Pemeta-100/Pemeta-500 Dosage & Drug Information

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

Concise Prescribing Info

Contents

Pemetrexed

Indications/Uses

Initial treatment of locally advanced or metastatic non-squamous NSCLC, in combination w/ cisplatin. Maintenance treatment of patients w/ locally advanced or metastatic non-squamous NSCLC in patients whose disease has not progressed after 4 cycles of platinum-based 1st line chemotherapy. Treatment of locally advanced or metastatic non-squamous NSCLC after prior chemotherapy. In combination w/ cisplatin for treatment of patients w/ malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

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Dosage/Direction for Use

In combination w/ cisplatin 500 mg/m² as IV infusion over 10 min on the 1st day of each 21-day cycle + cisplatin 75 mg/m² over 2 hr approx 30 min after completion of pemetrexed infusion on the 1st day of each 21-day cycle + adequate anti-emetic. Monotherapy for NSCLC after prior chemotherapy 500 mg/m² as IV infusion over 10 min on 1st day of each 21-day cycle.

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Overdosage

View Pemeta-100/Pemeta-500 overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity. Concomitant use of yellow fever vaccine. Breastfeeding.

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Special Precautions

Patients must be instructed to take folic acid & vit B₁₂ as prophylactic measure to reduce treatment-related hematologic & GI toxicity. Pretreatment w/ dexamethasone (or equiv) reduces incidence & severity of cutaneous reaction. Can cause bone marrow suppression. Not to be administered to patients whose CrCl is <45 mL/min. Caution when co-administering ibuprofen or other NSAIDs to patients w/ mild to moderate renal insufficiency (CrCl 45-79 mL/min). Patients should not begin a new cycle of treatment unless ANC >1,500 cells/mm³, platelet count >100,000 cells/mm³, & CrCl >45 mL/min. In patients w/ 3rd space fluid, consider draining the effusion prior to administration. Women of childbearing potential should be advised to avoid becoming pregnant. Can cause fetal harm when administered to a pregnant woman.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fatigue, stomatitis, pharyngitis, dyspnoea, chest pain, neuropathy. Serious renal events, including acute renal failure.

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Drug Interactions

Potentially delayed clearance w/ nephrotoxic drugs (eg, aminoglycosides, loop diuretics, platinum compd, cyclosporin); substances that are also tubularly secreted eg, probenecid, penicillin. Risk of decreased elimination & increased occurrence of adverse events w/ high doses of NSAIDs eg, ibuprofen & aspirin. Risk of fatal generalised vaccine disease when used w/ yellow fever vaccine. Risk of systemic, possibly fatal, disease w/ live attenuated vaccines.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Pemeta-100/Pemeta-500 detailed prescribing information

Storage

View Pemeta-100/Pemeta-500 storage conditions for details to ensure optimal shelf-life.

Description

View Pemeta-100/Pemeta-500 description for details of the chemical structure and excipients (inactive components).

Action

View Pemeta-100/Pemeta-500 mechanism of action for pharmacodynamics and pharmacokinetics details.

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

Presentation/Packing

Form

Pemeta-100 lyo powd for conc soln for IV inj 100 mg

Packing/Price

1's

Form

Pemeta-500 powd for conc soln for IV infusion 500 mg

Packing/Price

1's

Pemeta-100/Pemeta-500

pemetrexed

Manufacturer:

Admac Lifesciences

Distributor:

Orange Biotec