Pexitaz

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

IV infusion In combination w/ cisplatin 500 mg/m² over 10 min on Day 1 of each 21-day cycle + cisplatin 75 mg/m² infused over 2 hr approx 30 min on Day 1 of each 21-day cycle. Monotherapy for NSCLC after prior chemotherapy 500 mg/m² over 10 min on Day 1 of each 21-day cycle.

History of severe hypersensitivity. Concomitant yellow fever vaccine.

Not to begin new cycle of treatment unless ANC is ≥1,500 cells/mm³ & platelet count is ≥100,000 cells/mm³, & CrCl ≥45 mL/min. Serious CV events, including MI & cerebrovascular events (uncommon). Reports of skin reactions in patients not pre-treated w/ corticosteroid. Cases of radiation pneumonitis in patients treated w/ radiation either prior, during or subsequent to pemetrexed therapy; recall in patients who received RT wk or yr previously. Severe dehydration. Can suppress bone marrow function as manifested by neutropenia, thrombocytopenia & anemia (or pancytopenia). Perform CBC, including platelet counts & periodic chemistry tests on all patients receiving pemetrexed. Instruct patients to take folic acid & vit B₁₂ as prophylactic measure to reduce treatment-related toxicity. Patients should receive adequate antiemetic treatment & appropriate hydration prior to &/or after receiving treatment. Not recommended w/ live attenuated vaccines. Caution against driving or operating machinery if fatigue occurs. Serious renal events including acute renal failure w/ pemetrexed alone or in association w/ other chemotherapeutic agents. Patients w/ hepatic impairment eg, bilirubin >1.5x ULN; transaminase >3x ULN (hepatic metastases absent) or 3-5x ULN (hepatic metastases present). Patients w/ mild to moderate renal insufficiency (CrCl 45-79 mL/min) should avoid taking NSAIDs eg, ibuprofen, & ASA (>1.3 g daily) for 2 days before, on the day of, & 2 days following pemetrexed administration; NSAIDs w/ long elimination t_½ for at least 5 days prior to, on the day of, & at least 2 days following pemetrexed administration. Not to be administered in patients w/ CrCl <45 mL/min. Can have genetically damaging effects; sexually mature males are advised not to father a child during treatment & up to 6 mth thereafter. Possible to cause irreversible infertility in males; advise men to seek counselling on sperm storage before starting treatment. Women of childbearing potential must use effective contraception during treatment. May cause fetal harm when administered to a pregnant woman. Discontinue nursing if the mother is treated w/ pemetrexed. Not recommended for use in childn.

Neutropenia, leukopenia, anemia, thrombocytopenia, ALT/AST elevation, decreased CrCl, creatinine elevation, renal failure, thrombosis, embolism, cardiac ischemia, nausea, vomiting, constipation, anorexia, stomatitis, pharyngitis, diarrhea w/o colostomy, dehydration, dysphagia, esophagitis, odynophagia, dyspnea, chest pain, HTN, sensory neuropathy, mood alteration, depression, infection w/o neutropenia, infection w/ grade 3 or grade 4 neutropenia, febrile neutropenia, allergic reaction, hypersensitivity, rash, desquamation, conjunctivitis, taste disturbance, pyrexia, fatigue, fever, edema, myalgia, alopecia, dyspepsia, urticaria, arrhythmias, motor neuropathy, pruritis, erythema multiforme, abdominal pain, heart burn, increased γ-glutamyl transferase, arthralgia & other constitutional symptoms.

Delayed clearance w/ nephrotoxic drugs (eg, aminoglycoside, loop diuretics, platinum compd, cyclosporin); & tubularly secreted substances (eg, probenecid, penicillin). Decreased elimination &, consequently, increased occurrence of adverse events w/ high doses of NSAIDs (eg, ibuprofen >1,600 mg/day) & ASA at higher dose (≥1.3 g daily). Concomitant use w/ piroxicam or rofecoxib. Increase frequency of INR monitoring, if it is decided to treat patient w/ oral anticoagulants. Risk of fatal generalised vaccinale disease w/ yellow fever vaccine; systemic, possibly fatal, disease w/ other live attenuated vaccines.

Cytotoxic Chemotherapy

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

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