Alimta Dosage/Direction for Use

Pemetrexed (Alimta) must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Malignant pleural mesothelioma: In patients treated for malignant pleural mesothelioma, the recommended dose of Pemetrexed (Alimta) is 500 mg/m² of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m² BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle. Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin. Also, see cisplatin package insert for specific dosing advice.
Non-small cell lung cancer: Single Agent Use: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed (Alimta) is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Combination use with cisplatin: The recommended dose of pemetrexed is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m² BSA infused approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle. Patients should receive appropriate hydration prior to and/or after receiving cisplatin.
Combination use with pembrolizumab and platinum chemotherapy: The recommended dose of Pemetrexed (Alimta) when administered with pembrolizumab and platinum chemotherapy for the initial treatment of metastatic non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered after pembrolizumab and prior to carboplatin or cisplatin on Day 1 of each 21-day cycle for 4 cycles. Following completion of platinum-based therapy, treatment with Pemetrexed (Alimta) with or without pembrolizumab is administered until disease progression or unacceptable toxicity. See also pembrolizumab product insert for specific dosing advice.
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 4 mg of dexamethasone administered orally twice a day (see Precautions).
To reduce toxicity, patients treated with pemetrexed should also receive vitamin supplementation (see Precautions). Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1,000 micrograms) on a daily basis. At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed, and dosing should continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Patients must also receive an intramuscular injection of vitamin B₁₂ (1,000 micrograms) in the week preceding the first dose of pemetrexed and once every three 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 ≥1500 cells/mm³ and platelets should be ≥100,000 cells/mm³. Creatinine clearance should be ≥45 mL/min.
The total bilirubin should be ≤1.5 times the upper limit of normal. Alkaline phosphatase (AP), aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤3 times the upper limit of normal. Alkaline phosphatase, AST and ALT ≤5 times the upper limit of normal is acceptable if liver has tumor involvement.
Dose Adjustments: Dose adjustments at the start of a subsequent cycle should be based on nadir hematologic counts or maximum non-hematologic 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 5, 6 and 7, which are applicable for Pemetrexed (Alimta) used as a single agent or in combination with cisplatin. (See Table 5.)

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If patients develop non-hematologic toxicities (excluding neurotoxicity) ≥Grade 3, Pemetrexed (Alimta) should be withheld until resolution to less than or equal to the patient's pre-therapy value. Treatment should be resumed according to the guidelines in Table 6. (See Table 6.)

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In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed (Alimta) and cisplatin is documented in Table 7. Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed. (See Table 7.)

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Treatment with Pemetrexed (Alimta) should be discontinued if a patient experiences any hematologic or nonhematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Special populations: Elderly: In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse reaction compared to patients younger than 65 years old. No dose reductions other than those recommended for all patients are necessary.
Children: Pemetrexed is not recommended for use in children, as safety and efficacy have not yet been established in this group of patients.
Patients with 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 creatinine clearance 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 creatinine clearance below 45 mL/min; therefore, the use of pemetrexed is not recommended (see Precautions).
Patients with Hepatic Impairment: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified. However, patients with hepatic impairment such as bilirubin >1.5 times the upper limit of normal and/or transaminase>3.0 times the upper limit of normal (hepatic metastases absent) or >5.0 times the upper limit of normal (hepatic metastases present) have not been specifically studied.
Method of administration: Pemetrexed (Alimta) is for intravenous use. Pemetrexed (Alimta) should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
For precautions to be taken before handling or administering Pemetrexed (Alimta) and for instructions on reconstitution and dilution of Pemetrexed (Alimta) before administration, see Instructions for use and handling under Cautions for Usage.