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Pemetrexed should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Treatment-related adverse events of pemetrexed seen in clinical trials have been reversible. Skin rash has been reported more frequently in patients not pre-treated with a corticosteroid in clinical trials. Pre-treatment with dexamethasone (or equivalent) reduces the incidence and severity of cutaneous reaction (see Dosage & Administration). The effect of third-space fluid eg, pleural effusion and ascites on pemetrexed is unknown. In patients with clinically significant third-space fluid, consideration should be given to draining the effusion prior to pemetrexed administration.
Laboratory Tests: Complete blood cell counts including platelet counts and periodic chemistry tests should be performed on all patients receiving pemetrexed. Patients should be monitored for nadir and recovery which were tested in the clinical study before each dose and on days 8 and 15 of each cycle. Patients should not begin a new cycle of treatment unless the ANC ≥1500 cells/mm3, the platelet count is ≥100,00 cells/mm3, and CrCl ≥45 mL/min.
Hepatic Impairment: There was no effect of elevated AST, ALT or total bilirubin on the pharmacokinetics of pemetrexed (see Pharmacology under Actions).
Dose adjustments based on hepatic impairment experienced during treatment with pemetrexed are shown in Table 2 (see Dosage & Administration).
Renal Impairment: Pemetrexed is known to be primarily excreted by the kidneys. Decreased renal function will result in reduced clearance and greater exposure (AUC) to pemetrexed compared with patients with normal renal function (see Dosage & Administration). Cisplatin co-administration with pemetrexed has not been studied in patients with moderate renal impairment.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was clastogenic in the in vivo micronucleus assay in mouse bone marrow but was not mutagenic in multiple in vitro tests [Ames assay, chinese hamster ovary (CHO) cell assay]. Pemetrexed administered at IV doses of ≥0.1 mg/kg/day to male mice (about 1/1666 the recommended human dose on a mg/m2 basis) resulted in reduced fertility, hypospermia and testicular atrophy.
Use in pregnancy: Teratogenic Effects: Pregnancy Category D: See Warnings.
Use in lactation: It is not known whether pemetrexed or its metabolites are 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 pemetrexed, a decision should be made to discontinue nursing or discontinue Pemxcel taking into account the importance of Pemxcel for the mother.
Use in children: The safety and effectiveness of pemetrexed in pediatric patients have not been established.
Use in the elderly: Pemetrexed is known to be substantially excreted by the kidney and the risk of adverse reactions to Pemxcel may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Renal function monitoring is recommended with administration of pemetrexed. No dose reductions other than those recommended for all patients are necessary for patients ≥65 years (see Dosage & Administration).
