Alimta

In combination w/ cisplatin for treatment of chemotherapy naïve patients w/ unresectable malignant pleural mesothelioma. In combination w/ cisplatin for 1st 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. Monotherapy for 2nd line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. In combination w/ pembrolizumab & platinum chemotherapy for 1st line treatment of patients w/ metastatic non-squamous NSCLC, w/ no EGFR or ALK genomic tumor aberrations.

Malignant pleural mesothelioma 500 mg/m² as IV infusion over 10 min on the 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. Monotherapy for NSCLC 500 mg/m² as IV infusion over 10 min on the 1st day of each 21-day cycle. Combination w/ cisplatin for NSCLC 500 mg/m² as IV infusion over 10 min on the 1st day of each 21-day cycle + cisplatin 75 mg/m² infused approx 30 min after completion of the pemetrexed infusion on the 1st day of each 21-day cycle. Combination w/ pembrolizumab & platinum chemotherapy for NSCLC Patient w/ CrCl ≥45 mL/min 500 mg/m² as IV infusion over 10 min administered after pembrolizumab & prior to carboplatin or cisplatin on day 1 of each 21-day cycle for 4 cycles.

Hypersensitivity. Concomitant yellow fever vaccine. Lactation.

Can suppress bone marrow function as manifested by neutropenia, thrombocytopenia & anemia (or pancytopenia). Monitor patients for myelosuppression during therapy & do not give to patients until ANC returns to ≥1,500 cells/mm³ & platelet count returns to ≥100,000 cells/mm³. Instruct patients to take folic acid & vit B₁₂ as prophylactic measure to reduce treatment-related toxicity. Reports of skin reactions in patients not pre-treated w/ corticosteroid; serious renal events, including acute renal failure; nephrogenic diabetes insipidus & renal tubular necrosis; severe dehydration; serious CV events, including MI & cerebrovascular events (uncommon); cases of radiation pneumonitis in patients treated w/ radiation either prior, during or subsequent to pemetrexed therapy; cases of radiation recall in patients who received RT wk or yr previously. 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. Patients w/ hepatic impairment eg, bilirubin >1.5 times ULN &/or transaminase >3 times ULN (hepatic metastases absent) or >5 times ULN (hepatic metastases present) have not been specifically studied. 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_1/2 should be interrupted 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. Can have genetically damaging effects; sexually mature males are advised not to father a child during treatment & up to 3 mth thereafter. Possible to cause irreversible infertility in males. Women of childbearing potential must use effective contraception during treatment & for 6 mth following completion of treatment. Should not be used during pregnancy unless clearly necessary. Not recommended for use in childn.

Infection, pharyngitis; neutropenia, leukopenia, decreased Hb; stomatitis, anorexia, vomiting, diarrhea, nausea; rash, skin exfoliation; decreased CrCl; increased blood creatinine; fatigue. Sepsis; febrile neutropenia, decreased platelet count; hypersensitivity; dehydration; taste disorder, peripheral motor neuropathy, peripheral sensory neuropathy, dizziness; conjunctivitis, dry eye, increased lacrimation, keratoconjunctivitis sicca, eyelid edema, ocular surface disease; cardiac failure, arrhythmia; dyspepsia, constipation, abdominal pain; increased ALT/AST; hyperpigmentation, pruritus, erythema multiforme, alopecia, urticaria; renal failure, decreased GFR; pyrexia, pain, edema, chest pain, mucosal inflammation; increased γ-glutamyl transferase.

Delayed clearance w/ nephrotoxic drugs (eg, aminoglycoside, loop diuretic, platinum compd, cyclosporin); & tubularly secreted substances (eg, probenecid, penicillin). High doses of NSAIDs (eg, ibuprofen >1,600 mg/day) & ASA at higher dose (≥1.3 g daily) may decrease pemetrexed elimination &, consequently, increase occurrence of pemetrexed adverse reactions. Increase frequency of INR monitoring, if it is decided to treat patient w/ oral anticoagulants. Risk of fatal generalized vaccinale disease w/ yellow fever vaccine. Risk of 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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