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Capecitabine

Generic Name
Capecitabine
Brand Names
Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva
Drug Type
Small Molecule
Chemical Formula
C15H22FN3O6
CAS Number
154361-50-9
Unique Ingredient Identifier
6804DJ8Z9U

Overview

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Background

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Indication

Capecitabine is indicated as treatment for a variety of cancer types. For colorectal cancer, capecitabine is indicated as a single agent or a component of a combination chemotherapy regiment for the adjuvant treatment of stage III colon cancer and treatment unresectable or metastatic colorectal cancer. It can also be used as a part of a combination chemotherapy perioperative treatment of adult locally advanced rectal cancer. For breast cancer, capecitabine is indicated for advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated or as a regimen with docetaxel after disease progression on prior anthracycline-containing chemotherapy. For gastric, esophageal, or gastroesophageal junction (GEJ) cancer, capecitabine is indicated as a component of a combination chemotherapy treatment for the treatment of adult unresectable or metastatic gastric, esophageal, or GEJ cancer or adult HER2-overexpressing metastatic gastric or GEJ adenocarcinoma who have not received prior treatment for metastatic disease. Finally, for pancreatic cancer, capecitabine is indicated as adjuvant treatment for adult pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Associated Conditions

  • Advanced or Metastatic Breast Cancer
  • Carcinoma of Gallbladder
  • Cholangiocarcinoma
  • Hepatocellular Carcinoma
  • Locally Advanced Rectal Cancer (LARC)
  • Metastatic Adenocarcinoma of the Gastroesophageal Junction
  • Metastatic Gastric Cancers
  • Metastatic Neuroendocrine Tumors
  • Pancreatic Adenocarcinoma
  • Pancreatic Cancer, Advanced or Metastatic
  • Platinum-resistant Epithelial Ovarian Cancer
  • Refractory Fallopian Tube Carcinoma
  • Stage III Colon Cancer
  • Unresectable or Metastatic Colorectal Cancer
  • Metastatic pancreatic endocrine carcinoma
  • Refractory peritoneal cancer
  • Refractory, metastatic Colorectal carcinoma
  • Unresectable, metastatic Esophageal Cancer
  • Unresectable, metastatic Gastric Cancer
  • Unresectable, metastatic Gastroesophageal Junction Cancer

FDA Approved Products

Capecitabine
Manufacturer:Ascend Laboratories, LLC
Route:ORAL
Strength:150 mg in 1 1
Approved: 2022/06/24
NDC:67877-458
CAPECITABINE
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/05/31
NDC:68001-488
Capecitabine
Manufacturer:American Health Packaging
Route:ORAL
Strength:500 mg in 1 1
Approved: 2024/03/28
NDC:60687-149
CAPECITABINE
Manufacturer:BluePoint Laboratories
Route:ORAL
Strength:150 mg in 1 1
Approved: 2023/05/31
NDC:68001-487
Capecitabine
Manufacturer:Hikma Pharmaceuticals USA Inc.
Route:ORAL
Strength:150 mg in 1 1
Approved: 2017/05/08
NDC:0054-0271

Singapore Approved Products

CAPECITABINE ALVOGEN FILM COATED TABLETS 500 MG
Manufacturer:Remedica Ltd
Form:TABLET, FILM COATED
Strength:500 mg
Online:Yes
Approved: 2014/07/31
Approval:SIN14580P
CAPETERO CAPECITABINE TABLETS 150MG
Manufacturer:Hetero Labs Limited
Form:TABLET
Strength:150.00mg
Online:Yes
Approved: 2015/06/24
Approval:SIN14798P
XELODA TABLETS 150 mg
Manufacturer:F HOFFMANN-LA ROCHE LTD (Primary and Secondary Packager), Excella GmbH & Co. KG
Form:TABLET, FILM COATED
Strength:150 mg
Online:Yes
Approved: 1999/01/20
Approval:SIN10678P
CAPETERO CAPECITABINE TABLETS 500MG
Manufacturer:Hetero Labs Limited
Form:TABLET
Strength:500.00mg
Online:Yes
Approved: 2015/06/24
Approval:SIN14799P
INCITABINE FILM COATED TABLET 150MG
Manufacturer:REMEDICA LTD
Form:TABLET, FILM COATED
Strength:150 mg
Online:Yes
Approved: 2021/07/06
Approval:SIN16264P

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