Fasturtec Side Effects

Generic Name: rasburicase

Please note - some side effects for Fasturtec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

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.

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