Iritero Adverse Reactions

See Table 3.


Click on icon to see table/diagram/image


The following additional drug related events have been reported with Irinotecan, but do not meet the criteria as defined above as either drug-related NCI grades 1 - 4 or as a NCI grade 3 or 4 drug-related event: Rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, bradycardia, dizziness, extravasation, tumor lysis syndrome, and colonic ulceration.
Cardiac disorders: Myocardial ischemic events have been observed following Irinotecan therapy predominantly in patients with underlying cardiac disease, other known risk factors for cardiac disease or previous cytotoxic chemotherapy.
Gastrointestinal disorder: Intestinal obstruction, ileus, megacolon, or gastrointestinal hemorrhage, and cases of colitis, including typhlitis, ischemic and ulcerative colitis were reported. In some cases, colitis was complicated by ulceration, bleeding, ileus, or infection. Cases of ileus without preceding colitis have also been reported. Cases of intestinal perforation were reported. Cases of symptomatic pancreatitis or asymptomatic elevated pancreatic enzymes have been observed.
Hypovolemia: There have been cases or renal impairment and acute renal failure, generally in patients who became infected and/or volume depleted from severe gastrointestinal toxicities. Renal insufficiency, hypotension or circulatory failure have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting, or sepsis.
Immune system disorders: Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been reported.
Musculoskeletal disorders and connective tissue disorders: Early effects, such as muscular contraction or cramps and paresthesia, have been reported.
Nervous system disorders: Speech disorder, generally transient in nature, have been reported in patients treated with Irinotecan; in some cases, the event was attributed to the cholinergic syndrome observed during or shortly after infusion of Irinotecan.
Respiratory, thoracic and mediastinal disorders: Interstitial pneumonia and pneumonitis presenting as pulmonary infiltrates have been observed. Early effects, such as dyspnea, have been reported.
Investigations: Cases of hyponatremia mostly related with diarrhea and vomiting have been reported. Increases in serum levels of transaminases (i.e., AST and ALT) in the absence of progressive liver metastasis have been reported.