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TARCEVA (ERLOTINIB): USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category D

Erlotinib HCl (Tarceva) can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while being treated with Tarceva (Erlotinib HCl) tablets.

Erlotinib HCl (Tarceva) tablets has been shown to cause maternal toxicity with associated embryofetal lethality and abortion in rabbits when given at doses that result in plasma drug concentrations of approximately 3 times those in humans (AUCs at 150 mg daily dose). When given during the period of organogenesis to achieve plasma drug concentrations approximately equal to those in humans, based on AUC, there was no increased incidence of embryofetal lethality or abortion in rabbits or rats. However, female rats treated with 30 mg/m2/day or 60 mg/m2/day (0.3 or 0.7 times the clinical dose, on a mg/m2 basis) of erlotinib prior to mating through the first week of pregnancy had an increase in early resorptions that resulted in a decrease in the number of live fetuses.

No teratogenic effects were observed in rabbits or rats dosed with erlotinib during organogenesis at doses up to 600 mg/m2/day in the rabbit (3 times the plasma drug concentration seen in humans at 150 mg/day) and up to 60 mg/m2/day in the rat (0.7 times the clinical dose of 150 mg/day on a mg/m2 basis).

Nursing Mothers

It is not known whether erlotinib 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 from Tarceva tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of Erlotinib tablets in pediatric patients have not been established.

Geriatric Use

Maintenance Study

Of the total number of patients participating in the randomized NSCLC Maintenance trial, 66% were less than 65 years of age, and 34% of patients were aged 65 years or older. The hazard ratio for overall survival was 0.78 (95% CI: 0.65, 0.95) in patients less than 65 years of age and 0.88 (95% CI: 0.68, 1.15) in patients who were 65 years or older.

Second / Third Line Study

Of the total number of patients participating in the randomized 2nd/3rd line NSCLC trial, 61% were less than 65 years of age, and 39% of patients were aged 65 years or older. The survival benefit was maintained across both age groups [OS HR = 0.75 (95% CI: 0.6, 0.9) in patients less than 65 years of age, and OS HR = 0.79 (95% CI: 0.6, 1.0) in patients who were 65 years or older].

First-Line Pancreatic Cancer

In the pancreatic cancer study, 52 % of patients were younger than 65 years of age and 48 % were 65 years of age or older. There were no clinically relevant survival differences between the age groups [OS HR = 0.78 (95% CI: 0.6, 1.0) in patients less than 65 years of age, and OS HR = 0.94 (95% CI: 0.7, 1.2) in patients who were 65 years or older]. No meaningful differences in safety or pharmacokinetics were observed between younger and older patients in these studies. Therefore, no dosage adjustments are recommended in elderly patients.

Gender

Maintenance Study

Of the total number of patients participating in the randomized Maintenance trial, 73% were males and 27% females. There were no clinically relevant differences in safety and efficacy based on gender [OS HR = 0.88 (96% CI: 0.74, 1.05) in males and OS HR = 0.64 (95% CI: 0.46, 0.91) in females].

Second / Third Line Study

Of the total number of patients participating in the randomized 2nd/3rd line NSCLC trial, 65% were males and 35% females. There were no clinically relevant differences in safety and efficacy based on gender [OS HR = 0.76 (95% CI: 0.6, 0.9) in males and OS HR = 0.80 (95% CI: 0.6, 1.1) in females].

First Line Pancreatic Cancer

In the pancreatic cancer study, 51% of patients were males and 49% females. There were no clinically relevant differences in safety and efficacy based on gender [OS HR = 0.74 (95% CI: 0.6, 0.9) in males and OS HR = 1.0 (95% CI: 0.8, 1.3) in females].

Race

Maintenance Study

In the randomized Maintenance trial, 84% of all patients were Caucasian and 15% were Asian. There were no clinically relevant differences in safety and efficacy based on race [OS HR = 0.86 (95% CI: 0.73, 1.01) in Caucasians and OS HR = 0.66 (95% CI: 0.42, 1.05) in Asians].

Second / Third Line Study

In the randomized 2nd/3rd line NSCLC trial, 78% of all patients were Caucasian and 13% were Asian. There were no clinically relevant differences in safety and efficacy based on race [OS HR = 0.79 (95% CI: 0.6, 1.0) in Caucasians and OS HR = 0.61 (95% CI: 0.4, 1.0) in Asians].

First-Line Pancreatic Cancer

In the pancreatic cancer study, 86% of all patients were Caucasian and 8% were Asian. There were no clinically relevant differences in safety and efficacy based on race [OS HR = 0.88 (95% CI: 0.7, 1.1) in Caucasians and OS HR = 0.61 (95% CI: 0.3, 1.3) in Asians].

Patients with Hepatic Impairment

Patients with hepatic impairment (total bilirubin > ULN or Child Pugh A, B and C) should be closely monitored during therapy with Tarceva. Treatment with Erlotinib should be used with extra caution in patients with total bilirubin > 3 x ULN.

In vitro and in vivo evidence suggest that erlotinib is cleared primarily by the liver. However, erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh B) compared with patients with adequate hepatic function including patients with primary liver cancer or hepatic metastases.

Patients with Renal Impairment

Less than 9% of a single dose is excreted in the urine. No clinical studies have been conducted in patients with compromised renal function.

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