Medicinal Products

ANASTROZOLE RATIOPHARM 1 mg

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

Coated tablet
Box of 30
All forms

Indication

ANASTROZOLE RATIOPHARM 1 mg film-coated tablet is indicated for the treatment of advanced hormone receptor-positive breast cancer in postmenopausal women.

Dosage ANASTROZOLE RATIOPHARM 1 mg Film-coated tablet Box of 30

Dosage

The recommended dosage of ANASTROZOLE RATIOPHARM in adults, including the elderly, is one tablet at 1 mg once daily.

Special populations

Pediatric populations

ANASTROZOLE RATIOPHARM 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 RATIOPHARM 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 section )

Administration mode

ANASTROZOLE RATIOPHARM should be taken orally.

Against indications

ANASTROZOLE RATIOPHARM 1 mg film-coated tablets are contraindicated in:

· Pregnant or lactating women,

· Patients with known hypersensitivity to anastrozole or to any of the excipients listed under Composition .

Side effects Anastrozole Ratiopharm

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 clinical study in 9, 366 postmenopausal women with operable breast cancer who received adjuvant therapy for 5 years ( ATAC study: Anastrozole, Tamoxifen, Alone or in combination study).

The side effects listed below are classified by frequency and organ system class (SOC). Frequency groups are defined according to the following convention: very common (≥1 / 10), frequent (≥ 1/100 to <1/10), uncommon (≥1 / 1, 000 to ≤ 1/100), rare (≥ 1 / 10, 000 to ≤ 1 / 1, 000), 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 amino transferase

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 cases of Henoch-Schönlein purpura) **

Very rare

Stevens-Johnson Syndrome

Angi-edema

Musculoskeletal and connective tissue 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 therefore 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 the relapse of existing anastrozole hormone therapy. If bleeding persists, further exploration should be considered.

The table below presents the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, regardless of treatment causality, observed in patients receiving study treatment and up to 14 months of age. days after stopping treatment of the study.

Table 2. Pre-specified adverse events in the ATAC study

Undesirable effect

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 the spine, hip or wrist (Pouteau-Glues)

133 (4.3%)

91 (2.9%)

Wrist Fractures / Pouteau-Adhesives

67 (2.2%)

50 (1.6%)

Fractures of the spine

43 (1.4%)

22 (0.7%)

Hip fractures

28 (0.9%)

26 (0.8%)

cataracts

182 (5.9%)

213 (6.9%)

Vaginal bleeding

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 artery 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 venous thromboembolic event, 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 1000 patient-years and 15 per 1000 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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