Romisan

Romisan

irinotecan

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Irinotecan HCl trihydrate
Indications/Uses
Advanced colorectal cancer. In combination w/ 5-FU & folinic acid in patients w/o prior chemotherapy for advanced disease. As monotherapy on patients failed from established 5-FU containing treatment regimen.
Dosage/Direction for Use
Monotherapy for previously treated patient 350 mg/m2 IV over 30-90 min every 3 wk. Combination therapy for previously untreated patients 180 mg/m2 IV over 30-90 min every 2 wk, followed by infusion w/ folinic acid & 5-FU.
Contraindications
Chronic inflammatory bowel disease &/or bowel obstruction. Bilirubin >3 x ULN; severe bone marrow failure; patients w/ risk factor particularly those w/ WHO performance status >2. Pregnancy or lactation.
Special Precautions
Cholinergic symptoms, extravasation, hepatic, hematology, hypersensitivity reactions, late diarrhea, chronic inflammatory bowel disease &/or bowel obstruction, nausea & vomiting, neurologic, renal, resp, hepatic insufficiency; irradiation therapy, gastric cancer. May affect ability to drive or operate machinery. Pregnancy & lactation. Elderly.
Adverse Reactions
Cardiac, GI, immune system, musculoskeletal & connective tissue & resp disorders, hypovolemia.
Drug Interactions
Neuromuscular blocking agents, antineoplastic agents, dexamethasone, laxatives, diuretics, anticonvulsants, ketoconazole, St. John's wort, antazanavir sulfate.
ATC Classification
L01XX19 - irinotecan ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Romisan inj 40 mg/2 mL
Packing/Price
1's (Rp974,200/boks)
Form
Romisan inj 100 mg/5 mL
Packing/Price
1's (Rp2,009,150/boks)
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