This is the Header Notice module. It can be used for Cookie Law messages or any other text. Multiple modules with different styles can be added on any page.
Arimidex 1 Mg 28 Tablets

Unlimited Blocks

There's no limit to how many blocks you can create. You can position custom product page blocks in different positions and can also display custom blocks on out of stock products only.

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Adjuvant Treatment

1.2 First-Line Treatment

1.3 Second-Line Treatment

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

2.2 Patients with Hepatic Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Pregnancy and Premenopausal Women

4.2 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 Ischemic Cardiovascular Events

5.2 Bone Effects

5.3 Cholesterol

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 Tamoxifen

7.2 Estrogen

7.3 Warfarin

7.4 Cytochrome P450

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Adjuvant Treatment of Breast Cancer in Postmenopausal Women

14.2 First-Line Therapy in Postmenopausal Women with Advanced Breast Cancer

14.3 Second-Line Therapy in Postmenopausal Women with Advanced Breast Cancer who had Disease Progression following Tamoxifen Therapy

16 HOW SUPPLIED/STORAGE AND HANDLING

Storage

17 PATIENT COUNSELING INFORMATION

17.1 Pregnancy

17.2 Allergic (Hypersensitivity) Reactions

17.3 Ischemic Cardiovascular Events

17.4 Bone Effects

17.5 Cholesterol

17.6 Tickling, Tingling or Numbness

17.7 Tamoxifen

17.8 Missed Doses

*

Sections or subsections omitted from the full prescribing information are not listed.

 

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Adjuvant Treatment

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

1.2 First-Line Treatment

ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.

1.3 Second-Line Treatment

ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

The dose of ARIMIDEX is one 1 mg tablet taken once a day. For patients with advanced breast cancer, ARIMIDEX should be continued until tumor progression. ARIMIDEX can be taken with or without food.

For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial, ARIMIDEX was administered for five years [seeClinical Studies (14.1)].

No dosage adjustment is necessary for patients with renal impairment or for elderly patients [see Use in Specific Populations (8.6)].

2.2 Patients with Hepatic Impairment

No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. ARIMIDEX has not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

3 DOSAGE FORMS AND STRENGTHS

The tablets are white, biconvex, film-coated containing 1 mg of anastrozole. The tablets are impressed on one side with a logo consisting of a letter “A” (upper case) with an arrowhead attached to the foot of the extended right leg of the “A” and on the reverse with the tablet strength marking “Adx 1”.

4 CONTRAINDICATIONS

4.1 Pregnancy and Premenopausal Women

ARIMIDEX may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. ARIMIDEX is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using ARIMIDEX. If ARIMIDEX is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus or potential risk for loss of the pregnancy [see Use in Specific Populations (8.1)].

4.2 Hypersensitivity

ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Ischemic Cardiovascular Events

In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with ARIMIDEX in the ATAC trial (17% of patients on ARIMIDEX and 10% of patients on tamoxifen). Consider risk and benefits of ARIMIDEX therapy in patients with pre-existing ischemic heart disease [see Adverse Reactions (6.1)].

5.2 Bone Effects

Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline. Consider bone mineral density monitoring in patients treated with ARIMIDEX [see Adverse Reactions (6.1)].

5.3 Cholesterol

During the ATAC trial, more patients receiving ARIMIDEX were reported to have elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively) [seeAdverse Reactions (6.1)].

6 ADVERSE REACTIONS

Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling [see Adverse Reactions (6.2)].

Common adverse reactions (occurring with an incidence of ≥10%) in women taking ARIMIDEX included: hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema.

In the ATAC trial, the most common reported adverse reaction (>0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the ARIMIDEX group.

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.

6.1 Clinical Trials Experience

Adjuvant Therapy

Adverse reaction data for adjuvant therapy are based on the ATAC trial [seeClinical Studies (14.1)]. The median duration of adjuvant treatment for safety evaluation was 59.8 months and 59.6 months for patients receiving ARIMIDEX 1 mg and tamoxifen 20 mg, respectively.

Adverse reactions occurring with an incidence of at least 5% in either treatment group during treatment or within 14 days of the end of treatment are presented in Table 1.

Table 1 — Adverse reactions occurring with an incidence of at least 5% in either treatment group during treatment, or within 14 days of the end of treatment in the ATAC trial *

Body system and adverse reactions by 
COSTART†preferred term‡

ARIMIDEX 1 mg 
(N§ = 3092)

Tamoxifen 20 mg 
(N§ = 3094)

*The combination arm was discontinued due to lack of efficacy benefit at 33 months of follow-up.

†COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms.

‡A patient may have had more than 1 adverse reaction, including more than 1 adverse reaction in the same body system.

§N=Number of patients receiving the treatment.

¶Vaginal Hemorrhage without further diagnosis.

Body as a whole

   

Asthenia

 

575 (19)

 

544 (18)

Pain

 

533 (17)

 

485 (16)

Back pain

 

321 (10)

 

309 (10)

Headache

 

314 (10)

 

249    (8)

Abdominal pain

 

271    (9)

 

276    (9)

Infection

 

285    (9)

 

276    (9)

Accidental injury

 

311 (10)

 

303 (10)

Flu syndrome

 

175    (6)

 

195    (6)

Chest pain

 

200    (7)

 

150    (5)

Neoplasm

 

162    (5)

 

144    (5)

Cyst

 

138    (5)

 

162    (5)

Cardiovascular

   

Vasodilatation

 

1104 (36)

 

1264 (41)

Hypertension

 

402 (13)

 

349 (11)

Digestive

   

Nausea

 

343 (11)

 

335 (11)

Constipation

 

249 (8)

 

252 (8)

Diarrhea

 

265    (9)

 

216    (7)

Dyspepsia

 

206    (7)

 

169    (6)

Gastrointestinal disorder

 

210    (7)

 

158    (5)

Hemic and lymphatic

   

Lymphedema

 

304 (10)

 

341 (11)

Anemia

 

113    (4)

 

159    (5)

Metabolic and nutritional

   

Peripheral edema

 

311 (10)

 

343 (11)

Weight gain

 

285    (9)

 

274    (9)

Hypercholesterolemia

 

278    (9)

 

108 (3.5)

Musculoskeletal

   

Arthritis

 

512 (17)

 

445 (14)

Arthralgia

 

467 (15)

 

344 (11)

Osteoporosis

 

325 (11)

 

226    (7)

Fracture

 

315 (10)

 

209    (7)

Bone pain

 

201    (7)

 

185    (6)

Arthrosis

 

207    (7)

 

156    (5)

Joint Disorder

 

184    (6)

 

160    (5)

Myalgia

 

179    (6)

 

160    (5)

Nervous system

   

Depression

 

413 (13)

 

382 (12)

Insomnia

 

309 (10)

 

281    (9)

Dizziness

 

236    (8)

 

234    (8)

Anxiety

 

195    (6)

 

180    (6)

Paresthesia

 

215    (7)

 

145    (5)

Respiratory

   

Pharyngitis

 

443 (14)

 

422 (14)

Cough increased

 

261    (8)

 

287    (9)

Dyspnea

 

234    (8)

 

237    (8)

Sinusitis

 

184    (6)

 

159    (5)

Bronchitis

 

167    (5)

 

153    (5)

Skin and appendages

   

Rash

 

333 (11)

 

387 (13)

Sweating

 

145    (5)

 

177    (6)

Special Senses

   

Cataract Specified

 

182    (6)

 

213    (7)

Urogenital

   

Leukorrhea

 

86    (3)

 

286   (9)

Urinary tract infection

 

244   (8)

 

313 (10)

Breast pain

 

251    (8)

 

169    (6)

Breast Neoplasm

 

164    (5)

 

139    (5)

Vulvovaginitis

 

194   (6)

 

150    (5)

Vaginal Hemorrhage¶

 

122    (4)

 

180    (6)

Vaginitis

 

125    (4)

 

158    (5)

Certain adverse reactions and combinations of adverse reactions were prospectively specified for analysis, based on the known pharmacologic properties and side effect profiles of the two drugs (see Table 2).

Table 2 — Number of Patients with Pre-specified Adverse Reactions in ATAC Trial*

 

ARIMIDEX 
N=3092 
(%)

Tamoxifen 
N=3094 
(%)

Odds-ratio

95% CI

*Patients with multiple events in the same category are counted only once in that category.

†Refers to joint symptoms, including joint disorder, arthritis, arthrosis and arthralgia.

‡Percentages calculated based upon the numbers of patients with an intact uterus at baseline

Hot Flashes

 

1104 (36)

 

1264 (41)

0.80

0.73 − 0.89

Musculoskeletal Events†

 

1100 (36)

 

911 (29)

1.32

1.19 − 1.47

Fatigue/Asthenia

 

575 (19)

 

544 (18)

1.07

0.94 − 1.22

Mood Disturbances

 

597 (19)

 

554 (18)

1.10

0.97 − 1.25

Nausea and Vomiting

 

393 (13)

 

384 (12)

1.03

0.88 − 1.19

All Fractures

 

315 (10)

 

209   (7)

1.57

1.30 − 1.88

Fractures of Spine, Hip, or Wrist

 

133   (4)

 

91   (3)

1.48

1.13 − 1.95

 

Wrist/Colles’ fractures

 

67   (2)

 

50   (2)

   

 

Spine fractures

 

43   (1)

 

22   (1)

   

 

Hip fractures

 

28   (1)

 

26   (1)

   

Cataracts

 

182   (6)

 

213   (7)

0.85

0.69 − 1.04

Vaginal Bleeding

 

167   (5)

 

317 (10)

0.50

0.41 − 0.61

Ischemic Cardiovascular Disease

 

127   (4)

 

104   (3)

1.23

0.95 − 1.60

Vaginal Discharge

 

109   (4)

 

408 (13)

0.24

0.19 − 0.30

Venous Thromboembolic events

 

87   (3)

 

140   (5)

0.61

0.47 − 0.80

Deep Venous Thromboembolic Events

 

48   (2)

 

74   (2)

0.64

0.45 − 0.93

Ischemic Cerebrovascular Event

 

62   (2)

 

88   (3)

0.70

0.50 − 0.97

Endometrial Cancer‡

 

4 (0.2)

 

13 (0.6)

0.31

0.10 − 0.94

Ischemic Cardiovascular Events

Between treatment arms in the overall population of 6186 patients, there was no statistical difference in ischemic cardiovascular events (4% ARIMIDEX vs. 3% tamoxifen). In the overall population, angina pectoris was reported in 71/3092 (2.3%) patients in the ARIMIDEX arm and 51/3094 (1.6%) patients in the tamoxifen arm; myocardial infarction was reported in 37/3092 (1.2%) patients in the ARIMIDEX arm and 34/3094 (1.1%) patients in the tamoxifen arm.

In women with pre-existing ischemic heart disease 465/6186 (7.5%), the incidence of ischemic cardiovascular events was 17% in patients on ARIMIDEX and 10% in patients on tamoxifen. In this patient population, angina pectoris was reported in 25/216 (11.6%) patients receiving ARIMIDEX and 13/249 (5.2%) patients receiving tamoxifen; myocardial infarction was reported in 2/216 (0.9%) patients receiving ARIMIDEX and 8/249 (3.2%) patients receiving tamoxifen.

Bone Mineral Density Findings

Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline.

Because ARIMIDEX lowers circulating estrogen levels it may cause a reduction in bone mineral density.

A post-marketing trial assessed the combined effects of ARIMIDEX and the bisphosphonate risedronate on changes from baseline in BMD and markers of bone resorption and formation in postmenopausal women with hormone receptor-positive early breast cancer. All patients received calcium and vitamin D supplementation. At 12 months, small reductions in lumbar spine bone mineral density were noted in patients not receiving bisphosphonates. Bisphosphonate treatment preserved bone density in most patients at risk of fracture.

Postmenopausal women with early breast cancer scheduled to be treated with ARIMIDEX should have their bone status managed according to treatment guidelines already available for postmenopausal women at similar risk of fragility fracture.

Cholesterol

During the ATAC trial, more patients receiving ARIMIDEX were reported to have an elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively).

A post-marketing trial also evaluated any potential effects of ARIMIDEX on lipid profile. In the primary analysis population for lipids (ARIMIDEX alone), there was no clinically significant change in LDL-C from baseline to 12 months and HDL-C from baseline to 12 months.

In secondary population for lipids (ARIMIDEX+risedronate), there also was no clinically significant change in LDL-C and HDL-C from baseline to 12 months.

In both populations for lipids, there was no clinically significant difference in total cholesterol (TC) or serum triglycerides (TG) at 12 months compared with baseline.

In this trial, treatment for 12 months with ARIMIDEX alone had a neutral effect on lipid profile. Combination treatment with ARIMIDEX and risedronate also had a neutral effect on lipid profile.

The trial provides evidence that postmenopausal women with early breast cancer scheduled to be treated with ARIMIDEX should be managed using the current National Cholesterol Education Program guidelines for cardiovascular risk-based management of individual patients with LDL elevations.

Other Adverse Reactions

Patients receiving ARIMIDEX had an increase in joint disorders (including arthritis, arthrosis and arthralgia) compared with patients receiving tamoxifen. Patients receiving ARIMIDEX had an increase in the incidence of all fractures (specifically fractures of spine, hip and wrist) [315 (10%)] compared with patients receiving tamoxifen [209 (7%)].

Patients receiving ARIMIDEX had a higher incidence of carpal tunnel syndrome [78 (2.5%)] compared with patients receiving tamoxifen [22 (0.7%)].

Vaginal bleeding occurred more frequently in the tamoxifen-treated patients versus the ARIMIDEX-treated patients 317 (10%) versus 167 (5%), respectively.

Patients receiving ARIMIDEX had a lower incidence of hot flashes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events and ischemic cerebrovascular events compared with patients receiving tamoxifen.

10-year median follow-up Safety Results from the ATAC Trial

Results are consistent with the previous analyses.

Serious adverse reactions were similar between ARIMIDEX (50%) and tamoxifen (51%).

•Cardiovascular events were consistent with the known safety profiles of ARIMIDEX and tamoxifen.

•The cumulative incidences of all first fractures (both serious and non-serious, occurring either during or after treatment) was higher in the ARIMIDEX group (15%) compared to the tamoxifen group (11%). This increased first fracture rate during treatment did not continue in the post-treatment follow-up period.

•The cumulative incidence of new primary cancers was similar in the ARIMIDEX group (13.7%) compared to the tamoxifen group (13.9%). Consistent with the previous analyses, endometrial cancer was higher in the tamoxifen group (0.8%) compared to the ARIMIDEX group (0.2%).

•The overall number of deaths (during or off-trial treatment) was similar between the treatment groups. There were more deaths related to breast cancer in the tamoxifen than in the ARIMIDEX treatment group.

First-Line Therapy

Adverse reactions occurring with an incidence of at least 5% in either treatment group of trials 0030 and 0027 during or within 2 weeks of the end of treatment are shown in Table 3.

Table 3 – Adverse Reactions Occurring with an Incidence of at Least 5% in Trials 0030 and 0027

Body system 
Adverse Reaction*

Number (%) of subjects

 

ARIMIDEX 
(N=506)

Write a review

Note: HTML is not translated!
    Bad           Good

Arimidex 1 Mg 28 Tablets

  • Brand: Astra Zeneca
  • Product Code: 8699786090071
  • Availability: In Stock
  • $72.00

Tags: Arimidex 1 Mg 28 Tablets, Astra Zeneca, All Products