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Benzpee 100/500 Lyophilized Injection

Generic Name – Pemetrexed disodium
Drug Class – Antineoplastic agent
Pemetrexed is a folate analog inhibitor, approved by FDA for treatment of non small cell lung cancer (NSCLC) and mesothelioma. It acts by inhibiting enzymes involved in folate dependent synthetic pathways such as thymidine synthase. Inhibition of these enzymes may disrupt DNA synthesis and leads to cell death

Product Description

Benzpee (Pemetrexed for injection) is the lyophilized powder for injection. The lyophilization enhances the stability of the dry powder. Pemibenz lyophilized powder offers a rapid and enhanced dissolution which ultimately provides ease of intravenous administration.

Indications and Usage

Pemetrexed is indicated for:
a) Locally advanced and metastatic nonsquamous NSCLC as:
• Initial treatment in combination with cisplatin therapy
• Maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
• Single agent after prior chemotherapy
b) Malignant pleural mesothelioma (MPM) in combination with cisplatin2

Limitations of use
• Pemetrexed is not indicated for the treatment of patients with squamous NSCLC

Dosage and Administration

•Dosage Regimen for NSCLC

Pemetrexed Monotherapy
Pemetrexed 500 mg/m2 IV on day 1 of each 21-day cycle
Pemetrexed/Cisplatin Regimen
Pemetrexed Pemetrexed 500 mg/m2 IV on day 1 of each 21-day cycle
Cisplatin 75 mg/m2 IV beginning 30 minutes after pemetrexed

•Dosage Regimen for MPM

Pemetrexed/Cisplatin Regimen
Pemetrexed Pemetrexed 500 mg/m2 IV on day 1 of each 21-day cycle
Cisplatin 75 mg/m2 IV beginning 30 minutes after pemetrexed

• Dose may be reduced based on the toxicities from preceding cycle of therapy

Dosage Form and Strength
• Supplied as single-use sterile lyophilized powder for intraveneous infusion in glass vials
• Available in 500mg and 100mg for injection

Clinical Efficacy

• Efficacious and well tolerated for first-line, maintenance and second or third-line treatment of NSCLC with few grade 3 and 4 toxicities
• Shows good response rates and survival benefits in locally advanced, metastatic and inoperable Stage III NSCLC
• More effective in improving treatment outcomes in non squamous tumors as compared to squamous tumors
• Improves survival and pulmonary functions in patients with MPM whose disease is either unresectable or who are not candidates for curative surgery

Adverse reactions
• Like other folate antagonists, pemetrexed may cause various adverse effects such as nausea, vomiting, fatigue, diarrhea, anorexia, rashes and bone marrow suppression when used as a single agent.
• Some other uncommon side effects may also occur when used in combination with cisplatin include vomiting, constipation, neutropenia, leukopenia, thrombocytopenia, anemia, and stomatitis/pharyngitis

Contraindications
• It is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed or to any other ingredient used in the formulation

Special Precautions

• Patients should receive oral folic acid and vitamin B12 injections before the start and during therapy to reduce treatment related hematologic and gastrointestinal toxicities
• Patients may receive corticosteroids with the chemotherapy to decrease the incidence of skin rash
• Dose should be reduced in cases of hematologic and non hematologic toxicities
• Patients taking NSAIDs and nephrotoxic drugs should use caution as combined use may lead to potential drug interactions
• It should be used with caution in patients with moderate to renal insufficiency
• Women administered with pemetrexed should be advised to use effective contraceptive measures to avoid pregnancy during treatment
• It should not be administered in pregnant women, as it may cause harm to fetus

Chemo Injection Pemetrexed Disodium 100/500mg Manufacturer