Elitek Side Effects

Generic Name: rasburicase

Please note - some side effects for Elitek 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 of Elitek - for the Consumer

Elitek

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Elitek:

Diarrhea; headache; mouth sores or ulcers; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue or gray skin color; chest pain; chills; constipation; dark urine; fever; numbness or tingling of the skin; persistent sore throat; severe dizziness; shivering; weakness; yellowing of the eyes and skin.

Elitek Side Effects - for the Professional

Elitek

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to Elitek in 703 patients [63% male, 37% female; median age 10 years (range 10 days to 88 years); 73% Caucasian, 9% African, 4% Asian, 14% other/unknown]. Elitek was studied for adverse reactions, regardless of severity, in 347 patients (265 pediatric and 82 adults) enrolled in one active-controlled trial (Study 1), two uncontrolled trials (Studies 2 and 3), and one uncontrolled safety trial (n=82). Additionally, an expanded access experience enrolled 356 patients, for whom reliably collected data were limited to serious adverse reactions.

Among the 703 patients for whom serious adverse reactions were assessed, the most serious adverse reactions caused by Elitek were allergic reactions including anaphylaxis (<1%), rash (1%), hemolysis (<1%), and methemoglobinemia (<1%). The commonly observed serious adverse reactions were fever (5%), neutropenia with fever (4%), respiratory distress (3%), sepsis (3%), neutropenia (2%), and mucositis (2%). The following additional serious adverse reactions were observed in ≤1% of patients regardless of causality: acute renal failure, arrhythmia, cardiac failure, cardiac arrest, cellulitis, cerebrovascular disorder, chest pain, convulsions, cyanosis, diarrhea, dehydration, hot flushes, ileus, infection, intestinal obstruction, hemorrhage, myocardial infarction, paresthesia, pancytopenia, pneumonia, pulmonary edema, pulmonary hypertension, retinal hemorrhage, rigors, thrombosis, and thrombophlebitis.

Among the 347 patients for whom all adverse reactions regardless of severity were assessed, the most frequently observed adverse reactions (incidence ≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%). In Study 1, an active control study, the following adverse events occurred more frequently in Elitek-treated subjects than allopurinol-treated subjects: vomiting, fever, nausea, diarrhea, and headache. Although the incidence of rash was similar in the two arms, severe rash (NCI CTC3, Grade 3 or 4) was reported only in one Elitek-treated patient.

Immunogenicity

Elitek is immunogenic in healthy volunteers, and can elicit antibodies that inhibit the activity of rasburicase in vitro.

In a study of 28 healthy volunteers, the incidence of antibody responses to either a single dose or to 5 daily doses was assessed. Binding antibodies to rasburicase were detected by ELISA in 17/28 (61%) volunteers and neutralizing antibodies were detected in 18/28 (64%) volunteers. Time to detection of antibodies ranged from 1 to 6 weeks after Elitek exposure. In two subjects with extended follow-up, antibodies persisted for 333 and 494 days.

The incidence of antibody responses in patients with hematologic malignancy has not been adequately assessed. In clinical trials of patients with hematologic malignancies, 24 of the 218 patients tested (11%) developed antibodies by day 28 following Elitek administration. However, this is not a reliable estimate of the true incidence of antibody responses in patients with hematologic malignancies, because the data from the healthy volunteer study indicate that antibody may not be detectable until some time point beyond day 28.

The incidence of antibody responses detected is highly dependent on the sensitivity and specificity of the assay, which have not been fully evaluated. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including serum sampling, timing and methodology, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Elitek with the incidence of antibodies to other products may be misleading.

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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