Medicinal Products

ANASTROZOLE PHR LAB 1 mg

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

Filmstrip
box of 90
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Indication

Anastrozole is indicated in the treatment of advanced breast cancer with positive hormone receptors in menopausal women.

Posology ANASTROZOLE PHR LAB 1 mg tablet film pack of 90

Anastrozole is indicated in the treatment of advanced breast cancer with positive hormone receptors in menopausal women.

Against indications

Anastrozole is contraindicated at:

Pregnant or lactating women.

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

Side effects Anastrozole Phr Lab

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

The undesirable effects listed below are classified by frequency and by class of organ systems (SOC). Frequency groups are defined according to the following convention: very frequent (≥ 1/10), frequent (≥ 1/100, <1/10), not very frequent (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), and very rare (<1 / 10, 000). The most common undesirable effects were headache, hot flashes, nausea, skin rashes, arthralgia, joint stiffness, arthritis and asthenia.

Table 1. Undesirable effects by class of organ systems and frequency

Undesirable effects by SOC and frequency

Metabolism and nutrition disorders

FrÚquent

Anorexia

HypercholestÚrolÚmie

Nervous System Affections

Very good

CÚphalÚes

FrÚquent

Drowsiness

Carpal tunnel syndrome*

Vascular disorders

Very good

Hot flashes

Gastrointestinal disorders

Very good

NausÚes

FrÚquent

DiarrhÚes

vomiting

Hospital diseases

FrÚquent

Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase

Not very frequent

Increases in gamma-GT and bilirubin levels

HÚpatite

Skin and subcutaneous tissue disorders

Very good

skin rash

FrÚquent

Hair rarfaction (alopecia)

Allergic reactions

Not very frequent

Urticaria

Rare

polymorphic rhythms

Anaphylactoid reaction

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

Very rare

Stevens-Johnson Syndrome

Angio-oedÞme

Musculoskeletal and systemic disorders

Very good

Arthralgia / joint stiffness

Arthritis

OstÚoporose

FrÚquent

Bone pain

Not very frequent

Spring finger

Disorders of reproductive organs and breast

FrÚquent

Vaginal dryness

Vaginal bleeding ***

General disorders and administration site abnormalities

Very good

AsthÚnie

* Events of the Carpal Tunnel Syndrome type have been reported in greater numbers in patients treated with anastrozole in clinical trials than among those receiving treatment. by tamoxif? nne. However, the majority of these events occurred in patients with identifiable risk factors for the onset of these events.

** No case of cutaneous vasculitis or Henoch-Schönlein purpura has been observed in the ATAC study, the frequency of these events may be therefore to be considered as   rare? (≥ 0.01% and <0.1%) based on 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 explorations should be considered.

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

Table 2. Undesirable events predicted in the ATAC study

Undesirable effects

Anastrozole (N = 3092)

TamoxifÞne (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 / asthÚnie

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 heart 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 vascular cerebral vascular

62 (2.0%)

88 (2.8%)

Cancer of the endometrium

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 anastrozole and tamoxifÞne groups. The rate of fractures observed under anastrozole is similar to that reported in the populations of menopausal women with corresponding eges. 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 if the rates of fractures and osteoporosis observed in the ATAC study in patients on anastrozole reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both.

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals report any suspected adverse effects via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the Network of Regional Pharmacovigilance Centers Website: www.ansm.sante.fr.

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