Pemeta100mg/ml

Pemetrexed is used in the treatment of non-small cell lung cancer and malignant pleural mesothelioma. Pemetrexed 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 but do not stop taking it unless your doctor tells you to. The most common side effects of this medicine include nausea, vomiting, loss of appetite, and hair loss. This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells along with heart, liver and blood uric acid levels. Before taking it, tell your doctor if have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using.This medicine is not recommended during pregnancy or while breastfeeding. Use of effective contraception by both males and females during treatment is important to avoid pregnancy. Pemetrexed 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.

• Non-small cell lung cancer • Malignant pleural mesothelioma

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.

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 prior chemotherapy: As a single agent of locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy Single-agent use: 500 mg/m² IV infusion over 10 minutes on Day 1 of each 21-day cycle 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 Premedication Regimen Folic acid: 400-1000 mcg PO qDay beginning 7 days before first pemetrexed dose; continue during the full course of therapy and for 21 days after the last dose Vitamin B12: 1 mg IM beginning 1 week before first pemetrexed dose and repeat every 3 cycles thereafter; subsequent doses may be administered on the same day as pemetrexed Do not substitute PO B12 for IM (see Cautions) Dexamethasone: 4 mg PO BID on the day before, day of, and day after pemetrexed administration treatment to help prevent skin rash Dosage Modifications If nadir ANC 50,000/mm³ Adjust to 75% of previous dose (both drugs) If nadir platelets <50,000/mm³ regardless of nadir ANC Adjust to 50% of previous dose (both drugs) Any Grade 3 or 4 toxicities except mucositis Adjust to 75% of previous dose (both drugs) Any diarrhea requiring hospitalization Adjust to 75% of previous dose (both drugs) Grade 3 or 4 mucositis Adjust pemetrexed to 50% of previous dose CTC Grade 2 Adjust Cisplatin to 50% of previous dose Child Dose: Safety and efficacy not established Renal Dose: Renal impairment: CrCl (ml/min) Dosage Recommendation <45 Usage is not recommended.

Your doctor or nurse will give you this medicine. Kindly do not self administer.

Common: • Nausea • Vomiting • Sore throat • Loss of appetite • Stomatitis (Inflammation of the mouth) • Hair loss • Low blood platelets • Rash • Fatigue • Anemia (low number of red blood cells) • Diarrhea • Decreased white blood cell count (neutrophils) • Neuropathy

[UNSAFE] Pemetrexed may cause side effects which could affect your ability to drive. Pemetrexed may make you feel tired and this may affect your ability to drive. Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine. Inform your doctor immediately if you notice any signs of infection such as fever, sore throat, rash or severe diarrhea.

Hypersensitivity.

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.

[SAFE] Consuming alcohol with Pemetrexed does not cause any harmful side effects.

[CONSULT YOUR DOCTOR] Pemetrexed is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

[CAUTION] Pemetrexed should be used with caution during breastfeeding. Breastfeeding should be held until the treatment of the mother is completed and the drug is eliminated from her body.

[CAUTION] Pemetrexed should be used with caution in patients with kidney disease. Dose adjustment of Pemetrexed may be needed. Please consult your doctor. Use of Pemetrexed is not recommended in patients with moderate to severe kidney disease. [SAFE IF PRESCRIBED] Pemetrexed is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of Pemetrexed may not be needed in these patients. Please consult your doctor.

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