Ontak fdating

Ontak fdating

For these reasons the comparison of

The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to the intact fusion protein denileukin diftitox. Nursing Mothers It is not known whether Ontak is excreted in human milk.

Denileukin diftitox showed no evidence of mutagenicity in the Ames test and the chromosomal aberration assay. Do not use glass containers. For these reasons, the comparison of the incidence of antibodies to denileukin diftitox with the incidence of antibodies to other products may be misleading. No accumulation was evident between the first and fifth doses.

Additionally, the observed incidence of the antibody positivity may be influenced by several factors, including sample handling, concomitant medication, and underlying disease. These results are highly dependent on the sensitivity and the specificity of the assays.

Drug Interactions No formal drug-drug interaction studies have been conducted with Ontak. There have been no studies to assess the effect of denileukin diftitox on fertility.

Discard unused portions of Ontak immediately. Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Discontinue for adverse infusion reactions. Do not mix Ontak with other drugs. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Gender and age have no effect on pharmacokinetics of denileukin diftitox. Dosing Schedule and Administration Premedicate with an antihistamine and acetaminophen prior to each Ontak infusion.

Neomycin is used in the fermentation process but is undetectable in the final product. Do not administer as a bolus injection. Postmarketing Experience The following adverse reactions have been identified during postapproval use of Ontak. Bring Ontak to room temperature, before preparing the dose. Use only if the solution is clear, colorless and without visible particulate matter.

Ontak should be given to a pregnant woman only if clearly needed. After thawing, a haze may be visible which should clear when the solution is at room temperature.

Do not use glass containersDenileukin diftitox showed no evidence of

Systemic exposure was variable but proportional to dose. Do not administer Ontak through an in-line filter.