Capecitabine
Indications
Colorectal Cancer: Capecitabine
is indicated as a single agent for adjuvant treatment in patients with
Dukes' C colon cancer who have undergone complete resection of the
primary tumor when treatment with fluoropyrimidine therapy alone is
preferred. It is indicated as first-line treatment of patients with
metastatic colorectal carcinoma when treatment with fluoropyrimidine
therapy alone is preferred.
Breast Cancer: Capecitabine in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated.
Pancreatic Cancer: Capecitabine is indicated for the first line treatment of patients with locally advanced and metastatic pancreatic cancer in combination with gemcitabine.
Oesophagogastric Cancer: Capecitabine is indicated for the first line treatment of patients with advanced oesophagogastric cancer.
Breast Cancer: Capecitabine in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated.
Pancreatic Cancer: Capecitabine is indicated for the first line treatment of patients with locally advanced and metastatic pancreatic cancer in combination with gemcitabine.
Oesophagogastric Cancer: Capecitabine is indicated for the first line treatment of patients with advanced oesophagogastric cancer.
Pharmacology
Capecitabine is a prodrug of fluorouracil, a
pyrimidine antimetabolite, which is metabolised into
5-fluoro-2′-deoxyuridine-5′monophosphate (FdUMP) and 5-fluorouridine
triphosphate (FUTP). FdUMP covalently binds to thymidylate synthase,
inhibiting the formation of thymidilate, thus interfering with DNA
synthesis. Additionally, FUTP interferes with RNA synthesis.
Dosage & Administration
In case of stage-III colon cancer and locally advanced or metastatic breast cancer: 1.25 gm/m2 twice daily for 14 days, followed by a 7-day interval, given as 3-week cycles for a total 8 cycles .
For metastatic colorectal cancer, in combination therapy it is administered as 0.8-1 gm/m2 twice daily for 14 days repeated after 7 days interval.
For metastatic colorectal cancer, in combination therapy it is administered as 0.8-1 gm/m2 twice daily for 14 days repeated after 7 days interval.
Interaction
May interact with warfarin and increase
bleeding risk. May inhibit CYP2C9 enzyme, and therefore increase levels
of substrates such as phenytoin and other substrates of CYP2C9 enzymes.
The concomitant use of leucovorin is not recommended as it increases the
toxicity of capecitabine without any apparent advantage in response
rate.
Contraindications
Capecitabine is contraindicated in patients
with known dihydropy rimidine dehydrogenase (DPD) deficiency, it is
also contraindicated in patients with severe renal impairment
(creatinine clearance below 30 ml/min), and in patients with known
hypersensitivity to Capecitabine.
Side Effects
myocardial infarction, angina; hand-foot
syndrome (numbness, tingling, pain, redness, or blistering of the palms
of the hands and soles of the feet). This can lead to the disappearance
of fingerprints in some patients; diarrhea (sometimes severe), nausea,
stomatitis; neutropenia, anemia, thrombocytopenia; Hyperbilirubinemia.
Pregnancy & Lactation
Pregnancy Category D. There is positive
evidence of human fetal risk, but the benefits from use in pregnant
women may be acceptable despite the risk (e.g., if the drug is needed in
a life-threatening situation or for a serious disease for which safer
drugs cannot be used or are ineffective).
Precautions & Warnings
Patients receiving therapy with
capecitabine should be monitored by a physician experienced in the use
of cancer chemotherapeutic agents. Most adverse reactions are reversible
and do not need to result in discontinuation, although doses may need
to be withheld or reduced. During therapy, tablets should not be broken
to adjust the dose.
Overdose Effects
Symptoms: Nausea, vomiting, diarrhoea, GI irritation and bleeding, bone marrow depression.
Management: Supportive treatment aimed at correcting the presenting clinical manifestations.
Management: Supportive treatment aimed at correcting the presenting clinical manifestations.
Therapeutic Class
Cytotoxic Chemotherapy
Storage Conditions
Product should be stored at a dry place of controlled room temperature below 30° C and kept out of the reach of children.
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