Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: α,α,α′,α′ - Tetramethyl - 5 - (1H - 1,2,4 - triazol - 1 - ylmethyl) - 1,3 - benzenediacetonitrile
Molecular Formula: C17H19N5
CAS Number: 120511-73-1
Brands: Arimidex
Introduction
Antineoplastic agent; selective aromatase inhibitor (type II).1 16 b
Uses for Anastrozole
Breast Cancer
First-line therapy for hormone receptor-positive (i.e., estrogen receptor-positive, progesterone receptor-positive, or both) or hormone receptor-unknown locally advanced or metastatic breast cancer in postmenopausal women.1 15 20 b
Second-line therapy for advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.1 20 b Usually ineffective in patients with hormone-receptor-negative breast cancer and those who fail tamoxifen therapy.1 b
Adjunct to surgery (with or without radiation therapy and/or chemotherapy) either as treatment of choice or as an alternative agent in postmenopausal women for early-stage hormone receptor-positive breast cancer.1 15 20 49 b May be more effective than tamoxifen;24 50 however, further studies needed to clarify efficacy and safety.25
A treatment of choice as initial adjuvant therapy for postmenopausal women with hormone receptor-positive invasive breast cancer who have a contraindication to tamoxifen.49 Alternative agent in postmenopausal women at increased risk for tamoxifen-associated toxicity (e.g., those with a history of thromboembolic or cerebrovascular disease).25 29
Not recommended as a single agent in premenopausal women with breast cancer.1 25 48 49 b (See Contraindications under Cautions.)
Not recommended as adjuvant therapy in postmenopausal women with hormone-receptor-negative breast cancer.1 25 49 b
Has been used as sequential adjuvant therapy following adjuvant tamoxifen for hormone receptor-positive early-stage breast cancer† in postmenopausal women.20 49
Has been used as extended adjuvant therapy following adjuvant tamoxifen for hormone receptor-positive early-stage breast cancer† in postmenopausal women.54
Has been used for reduction in the incidence of breast cancer† in women at high risk for developing the disease.44
Has been used as adjuvant therapy in premenopausal women with hormone receptor-positive breast cancer† in combination with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin).25 49
Gynecomastia
Has been used in adolescent boys for treatment of pubertal gynecomastia†; however, manufacturer states that efficacy is not established.b
McCune-Albright Syndrome
Has been used in young girls with McCune-Albright syndrome and progressive precocious puberty†; however, manufacturer states that efficacy is not established.b
Anastrozole Dosage and Administration
General
Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.
Administration of corticosteroid replacement therapy not necessary.1 b (See Actions.)
Administration
Oral Administration
Administer orally once daily without regard to meals.1 b
Dosage
Adults
Breast Cancer
First-line Treatment of Locally Advanced or Metastatic Breast Cancer
Oral
1 mg once daily.1 b Continue therapy until tumor progresses.1 b
Second-line Treatment of Advanced Breast Cancer
Oral
1 mg once daily.1 b Continue therapy until tumor progresses.1 b
Adjuvant Treatment of Early Breast Cancer
Oral
1 mg once daily.1 b Optimum duration unknown; duration of therapy in clinical study was 5 years.1 b
Special Populations
Hepatic Impairment
Dosage adjustment not required in patients with mild to moderate hepatic impairment.1 b (See Special Populations under Pharmacokinetics.)
Not studied in patients with severe hepatic impairment.1 b
Renal Impairment
Dosage adjustment not required.1 b (See Special Populations under Pharmacokinetics.)
Geriatric Patients
Dosage adjustment not required.1 b (See Special Populations under Pharmacokinetics.)
Cautions for Anastrozole
Contraindications
Known hypersensitivity to anastrozole or any ingredient in the formulation.1 b
Premenopausal women.b
Pregnancy.b
Warnings/Precautions
Warnings
Cardiovascular Effects
Increased incidence of ischemic cardiovascular events (e.g., angina pectoris) reported in patients with preexisting ischemic heart disease; consider risks and benefits of therapy in these patients.b
Musculoskeletal Effects
Risk of osteoporosis;36 c decreases in bone mineral density (BMD) at lumbar spine and hip reported.43 48 b
Risk of adverse musculoskeletal effects (e.g., joint disorder, arthritis, arthrosis, arthralgia) and fractures (including fractures of the spine, hip, and wrist).1 b
Monitor BMD prior to and at annual intervals during therapy.36 37 c
Therapy with an oral bisphosphonate agent recommended in patients with osteoporosis; carefully monitor patients with osteopenia.36 46 47
Lipid Effects
Increases in total serum cholesterol reported during therapy;b consider monitoring serum cholesterol.46 b
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm; embryotoxic and fetotoxic in animals.1 b Exclude pregnancy before initiating treatment.1 If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.1 b (See Contraindications under Cautions.)
Sensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria reported rarely.1 48 b Possible mucocutaneous disorders (e.g., erythema multiforme and Stevens-Johnson syndrome).1 b
General Precautions
Hepatic Effects
Increases in serum AST, ALT, and alkaline phosphatase concentrations reported commonly;1 b hepatitis and increased serum concentrations of γ-glutamyltransferase (GGT) and bilirubin reported rarely.1 b
Specific Populations
Pregnancy
Category X.b (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)
Lactation
Not known whether anastrozole is distributed into milk; discontinue nursing or the drug.b
Pediatric Use
Safety and efficacy not established.1 47
Has been used in clinical studies of adolescent boys 11–18 years of age with gynecomastia† and in girls 2 to <10 years of age with McCune-Albright syndrome and progressive precocious puberty†;b however, efficacy not established for these indications.b
Geriatric Use
No substantial differences in efficacy for patients ≥65 years of age relative to younger adults when used as second line therapy for advanced breast cancer;1 b moderately greater efficacy observed for patients ≥65 years of age when used as first-line therapy for locally advanced or metastatic breast cancer.1 b
For adjuvant treatment of hormone receptor-positive early-stage breast cancer, efficacy (e.g., disease-free survival benefit) in postmenopausal women ≥65 years of age was less than efficacy observed in postmenopausal women <65 years of age.b
Hepatic Impairment
Not studied in patients with severe hepatic impairment.1 b
Common Adverse Effects
Vasodilation, hot flushes (flashes), diarrhea, nausea, vomiting, asthenia, pain (including back pain), arthritis, arthralgia, fractures, increased liver function tests, hypertension, osteoporosis, peripheral edema, lymphedema, pharyngitis, depression, rash, insomnia, headache, increased cough, dyspnea.b
Interactions for Anastrozole
Inhibits CYP1A2, 2C8/9, and 3A4 in vitro, but only at relatively high concentrations.1 b Does not inhibit CYP2A6 or CYP2D6 in vitro.1 b Pharmacokinetic interaction unlikely with drugs metabolized by CYP isoenzymes at recommended dosages.1 b
Specific Drugs
Drug | Interaction | Comment |
|---|---|---|
Antipyrine | Pharmacokinetic interaction unlikely1 b | |
Estrogens | Antagonistic pharmacologic effects1 b | Concomitant use not recommended1 b |
Raloxifene | Possible decreased plasma anastrozole concentrations36 37 | Concomitant use not recommended36 37 Advise women receiving anastrozole who require osteoporosis therapy that an oral bisphosphonate (rather than raloxifene) is recommended36 37 46 47 |
Tamoxifen | Possible decreased plasma anastrozole concentrations1 26 b | Concomitant use not recommended1 36 37 b |
Warfarin | No clinically important effects on anticoagulant activity or pharmacokinetics of warfarinb |
Anastrozole Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed after oral administration, with peak plasma concentrations usually attained within 2 hours under fasting conditions.b
Steady-state plasma concentrations achieved in about 7 days.1 b
Onset
Serum estradiol concentrations reduced by approximately 70% within 24 hours of a 1-mg dose1 b and by approximately 80% after 14 days of daily dosing.1 b
Duration
Suppression of serum estradiol concentrations maintained for up to 6 days after discontinuance of daily anastrozole administration.1 b
Food
Food reduces rate but does not affect extent of absorption.1 b
Distribution
Extent
Anastrozole crosses the placenta in animals;1 b not known whether anastrozole crosses the placenta in humans.1
Not known whether anastrozole is distributed into milk.1 b
Plasma Protein Binding
40%.1 b
Elimination
Metabolism
Undergoes N-dealkylation, hydroxylation, and glucuronidation in the liver to multiple, pharmacologically inactive, metabolites.1 b
Elimination Route
Hepatic metabolism (85%) and renal excretion (10%).b
Half-life
Terminal half-life is approximately 50 hours in postmenopausal women.1 b
Special Populations
No evidence of altered pharmacokinetics observed in women >80 years of age compared with women <50 years of age.1 b
Individuals with severe renal impairment (Clcr <30 mL/minute): Renal clearance and total body clearance decreased by approximately 50 and 10%, respectively.b
Individuals with stable hepatic cirrhosis (related to alcohol abuse): Clearance reduced by approximately 30% compared with those with normal hepatic function;1 however, plasma concentrations within range compared with individuals with normal hepatic function.1 b
Stability
Storage
Oral
Tablets
20–25°C.1 b
Actions
Selectively inhibits conversion of androgens to estrogens.1 6 14
Decreased serum and tumor concentrations of estrogen inhibit breast tumor growth and delay disease progression.1 14 16
Does not affect synthesis of adrenal corticosteroid, aldosterone, or thyroid hormone.1 6 14 b
Advice to Patients
Importance of providing patient with a copy of the manufacturer’s patient information.c
Advise patients that anastrozole may be administered without regard to meals.1 b c
Risk of osteoporosis.c Life-style changes (e.g., weight-bearing exercise, abstinence from smoking, moderation of alcohol consumption) and dietary supplementation with calcium and vitamin D advised.36 46 47
Advise patients that anastrozole is for use in postmenopausal women only.1 47
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; importance of avoiding pregnancy during therapy.1 Warn women of potential hazard to the fetus in cases of inadvertent exposure of pregnant women to anastrozole.b
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., estrogens, raloxifene, tamoxifen), OTC, and herbal drugs, as well as concomitant illnesses (e.g., ischemic heart disease).1 b c
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 1 mg* | Anastrozole Film-coated Tablets | |
Arimidex | AstraZeneca |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 11/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Anastrozole 1MG Tablets (ZYDUS PHARMACEUTICALS (USA)): 30/$186.01 or 60/$359.96
Arimidex 1MG Tablets (ASTRAZENECA): 30/$458.97 or 90/$1,313.01
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 30, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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a. AHFS Drug Information 2009. McEvoy GK, ed. Anastrozole. Bethesda, MD: American Society of Health-System Pharmacists; 2009:928–33.
b. AstraZeneca. Arimidex (anastrozole) tablets prescribing information. Wilmington, DE; 2008 Dec.
c. AstraZeneca. Arimidex (anastrozole) tablets patient information. Wilmington, DE; 2008 Dec.
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