Medicinal Products

ANASTROZOLE ACCORD 1 mg

Generic drug of Arimidex
Therapeutic class: Oncology and hematology
active ingredients: Anastrozole
laboratory: Accord Healthcare Ltd

Coated tablet
Box of 90
All forms

Indication

Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in patients with negative estrogen receptors unless they had previously demonstrated a positive clinical response to tamoxifen.

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 ANASTROZOLE ACCORD 1 mg Film-coated tablet Box of 90

Adults including the elderly: a 1 mg tablet to be taken orally once a day.

Children: Anastrozole Tablets is not recommended in children because of insufficient data on safety and efficacy (see sections Warnings and Precautions and Pharmacodynamic Properties ).

Renal Insufficiency: No dose modification is recommended in patients with mild or moderate renal impairment.

Hepatic impairment: No dose modification is recommended in patients with mild hepatic impairment.

When the disease is at an early stage, the recommended duration of treatment should be 5 years.

Against indications

Anastrozole is contraindicated in the following cases:

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

· Premenopausal women,

· Pregnant or breastfeeding women,

· Patients with moderate to severe hepatic impairment

Concomitant administration of estrogen-containing therapies with Anastrozole should be avoided due to the risk of reversal of pharmacological action.

Concomitant treatment with tamoxifen (see section Interactions with other medicinal products and other forms of interaction ).

Adverse effects Anastrozole Accord

The following table presents adverse effects from clinical studies, post-marketing studies, or spontaneous reports. Unless otherwise indicated, frequency categories were calculated from the number of adverse events reported in a large, phase III study in 9366 postmenopausal women with operable breast cancer who received adjuvant therapy for five years ( ATAC study: "Anastrozole, Tamoxifen, Alone or in Combination").

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

Frequency

Organ system

Undesirable effect

Very common (³ 1/10)

Vascular disorders

Flushing, usually mild to moderate

General disorders

Asthenia, usually mild to moderate

Musculoskeletal, systemic and bone disorders

Pain / joint stiffness, arthritis, osteoporosis

The nervous system

Headache, usually mild to moderate

Gastrointestinal disorders

Nausea, usually mild to moderate

Skin and subcutaneous tissue disorders

Rash, usually of mild or moderate intensity

Frequent

(≥1 / 100 to <1/10)

Skin and subcutaneous tissue disorders

Hair loss (alopecia), usually of mild or moderate intensity

Allergic reaction

Gastrointestinal disorders

Vomiting, usually mild to moderate

Diarrhea, usually of mild or moderate intensity

Nervous system disorders

Drowsiness, usually mild or moderate

Carpal tunnel syndrome*

Hepatobiliary disorders

Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase

Disorders of the reproductive organs and breast

Vaginal bleeding, usually mild to moderate * **

Vaginal dryness, usually mild to moderate

Metabolism and nutrition disorders

Anorexia, usually mild

Hypercholesterolemia, usually of mild or moderate intensity

Musculoskeletal and bone disorders

Bone pain

Rare

(≥1 / 1000 to <1/100)

Hepatobiliary disorders

Increases in gamma-GT and bilirubin, hepatitis

Skin and subcutaneous tissue disorders

Urticaria

Musculoskeletal, systemic and bone disorders

Spring finger

Rare

(<1 / 10, 000)

Skin and subcutaneous tissue disorders

Erythema multiforme

Anaphylactoid reaction

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

Very rare

Skin and subcutaneous tissue disorders

Steven-Johnson Syndrome **

angioedema *

* Carpal tunnel syndrome-like 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 be considered as "rare" (≥ 0.01% and <0.1 %) on the basis of the least favorable estimate.

*** Frequent cases of vaginal bleeding have been reported, mainly in patients with advanced breast cancer, during the first few weeks after replacement of their existing hormone therapy with Anastrozole. If bleeding persists, additional tests should be performed.

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

Table 2 Pre-specified adverse events in the ATAC study

Unwanted events

Anastrozole (N = 3092)

Tamoxifen (N = 3094)

Flushing

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 events, including pulmonary embolism

48 (1.6%)

74 (2.4%)

Ischemic cerebrovascular events

62 (2.0%)

88 (2.8%)

Endometrial cancer

4 (0.2%)

13 (0.6%)

Fracture rates of 22 per 1000 patient-years and 15 per 1000 patient-years were observed for the Anastrozole and Tamoxifen groups, respectively, after a median follow-up of 68 months. The fracture rate observed for Anastrozole is similar to that reported in postmenopausal women of similar age. The incidence of osteoporosis was 10.5% in patients treated with Anastrozole and 7.3% in patients treated with tamoxifen.

It was not determined whether the fracture and osteoporosis rates observed in the ATAC study in anastrozole-treated patients reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both.

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