Pemirex

Pemirex Dosage/Direction for Use

pemetrexed

Manufacturer:

Korea United Pharm

Distributor:

Masu
Full Prescribing Info
Dosage/Direction for Use
Pemetrexed must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Combination use with cisplatin: The recommended dose of Pemetrexed is 500 mg/m2 administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m2 infused over 2 hours beginning approximately 30 minutes after the end of Pemetrexed administration. Patients should receive hydration consistent with local practice prior to and/or after receiving cisplatin.
Single-agent use: Non-Small Cell Lung Cancer: The recommended dose of Pemetrexed is 500 mg/m2 administered as an intravenous infusion over 10 minutes on Day 1 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 4 mg of dexamethasone administered orally twice a day.
To reduce toxicity, patients treated with Pemetrexed must also receive vitamin supplementation. Patients must take oral folic acid or a multivitamin containing folic acid (350 - 1,000 µg) 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 must 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 µg) 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. (See Table 1.)

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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 re-treated using the guidelines in Tables 2, 3, and 4, which are applicable for Pemetrexed used as a single agent or in combination with cisplatin. (See Table 2.)

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If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), Pemetrexed 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 3. (See Table 3.)

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

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Treatment with Pemetrexed 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 of age or older are at increased risk of adverse events compared to patients younger than 65 years old. No dose reductions other than those recommended for all patients are necessary.
Paediatric population: There is no relevant use of Pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
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.
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.
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