xeloda side effects, xeloda mechanism of action,
xeloda dosing, xeloda hair loss, xeloda package insert     September 4, 2011
Xeloda Facts
Based on Xeloda Insert Package  (September 4, 2011)

Xeloda Indications and Usage

1. Colorectal Cancer - XELODA is indicated as a single agent for adjuvant treatment in patients with Dukes' C
colon cancer. XELODA is also indicated as first-line treatment of patients with metastatic colorectal carcinoma
when treatment with fluoropyrimidine therapy alone is preferred.

2. Breast Cancer - XELODA in combination with docetaxel is indicated for the treatment of patients with
metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. XELODA monotherapy
is also indicated for the treatment of patients with metastatic breast cancer under certain conditions.

Xeloda (capecitabine) is the a FDA-approved oral chemotherapy for both metastatic breast cancer and
adjuvant and metastatic colorectal cancer. Xeloda is transformed by thymidine phosphorylase to 5-FU, a
cytotoxic (cell-killing) drug in the body. Because many cancers have higher levels of TP than does normal
tissue, more 5-FU is delivered to the tumor than to other tissue. [4]

Xeloda Dosing

XELODA tablets should be swallowed whole with water within 30 minutes after a meal. XELODA dosing is
calculated according to body surface area.

Standard Starting Xeloda Dosing
The recommended dose of XELODA for monotherapy is 1250 mg/m2 administered orally twice daily (morning
and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given
as 3-week cycle. Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6
months. [ie, Dosing: XELODA 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period,
given as 3-week cycles for a total of 8 cycles (24 weeks)].

In combination with docetaxel for metastatic breast cancer, the recommended dose of XELODA is 1250
mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 as a 1-
hour intravenous infusion every 3 weeks.

Dose Management Guidelines
XELODA dosage may need to be individualized to optimize patient management. Patients should be carefully
monitored for toxicity, side effects and doses of XELODA should be modified as necessary to accommodate
individual patient tolerance to treatment. Patients should discuss with their medical doctors for the adjustment
of Xeloda dosing, based on the recommendations of the insert.

There is also a dosing adjustment for patients with moderate renal impairment (i.e. baseline creatinine
clearance = 30-50 mL/min) or in combination with docetaxel.

Dosage Forms and Strengths
XELODA is a biconvex, oblong film-coated tablets. Each tablet contains 150 mg or 500 mg of capecitabine.

Patients with dihydroypyrimidine dehydrogenase deficiency, severe renal impairment and hypersensitivity
should avoid XELODA.

Xeloda Side Effects

Because clinical trials are conducted under widely varying conditions, adverse side effects rates observed in
the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may
not reflect the rates observed in practice. In general, XELODA can induce diarrhea, sometimes severe.
Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if
they become dehydrated.

The adverse side effects occurring in ≥5% of patients from one phase 3 trial in patients with Dukes' C colon
cancer who received at least one dose of study medication and had at least one safety assessment:

Gastrointestinal Side Effects - diarrhea, nausea, stomatitis, vomiting, abdominal pain, constipation, dyspepsia
Skin Side Effects - hand-and-foot syndrome, alopecia, rash and erythema.
General Side Effects - fatique, pyrexia, asthenia and lethargy
Nervous System Side Effects - dizziness, headache and dysgeusia
Metabolism Side Effects - Anorexia
Eye Side Effects - Conjunctivitis
Blood and Lymphatic Side Effects - Neutropenia
Respiratory Thoracic Side Effects - Epistaxis

Grade 3/4 Laboratory Abnormalities Reported in ≥1% of Patients Receiving XELODA Monotherapy for
Adjuvant Treatment of Colon Cancer (Safety Population): increased ALAT (SGPT), increased or decreased
calcium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, decreased platelets and
increased bilirubin.

Xeloda side effects in
metastatic colorectal cancer (>5% incidence) also include oral discomfort, upper GI
inflammatory disorders, gastrointestinal motility disorder, gastrointestinal disorders, GI hemorrhage, ileus,
edema, chest pain, insomnia, taste disturbance, peripheral sensory neuropathy, appetite decreased,
dehydration, venous thrombosis, depression, mood alteration. etc.

Xeloda side effects in combination with Docetaxel in breast cancer are similar, for details, please, consult with
your medical doctor or pharmacist.

Xeloda has interactions with other drugs such as anticoagulants, phenytoin, leucovorin, and CYP2C9
substrates, leading to different types or severity of side effects. Users may follow doctor's instruction on
medication. Food was also shown to reduce the rate and extent of the absorption of Xeloda.


The manifestations of acute overdose would include nausea, vomiting, diarrhea, gastrointestinal irritation and
bleeding, and bone marrow depression. Single doses of XELODA were not lethal to mice, rats, and monkeys
at doses up to dosage of 2000 mg/kg (2.4, 4.8, and 9.6 times the recommended human daily dose on a
mg/m2 basis).

Some supplements and herbs are shown to support patients with cancer, however, they may also interact
with Xeloda or other medications. Users must consult with their medical doctors before taking any

Herbal / Dietary Supplements / Foods that show anti-cancer activities in vitro and animal studies
Avocados Banana, Bitter Melon, Brown Seaweed, Capsicum, Cauliflower, Celery, Chlorophyll, Cordyceps,
Curcumin, Dandelion, Ellagic acid, Oldenlandia, Falcarinol, Fenugreek, Feverfew, Fish Oil, Forskolin,
, Garlic, Gotu Kola, Green Tea, Grape Seed Extract, Honokiol, Orange, Isothiocyanates, Linseed
Oil, Limes, Lycopene, Maitake, Milk Thistle, Onion, Peony, Phellinus, Quercetin, Pterostibene, Pycnogenol,
Reishi, Rhubarb, Saffron, Stinging Nettle, Sweet Potatoes, and more.

Drugs listed in this website for chemotherapy:
Xeloda, Avastin,
website is for reference only. Please, discuss with your doctor before taking any medicine or supplement. All rights reserved 2011.