Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Antitumor agent. The mechanism of action is associated with the inhibition of the cellular enzyme topoisomerase I involved in the synthesis of DNA. Has immunosuppressive activity.
Inhibits acetylcholinesterase.
PHARMACOKINETICS
With IV infusion, irinotecan is metabolized to form the active metabolite SN-38. Metabolism occurs mainly in the liver. The average amount of excretion of irinotecan with urine in 24 hours is 19.9%, and the metabolite SN-38 is 0.25%.
The kinetic profile of irinotecan is dose independent.
INDICATIONS
Locally-distributed or metastatic colorectal cancer (as a means of second-line therapy).
DOSING MODE
Established individually, depending on the indications and stage of the disease, the state of the hematopoiesis system, the scheme of antitumor therapy.
SIDE EFFECT
From the hemopoietic system: neutropenia (reversible), anemia, thrombocytopenia.
On the part of the digestive system: diarrhea, nausea, vomiting; possible - pain in the abdomen, stomatitis, constipation.
Acute cholinergic syndrome: early diarrhea, abdominal pain, conjunctivitis, rhinitis, arterial hypotension, vasodilation, sweating, chills, general malaise, dizziness, visual impairment, increased tear and salivation (during or within the first 24 hours after administration).
Dermatological reactions: reversible alopecia is possible.
Allergic reactions: rarely - skin rash.
Other: shortness of breath, involuntary muscle contractions, seizures, paresthesia, asthenia, fever (in the absence of infection and severe neutropenia).
CONTRAINDICATIONS
Chronic inflammatory bowel diseases, obstructive conditions of the intestine, increase in the level of bilirubin in the blood more than 1.5 times higher than IGN, severe myelodepression, pregnancy, lactation; severe reactions of hypersensitivity to irinotecan in the anamnesis.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation (breastfeeding).
Patients of childbearing age should use reliable contraceptive methods during the treatment period and within 3 months after its termination.
SPECIAL INSTRUCTIONS
They are used with caution in patients who received previous radiation therapy in the abdominal or pelvic area, with previously observed hyperleukocytosis, and with a Karnovsky index (reflecting the general condition) of less than 50%.
When developing against the background of treatment of neutropenia, nausea, vomiting, diarrhea, correction of the dosing regimen is required. Do not apply until the recovery of neutrophils in peripheral blood (> 1500 / Ојl).
With the development of the first episode of diarrhea, immediate measures must be taken to correct it. The duration of neutropenia is usually 8 days, complete recovery of neutrophils is observed by day 22. An acute cholinergic syndrome occurs in approximately 83% of patients, occurs during administration or 24 hours after administration.
Patients of childbearing age should use reliable contraceptive methods during the treatment period and within 3 months after its termination.
Impact on the ability to drive vehicles and manage mechanisms
During treatment, especially within 24 hours after the administration of irinotecan, it is not recommended to engage in potentially dangerous activities associated with the need for concentration and high speed of psychomotor reactions.
DRUG INTERACTION
Clinical studies of the drug interaction of irinotecan have not been conducted.
Due to the anticholinesterase activity of irinotecan, an increase in the duration of the neuromuscular blockade caused by suxamethonium chloride is possible;antagonistic interaction in the neuromuscular blockade caused by nondepolarizing muscle relaxants.