1. Clinical & Scientific Overview
Anastrozole (TIP-MED-000566, Reference Code [ONC-17]) is classified under
Oncology & Antineoplastic Medicines as a Hormonal Oncology Therapy (Aromatase Inhibitor) • Third-Generation Non-Steroidal Selective Aromatase Inhibitor.
Within the Indian regulatory and compendial framework, it is governed under Schedule H (Prescription Only — Specialist Oncology Supervision).
Arimidex (AstraZeneca Pharma India), Armotraz (Cipla Ltd), Altraz (Alkem Laboratories)
Film-Coated Tablet: 1 mg
Oncology Specialisation & Cytotoxic Safety Protocol
Hormonal Oncology Therapy (Aromatase Inhibitor)
Antineoplastic Hormonal Agent
Standard Regimen & Cycle Context: 1 mg orally once daily (for 5–10 years in adjuvant setting).
Signature Dose-Limiting Toxicities & Organ Monitoring: Accelerated bone mineral density (BMD) loss and osteoporotic fractures, Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIAMS — symmetrical morning joint stiffness and arthralgia in hands/wrists/knees), hot flushes, and dyslipidaemia; ineffective in premenopausal women without concurrent GnRH agonist ovarian suppression.
Extravasation, Premedication & Safe Cytotoxic Handling: Confirm postmenopausal endocrine status before initiation; obtain baseline DEXA bone mineral density scan and co-prescribe Calcium (1,000–1,200 mg/day) + Vitamin D3 (800–2,000 IU/day) +/- bisphosphonate/denosumab.
3. Mechanism of Action & Pharmacodynamics
Reversibly binds the haem iron atom of cytochrome P450 aromatase (CYP19A1) in peripheral adipose tissue, adrenal glands, and breast tumour tissue, suppressing conversion of androstenedione and testosterone into estrone and estradiol by >96% in postmenopausal women.
4. Therapeutic Indications & Evidence-Supported Uses
- Adjuvant and metastatic Hormone Receptor-Positive (ER+/PR+) Breast Cancer in postmenopausal women
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Educational Oncology Regimen Context (Specialist Reference Only): 1 mg orally once daily (for 5–10 years in adjuvant setting).
Administration & Meal Timing: 1 mg orally once daily (for 5–10 years in adjuvant setting).
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 Anastrozole 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: Accelerated bone mineral density (BMD) loss and osteoporotic fractures, Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIAMS — symmetrical morning joint stiffness and arthralgia in hands/wrists/knees), hot flushes, and dyslipidaemia; ineffective in premenopausal women without concurrent GnRH agonist ovarian suppression.
8. Adverse Effects Profile
- Accelerated bone mineral density (BMD) loss and osteoporotic fractures, Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIAMS — symmetrical morning joint stiffness and arthralgia in hands/wrists/knees), hot flushes, and dyslipidaemia; ineffective in premenopausal women without concurrent GnRH agonist ovarian suppression.
- Accelerated bone mineral density (BMD) loss and osteoporotic fractures, Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIAMS — symmetrical morning joint stiffness and arthralgia in hands/wrists/knees), hot flushes, and dyslipidaemia; ineffective in premenopausal women without concurrent GnRH agonist ovarian suppression.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Accelerated bone mineral density (BMD) loss and osteoporotic fractures, Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIAMS — symmetrical morning joint stiffness and arthralgia in hands/wrists/knees), hot flushes, and dyslipidaemia; ineffective in premenopausal women without concurrent GnRH agonist ovarian suppression.
- 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: Confirm postmenopausal endocrine status before initiation; obtain baseline DEXA bone mineral density scan and co-prescribe Calcium (1,000–1,200 mg/day) + Vitamin D3 (800–2,000 IU/day) +/- bisphosphonate/denosumab.
Pharmacist Patient Counselling Points:
- Confirm postmenopausal endocrine status before initiation; obtain baseline DEXA bone mineral density scan and co-prescribe Calcium (1,000–1,200 mg/day) + Vitamin D3 (800–2,000 IU/day) +/- bisphosphonate/denosumab.
- 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: Confirm postmenopausal endocrine status before initiation; obtain baseline DEXA bone mineral density scan and co-prescribe Calcium (1,000–1,200 mg/day) + Vitamin D3 (800–2,000 IU/day) +/- bisphosphonate/denosumab.
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.
13. Related Reference Monographs, Educational Guides & Visual Concept
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