Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following frequency categories for adverse drug reactions (ADRs) were calculated based on reports from ZOLADEX clinical trials and post-marketing sources. The most commonly observed adverse reactions include hot flushes, sweating and injection site reactions.

The following convention has been used for classification of frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥ 1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data).

Table:     ZOLADEX LA adverse drug reactions presented by MedDRA System Organ Class

SOC                                   Frequency                       Adverse reaction 
Neoplasms benign, malignant and       Very rare                       Pituitary tumour unspecified (including cysts and polyps)

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Blood and lymphatic system disorders Not knownh                Anaemia, Leucopenia and Thrombocytopenia

Immune system disorders                 Uncommon               Drug hypersensitivity 
Rare                   Anaphylactic reaction

Endocrine disorders                     Very rare              Pituitary haemorrhage 
Metabolism and nutrition disorders      Common                 Glucose tolerance impaireda 
Psychiatric disorders                   Very common            Libido decreasedb 
Common                 Mood changes, depression

Very rare              Psychotic disorder
Nervous system disorders                Common                 Paraesthesia 
Spinal cord compression

Not known              Memory impairment
Cardiac disorders                       Common                 Cardiac failuref, myocardial infarctionf 
Not known              QT prolongation (see sections 4.4 and 4.5)

Vascular disorders                      Very common            Hot flushb 
Common                 Blood pressure abnormalc

Not knownh             Pulmonary embolism
Hepatobiliary disorders                 Not knownh             Hepatic dysfunction and Jaundice 
Skin and subcutaneous tissue            Very common            Hyperhidrosisb disorders                               Common                 Rashd

Not known              Alopeciag

Musculoskeletal, connective tissue and Common                  Bone paine bone disorders                          Uncommon               Arthralgia 
Respiratory, thoracic and mediastinal   Not knownh             Interstitial lung disease 
Renal and urinary disorders             Uncommon               Ureteric obstruction 
Reproductive system and breast          Very common            Erectile dysfunction disorders                               Common                 Gynaecomastia 
Uncommon               Breast tenderness

General disorders and administration    Common                 Injection site reaction site conditions
Not knownh             Tumour flare (on initiation of treatment)


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Investigations                           Common                                    Bone density decreased (see section 4.4), weight increased

 a A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes mellitus.
b These are pharmacological effects which seldom require withdrawal of therapy. Hyperhidrosis and hot flushes may continue after stopping Zoladex.
c These may manifest as hypotension or hypertension, have been occasionally observed in patients administered Zoladex.
d These are generally mild, often regressing without discontinuation of therapy.
e Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically.
f Observed in a pharmaco-epidemiology study of LHRH agonists used in the treatment of prostate cancer. The risk appears to be increased when used in combination with anti-androgens.
g Particularly loss of body hair, an expected effect of lowered androgen levels.
h Frequency of the adverse drug reactions is based on spontaneous data.


Description of selected adverse event

Blood pressure abnormal: The changes are usually transient, resolving either during continued therapy or after cessation of therapy with Zoladex. Rarely, such changes have been sufficient to require medical intervention, including withdrawal of treatment from Zoladex.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il