Pemetrexed Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Malignant Pleural Mesothelioma

Initial Dose:

500 mg/m2 of pemetrexed administered as an intravenous infusion over 10 minutes on day 1 of each 21 day cycle along with cisplatin.

Cisplatin 75 mg/m2 infused over 2 hours beginning approximately 30 minutes after the end of the pemetrexed administration. Patients should receive hydration consistent with local practice prior to and/or after receiving cisplatin.

Pretreatment with dexamethasone (or equivalent) reduces the incidence and severity of cutaneous reactions. Administer dexamethasone 4 mg orally twice a day, on the day before, the day of, and the day after pemetrexed administration.

To reduce toxicity, patients treated with pemetrexed must be instructed to take a low-dose oral folic acid preparation or a multivitamin with folic acid on a daily basis. Initiate folic acid 400 mcg to 1000 mcg orally once daily beginning 7 days before the first dose of pemetrexed and continue during the full course of therapy and for 21 days after the last dose of pemetrexed.

Patients must also receive one intramuscular injection of vitamin B12 during the week preceding the first dose of pemetrexed and every 3 cycles thereafter. Subsequent vitamin B12 injections may be given on the same day as pemetrexed.

Usual Adult Dose for Non-Small Cell Lung Cancer

Initial Dose:

500 mg/m2 of pemetrexed administered as an intravenous infusion over 10 minutes on day 1 of each 21 day cycle.

Pretreatment with dexamethasone (or equivalent) reduces the incidence and severity of cutaneous reactions. Administer dexamethasone 4 mg orally twice a day, on the day before, the day of, and the day after pemetrexed administration.

To reduce toxicity, patients treated with pemetrexed must be instructed to take a low-dose oral folic acid preparation or a multivitamin with folic acid on a daily basis. Initiate folic acid 400 mcg to 1000 mcg orally once daily beginning 7 days before the first dose of pemetrexed and continue during the full course of therapy and for 21 days after the last dose of pemetrexed.

Patients must also receive one intramuscular injection of vitamin B12 during the week preceding the first dose of pemetrexed and every 3 cycles thereafter. Subsequent vitamin B12 injections may be given on the same day as pemetrexed.

Renal Dose Adjustments

Insufficient numbers of patients with creatinine clearance below 45 mL/min have been treated to make dosage recommendations for this group of patients.

Liver Dose Adjustments

Data not available

Dose Adjustments

Complete blood cell counts, including platelet counts, should be performed on all patients receiving pemetrexed. Patients should be monitored for nadir and recovery. In the clinical studies, these blood counts were taken before each dose, and on days 8 and 15 of each cycle. Patients should not begin a new cycle of treatment unless the ANC is >= 1500 cells/mm3, the platelet count is >=100,000 cells/mm3, and the creatinine clearance is >= 45 mL/min. Periodic chemistry tests should be performed to evaluate renal and hepatic function.

Dose adjustments at the start of a subsequent cycle should be based on nadir hematologic counts or maximum nonhematologic toxicity from the preceding cycle of therapy. Treatment may be delayed to allow sufficient time for recovery. Once recovered, patients should be treated according to the following guidelines:

Nadir ANC <500/mm3 and nadir platelets >=50,000/mm3 - use 75% or the previous dose for pemetrexed (and cisplatin if indication is malignant pleural mesothelioma).

Nadir platelets <50,000/mm3 regardless of nadir ANC - use 50% or the previous dose for pemetrexed (and cisplatin if indication is malignant pleural mesothelioma).

If patients develop nonhematologic toxicities (excluding neurotoxicity) >=grade 3 (except grade 3 transaminase elevations), pemetrexed should be withheld until resolution to less than or equal to the patient's pretherapy value. Treatment should be resumed according to the following guidelines:

Any grade 3 toxicities (except grade 3 transaminase elevation) or any grade 3 or 4 toxicities except mucositis - use 75% of the previous dose for pemetrexed (and cisplatin if indication is malignant pleural mesothelioma).

Any diarrhea requiring hospitalization - use 75% of the previous dose for pemetrexed (and cisplatin if indication is malignant pleural mesothelioma).

Grade 3 or grade 4 mucositis - use 50% of the previous dose of pemetrexed (and 100% of the previous dose of cisplatin if indication is malignant pleural mesothelioma).

Neurotoxicity: The recommended dose adjustments are recommended:

CTC grade 0 to 1 - use 100% of the previous dose for pemetrexed (and cisplatin if indication is malignant pleural mesothelioma).

CTC grade 2 - use 100% of the previous dose of pemetrexed (and 50% of the previous dose of cisplatin if indication is malignant pleural mesothelioma).


Therapy should be discontinued if grade 3 or 4 neurotoxicity is present.

Pemetrexed should be discontinued if a patient experiences any hematologic or nonhematologic grade 3 or grade 4 toxicity after 2 dose reductions (except grade 3 transaminase elevations) or immediately if grade 3 or grade 4 neurotoxicity is observed.

Precautions

Efficacy has not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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