Pexate 100/Pexate 500

In combination w/ cisplatin for chemotherapy-naive patients w/ unresectable malignant pleural mesothelioma. 1st-line treatment in combination w/ cisplatin & monotherapy for 2nd-line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. Monotherapy for maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Malignant pleural mesothelioma 500 mg/m² as IV infusion over 10 min on 1st day of each 21-day cycle + cisplatin 75 mg/m² infused over 2 hr approx 30 min after completion of pemetrexed infusion. NSCLC Monotherapy: 500 mg/m² as IV infusion over 10 min on 1st day of each 21-day cycle. In combination w/ cisplatin: 500 mg/m² IV infusion over 10 min on 1st day of each 21-day cycle + cisplatin 75 mg/m² infused approx 30 min after completion of pemetrexed infusion. Premed regimen: Oral dexamethasone 4 mg bid prior to, on the day of & the day after pemetrexed administration. Vit supplementation: Oral folic acid or multivit containing folic acid 350-1,000 mcg daily. Administer IM Vit B₁₂ 1,000 mcg in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter.

Hypersensitivity. Concomitant use w/ yellow fever vaccine. Lactation.

May suppress bone marrow function manifested by neutropenia, thrombocytopenia & anaemia (or pancytopenia). Monitor for myelosuppression during therapy; avoid use until ANC returns to ≥1,500 cells/mm³ & platelet count returns to ≥100,000 cells/mm³. Instruct patient to take folic acid & vit B₁₂ to reduce treatment-related toxicity. Possible skin reactions in patients not pre-treated w/ corticosteroids. Avoid taking NSAIDs (eg, ibuprofen & ASA) w/ long-elimination t_½ at least 5 days prior to, on the day of & at least 2 days after pemetrexed in patients w/ mild to moderate renal insufficiency (CrCl 45-79 mL/min). Consider drainage of 3rd space fluid collection prior to treatment. Possible severe dehydration w/ cisplatin; patient should receive adequate antiemetic treatment & appropriate hydration prior to &/or after receiving treatment. Possible serious CV events including MI & cerebrovascular events when combined w/ another cytotoxic agent. Immunodepressed status in cancer patients. Concomitant use of live attenuated vaccines is not recommended. May cause fatigue; may affect ability to drive & use machines. Not recommended in patients w/ CrCl <45 mL/min. Hepatic impairment. Possibility of irreversible infertility in men; advise sexually mature males not to father a child during treatment & up to 6 mth thereafter; seek counseling on sperm storage before starting treatment. Women of childbearing potential must use effective contraception during treatment. Pregnancy. No relevant use in paed for malignant pleural mesothelioma & NSCLC.

Bone marrow suppression (eg, anaemia, neutropenia, leukopenia, thrombocytopenia); GI toxicities (eg, anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis & stomatitis); renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis & neuropathy. Possible SJS & TEN.

Delayed clearance w/ nephrotoxic drugs (eg, aminoglycosides, loop diuretics, platinum compd, cyclosporin); tubularly secreted substances (eg, probenecid, penicillin). May decrease elimination & increase occurrence of adverse events w/ high doses of NSAIDs (eg, ibuprofen, aspirin). Potential INT w/ NSAIDs w/ longer t_½ (eg, piroxicam or rofecoxib) in patients w/ mild to moderate renal insufficiency. Increased thrombotic risk w/ oral anticoagulants. Risk of fatal generalised vaccinale disease w/ yellow fever vaccine. Risk of systemic (possibly fatal) disease w/ live attenuated vaccines (except yellow fever).

Cytotoxic Chemotherapy

L01BA04 - pemetrexed ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.

Rx