Podoxred

Podoxred

pemetrexed

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Pemetrexed disodium
Indications/Uses
Malignant pleural mesothelioma: In combination w/ cisplatin for chemotherapy-naive patients w/ unresectable malignant pleural mesothelioma. NSCLC: In combination w/ cisplatin as 1st-line treatment or monotherapy for 2nd-line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. Monotherapy for maintenance of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
Dosage/Direction for Use
In combination w/ cisplatin 500 mg/m2 IV infusion over 10 min on 1st day of each 21-day cycle (cisplatin 75 mg/m2 infused over 2 hr approx 30 min after completion of pemetrexed infusion). Monotherapy 500 mg/m2 IV infusion over 10 min on 1st day of each 21-day cycle. Premed Oral dexamethasone 4 mg bd given the day prior to, on the day of & day after treatment. Oral folic acid 350-1,000 mcg daily at least 5 doses during the 7 days preceding 1st dose of pemetrexed, continued during the full course of therapy & for 21 days after last dose of pemetrexed. Vit B12 1,000 mcg IM inj in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter.
Contraindications
Hypersensitivity. Concomitant use w/ yellow fever vaccine. Lactation.
Special Precautions
Discontinue use if Grade 3 or 4 haematologic or non-haematologic toxicity is observed. Serious CV events eg, MI & cerebrovascular events; serious renal events; dehydration, preexisting HTN or diabetes. Effect of 3rd-space fluid eg, pleural effusion or ascites. Monitor for myelosuppression, complete blood & platelet counts during therapy. Not recommended in immunodepressed status & concomitant use w/ live attenuated vaccines. GI toxicity when given in combination w/ cisplatin, ensure adequate antiemetic treatment & appropriate hydration prior to &/or after therapy. Concomitant use w/ other radiosensitising agents. Interrupt NSAIDs w/ long t½ for at least 5 days prior to, on the day of & at least 2 days after administration. May affect ability to drive & use machines. Avoid NSAIDs for 2 days prior to, on the day of & 2 days following administration in patients w/ mild to moderate renal impairment (CrCl 45-79 mL/min). Not recommended in patients w/ CrCl <45 mL/min. Males should not father a child during & up to 6 mth after treatment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. 500 mg: Controlled Na diet.
Adverse Reactions
Decreased neutrophils/granulocytes, leukocytes, Hb, platelets; sensory neuropathy; diarrhoea, vomiting, stomatitis/pharyngitis, nausea, anorexia, constipation; rash, alopecia; elevated creatinine, decreased CrCl; fatigue. Dehydration; taste disturbance; conjunctivitis; dyspepsia.
Drug Interactions
Delayed clearance w/ nephrotoxic drugs (eg, aminoglycoside, loop diuretics, platinum compd, cyclosporin), probenecid, penicillin. Decreased elimination & increased occurrence of adverse events w/ high-dose NSAIDs, ASA. Monitor increased INR frequency w/ oral anticoagulants. Risk of fatal generalised vaccinale disease w/ yellow fever vaccine. Increased risk of systemic, possibly fatal disease w/ live attenuated vaccines.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BA04 - pemetrexed ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Podoxred powd for inj 100 mg
Packing/Price
1's
Form
Podoxred powd for inj 500 mg
Packing/Price
1's
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