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Capecitabine (Xeloda)

Trade Name : Xeloda

Genentech, Inc.

TABLET, FILM COATED

Strength 150 mg/1

CAPECITABINE Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Capecitabine (Xeloda) which is also known as Xeloda and Manufactured by Genentech, Inc.. It is available in strength of 150 mg/1 per ml. Read more

Capecitabine (Xeloda) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: XELODA-WARFARIN INTERACTION
  • See full prescribing information for complete boxed warning.
  • Patients receiving concomitant XELODA and oral coumarin-derivative anticoagulants such as warfarin and phenprocoumon should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Altered coagulation parameters and/or bleeding, including death, have been reported during concomitant use.
  • Occurrence: Within several days and up to several months after initiating XELODA therapy; may also be seen within 1 month after stopping XELODA
  • Predisposing factors: age>60 and diagnosis of cancer
  • XELODA (capecitabine) is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
  • Adjuvant Colon Cancer
  • Metastatic Colorectal Cancer
  • Metastatic Breast Cancer
  • No data
  • Take XELODA with water within 30 min after a meal ()
  • Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles ()
  • Adjuvant treatment is recommended for a total of 6 months (8 cycles) ()
  • In combination with docetaxel, the recommended dose of XELODA is 1250 mg/m twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m as a 1-hour IV infusion every 3 weeks ()
  • XELODA dosage may need to be individualized to optimize patient management ()
  • Reduce the dose of XELODA by 25% in patients with moderate renal impairment ()
  • XELODA is supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg of capecitabine and each peach-colored tablet contains 500 mg of capecitabine.
  • Tablets: 150 mg and 500 mg ()
  • No data
  • Severe Renal Impairment ()
  • Hypersensitivity ()
  • No data
  • Coagulopathy
  • Diarrhea
  • Cardiotoxicity
  • Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity:
  • Dehydration and Renal Failure
  • Embryo-Fetal Toxicity
  • Mucocutaneous and Dermatologic Toxicity
  • Hyperbilirubinemia
  • Hematologic
  • 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.
  • Most common adverse reactions (u226530%) were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Anticoagulants: Monitor anticoagulant response (INR or prothrombin time) frequently in order to adjust the anticoagulant dose as needed. (, )
  • Phenytoin: Monitor phenytoin levels in patients taking XELODA concomitantly with phenytoin. The phenytoin dose may need to be reduced. ()
  • Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin. ()
  • CYP2C9 substrates: Care should be exercised when XELODA is coadministered with CYP2C9 substrates. ()
  • Allopurinol: Avoid the use of allopurinol during treatment with XELODA.
  • Food reduced both the rate and extent of absorption of capecitabine. (, , )
  • No data
  • Lactation
  • Females and Males of Reproductive Potential:
  • Geriatric
  • Hepatic Impairment
  • Renal Impairment
  • The manifestations of acute overdose would include nausea, vomiting, diarrhea, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary supportive medical interventions aimed at correcting the presenting clinical manifestations. 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 lowu2013molecular-weight metabolite of the parent compound.
  • Single doses of XELODA were not lethal to mice, rats, and monkeys at doses up to 2000 mg/kg (2.4, 4.8, and 9.6 times the recommended human daily dose on a mg/m basis).
  • XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5-fluorouracil.
  • The chemical name for capecitabine is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula:
  • Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20u00baC.
  • XELODA is supplied as biconvex, oblong film-coated tablets for oral administration. 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.
  • No data
  • Adequate studies investigating the carcinogenic potential of capecitabine have not been conducted. Capecitabine was not mutagenic to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay). Capecitabine was clastogenic in vitro to human peripheral blood lymphocytes but not clastogenic to mouse bone marrow (micronucleus test). Fluorouracil causes mutations in bacteria and yeast. Fluorouracil also causes chromosomal abnormalities in the mouse micronucleus test .
  • In studies of fertility and general reproductive performance in female mice, oral capecitabine doses of 760 mg/kg/day (about 2300 mg/m/day) disturbed estrus and consequently caused a decrease in fertility. In mice that became pregnant, no fetuses survived this dose. The disturbance in estrus was reversible. In males, this dose caused degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids. In separate pharmacokinetic studies, this dose in mice produced 5'-DFUR AUC values about 0.7 times the corresponding values in patients administered the recommended daily dose.
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Distributed by:
  • Genentech USA, Inc.
  • XELODA is a registered trademark of Hoffmann-La Roche, Inc.
  • u00a9 2019 Genentech, Inc. All rights reserved.
  • No data
  • Representative sample of labeling (see the section for complete listing):
  • NDC 0004-1100-20
  • Xelodan (capecitabine)Tablets
  • 150 mg
  • Each tablet contains 150 mgcapecitabine.
  • Rx only
  • 60 tabletsGenentech
  • 10210268
  • NDC 0004-1101-50
  • Xelodan (capecitabine)Tablets
  • 500 mg
  • Each tablet contains 500 mgcapecitabine.
  • Rx only
  • 120 tabletsGenentech
  • 10210269

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