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Fontrexed 500mg powder for injection

Ferron Par Pharmaceuticals

Ingredients in every vial

Pemetrexed disodium hemipentahydrate 500 mg

Each package contains

1 vial of 500 mg

Dosage form

Powder for injection

Dosage formPowder for injection

Flavour

None

W.H.O. classification

L01B
L01B

A.T.C. Level 1

Anatomical Main group

L - Antineoplastic and immunomodulating agents
L01B

A.T.C. Level 2

Therapeutic subgroup

L01 - Antineoplastic Agents
L01B

A.T.C. Level 3

Pharmacological subgroup

L01B - Antimetabolites

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

Malignant pleural mesothelioma
Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Non-Small-Cell lung cancer
Pemetrexed in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic Non-Small-Cell lung cancer other than predominantly squamous cell histology.

Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic Non-Small-Cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. First-line treatment should be a platinum-based with other cytotoxics chemotherapy.

Pemetrexed is indicated as a single-agent for the treatment of patients with locally advanced or metastatic nonsquamous Non-Small-Cell lung cancer after prior chemotherapy (as second line). Pemetrexed is not indicated for treatment of patients with squamous cell Non-Small-Cell lung cancer.

Dosage

18 TO 65 YEARS OLD
— Pemetrexed in combination with cisplatin
The recommended dose of pemetrexed 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 2 hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle. Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin.

— Pemetrexed as a single agent
In patients treated for non-small cell lung cancer after prior chemotherapy, 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.

— 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 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 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 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 ≥1,500 cells/mm3 and platelets should be ≥100,000 cells/mm3. Creatinine clearance should be ≥45 ml/minute.
The total bilirubin should be ≤1.5-times upper limit of normal. Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT), and alanine aminotransferase (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 tumor involvement.

65 YEARS OLD AND ABOVE
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.

UP TO 18 YEARS
Pemetrexed is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.

ADMINISTRATION
Pemetrexed must only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.

PATIENTS WITH RENAL IMPAIRMENT
(standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m-DTPA serum clearance method)

Pemetrexed is primarily eliminated unchanged by renal excretion. Patients with creatinine clearance of ≥45 ml/minute 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/minute; 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 aminotransferase >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.