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Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
Date:10/23/2007

of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. The most common adverse reactions are vomiting (9%), hypokalemia (7%), hyperglycemia (7%), convulsions (6%), and mental impairments (6%). Do not administer to patients with known hypersensitivity to sodium phenylacetate or sodium benzoate. Acute symptomatic hyperammonemia should be treated as life-threatening. Uncontrolled hyperammonemia can result in brain damage or death. Dialysis may be required, preferably hemodialysis, to remove a large burden of ammonia. Administration must be through a central line; use of a peripheral line may cause burns. Do not administer undiluted product. Because of prolonged plasma levels achieved by phenylacetate in pharmacokinetic studies, repeat loading doses should not be administered. Use caution when administering to patients with hepatic or renal insufficiency. AMMONUL(R) may cause nausea and vomiting. An antiemetic may be administered during infusion. See the prescribing information for a complete listing of warnings, precautions, and drug interactions.

About BUPHENYL(R)

BUPHENYL(R) is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). BUPHENYL(R) should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation. The most common adverse reactions associated with BUPHENYL(R) were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these drugs have been reported to increase blood ammonia levels, and probenecid may affect the kidneys' excretion. Use with great care, if at all, in patients wi
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SOURCE Hyperion Therapeutics, Inc.
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