Brand Name
Xeloda
Generic Name
Capecitabine
View Brand Information FDA approval date: April 30, 1998
Classification: Nucleoside Metabolic Inhibitor
Form: Tablet
What is Xeloda (Capecitabine)?
XELODA is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
Approved To Treat
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Brand Information
XELODA (capecitabine)
WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and INCREASED RISK OF BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS
Increased risk of serious adverse reactions or death in patients with complete DPD deficiency
• Test patients for genetic variants of
Increased risk of bleeding with concomitant use of Vitamin K antagonists
• Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin [see
• Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time XELODA was introduced. These events occurred in patients with and without liver metastases.
• Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see
• Test patients for genetic variants of
Increased risk of bleeding with concomitant use of Vitamin K antagonists
• Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin [see
• Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time XELODA was introduced. These events occurred in patients with and without liver metastases.
• Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see
1DOSAGE FORMS AND STRENGTHS
Tablets, film-coated:
- 150 mg: biconvex, oblong, light-peach colored, with "XELODA" on one side and "150" on the other
- 500 mg: biconvex, oblong, peach colored, with "XELODA on one side and "500" on the other
2CONTRAINDICATIONS
XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cardiotoxicity
- Diarrhea
- Dehydration
- Renal Toxicity
- Serious Skin Toxicities
- Palmar-Plantar Erythrodysesthesia Syndrome
- Myelosuppression
- Hyperbilirubinemia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction 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.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of XELODA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye: lacrimal duct stenosis, corneal disorders including keratitis
Hepatobiliary: hepatic failure
Immune System Disorders: angioedema
Nervous System: toxic leukoencephalopathy
Renal & Urinary: acute renal failure secondary to dehydration including fatal outcome
Skin & Subcutaneous Tissue: cutaneous lupus erythematosus, severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN), persistent or severe PPES can eventually lead to loss of fingerprints
4OVERDOSAGE
Administer uridine triacetate within 96 hours for management of XELODA overdose.
Although no clinical experience using dialysis as a treatment for XELODA overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5'-DFUR, a low–molecular-weight metabolite of the parent compound.
5DESCRIPTION
Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C
Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C.
XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.
6REFERENCES
1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
7HOW SUPPLIED/STORAGE AND HANDLING
XELODA (capecitabine) tablets are supplied as follows:
- 150 mg, biconvex, oblong, film-coated, light peach tablets with "XELODA" on one side and "150" on the other; available in bottles of 60 tablets (NDC 61269-470-60), individually packaged in a carton.
- 500 mg, biconvex, oblong, film-coated, peach tablets with "XELODA" on one side and "500" on the other; available in bottles of 120 tablets (NDC 61269-475-12), individually packaged in a carton.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Carton
NDC 61269-470-60
Xeloda
150 mg
Each tablet contains 150 mg
Rx only
Warning: Hazardous Drug
60 tablets
CHEPLAPHARM
10PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Carton
NDC 61269-475-12
Xeloda®
(capecitabine)
Tablets
500 mg
Each tablet contains 500 mg
capecitabine.
Rx only
Warning: Hazardous Drug
120 tablets
CHEPLAPHARM