Rasburicase Side Effects

Some side effects of rasburicase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rasburicase: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking rasburicase: hives; chest pain or tightness, difficult breathing; fainting; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• change in your mental state;

• headache, tired feeling, dizziness;

• blue colored lips;

• feeling short of breath;

• feeling like you might pass out;

• fast, slow, or uneven heart rate;

• seizure (convulsions);

• white patches or sores inside your mouth or on your lips; or

• pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects of rasburicase may include:

• nausea, vomiting, stomach pain;

• diarrhea, constipation;

• anxiety;

• fever, sore throat;

• mild rash; 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.

For Healthcare Professionals

Applies to rasburicase: intravenous powder for injection

Immunologic

Immunologic side effects associated with the use of rasburicase in healthy volunteers have included reports of development of binding antibodies to rasburicase and neutralizing antibodies.

Metabolic

Metabolic side effects including at least one case of hypocalcemia have been reported.

Gastrointestinal

Gastrointestinal (GI) side effects have been reported the most frequently. These have included vomiting, nausea, abdominal pain, constipation, and diarrhea. Ileus and intestinal obstruction have been reported in less than 1% patients included in studies (n = 703). At least one case of GI hemorrhage has also been reported.

Respiratory

Respiratory side effects have included respiratory distress, pulmonary edema, pulmonary hypertension, and pneumonia.

Cardiovascular

Cardiovascular side effects have been reported rarely. Less than 1% (n = 703) of patients have reported arrhythmia, cardiac failure, cardiac arrest, chest pain, and myocardial infarction.

Renal

Renal side effects have been reported rarely. Acute renal failure has been reported in less than 1% of patients included in the studies (n = 703).

Ocular

Ocular side effects have included reports of retinal hemorrhage.

Hematologic

A 50-year-old male who was admitted to the hospital for new onset seizure, diabetic ketoacidosis, respiratory failure, and acute renal failure experienced hemolytic anemia and methemoglobinemia coincident with rasburicase therapy. He was given one dose of intravenous rasburicase 22.5 mg for acute renal failure secondary to hyperuricemia. Routine arterial blood gas analysis performed after rasburicase was given revealed elevated methemoglobin concentrations, which peaked at 14.7%. Hemolytic anemia developed as evidenced by a reduction in blood hemoglobin from 14.8 to 5.3 g/dL. The patient made a complete recovery following aggressive fluid therapy, blood transfusions, and respiratory support.

Hematologic side effects have included reports of neutropenia (2%), neutropenia with fever (4%), thrombosis, thrombophlebitis, and pancytopenia. At least two cases of methemoglobinemia have also been reported, in addition to a case of hemolytic anemia.

Dermatologic

Dermatologic side effects have included reports of rash (13%) and cellulitis (1% or less).

Nervous system

Nervous system side effects have included headache (1.8%), cerebrovascular disorder, and convulsions.

Musculoskeletal

Musculoskeletal side effects including at least one case of arthralgia and one case of gout have been reported.

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported in 0.7% of patients.

Hepatic

Hepatic side effects including increased serum glutamic pyruvate transaminase have been reported. At least 3 cases of increased liver enzymes have also been reported.

Other

Other side effects including fever (1.4% to 5%) and rigors (1.1%) have been reported. A neonate with glucose-6-phosphate dehydrogenase (G6PD) deficiency died following a single dose of rasburicase.

A case report describes the lethal effect of a single dose of rasburicase in a preterm newborn infant with glucose-6-phosphate dehydrogenase (G6PD) deficiency who was treated for an increase in uric acid levels. It is suggested that G6PD testing be considered before rasburicase use.

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