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These highlights do not include all the information needed to use Anastrozole Tablets safely and effectively. See full prescribing information for Anastrazole Tablets. Anastrozole Tablets for oral use Initial U.S. Approval: 1995 | Anastrozole

13:50 EDT 24th July 2014 | BioPortfolio

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      Anastrozole tablets 1 mg is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

      Anastrozole tablets 1 mg is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.

      Anastrozole tablets 1 mg 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 anastrozole.

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

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 are presented in Table 1.

A patient may have had more than 1 adverse event.

Less frequent adverse experiences reported in patients receiving Anastrozole tablets 1 mg in either Trial 0030 or Trial 0027 were similar to those reported for second-line therapy.

Based on results from second-line therapy and the established safety profile of tamoxifen, the incidences of 9 pre-specified adverse event categories potentially causally related to one or both of the therapies because of their pharmacology were statistically analyzed. No significant differences were seen between treatment groups.

A patient may have had more than 1 adverse reaction. Includes pulmonary embolus, thrombophlebitis, retinal vein thrombosis. Includes myocardial infarction, myocardial ischemia, angina pectoris, cerebrovascular accident, cerebral ischemia and cerebral infarct.

Second-Line Therapy Anastrozole tablets were tolerated in two controlled clinical trials (i.e., Trials 0004 and 0005), with less than 3.3% of the anastrozole tablets-treated patients and 4% of the megestrol acetate-treated patients withdrawing due to an adverse reaction.

Body system and adverse reactions by COSTART† preferred term‡ Anastrozole Tablets 1 mg
(N§ = 3092)
Tamoxifen 20 mg
(N§ = 3094)

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)
  Anastrozole
N=3092
(%)
Tamoxifen
N=3094
(%)
Odds-ratio 95% CI

Hot Flashes

1104 (36)

1264 (41)

0.8

0.73 to 0.89

Musculoskeletal Events†

1100 (36)

911 (29)

1.32

1.19 to 1.47

Fatigue/Asthenia

575 (19)

544 (18)

1.07

0.94 to 1.22

Mood Disturbances

597 (19)

554 (18)

1.1

0.97 to 1.25

Nausea and Vomiting

393 (13)

384 (12)

1.03

0.88 to 1.19

All Fractures

315 (10)

209 (7)

1.57

1.3 to 1.88

Fractures of Spine, Hip, or Wrist

133 (4)

91 (3)

1.48

1.13 to 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 to 1.04

Vaginal Bleeding

167 (5)

317 (10)

0.5

0.41 to 0.61

Ischemic Cardiovascular Disease

127 (4)

104 (3)

1.23

0.95 to 1.6

Vaginal Discharge

109 (4)

408 (13)

0.24

0.19 to 0.3

Venous Thromboembolic events

87 (3)

140 (5)

0.61

0.47 to 0.8

Deep Venous Thromboembolic Events

48 (2)

74 (2)

0.64

0.45 to 0.93

Ischemic Cerebrovascular Event

62 (2)

88 (3)

0.7

0.5 to 0.97

Endometrial Cancer‡

4 (0.2)

13 (0.6)

0.31

0.1 to 0.94
Body system
Adverse Reaction*
Number (%) of subjects
  Anastrozole
(N=506)
Tamoxifen
(N=511)

Whole body

 

 

Asthenia

83 (16)

81 (16)

Pain

70 (14)

73 (14)

Back pain

60 (12)

68 (13)

Headache

47 (9)

40 (8)

Abdominal pain

40 (8)

38 (7)

Chest pain

37 (7)

37 (7)

Flu syndrome

35 (7)

30 (6)

Pelvic pain

23 (5)

30 (6)

Cardiovascular

 

 

Vasodilation

128 (25)

106 (21)

Hypertension

25 (5)

36 (7)

Digestive

 

 

Nausea

94 (19)

106 (21)

Constipation

47 (9)

66 (13)

Diarrhea

40 (8)

33 (6)

Vomiting

38 (8)

36 (7)

Anorexia

26 (5)

46 (9)

Metabolic and Nutritional

 

 

Peripheral edema

51 (10)

41 (8)

Muscoloskeletal

 

 

Bone pain

54 (11)

52 (10)

Nervous

 

 

Dizziness

30 (6)

22 (4)

Insomnia

30 (6)

38 (7)

Depression

23 (5)

32 (6)

Hypertonia

16 (3)

26 (5)

Respiratory

 

 

Cough increased

55 (11)

52 (10)

Dyspnea

51 (10)

47 (9)

Pharyngitis

49 (10)

68 (13)

Skin and appendages

 

 

Rash

38 (8)

34 (8)

Urogenital

 

 

Leukorrhea

9 (2)

31 (6)

Manufacturer

APP Pharmaceuticals, LLC

Active Ingredients

Source

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Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study).

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Central precocious puberty in a case of late-diagnosed familial testotoxicosis and long-term treatment monitoring.

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