Medicinal Products

ARIMIDEX 1 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Anastrozole
laboratory: BB Farma Srl

Coated tablet
Box of 28
All forms

Indication

ARIMIDEX is indicated in the:

· Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women;

· Adjuvant treatment of hormone receptor-positive invasive breast cancer at an early stage in postmenopausal women;

· Adjuvant treatment of hormone receptor-positive invasive breast cancer at an early stage in postmenopausal women who received adjuvant tamoxifen therapy for 2 to 3 years.

Dosage ARIMIDEX 1 mg Film-coated tablet Box of 28

Dosage

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

In hormone-receptor-positive invasive breast cancer early in postmenopausal women, the recommended duration of adjuvant hormone therapy is 5 years.

Special Populations

Pediatric population

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

Renal failure

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

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

ARIMIDEX should be taken orally.

Against indications

ARIMIDEX is contraindicated in:

· Pregnant or lactating women;

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

Arimidex side effects

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: ARIMIDEX, 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

Rare

Hypercalcemia (with or without increased parathyroid hormone)

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

myalgia

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-like events have been reported in more patients treated with ARIMIDEX in clinical trials than among those treated with tamoxifen. 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 reliance on existing hormone therapy with ARIMIDEX. 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

Side effects

ARIMIDEX

(N = 3, 092)

tamoxifen

(N = 3, 094)

Hot flashes

1, 104

(35.7%)

1, 264

(40.9%)

Pain / joint stiffness

1, 100

(35.6%)

911

(29.4%)

Mood disorder

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 1, 000 patient-years and 15 per 1, 000 patient-years, respectively, in the ARIMIDEX and tamoxifen groups. The fracture rate observed with ARIMIDEX is similar to that reported in postmenopausal women of similar ages. The incidence of osteoporosis was 10.5% in patients treated with ARIMIDEX 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 receiving ARIMIDEX reflect a protective effect of tamoxifen, a specific effect of ARIMIDEX, or both.

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