Rasburicase

Rasburicase helps control uric acid levels in adults and children who are getting treatment for cancer, including leukemia, lymphoma, and some tumors.

Rasburicase might also be used for reasons not mentioned in this medication guide.

Rasburicase is given as an infusion into a vein. A healthcare provider will give you this injection.

rasburicase must be given slowly, and the infusion can take at least 30 minutes to complete.

Rasburicase is usually given once per day for up to 5 days. Follow your doctor's dosing instructions very carefully.

While using rasburicase, you may need frequent blood tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using rasburicase.

You should not receive rasburicase if you have ever had an allergic reaction or blood cell problems after receiving rasburicase, or if you have a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, chest pain and tightness, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Tell your caregivers or call your doctor at once if you have signs of a serious blood disorder--blue-colored skin or lips, headache, feeling weak or tired, trouble breathing, feeling like you might pass out, pounding heartbeats or fluttering in your chest.

You should not receive this medicine if:

• you have ever had an allergic reaction or blood cell problems after receiving rasburicase; or
• you have an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

If you are of African or Mediterranean descent, your doctor may perform blood tests to make sure you do not have conditions that would prevent you from safely receiving rasburicase.

Rasburicase may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Rasburicase is not approved for use by anyone younger than 1 month old.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; wheezing, chest pain and tightness, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Tell your caregivers or call your doctor right away if you have:

• pale or yellowed skin, dark colored urine;
• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• fever, flu symptoms, rapid heart rate, rapid and shallow breathing, fainting; or
• signs of a serious blood disorder--blue-colored skin or lips, headache, feeling weak or tired, trouble breathing, feeling like you might pass out, pounding heartbeats or fluttering in your chest.

Your treatment with rasburicase may be permanently stopped if you have a serious allergic reaction.

Common side effects of rasburicase may include:

• nausea, vomiting, stomach pain;
• diarrhea, constipation;
• anxiety;
• headache;
• abnormal liver function tests, decreased phosphate levels;
• throat pain;
• fever; or
• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hyperuricemia Secondary to Chemotherapy:

0.2 mg/kg as a 30-minute IV infusion once a day for up to 5 daysComments:-Use beyond 5 days or administration of more than 1 course of therapy is not recommended-The exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgement.-This drug is only approved for a single course of treatment.Use: For the initial management of plasma uric acid levels in patients with leukemia, lymphoma, and solid tumor malignancies who are receiving chemotherapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Usual Pediatric Dose for Hyperuricemia Secondary to Chemotherapy:

0.2 mg/kg as a 30-minute IV infusion once a day for up to 5 daysComments:-Use beyond 5 days or administration of more than 1 course of therapy is not recommended.-The exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgement.-This drug is only approved for a single course of treatment.Use: For the initial management of plasma uric acid levels in patients with leukemia, lymphoma, and solid tumor malignancies who are receiving chemotherapy expected to result in tumor lysis and subsequent elevation of plasma uric acid

Call your doctor for instructions if you miss an appointment for your Rasburicase injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Other drugs may affect rasburicase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.