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Mesothelioma Alimta pemetrexed
ALIMTA (pemetrexed) is a multitarget anticancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
The pharmacokinetics of pemetrexed following single agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10-minute period. Pemetrexed has a steady-state volume of distribution of 16.1 litres. In vitro studies indicate that pemetrexed is approximately 81 % bound to plasma proteins. Binding was not notably affected by varying degrees of renal impairment.
Pemetrexed undergoes limited hepatic metabolism. Pemetrexed is primarily eliminated in the urine, with 70 % to 90 % of the administered dose being recovered unchanged in urine within the first 24 hours following administration. Pemetrexed total systemic clearance is 91.8 mL/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 mL/min).
Between-patient variability in clearance is moderate at 19.3 %. Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose. The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
ALIMTA is indicated for the treatment of patients with malignant pleural mesothelioma in combination with cisplatin.
ALIMTA is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy.
Dosage and Administration
ALIMTA should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy. The ALIMTA solution must be prepared according to the instructions provided (see Instructions for Use and Handling section).
Patients receiving ALIMTA should be monitored before each dose with a complete blood count, including a differential and platelet count. Periodic blood chemistry tests should be collected to evaluate renal and hepatic function. Absolute Neutrophil Count (ANC) should be greater than or equal to 1500 cells/mm3 and platelets should be greater than or equal to 100,000 cells/mm3 prior to the start of each cycle.
Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum nonhaematologic toxicity from the preceding cycle of therapy. Treatment may be delayed to allow sufficient time for recovery. Upon recovery patients should be retreated using the guidelines in Tables 3, 4 and 5, which are applicable for ALIMTA used as a single agent or in combination with cisplatin.
The pharmacokinetics of pemetrexed in special populations were examined in about 400 patients in controlled and single arm studies.
Geriatric - No effect of age on the pharmacokinetics of pemetrexed was observed over a range of 26 to 80 years.
Pediatric - Pediatric patients were not included in clinical trials.
Gender - The pharmacokinetics of pemetrexed were not different in male and female patients.
Race - The pharmacokinetics of pemetrexed were similar in Caucasians and patients of African descent. Insufficient data are available to compare pharmacokinetics for other ethnic groups.
Hepatic Insufficiency - There was no effect of elevated AST (SGOT), ALT (SGPT), or total bilirubin on the pharmacokinetics of pemetrexed. However, studies of hepatically impaired patients have not been conducted.
Renal Insufficiency - Pharmacokinetic analyses of pemetrexed included 127 patients with reduced renal function. Plasma clearance of pemetrexed in the presence of cisplatin decreases as renal function decreases, with increase in systemic exposure. Patients with creatinine clearances of 45, 50, and 80 mL/min had 65%, 54%, and 13% increases, respectively in pemetrexed total systemic exposure (AUC) compared to patients with creatinine clearance of 100 mL/min.
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