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Topoblock Special Precautions

irinotecan

Manufacturer:

Venus Remedies

Distributor:

Qualimed
Full Prescribing Info
Special Precautions
Care of Intravenous Site: Irinotecan is administered by intravenous infusion so care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sterile water and application of ice are recommended.
Pre-medication with Antiemetics: Irinotecan is emetogenic. It is recommended that patients receive pre-medication with antiemetic agents starting at least 30 minutes before administration of irinotecan.
Treatment of Cholinergic Symptoms: Prophylactic and therapeutic administration of 0.25 to 1 mg of intravenous or subcutaneous atropine should be considered (unless clinically contraindicated) in patients experiencing rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, abdominal cramping, or diarrhoea (occurring during or shortly after infusion of irinotecan). These symptoms are expected to occur more frequently with higher irinotecan doses.
Patients at Particular Risk: Physicians should exercise particular caution in monitoring the effects of irinotecan in the elderly (>65 years) and in patients who had previously received pelvic/abdominal irradiation. The use of irinotecan in patients with significant hepatic dysfunction has not been established in clinical trials of either dosing schedule, irinotecan was not administered to patients with serum bilirubin >2.0 mg/dL, or transaminase >3 times the upper limit of normal if no liver metastasis or transaminase >5 times the upper limit of normal with liver metastasis. However in clinical trials of the weekly schedule, it has been noted that patients with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg/dL) have had a significantly greater likelihood of experiencing first-course grade 3 or 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dL {50.0%[19/38]17.7% [47/226]; p<0.001}.
Patients with abnormal glucuronidation of bilirubin, such as those with Gilbert's Syndrome, may also be at greater risk of myelosuppression when receiving therapy with irinotecan. An association between baseline bilirubin elevations and an increased risk of late diarrhoea has not been observed in studies of the weekly dosage schedule.
Laboratory Tests: Careful monitoring of white blood cell count with differential, haemoglobin and platelet count is recommended before each dose of irinotecan.
Use in Children: The safety and effectiveness of irinotecan in paediatric patients have not been established.
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