Campto

Campto

irinotecan

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Irinotecan HCl trihydrate
Indications/Uses
In combination w/ 5-fluorouracil & folinic acid for advanced colorectal cancer in patients w/o prior chemotherapy for advanced disease or as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. In combination w/ cisplatin in patients w/ small cell lung cancer.
Dosage/Direction for Use
IV infusion Adult Monotherapy for previously treated patient 350 mg/m2 over 30-90 min every 3 wk. Combination therapy for previously untreated patient 180 mg/m2 over 30-90 min every 2 wk, followed by infusion w/ folinic acid & 5-fluorouracil. Combination w/ cisplatin 65 mg/m2 of irinotecan over 30-90 min & 30 mg/m2 of cisplatin given repeatedly for 6 wk, comprising days 1 & 8 every 21 days. Patient w/ bilirubin 1.5-3 times the upper limit of normal 200 mg/m2, 1.5 times the upper limit of normal 350 mg/m2.
Contraindications
Severe hypersensitivity. Chronic inflammatory bowel disease &/or bowel obstruction; bilirubin >3 times the upper limit of normal; severe bone marrow failure; WHO performance status >2. Pregnancy & lactation.
Special Precautions
Not to be used in patients w/ severe bone marrow failure; ECOG performance status 3 or 4. Patients w/ reduced UGT1A1 activity; late diarrhea; nausea & vomiting; gastric cancer. Crigler-Najjar (types 1 & 2) & Gilbert's syndrome. Discontinue temporarily if neutropenic fever occurs or if absolute neutrophil count <1,000/mm3. Consider administration of atropine in patients experiencing cholinergic symptoms. Monitor infusion site for signs of inflammation; resp symptoms; liver function; hematologic toxicities. Increased risk of hematotoxicity in patients w/ hyperbilirubinemia. Avoid concomitant administration of live or live attenuated vaccines. Treatment must not be initiated until resolution of bowel obstruction. Increased risk of myelosuppression in patients who previously received pelvic/abdominal irradiation following administration. Hereditary fructose intolerance. May affect ability to drive or operate machinery. Women of childbearing potential should avoid becoming pregnant. Elderly ≥65 yr.
Adverse Reactions
Late/early diarrhea, nausea, vomiting, abdominal cramping/pain, anorexia, stomatitis; leukopenia, anemia, neutropenia; asthenia, fever; decreased wt, dehydration; alopecia; thromboembolic events.
Drug Interactions
Increased systemic exposure w/ CYP3A4 &/or UGT1A1 inhibitors. Increased exposure to SN-38 w/ ketoconazole, atazanavir sulfate. Reduced exposure to SN-38 w/ CYP3A inducing anticonvulsants eg, carbamazepine, phenobarb or phenytoin, St. John's wort. May prolong the neuromuscular blocking effects of suxamethonium. Neuromuscular blockade of non-depolarising drugs may be antagonised. Exacerbated adverse effects w/ antineoplastic agents. Enhanced likelihood of lymphocytopenia & hyperglycemia w/ dexamethasone. Worsened diarrhea incidence or severity w/ laxative. Dehydration secondary to vomiting &/or diarrhea may be induced w/ diuretics.
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Campto conc for soln for infusion 100 mg/5 mL
Packing/Price
(vial) 1's (Rp4,053,835/boks)
Form
Campto conc for soln for infusion 40 mg/2 mL
Packing/Price
(vial) 1's (Rp1,748,589/boks)
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