Capetero Adverse Reactions

Clinical Trials: Summary of the safety profile: The overall safety profile of Capecitabine is based on data from over 3000 patients treated with Capecitabine as monotherapy or Capecitabine in combination with different chemotherapy regimens in multiple indications. The safety profiles of Capecitabine monotherapy for the metastatic breast cancer, metastatic colorectal cancer and adjuvant colon cancer populations are comparable. See Pharmacology: Pharmacodynamics under Actions for details of major studies, including study designs and major efficacy results.
The most commonly reported and/or clinically relevant treatment-related adverse drug reactions (ADRs) were gastrointestinal disorders (especially diarrhoea, nausea, vomiting, abdominal pain, stomatitis), hand-foot syndrome (palmar-plantar erythrodysesthesia), fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction on those with preexisting compromised renal function, and thrombosis/embolism.
Tabulated summary of adverse reactions: ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of Capecitabine are listed in Table 7 for Capecitabine given as a single agent and in Table 8 for Capecitabine given in combination with different chemotherapy regimens in multiple indications. The following headings are used to rank the ADRs by frequency: very common (≥1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100). Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Capecitabine Monotherapy: Table 7 lists ADRs associated with the use of Capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, S014695, and S014796). ADRs are added to the appropriate frequency grouping according to the overall incidence from the pooled analysis. (See Table 7.)

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Capecitabine in combination therapy: Table 8 lists ADRs associated with the use of Capecitabine in combination with different chemotherapy regimens in multiple indications based on safety data from over 1400 patients. ADRs are added to the appropriate frequency grouping (Very common or Common) according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with Capecitabine monotherapy or seen at a higher frequency grouping compared to Capecitabine monotherapy (see Table 7). Uncommon ADRs reported for Capecitabine in combination therapy are consistent with the ADRs reported for Capecitabine monotherapy or reported for monotherapy with the combination agent (in literature and/or respective summary of product characteristics).
Some of the ADRs are reactions commonly seen with the combination agent (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab); however an exacerbation by Capecitabine therapy can not be excluded. (See Table 8.)

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Post Marketing: The following additional serious adverse reactions have been identified during post-marketing exposure: Rare: Acute renal failure secondary to dehydration including fatal outcome, see Precautions. Very rare: Cutaneous lupus erythematosus, Severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN), see Precautions. Very rare: lacrimal duct stenosis, corneal disorders including keratitis. Very rare: hepatic failure and cholestatic hepatitis have been reported during clinical trials and post-marketing exposure.