Irinocan 40/Irinocan 100

Irinocan 40/Irinocan 100

irinotecan

Manufacturer:

Accord Healthcare

Distributor:

DKSH
Concise Prescribing Info
Contents
Irinotecan HCl trihydrate
Indications/Uses
Advanced colorectal cancer in combination w/ 5-fluorouracil & folinic acid in patients w/o prior chemotherapy for advanced disease & as monotherapy in patients who failed an established 5-fluorouracil containing treatment regimen. In combination w/ cetuximab in patients w/ epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer who had not received prior treatment for metastatic disease or after failure of irinotecan including cytotoxic therapy. 1st-line treatment in metastatic carcinoma of colon or rectum in combination w/ 5-fluorouracil, folinic acid & bevacizumab. 1st-line treatment in metastatic colorectal carcinoma in combination w/ capecitabine w/ or w/o bevacizumab.
Dosage/Direction for Use
Monotherapy Previously treated patient 350 mg/m2 as IV infusion over 30-90 min period every 3 wk. Combination therapy Previously untreated patient 180 mg/m2 once every 2 wk as IV infusion over 30-90 min period followed by folinic acid & 5-fluorouracil infusion every 2 wk. Hepatic impairment bilirubin up to 1.5 x upper limit of normal range (ULN) 350 mg/m2, bilirubin 1.5-3 x ULN 200 mg/m2.
Contraindications
Hypersensitivity. Chronic inflammatory bowel disease &/or bowel obstruction, bilirubin >3 x ULN, severe bone marrow failure, WHO performance status >2. Concomitant use w/ St. John's wort. Lactation.
Special Precautions
Increased risk of delayed diarrhea in patients who had previous abdominal/pelvic radiotherapy, w/ baseline hyper leucocytosis, performance status ≥2 & women. Patients who received previous pelvic/abdominal irradiation than in those who had not received such irradiation; baseline serum total bilirubin levels of ≥1 mg/dL. Monitor CBC wkly. Patients who experienced severe haematological events. Increased risk of infections & haematological toxicity in patients w/ severe diarrhoea. Nausea & vomiting. Acute cholinergic syndrome. Caution in patients w/ asthma. Risk factors associated w/ the development of interstitial pulmonary disease including use of pneumotoxic drugs, radiation therapy & colony stimulating factors. Avoid extravasation & monitored for signs of inflammation at infusion site. Patients w/ extensive prior irradiation (eg, >25% of bone marrow irradiated & w/in 6 wk prior to start treatment w/ irinotecan). Underlying cardiac disease, risk factors for cardiac disease, previous cytotoxic chemotherapy. Thromboembolic events (pulmonary embolism, venous thrombosis & arterial thromboembolism) in patients w/ multiple risk factors in addition to the underlying neoplasm. Avoid administration of live vaccines. Hereditary fructose intolerance. Avoid concomitant w/ a strong CYP3A4 inhibitor (eg, ketoconazole) or inducer (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort). May affect ability to drive & use machines. Use effective contraceptive measures during & for at least 3 mth after cessation of therapy. Liver impairment; bilirubin >3 x ULN. Not recommended in renal impairment. Do not use in pregnancy. Do not use in childn. Elderly.
Adverse Reactions
Delayed diarrhoea & blood disorders including neutropenia, anaemia & thrombocytopenia. Monotherapy: Neutropenia, anaemia; decreased appetite; cholinergic syndrome; diarrhoea, vomiting, nausea, abdominal pain; alopecia (reversible); mucosal inflammation, pyrexia, asthenia. Combination therapy: Thrombocytopenia, neutropenia, anaemia; decreased appetite; cholinergic syndrome; diarrhoea, vomiting, nausea; Increased transaminases (SGPT & SGOT), bilirubin, blood alkaline phosphatase; alopecia (reversible); mucosal inflammation, asthenia.
Drug Interactions
Prolonged neuromuscular blocking effects of suxamethonium. Antagonized neuromuscular blockade of non-depolarising drugs. Reduced exposure & pharmacodynamic effect w/ CYP3A-inducing anticonvulsants (eg, carbamazepine, phenobarb, phenytoin). May alter metabolism w/ CYP450 3A4 inhibitors (eg, ketoconazole) & inducers (eg, rifampicin, carbamazepine, phenobarb, phenytoin). Decreased plasma conc w/ St. John's wort. Increased systemic exposure to SN-38 w/ atazanavir sulfate. Possibility of interaction w/ oral anticoagulants. Risk of fatal generalised reaction to vaccines w/ Yellow fever vaccine. Risk of systemic, possible fatal disease (eg, infections) w/ live attenuated vaccines (except Yellow fever). Risk of exacerbation of convulsions resulting from decreased phenytoin digestive absorption by cytotoxic drug or risk of toxicity enhancement due to increased hepatic metabolism by phenytoin. Excessive immunosuppression w/ risk of lymphoproliferation w/ ciclosporine & tacrolimus.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Irinocan 100 soln for infusion (conc) 100 mg/5 mL
Packing/Price
5 mL x 1's
Form
Irinocan 40 soln for infusion (conc) 40 mg/2 mL
Packing/Price
2 mL x 1's
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