Accord Pemetrexed

Accord Pemetrexed





Accord Healthcare
Concise Prescribing Info
In combination w/ cisplatin for chemotherapy-naive patients w/ unresectable malignant pleural mesothelioma. Monotherapy for 2nd-line treatment or in combination w/ cisplatin for 1st-line treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Monotherapy for maintenance of locally advanced or metastatic non-small cell lung cancer 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 regimen Oral dexamethasone 4 mg bd given the day prior to, on the day of & day after pemetrexed administration. 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. IM vit B12 (1,000 mcg) in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter.
Hypersensitivity. Concomitant use w/ yellow fever vaccine. Lactation.
Special Precautions
Discontinue use if Grade 3 or 4 haematologic & non-haematologic toxicity is observed. Monitor for myelosuppression during therapy. Severe CV events eg, MI & cerebrovascular events; dehydration, preexisting HTN or diabetes; pneumonitis; nephrogenic diabetes insipidus, renal tubular necrosis. Controlled Na diet. Ensure adequate antiemetic treatment & appropriate hydration prior to &/or after therapy. Monitor complete blood count including white cell & platelet counts & evaluate renal & hepatic function prior to each dose. Regularly monitor for acute tubular necrosis, signs & symptoms of hypernatraemia. Not recommended in immunodepressed status & concomitant use w/ live attenuated vaccines. Concomitant use w/ other radiosensitising agents. May affect ability to drive & use machines. Avoid NSAIDs for 2 days prior to, on the day of & 2 days following premetrexed 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 & lactation.
Adverse Reactions
Bone marrow suppression eg, anaemia, neutropenia, leukopenia, thrombocytopenia; GI toxicities eg, anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, stomatitis. Renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis, neuropathy.
Drug Interactions
Delayed clearance w/ nephrotoxic drugs, probenecid & penicillin. Decreased elimination & increased adverse events w/ high-dose NSAIDs & aspirin. Monitor increased INR frequency w/ anticoagulation treatment. Risk of fatal generalized vaccinale disease w/ yellow fever vaccine. Increased systemic, possibly fatal disease w/ live attenuated vaccines.
ATC Classification
L01BA04 - pemetrexed ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.
Accord Pemetrexed powd for infusion 100 mg
Accord Pemetrexed powd for infusion 500 mg
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