Pemetrex - Injection Pemetrexed - 500mg/5ml 1 Injection(s) / Injection Beacon Pharmaceuticals PLC Introduction: Pemetrex is used in the treatment of non-small cell lung cancer and malignant pleural mesothelioma. Pemetrex is given as an injection by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits... Uses of Pemetrex: Non-small cell lung cancerMalignant pleural mesothelioma Side effects of Pemetrex: NauseaVomitingSore throatLoss of appetiteStomatitis (Inflammation of the mouth)Hair lossLow blood plateletsRashFatigueAnemia (low number of red blood cells)DiarrheaDecreased white blood cell count (neutrophils)Neuropathy How to use Pemetrex: Your doctor or nurse will give you this medicine. Kindly do not self administer. How Pemetrex works: Pemetrex interferes with the growth of DNA and RNA of the cancer cells by substituting their building blocks. It prevents the cancer cells from growing and multiplying. Indication: Non-small cell lung cancer, Malignant pleural mesothelioma Administration: IV Preparation Aseptically reconstitute with 20 mL of 0.9% NaCl (preservative free) to give a 25 mg/mL solution Gently swirl until completely dissolved; resulting solution is clear and ranges in color from colorless to yellow/green-yellow without adversely affecting quality Aseptically dilute required dose to 100 mL with 0.9% NaCl (preservative free) IV Administration Infuse over 10 min Adult Dose: Intravenous Malignant Pleural Mesothelioma Indicated for mesothelioma in combination with cisplatin in patients whose disease is unresectable or are not candidates for curative surgery Combination use with cisplatin: 500 mg/m² IV over 10 minutes on Day 1 of each 21-day cycle; administer cisplatin (75 mg/m² IV over 2 hr) 30 minutes after end of premetrexed infusion Nonsquamous Non-Small Cell Lung Carcinoma Indications Initial treatment: In combination with cisplatin for initial treatment with locally advanced or metastatic nonsquamous NSCLC Maintenance: Locally advanced or metastatic nonsquamous NSCLC in patients whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy After... Child Dose: Safety and efficacy not established Renal Dose: Renal impairment: CrCl (ml/min) Dosage Recommendation <45 Usage is not recommended. Contraindication: Hypersensitivity. Mode of Action: Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis. Precaution: Monitor CBC, platelet counts, and CrCl for nadir and recovery before each cycle. Periodic hepatic monitoring Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy. Lactation: not safe Side Effect: >10% Nausea (84%),Fatigue (80%),Pulmonary dyspnea (66%),Neutropenia (58%),Vomiting (58%),Leukopenia (55%),Constipation (44%),Chest pain (40%),Anorexia (35%),Anemia (33%),Pharyngitis (28%),Stomatitis (28%),Thrombocytopenia (27%),Diarrhea without colostomy (26%),Rash/desquamation (22%),Fever (17%),Neuropathy/sensory (17%),Creatinine elevation (16%),Mood alteration/depression (14%),Infection without neutropenia (11%) 1-10% Dehydration, thrombosis/embolism (7%),Dysphagia/esophagitis/odynophagia (6%),Infection with Grade 3 or Grade 4 neutropenia (6%),Neutropenia-other (3%),Allergic reaction/hypersensitivity (2%),Renal failure (2%),Febrile neutropenia (1%) <1% Esophagitis,Arrhythmia,Motor neuropathy,Febrile neutropenia,Erythema multiforme Potentially Fatal: Acute renal failure. Interaction: High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.