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Dose limiting toxicities include diarrhea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia). Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be with held or reduced.
Diarrhea: Capecitabine can induce diarrhea. Patient with severe diarrhea should be carefully monitored and if they become dehydrated, should be given fluid and electrolyte replacement.
Dehydration: dehydration should be prevented or corrected at the onset. Patients with anorexia, asthenia, nausea, vomiting or diarrhea may rapidly become dehydrated.
Dehydration may cause acute renal failure, especially in patients with pre-existing compromised renal function or when Capecitabine is given concomitantly with known nephrotoxic agents.
If grade 2 (or higher) dehydration occur, Capecitabine treatment should be immediately interrupted and the dehydration corrected. Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled. Dose modification should be applied for the precipitating adverse event as necessary.
Dihydropyrimidine dehydrogenase (DPD) deficiency: rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity. Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil. Patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus that cause complete or near complete absence of DPD activity, have the highest risk of life-threatening or fatal toxicity and should not be treated with Capecitabine. No doses has been proven safe for patients with complete absence of DPD activity.
For patients with partial DPD deficiency where the benefits of Capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution, initially with a substantial dose reduction and frequent subsequent monitoring and dose adjustment according to toxicity.
In patients with unrecognised DPD deficiency treated with Capecitabine, life-threatening toxicities manifesting as acute overdose may occur. In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately. Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.
