Medicinal Products

AROMASIN 25 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Exemestane
laboratory: Pfizer Holding France

Coated tablet
Box of 30
All forms

Indication

Aromasine is indicated for the adjunctive treatment of early stage invasive breast cancer expressing estrogen receptors in postmenopausal women following initial adjuvant treatment with tamoxifen for 2 to 3 years.

Aromasine is indicated for the treatment of advanced breast cancer in postmenopausal women naturally or artificially after failure of antiestrogen therapy.

Efficacy has not been demonstrated in patients whose tumor cells do not have estrogen receptors.

Dosage AROMASINE 25 mg Coated tablet Box of 30

Adults and seniors

The recommended dose of Aromasine is 1 25 mg tablet once a day, preferably after a meal. Treatment with Aromasine should be maintained until signs of tumor progression appear.

In patients with early-stage breast cancer, treatment with Aromasine should be continued for a total of five years of sequential adjuvant hormonal therapy (tamoxifen followed by Aromasine). It will be suspended in case of relapse of the tumor.

In patients with advanced breast cancer, treatment with Aromasine should be continued until signs of tumor progression develop.

No dose adjustment is necessary in patients with hepatic or renal impairment (see section 5.2 ).

children

Use is not recommended in children.

Against indications

Aromasine is contraindicated in patients with known hypersensitivity to the active substance or to excipients, in pre-menopausal women and in pregnant or lactating women.

Aromasine side effects

In all clinical studies conducted at a conventional dose of 25 mg daily, Aromasine was generally well tolerated, with side effects generally mild to moderate. The rate of discontinuation of treatment for adverse reactions is 7.4% in patients with early-stage breast cancer receiving adjuvant therapy with Aromasine after initial adjuvant tamoxifen therapy. The most commonly reported adverse reactions are hot flushes (22%), arthralgia (18%) and fatigue (16%).

In the overall population of patients with advanced breast cancer, the rate of discontinuation due to adverse events is 2.8%.

The most commonly reported adverse events are hot flashes (14%) and nausea (12%).

Most side effects can be attributed to the normal pharmacological consequences of estrogen deficiency (eg hot flashes).

Reported adverse reactions are listed below by system organ class and frequency. Their frequency is defined as follows: very common (> 10%), frequent (> 1%, ≤10%), infrequent (> 0.1%, ≤1%), rare (> 0.01%, ≤ 0.1%).

Metabolism and nutrition disorders:

frequent

Anorexia.

Psychiatric disorders:

Very frequent

Insomnia.

frequent

Depression.

Nervous system disorders:

Very frequent

Headache.

frequent

Dizziness, carpal tunnel syndrome.

Uncommon

Drowsiness.

Vascular disorders:

Very frequent

Hot flashes.

Gastrointestinal disorders:

Very frequent

Nausea.

frequent

Abdominal pain, vomiting, constipation, dyspepsia, diarrhea.

Skin and subcutaneous tissue disorders:

Very frequent

Increased sweating

frequent

Transient rash, alopecia.

Skeletal muscle and bone disorders:

Very frequent

Joint and musculoskeletal pain (*)

frequent

Osteoporosis, fractures.

General disorders and administration site defects:

Very frequent

Tired.

frequent

Pain, peripheral edema.

Uncommon

Asthenia.

(*) Includes: arthralgia and, less frequently, limb pain, osteoarthritis, back pain, arthritis, myalgia and joint stiffness

Hematological and lymphatic system disorders:

In patients with advanced breast cancer, cases of thrombocytopenia and leukopenia have been reported rarely. An occasional decrease in lymphocytes was observed in approximately 20% of patients receiving Aromasine, particularly in those already with lymphocytopenia. However, mean lymphocyte values ​​in these patients did not change significantly over time and no increase in viral infections was observed. These effects have not been observed in early breast cancer studies.

Hepatobiliary disorders:

Elevations in liver function parameters including hepatic enzymes, biliriburin and alkaline phosphatase were observed.

The table below presents the frequency of predisposed adverse events and conditions in the Intergroup Exemestane Study (IES) early stage breast cancer study, regardless of causality, reported in patients undergoing treatment and up to 30 days after stopping it.

Adverse events and conditions

exemestane

tamoxifen

(n = 2, 249)

(n = 2, 279)

Hot flashes

491 (21.8%)

457 (20.1%)

Tired

367 (16.3%)

344 (15.1%)

headaches

305 (13.6%)

255 (11.2%)

Insomnia

290 (12.9%)

204 (9.0%)

Increased sweating

270 (12.0%)

242 (10.6%)

Gynecological disorders

235 (10.5%)

340 (14.9%)

Dizzying sensations

224 (10.0%)

200 (8.8%)

nausea

200 (8.9%)

208 (9.1%)

osteoporosis

116 (5.2%)

66 (2.9%)

Vaginal haemorrhage

90 (4.0%)

121 (5.3%)

Other primary cancer

84 (3.6%)

125 (5.3%)

vomiting

50 (2.2%)

54 (2.4%)

Vision disorders

45 (2.0%)

53 (2.3%)

Thromboembolic complications

16 (0.7%)

42 (1.8%)

Osteoporotic fracture

14 (0.6%)

12 (0.5%)

Myocardial infarction

13 (0.6%)

4 (0.2%)

In the IES study, the frequency of ischemic cardiac events in the exemestane and tamoxifen treatment groups was 4.5% and 4.2%, respectively. No significant difference was observed for cardiovascular events including arterial hypertension (9.9% versus 8.4%), myocardial infarction (0.6% versus 0.2%) and heart failure. (1.1% versus 0.7%).

In the IES study, exemestane is associated with a higher incidence of hypercholesterolemia compared with tamoxifen (3.7% vs. 2.1%).

In another randomized, double-blind study in postmenopausal women with early-stage, low-risk breast cancer treated with exemestane (N = 73) or placebo (N = 73) over 24 months, Exemestane is associated on average with a 7-9% reduction in plasma HDL-cholesterol, compared with a 1% increase for placebo. A 5-6% reduction in apolipoprotein A1 was observed in the exemestane group versus 0-2% in the placebo group. The effect on the other lipid parameters analyzed (total cholesterol, LDL cholesterol, triglycerides, apolipoprotein-B and lipoprotein -a) is very similar in both groups. The clinical significance of these findings is unclear.

In the IES study, the frequency of gastric ulcers was higher in the exemestane group than in the tamoxifen group (0.7% versus <0.1%). In most cases, patients treated with exemestane who developed gastric ulcer concomitantly received nonsteroidal anti-inflammatory drugs and / or had a history of ulcer.

Adverse reactions reported after the placing on the market:

Hepatobiliary disorders: Hepatitis, cholestatic hepatitis.

Because reactions are reported on a voluntary basis from a population whose size is not clearly defined, it is not always possible to estimate their frequency or to identify the causal relationship with the population. taking the medication reliably.

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