Pemxcel Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Pemetrexed

Indications/Uses

Locally advanced or metastatic nonsquamous non-small cell lung cancer: Initial treatment in combination w/ cisplatin; maintenance treatment for whom disease has not progressed after 4 cycles of platinum-based 1st-line chemotherapy; single-agent treatment after prior chemotherapy. Malignant pleural mesothelioma for whom disease is either unresectable or are otherwise not candidates for curative surgery (in combination w/ cisplatin).

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Dosage/Direction for Use

Premed may be administered prior to therapy. Combination use w/ cisplatin: Malignant pleural mesothelioma Recommended dose: 500 mg/m² IV infusion over 10 min on day 1 of each 21-day cycle. Recommended dose of cisplatin: 75 mg/m² infused over 2 hr beginning approx 30 min after the end pemetrexed administration. Single-agent use: Nonsquamous non-small cell lung cancer Recommended dose: 500 mg/m²IV infusion over 10 min on day 1 of each 21-day cycle.

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Overdosage

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Contraindications

History of severe hypersensitivity to pemetrexed.

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Warnings

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Special Precautions

Not for squamous cell non-small cell lung cancer. Low-dose oral folic acid prep or multivit w/ folic acid may be taken on a daily basis to reduce toxicity. Required laboratory monitoring of ANC, platelet count & CrCl. Patients w/ clinically significant 3rd space fluid. Use caution when administering concurrently w/ NSAIDs to patients w/ mild to moderate renal insufficiency. Hepatic & renal impairment. Pregnancy & lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fatigue, nausea & anorexia. Vomiting, neutropenia, leukopenia, anemia, stomatitis or pharyngitis, thrombocytopenia & constipation.

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Drug Interactions

Concomitant administration of nephrotoxic drugs & tubularly secreted substances (eg, probenecid) could result in delayed clearance of pemetrexed. Patients w/ mild to moderate renal insufficiency should avoid taking NSAIDs for 2 days before, the day of & 2 days following administration of pemetrexed.

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Storage

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Description

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

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

Regulatory Classification

POM

Presentation/Packing

Form

Pemxcel lyophilized powd for infusion 100 mg

Packing/Price

1's

Form

Pemxcel lyophilized powd for infusion 500 mg

Packing/Price

1's

Pemxcel

pemetrexed

Manufacturer:

Khandelwal Lab

Distributor:

Ni Lay Naing