Alimta Dosage/Direction for Use

Combination Use with Cisplatin: The recommended dose of Alimta is 500 mg/m² of body surface area (BSA) administered as an IV infusion over 10 min on the 1st day of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m² BSA infused over 2 hrs approximately 30 min after completion of the pemetrexed infusion on the 1st day of each 21-day cycle.
Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin.
Single Agent Use: Non-Small Cell Lung Cancer (NSCLC): In patients treated for NSCLC after prior chemotherapy, the recommended dose of Alimta is 500 mg/m² BSA administered as an IV infusion over 10 min on the 1st day of each 21-day cycle.
Premedication Regimen: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of and the day after pemetrexed administration. The corticosteroid should be equivalent to dexamethasone 4 mg administered orally twice daily (see Precautions). To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see Precautions). Patients must take oral folic acid or a multivitamin containing folic acid (350-1000 mcg) on a daily basis. At least 5 doses of folic acid must be taken during the 7 days preceding the 1st dose of pemetrexed and dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Patients must also receive an IM injection of vitamin B₁₂ (1000 mcg) in the week preceding the 1st dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B₁₂ injections may be given on the same day as pemetrexed.
Monitoring: Patients receiving pemetrexed should be monitored before each dose with a complete blood count, including a differential white cell count (WCC) and platelet count. Prior to each chemotherapy administration, blood chemistry tests should be collected to evaluate renal and hepatic function. Before the start of any cycle of chemotherapy, patients are required to have the following: Absolute neutrophil count (ANC) should be ≥1,500 cells/mm³ and platelets should be ≥100,000 cells/mm³; CrCl should be ≥45 mL/min.
The total bilirubin should be ≤1.5 times upper limit of normal. Alkaline phosphatase (AP), aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤3 times upper limit of normal. Alkaline phosphatase, AST and ALT ≤5 times upper limit of normal is acceptable if liver has tumour involvement.
Dose Adjustments: Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum non-haematologic 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 4, 5 and 6 (see Tables 4,5 and 6), which are applicable for Alimta used as a single agent or in combination with cisplatin. (See Tables 4.)


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If patients develop non-haematologic toxicities ≥Grade 3 (excluding neurotoxicity), Alimta should be withheld until resolution to less than equal to the patient's pre-therapy value. Treatment should be resumed according to the guidelines in Table 5. (See Table 5.)


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In the event of neurotoxicity, the recommended dose adjustment for Alimta and cisplatin is documented in Table 6. Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed. (See Table 6.)


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Treatment with Alimta should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Elderly: In clinical studies, there has been no indication that patients ≥65 years are at increased risk of adverse events compared to patients <65 years. No dose reductions other than those recommended for all patients are necessary.
Renal Impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA Serum Clearance Method): Pemetrexed is primarily eliminated unchanged by renal excretion. In clinical studies, patients with CrCl of ≥45 mL/min required no dose adjustments other than those recommended for all patients. There are insufficient data on the use of pemetrexed in patients with CrCl <45 mL/min. Therefore the use of pemetrexed is not recommended (see Precautions).
Hepatic Impairment: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified. However, patients with hepatic impairment eg, bilirubin >1.5 times the upper limit of normal and/or aminotransaminase >3 times the upper limit of normal (hepatic metastases absent) or >5 times the upper limit of normal (hepatic metastases present) have not been specifically studied.
Administration: Alimta should be administered as an IV infusion over 10 min on the 1st day of each 21-day cycle. For instructions on reconstitution and dilution, see Cautions for Usage. (See Cautions for Usage.)