Pemexed

Pemexed

pemetrexed

Manufacturer:

Mega Lifesciences

Distributor:

Zuellig Pharma

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Pemetrexed
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
Premed: 4 mg dexamethasone orally bid. 350-1,000 mcg folic acid daily. Take at least 5 doses of folic acid during 7 days preceding 1st dose of pemetrexed, & continue during full course of therapy & for 21 days after the last dose of pemetrexed. 1,000 mcg vit B12 IM inj in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter. Give subsequent vit B12 inj on the same day as pemetrexed. IV Give as IV infusion over 10 min. In combination w/ cisplatin 500 mg/m2 & 75 mg/m2 cisplatin infused over 2 hr approx 30 min after completion of pemetrexed infusion on 1st day of each 21-day cycle. NSCLC Monotherapy: 500 mg/m2 on 1st day of each 21-day cycle.
Contraindications
Hypersensitivity. Concomitant use w/ yellow fever vaccine. Lactation.
Special Precautions
Not to be given to patients until ANC returns to ≥1,500 cells/mm3 & platelet count returns to ≥100,000 cells/mm3. Not recommended in patients w/ CrCl <45 mL/min. Monitor patients for myelosuppression during therapy. Regularly monitor patients for acute tubular necrosis, decreased renal function & signs & symptoms of nephrogenic diabetes insipidus (eg, hypernatraemia). Neutropenia, thrombocytopenia & anaemia. Dehydration or pre-existing HTN or diabetes; nephrogenic diabetes insipidus & renal tubular necrosis. Serious CV events including MI & cerebrovascular events. Cases of radiation pneumonitis in patients treated w/ radiation either prior, during or subsequent to therapy; radiation recall in patients who received RT wk or yr previously. Instruct patient to take folic acid & vit B12 as prophylactic measure to reduce treatment-related toxicity. Pre-treatment w/ dexamethasone (or equiv) to reduce incidence & severity of skin reactions. Consider drainage of 3rd space fluid collection prior to treatment. Adequate antiemetic & appropriate hydration prior to &/or after receiving treatment. Avoid taking NSAIDs (eg, ibuprofen & ASA) for 2 days before, on the day of, & 2 days following therapy. Not recommended in concomitant use w/ live attenuated vaccines. May affect ability to drive & use machines. 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 must use effective contraception during treatment. Sexually mature males should not father a child during treatment & up to 6 mth thereafter. Men should seek counselling on sperm storage before starting treatment. Recommend contraceptive measures or abstinence. Not to be used during pregnancy (serious birth defects). Discontinue lactation during therapy. Paed.
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. Decreased elimination w/ higher doses of NSAIDs or ASA. Concomitant use w/ 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
Pemexed powd for inj 500 mg
Packing/Price
1's
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