Medicinal Products

ANASTROZOLE SANDOZ 1 mg

Generic drug of Arimidex
Therapeutic class: Oncology and hematology
active ingredients: Anastrozole
laboratory: Sandoz

Coated tablet
Box of 90
All forms

Indication

Anastrozole is indicated in:

· The treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.

Dosage ANASTROZOLE SANDOZ 1 mg Film-coated tablet Box of 90

Dosage

The recommended dosage of anastrozole in adults, including the elderly, is from a 1 mg tablet once a day.

Special Populations

Pediatric population

Anastrozole is not recommended for use in children and adolescents because of insufficient safety data and efficacy (see sections Warnings and Precautions and Pharmacodynamic Properties ).

Renal failure

No dosage modification is recommended for patients with mild or moderate renal impairment. In patients with severe renal impairment, anastrozole should be administered with caution (see Warnings and Precautions and Pharmacokinetic Properties sections).

Hepatic insufficiency

No dosage modification is recommended for patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment (see Warnings and Precautions ).

Administration mode

Anastrozole should be taken orally.

Against indications

The use of anastrozole is contraindicated in the following situations:

· Pregnancy or breastfeeding

· Known hypersensitivity to anastrozole or any of the excipients listed under Composition .

Adverse effects Anastrozole Sandoz

The following table presents adverse effects from clinical studies, post-marketing studies, or spontaneous reports. Unless specified, frequency groups were calculated from the number of adverse events reported in a large phase III study in 9, 366 postmenopausal women with operable breast cancer who received adjuvant therapy for 5 years (study ATAC: Anastrozole Tamoxifen, Alone or Combination Study).

The side effects listed below are classified by frequency and system organ class (SOC). Frequency groups are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), and very rare (<1/10 000). The most common side effects were headache, hot flush, nausea, rash, arthralgia, joint stiffness, arthritis and asthenia.

Table 1 Adverse reactions by system organ class and frequency

Side effects by SOC and frequency

Metabolism and nutrition disorders

Frequent

Anorexia

hypercholesterolemia

Nervous system disorders

Very common

headaches

Frequent

Drowsiness

Carpal tunnel syndrome*

Vascular disorders

Very common

Hot flashes

Gastrointestinal disorders

Very common

nausea

Frequent

diarrhea

vomiting

Hepatobiliary disorders

Frequent

Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase

Rare

Increases in gamma-GT and bilirubin levels

Hepatitis

Skin and subcutaneous tissue disorders

Very common

Skin rash

Frequent

Hair resorption (alopecia)

Allergic reactions

Rare

Urticaria

Rare

Erythema multiforme

Anaphylactoid reaction

Cutaneous vasculitis (including some cases of Henoch-Schönlein purpura) **

Very rare

Stevens-Johnson Syndrome

Angioedema

Musculoskeletal and systemic disorders

Very common

Arthralgia / joint stiffness

Arthritis

osteoporosis

Frequent

Bone pain

Rare

Spring finger

Disorders of reproductive organs and breast

Frequent

Vaginal dryness

Vaginal bleeding ***

General disorders and administration site conditions

Very common

Asthenia

* Carpal tunnel syndrome events have been reported in greater numbers in patients treated with anastrozole in clinical trials than among those receiving tamoxifen therapy. However, the majority of these events occurred in patients with identifiable risk factors for the onset of these events.

** Since no case of cutaneous vasculitis or Henoch-Schönlein purpura was observed in the ATAC study, the frequency of these events can be considered as "rare" (≥ 0.01% and <0.1 %) on the basis of the least favorable estimate.

*** Vaginal bleeding has been reported frequently, mainly in patients with advanced breast cancer, during the first few weeks after releasing existing hormone therapy with anastrozole. If bleeding persists, further exploration should be considered.

The table below shows the frequency of prespecified adverse events in the ATAC study, after a median follow-up of 68 months regardless of treatment-related causality, observed in women receiving study treatment and up to 14 days later. stopping treatment of the study.

Table 2 Pre-specified adverse events in the ATAC study

Unwanted events

anastrozole

(n = 3092)

tamoxifen

(n = 3094)

Hot flashes

1104 (35.7%)

1264 (40.9%)

Pain / joint stiffness

1100 (35.6%)

911 (29.4%)

Mood disorders

597 (19.3%)

554 (17.9%)

Fatigue / asthenia

575 (18.6%)

544 (17.6%)

Nausea and vomiting

393 (12.7%)

384 (12.4%)

fractures

315 (10.2%)

209 (6.8%)

Fractures of vertebrae, hip or wrist / Pouteau-Adhesives

133 (4.3%)

91 (2.9%)

Wrist fractures / Pouteau-Adhesives

67 (2.2%)

50 (1.6%)

Vertebral fractures

43 (1.4%)

22 (0.7%)

Hip fractures

28 (0.9%)

26 (0.8%)

Cataract

182 (5.9%)

213 (6.9%)

Vaginal haemorrhage

167 (5.4%)

317 (10.2%)

Ischemic cardiovascular disease

127 (4.1%)

104 (3.4%)

Angina pectoris

71 (2.3%)

51 (1.6%)

Myocardial infarction

37 (1.2%)

34 (1.1%)

Coronary disease

25 (0.8%)

23 (0.7%)

Myocardial ischemia

22 (0.7%)

14 (0.5%)

Vaginal discharge

109 (3.5%)

408 (13.2%)

Any venous thromboembolic event

87 (2.8%)

140 (4.5%)

Deep vein thromboembolism, including pulmonary embolism

48 (1.6%)

74 (2.4%)

Ischemic cerebral vascular events

62 (2.0%)

88 (2.8%)

Endometrial cancer

4 (0.2%)

13 (0.6%)

After a median follow-up of 68 months, the observed fracture rates were 22 per 1, 000 patient-years and 15 per 1, 000 patient-years in the anastrozole and tamoxifen groups, respectively. The fracture rate observed with anastrozole is similar to that reported in postmenopausal women of similar ages. The incidence of osteoporosis was 10.5% in patients treated with anastrozole and 7.3% in patients treated with tamoxifen.

It could not be established whether the fracture and osteoporosis rates observed in the ATAC study in patients on anastrozole showed a protective effect of tamoxifen, a specific effect of anastrozole, or both.

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