"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
While there is no experience with overdosage in human clinical trials, PAA, a toxic metabolite of RAVICTI, can accumulate in patients who receive an overdose. In case of overdosage, discontinue the drug and contact poison control [see WARNINGS AND PRECAUTIONS].
RAVICTI is contraindicated in patients
- Less than 2 months of age. Children < 2 months of age may have immature pancreatic exocrine function, which could impair hydrolysis of RAVICTI, leading to impaired absorption of phenylbutyrate and hyperammonemia [see Use In Specific Populations].
- With known hypersensitivity to phenylbutyrate. Signs of hypersensitivity include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash.
Last reviewed on RxList: 1/26/2016
Additional Ravicti Information
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