Rasburicase may cause serious and fatal hypersensitivity reactions including anaphylaxis, hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, and methemoglobinemia. Therapy should be immediately and permanently discontinued in any patient developing these conditions. Rasburicase will cause enzymatic degradation of the uric acid within blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin, immediately immerse and maintain samples in an ice water bath, and assay the plasma samples within 4 hours of collection .
Rasburicase injection treats high uric acid blood levels (hyperuricemia) that are caused by cancer treatment. This medicine is used in adults and children with certain types of cancer (e.g., leukemia, lymphoma, or solid tumors).
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rasburicase injection in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rasburicase injection in the elderly. M
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so the needle will need to stay in place for up to 30 minutes.
It is very important that your doctor check you or your child while you are receiving this medicine to make sure the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; dizziness; lightheadedness; swelling of your hands, face, or mouth; trouble with breathing; or chest pain after you get the injection.
Patients of African or Mediterranean ancestry are at higher risk of serious side effects and should be carefully evaluated by their doctor before starting this medicine.
Check with your doctor right away if you or your child develop any of the following symptoms: bluish-colored lips, fingernails, or palms; dark urine; fever; headache; pale skin; rapid heart rate; shortness of breath; sore throat; or unusual bleeding or bruising after you receive this medicine.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.