Pemetrexed Eurodrug

Pemetrexed Eurodrug

pemetrexed

Manufacturer:

Oncomed

Distributor:

Pacific Healthcare

Marketer:

Pacific Healthcare
Concise Prescribing Info
Contents
Pemetrexed diNa hemipentahydrate
Indications/Uses
In combination w/ cisplatin for chemotherapy naïve patients w/ unresectable malignant pleural mesothelioma; 1st-line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. Monotherapy for maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy; 2nd-line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology.
Dosage/Direction for Use
IV infusion Administer over 10 min on 1st day of each 21-day cycle. Premed: Dexamethasone 4 mg orally bid prior to, on the day of & the day after pemetrexed infusion. Oral folic acid or multivit containing folic acid (350-1,000 mcg) daily at least 5 doses during 7 days preceding 1st dose of pemetrexed, & continue during full course of therapy & for 21 days after last dose of pemetrexed. Vit B12 1,000 mcg IM in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter. May administer subsequent vit B12 inj on same day as pemetrexed. In combination w/ cisplatin 500 mg/m2 + cisplatin 75 mg/m2 over 2 hr approx 30 min after pemetrexed completion. Monotherapy for NSCLC after prior chemotherapy 500 mg/m2.
Contraindications
Hypersensitivity. Concomitant use w/ yellow fever vaccine. Lactation.
Special Precautions
Discontinue therapy if any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions, or if Grade 3 or 4 neurotoxicity is observed. Radiation pneumonitis; radiation recall in patients who received RT wk or yr previously. Monitor patients for myelosuppression during therapy & not to be given until ANC returns to ≥1,500 cells/mm3 & platelet count ≥100,000 cells/mm3; acute tubular necrosis, decreased renal function & signs & symptoms of nephrogenic diabetes insipidus (eg, hypernatraemia). Patients w/ underlying risk factors including dehydration or pre-existing HTN, diabetes or CV risk factors. Patients treated w/ radiation either prior, during or subsequent to pemetrexed therapy. Monitor CBC including differential white cell & platelet count, & collect blood chemistry tests to evaluate renal & hepatic function prior to each chemotherapy. Take folic acid & vit B12 as prophylactic measure to reduce treatment-related toxicity. Consider drainage of 3rd space fluid collection prior to treatment. Ensure adequate anti-emetic treatment & appropriate hydration prior to &/or after receiving treatment. Not recommended in concomitant use w/ live attenuated vaccines. Avoid concomitant use w/ NSAIDs eg, ibuprofen, & ASA (>1.3 g daily) for 2 days before, on the day of, & 2 days following treatment in patients w/ mild to moderate renal insufficiency (CrCl 45-79 mL/min). Interrupt NSAIDs w/ long elimination t½ for at least 5 days prior to, on the day of, & at least 2 days following treatment in patients w/ mild to moderate renal insufficiency eligible for pemetrexed therapy. Concomitant use w/ other radiosensitising agents. May cause fatigue & affect ability to drive & use machines. Not recommended in patients w/ CrCl <45 mL/min. Serious renal events including acute renal failure. Hepatic impairment eg, bilirubin >1.5x ULN &/or aminotransferase >3x ULN (hepatic metastases absent) or >5x ULN (hepatic metastases present). Women of childbearing potential should use effective contraception during & for 6 mth following treatment. Sexually mature males should use effective contraception & advise not to father a child during treatment & up to 3 mth thereafter, & to seek counselling on sperm storage before starting treatment. Not to be used during pregnancy. Discontinue lactation during therapy. Childn.
Adverse Reactions
Infection, pharyngitis; neutropenia, leukopenia, decreased Hb; stomatitis, anorexia, vomiting, diarrhoea, nausea; rash, skin exfoliation; decreased CrCl, increased blood creatinine; fatigue. Sepsis; febrile neutropenia, decreased platelet count; hypersensitivity; dehydration; taste disorder, peripheral motor & sensory neuropathy, dizziness; conjunctivitis, dry eye, increased lacrimation, keratoconjunctivitis sicca, eyelid oedema, ocular surface disease; cardiac failure, arrhythmia; dyspepsia, constipation, abdominal pain; increased ALT & AST; hyperpigmentation, pruritus, erythema multiforme, alopecia, urticaria; renal failure, decreased GFR; pyrexia, pain, oedema, chest pain, mucosal inflammation; increased γ-glutamyltransferase. SJS, TEN.
Drug Interactions
Delayed clearance w/ nephrotoxic drugs (eg, aminoglycoside, loop diuretics, platinum compd, cyclosporin); tubularly secreted substances eg, probenecid, penicillin. May decrease elimination w/ high dose NSAIDs eg, ibuprofen (>1,600 mg daily) & ASA (≥1.3 g daily) in patients w/ normal renal function (CrCl ≥80 mL/min). Concomitant use w/ NSAIDs w/ longer t½ eg, piroxicam or rofecoxib; oral anticoagulants; 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
Pemetrexed Eurodrug powd for conc for soln for infusion 100 mg
Packing/Price
((lyo)) 1's
Form
Pemetrexed Eurodrug powd for conc for soln for infusion 500 mg
Packing/Price
((lyo)) 1's
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