders, your doctor may want to observe you for several hours after AcuTect is given because long-term information is not available. Emergency equipment and health care professionals trained to recognize and treat severe allergic reactions should be available.

General Precautions with AcuTect:

The contents of AcuTect Kit must be used in a reconstituted form. AcuTect is a radioactive drug and must be handled with care. Appropriate safety measures should be taken to minimize exposure to clinical personnel and to the patient.

AcuTect should be used only by doctors who are licensed to use radioactive drugs.

To decrease the radiation absorbed by the bladder, you should drink plenty of fluids to ensure frequent urination during the first several hours after the AcuTect injection. The radioactive drug generally is eliminated over about 24 hours with 75% occurring during the first 8 hours.

If you are unable to control your urination completely, your doctor may insert a bladder catheter (tube) to minimize the risk of radioactive contamination of your clothing, bed linen, and environment.

To protect yourself and others, you need to take the following precautions for 12 hours after your dose of AcuTect:

• Use a toilet and not a urinal
• Flush the toilet several times after each use
• Clean up any spilled urine immediately
• Wash your hands thoroughly after each time you go to the toilet
• If blood or urine gets onto clothing, the clothing should be washed separately

What should I tell my doctor or health care provider?

Tell your health care provider if you are trying to become pregnant, or are already pregnant. If you are breast-feeding, it is recommended that you switch to infant formula while AcuTect is used and until the radioactive drug is eliminated from your system.

What are some possible side effects of AcuTect?

AcuTect is generally well tolerated. Your health care provider can discuss with you a complete list of possible side effects.

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

AcuTect's Labeling