Qualitinib Special Precautions

Hepatotoxicity: Asymptomatic increases in liver transaminases have been observed in Gefitinib treated patients; therefore, periodic liver function (transaminases, bilirubin, and alkaline phosphatase) testing should be considered. Discontinuation of Gefitinib should be considered if changes are severe.
Patients with Hepatic Impairment: In vitro and in vivo evidence suggest that Gefitinib is clearly primarily by the liver. Therefore, Gefitinib exposure may be increased in patients with hepatic dysfunction. In patients with liver metastases and moderately to severely elevated biochemical liver abnormalities, however, Gefitinib pharmacokinetics were similar to the pharmacokinetics of individuals without liver abnormalities. The influence of non-cancer related hepatic impairment on the pharmacokinetics of Gefitinib has not been evaluated.
Patients with Severe Renal Impairment: The effect of severe renal impairment on the pharmacokinetics of Gefitinib is not known. Patients with severe renal impairment should be treated with caution when given Gefitinib.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Gefitinib has been tested for genotoxicity in a series of in vitro (bacterial mutation, mouse lymphoma, and human lymphocyte) assays and an in vivo rat micronucleus test. Under the conditions of these assays, Gefitinib did not cause genetic damage.
Carcinogenicity studies have not been conducted with Gefitinib.
Use in Pregnancy: Pregnancy Category D.
Use in Lactation: It is not known whether Gefitinib is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breast-feeding while receiving Gefitinib therapy.
Use in Children: Gefitinib is not indicated for use in pediatric patients as safety and effectiveness have not been established. In clinical trials of Gefitinib alone or with radiation in pediatric patients with primary Central Nervous System (CNS) tumors, cases of CNS hemorrhage and death have been reported. There are insufficient data in pediatric patients to establish a causal relationship. There is no evidence to suggest increased risk of cerebral hemorrhage in adult patients with NSCLC receiving Gefitinib.
Use in the Elderly: Of the total number of patients participating in trials of second- and third-line Gefitinib treatment of NSCLC, 65% were aged 64 years or less, 30.5% were aged 65 to 74 years, and 5% of patients were aged 75 years or older. No differences in safety or efficacy were observed between younger and older patients.