• Assess for signs of infection (fever, chills, sore throat, cough, hoarseness, pain in lower back or side, difficult or painful urination). Assess for bleeding (bleeding gums; bruising; petechiae; and guaiac-test stools, urine, and emesis). Avoid IM injections and taking rectal temperatures. Apply pressure to venipuncture sites for 10 min. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
• Assess mucous membranes, number and consistency of stools, and frequency of vomiting. Notify health care professional if symptoms of toxicity (stomatitis, uncontrollable vomiting, diarrhea, fever) occur; drug may need to be discontinued or dose decreased. Patients with severe diarrhea should be monitored carefully, administered antidiarrheal agents (loperamide) and given fluid and electrolyte replacements if they become dehydrated. Grade 2 diarrhea (4–6 stools/day or nocturnal stools), Grade 3 (7–9 stools/day or incontinence and malabsorption), Grade 4 (≥10 stools/day or grossly bloody diarrhea or need for parenteral support). If grade 2, 3, or 4 diarrhea occurs, immediately stop therapy until diarrhea resolves or decreases in intensity to Grade 1. Grade 3 or 4 diarrhea usually lasts 5 days.
• Assess patient for mucocutaneous and dermatologic toxicity (Stevens-Johnson syndrome, toxic epidermal necrolysis, hand-and-foot syndrome). Grade 1 (numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of hands and/or feet, and/or discomfort that does not disrupt normal activities). Grade 2 (painful erythema, swelling of hands and/or feet, and/or discomfort affecting the patient’s activities of daily living). Grade 3 (moist desquamation, ulceration, blistering or severe pain of hands and/or feet, and/or severe discomfort causing patient to be unable to work or perform activities of daily living). Persistent or severe hand-and-foot syndrome of Grade 2 and above can lead to loss of fingerprints, affecting patient identification. If Grade 2 or 3 occurs, interrupt therapy until Grade 1. Decrease doses following Grade 3.

Lab Test Considerations:

• Verify negative pregnancy test before starting therapy.Consider testing for genetic variants of dihydropyrimidine dehydrogenase deficiency prior to initiating therapy to reduce risk of serious adverse reactions. Serious adverse reactions may still occur even if no dihydropyrimidine dehydrogenase deficiency variants are identified. An FDA-authorized test for the detection of genetic variants of dihydropyrimidine dehydrogenase deficiency to identify patients at risk of serious adverse reactions due to increased systemic exposure to capecitabine is not currently available. Currently available tests used to identify dihydropyrimidine dehydrogenase deficiency variants may vary in accuracy and design.Monitor CBC at baseline and before each cycle. If baseline neutrophil count <1.5 x 10⁹ /L or platelet count <100 x 10⁹ /L, therapy is not recommended. For grade 3 to 4 myelosuppression, hold dose and then resume at same or reduced dose, or permanently discontinue, based on occurrence.Monitor hepatic (serum alkaline phosphatase, AST, ALT, and bilirubin), and renal function before and periodically during therapy. May cause leukopenia, anemia, and thrombocytopenia. Leukopenia may require discontinuation of therapy. Therapy should be interrupted if serum bilirubin ↑ to 1.5 times normal or greater; may be reinstituted after bilirubin returns to normal.
  • Monitor INR frequently in patients receiving warfarin and capecitabine to adjust warfarin dose. May cause ↑ bleeding within a few days to several mo of initiation of therapy to 1 mo following discontinuation of therapy. Risk is greater in patients over 60 yr.