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 non-small cell lung cancer other than predominantly squamous cell histology. 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. Monotherapy for the 2nd line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer 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 non-small cell lung cancer 500 mg/m² by IV infusion over 10 min on 1st day of each 21-day cycle. Pre-medication regimen: Corticosteroid, equivalent 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/ absolute neutrophil count <1,500 cells/mm³ & platelet count <100,000 cells/mm³. Pre-treatment w/ dexamethasone (or equivalent) & 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 radiotherapy wk or yr previously. Concomitant use w/ live attenuated vaccine is not recommended. May affect ability to drive & operate machines. Avoid high-dose NSAIDs 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 6 mth thereafter; counselling on sperm storage prior to treatment initiation is recommended. Women of childbearing potential must use effective contraception during treatment. Pregnancy. 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 & acetylsalicylic acid ≥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