Alimta

Pemetrexed disodium

In combination w/ cisplatin for the treatment of chemotherapy naïve patients w/ unresectable malignant pleural mesothelioma. In combination w/ cisplatin for the 1st line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. Monotherapy for the 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. Monotherapy for the 2nd line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology.

In combination w/ cisplatin 500 mg/m² by 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 on the 1st day of each 21-day cycle. Ensure adequate anti-emetic treatment & appropriate hydration prior to &/or after receiving cisplatin. As monotherapy for NSCLC 500 mg/m² by IV infusion over 10 min on 1st day of each 21-day cycle. Pre-medication regimen: Corticosteroid, equiv to dexamethasone 4 mg PO bd, given the day prior to, on the day of, & the day after pemetrexed administration.

Hypersensitivity. Concomitant yellow fever vaccine. Lactation.

Monitor patients for myelosuppression; should not be given in patients w/ ANC <1,500 cells/mm³ & platelet count <100,000 cells/mm³. Pre-treatment w/ dexamethasone (or equiv) & co-administration w/ folic acid & vit B₁₂ while under treatment is recommended. Reports of serious renal events (eg, acute renal failure). Regularly monitor patients for acute tubular necrosis, decreased renal function & signs & symptoms of nephrogenic diabetes insipidus. Uncommon reports of serious CV events (eg, MI & CVA) usually in combination w/ another cytotoxic agent & in patients w/ pre-existing CV risk factors. Reports of radiation pneumonitis in patients treated w/ radiation prior, during or subsequent to pemetrexed therapy. Radiosensitising agents must be used w/ caution. Reports of radiation recall in patients who received RT wk or yr previously. Concomitant use w/ live attenuated vaccine is not recommended. May affect ability to drive & operate machines. Avoid high-dose NSAIDs or ASA in patients w/ mild to moderate renal insufficiency (CrCl 45-79 mL/min) 2 days before, on the day of, & 2 days following pemetrexed administration. Concomitant administration w/ NSAIDs having longer t_½ (eg, piroxicam or rofecoxib) should be interrupted in patients w/ mild to moderate renal insufficiency for at least 5 days prior to, on the day of, & at least 2 days following pemetrexed administration. Not recommended in patients w/ CrCl <45 mL/min. Contraceptive measures or abstinence are recommended in males during treatment & up to 3 mth thereafter; counselling on sperm storage prior to treatment initiation is recommended. Women of childbearing potential must use effective contraception during treatment & for 6 mth following treatment completion. Not to be used during pregnancy unless clearly necessary. Discontinue breast-feeding while under therapy. 500-mg: May affect patients on controlled Na diet.

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

Potentially delay in clearance w/ nephrotoxic drugs (eg, aminoglycosides, loop diuretics, platinum compd, cyclosporin); drugs that are tubularly secreted (eg, probenecid, penicillin). Decreased elimination w/ high dose NSAIDs (eg, ibuprofen >1,600 mg/day & ASA ≥1.3 g/day). Possible interaction w/ oral anticoagulants. Risk of fatal generalised vaccinale disease w/ yellow fever vaccine. Risk of systemic, possibly fatal, disease w/ live attenuated vaccine.

Cytotoxic Chemotherapy

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

P₁S₁S₃