Mylan Launches Generic Version of Injectable Cerebyx

Mylan has launched a generic version of Pfizer’s Cerebyx, an injectable variety of fosphenytoin sodium. The FDA approved Mylan’s abbreviated new drug application for the product, which is indicated to treat certain types of seizures.

The generic version of Cerebyx will be 1 of 450 injectable products in Mylan’s portfolio. Mylan markets its injectables in a wide variety of forms, including liquid and dry power.

The rate of intravenous Cerebyx administration should not exceed 150-mg phenytoin sodium equivalents per minute. There is a risk of severe hypotension and cardio arrhyhtmias.

After the product is administered intravenously, cardiac activity should be closely monitored. The risk of cardiovascular toxicity increases with infusion rates above the recommended rate. However, some of these instances have been reported at or below the recommendation as well.

The most common adverse events associated with Cerebyx are pruritus, ataxia, dizziness, drowsiness, and nystagmus. There may also be a burning sensation at the injection site, or pain.

In rare instances, patients may experience adverse effects including abdominal pain, a decrease in body movement, aggression and agitation. Dermatologic, gastrointestinal, and hematologic adverse effects have also been reported in some individuals.