Medicinal Products

ANASTROZOLE BLUEFISH 1 mg

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

Coated tablet
Box of 30
All forms

Indication

ANASTROZOLE BLUEFISH is indicated for the treatment of hormone receptor-positive breast cancer in postmenopausal women.

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

Dosage

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

Special Populations

Pediatric population

ANASTROZOLE BLUEFISH 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 BLUEFISH 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:

· Pregnant or lactating women.

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

Adverse effects Anastrozole Bluefish

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 frequency and by class of organ systems (SOC).

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

Increased levels of alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase.

Rare

Increased levels of gamma-GT and bilirubin.

Hepatitis.

Skin and subcutaneous tissue disorders

Very common

Rash.

Frequent

Alopecia.

Allergic reactions.

Rare

Urticaria

Rare

Erythema multiforme

Anaphylactoid reactions.

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-like events have been reported in patients treated with ANASTROZOLE BLUEFISH in clinical trials compared to 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 ANASTROZOLE BLUEFISH relies on existing hormone therapy. If bleeding persists, further exploration should be considered.

The table below shows the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, independent 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-Adhesives

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%)

Cataract

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 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 incidence of fractures was 22 per 1000 patient-years in the anastrozole group and 15 per 1000 patient-years in the tamoxifen group. The incidence of fractures observed with anastrozole is comparable to that seen in postmenopausal women of the same age. The incidence of osteoporosis was 10.5% in women treated with anastrozole and 7.3% in women treated with tamoxifen.

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

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