1. Clinical & Scientific Overview
Capecitabine (TIP-MED-000555, Reference Code [ONC-06]) is classified under
Oncology & Antineoplastic Medicines as a Antimetabolite (Fluoropyrimidine) • Oral Fluoropyrimidine Carbamate Prodrug of 5-Fluorouracil (5-FU).
Within the Indian regulatory and compendial framework, it is governed under Schedule H (Prescription Only — Specialist Oncology Supervision).
Xeloda (Roche Products India), Capegard (Cipla Ltd), Capiibine (Dr. Reddy's Laboratories)
Film-Coated Tablet: 150 mg, 500 mg
Oncology Specialisation & Cytotoxic Safety Protocol
Antimetabolite (Fluoropyrimidine)
Antineoplastic Cytotoxic
Standard Regimen & Cycle Context: 1,000–1,250 mg/m2 orally twice daily within 30 minutes AFTER meals on Days 1–14 of a 21-day cycle.
Signature Dose-Limiting Toxicities & Organ Monitoring: DPD (Dihydropyrimidine Dehydrogenase / DPYD gene) deficiency causes life-threatening/fatal mucositis, secretory diarrhoea, neutropenia, and neurotoxicity; Palmar-Plantar Erythrodysaesthesia (Hand-Foot Syndrome — painful redness, peeling, and blistering of palms and soles); severe CYP2C9 interaction with Warfarin (Boxed Warning: INR surges and fatal bleeding).
Extravasation, Premedication & Safe Cytotoxic Handling: Take tablets with water within 30 minutes AFTER the end of a meal; screen for DPYD variants if available; apply urea-based emollients to hands/feet and hold dose immediately for Grade 2/3 Hand-Foot Syndrome or diarrhoea.
3. Mechanism of Action & Pharmacodynamics
Undergoes 3-step enzymatic activation: hepatic carboxylesterase -> cytidine deaminase -> tumour-selective Thymidine Phosphorylase (TP, overexpressed in tumour tissue) to generate 5-FU in situ, which forms FdUMP to inhibit thymidylate synthase (TS).
4. Therapeutic Indications & Evidence-Supported Uses
- Adjuvant and metastatic Colorectal Cancer (CAPOX / XELOX regimen)
- Metastatic Breast Cancer and Gastric/Gastro-oesophageal cancer
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Educational Oncology Regimen Context (Specialist Reference Only): 1,000–1,250 mg/m2 orally twice daily within 30 minutes AFTER meals on Days 1–14 of a 21-day cycle.
Administration & Meal Timing: 1,000–1,250 mg/m2 orally twice daily within 30 minutes AFTER meals on Days 1–14 of a 21-day cycle.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Specialist oncology pharmacokinetic profile; dosing depends on Body Surface Area (BSA in m2), Calvert GFR formula, or flat targeted dosing with strict organ-function adjustments.
Hepatic enzymatic activation/inactivation or proteolytic degradation (for monoclonal antibodies); see specific polymorphism and interaction notes.
Verify serum creatinine and eGFR before every cycle; see drug-specific renal dosing and uroprotection rules.
Check total bilirubin, AST, and ALT prior to each cycle; taxanes, anthracyclines, and TKIs require strict hepatic dose modification.
7. Contraindications, Precautions & High-Risk Warnings
- Severe hypersensitivity to Capecitabine or formulation vehicle
- Pregnancy and lactation (potent teratogen/embryotoxic class warning unless explicitly evaluated by oncology specialist)
- Severe unrecovered bone marrow aplasia or decompensated organ failure per protocol thresholds
Key Clinical Precautions: DPD (Dihydropyrimidine Dehydrogenase / DPYD gene) deficiency causes life-threatening/fatal mucositis, secretory diarrhoea, neutropenia, and neurotoxicity; Palmar-Plantar Erythrodysaesthesia (Hand-Foot Syndrome — painful redness, peeling, and blistering of palms and soles); severe CYP2C9 interaction with Warfarin (Boxed Warning: INR surges and fatal bleeding).
8. Adverse Effects Profile
- DPD (Dihydropyrimidine Dehydrogenase / DPYD gene) deficiency causes life-threatening/fatal mucositis, secretory diarrhoea, neutropenia, and neurotoxicity; Palmar-Plantar Erythrodysaesthesia (Hand-Foot Syndrome — painful redness, peeling, and blistering of palms and soles); severe CYP2C9 interaction with Warfarin (Boxed Warning: INR surges and fatal bleeding).
- DPD (Dihydropyrimidine Dehydrogenase / DPYD gene) deficiency causes life-threatening/fatal mucositis, secretory diarrhoea, neutropenia, and neurotoxicity; Palmar-Plantar Erythrodysaesthesia (Hand-Foot Syndrome — painful redness, peeling, and blistering of palms and soles); severe CYP2C9 interaction with Warfarin (Boxed Warning: INR surges and fatal bleeding).
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- DPD (Dihydropyrimidine Dehydrogenase / DPYD gene) deficiency causes life-threatening/fatal mucositis, secretory diarrhoea, neutropenia, and neurotoxicity; Palmar-Plantar Erythrodysaesthesia (Hand-Foot Syndrome — painful redness, peeling, and blistering of palms and soles); severe CYP2C9 interaction with Warfarin (Boxed Warning: INR surges and fatal bleeding).
- Avoid live-attenuated vaccines during immunosuppressive chemotherapy; verify CYP3A4, UGT1A1, DPD, and QTc interactions before each cycle.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Take tablets with water within 30 minutes AFTER the end of a meal; screen for DPYD variants if available; apply urea-based emollients to hands/feet and hold dose immediately for Grade 2/3 Hand-Foot Syndrome or diarrhoea.
Pharmacist Patient Counselling Points:
- Take tablets with water within 30 minutes AFTER the end of a meal; screen for DPYD variants if available; apply urea-based emollients to hands/feet and hold dose immediately for Grade 2/3 Hand-Foot Syndrome or diarrhoea.
- Report fever >=38.0°C (100.4°F) immediately (medical emergency: possible febrile neutropenia).
- Follow strict reproductive contraception and safe cytotoxic oral handling instructions.
Storage, Stability & Dispensing Safeguards: Take tablets with water within 30 minutes AFTER the end of a meal; screen for DPYD variants if available; apply urea-based emollients to hands/feet and hold dose immediately for Grade 2/3 Hand-Foot Syndrome or diarrhoea.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: National Cancer Grid (NCG) India Consensus Guidelines; NLEM 2022 Antineoplastic Section; Indian Pharmacopoeia (IP) & CDSCO Approved Oncology Prescribing Information.
Official Verification Portals: National Cancer Grid (NCG) India — Evidence-Based Oncology Guidelines • CDSCO — Central Drugs Standard Control Organization Approved Drug Data • Indian Pharmacopoeia Commission (IPC)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.