Generic drug of Arimidex
Therapeutic class: Oncology and hematology
active ingredients: Anastrozole
Box of 90
ANASTROZOLE BIOGARAN is indicated in the:
· Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Dosage ANASTROZOLE BIOGARAN 1 mg Film-coated tablet Box of 90
The recommended dosage of ANASTROZOLE BIOGARAN in adults, including the elderly, is one tablet at 1 mg once daily.
ANASTROZOLE BIOGARAN is not recommended for use in children and adolescents due to insufficient safety data and efficacy (see Warnings and Precautions and Pharmacodynamic Properties sections).
No dosage modification is recommended for patients with mild or moderate renal impairment. In patients with severe renal impairment, ANASTROZOLE BIOGARAN should be administered with caution (see Warnings and Precautions and Pharmacokinetic Properties sections).
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 ).
ANASTROZOLE BIOGARAN should be taken orally.
ANASTROZOLE BIOGARAN is contraindicated in:
· Pregnant or lactating women;
· Patients with known hypersensitivity to anastrozole or to any of the excipients listed in the Composition section.
Side effects Anastrozole Biogaran
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 in 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
Nervous system disorders
Carpal tunnel syndrome*
Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
Increases in gamma-GT and bilirubin levels
Skin and subcutaneous tissue disorders
Hair resorption (alopecia)
Cutaneous vasculitis (including some cases of Henoch-Schönlein purpura) **
Musculoskeletal and systemic disorders
Arthralgia / joint stiffness
Disorders of reproductive organs and breast
Vaginal bleeding ***
General disorders and administration site conditions
* Carpal tunnel syndrome-like events have been reported in greater numbers in patients treated with AANASTROZOLE 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 ANASTROZOLE relies on existing 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
1, 104 (35.7%)
1, 264 (40.9%)
Pain / joint stiffness
1, 100 (35.6%)
Fatigue / asthenia
Nausea and vomiting
Fractures of the spine, hip or wrist (Pouteau-Glues)
Wrist Fractures / Pouteau-Adhesives
Fractures of the spine
Ischemic cardiovascular disease
Coronary artery disease
Any venous thromboembolic event
Deep venous thromboembolic event, including pulmonary embolism
Ischemic cerebrovascular events
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.