Enantone 1-Month DPS 3.75 mg/Enantone 3-Month DPS 11.25 mg/Enantone 6-Month DPS 30 mg Adverse Reactions

Enantone 1-Month DPS 3.75 mg: The following table shows the incidence of adverse reactions, including abnormalities in laboratory data, according to the indicated diseases and phase of investigation. (See Table 7.)

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The adverse reactions listed as follows have been observed in the previously mentioned investigations, spontaneous reports, etc.
Since ENANTONE is a sustained release preparation, the patient's condition should be observed while the effect of this drug lasts after the final dosing.
Clinically significant adverse reactions: For all indications: Since interstitial pneumonia, accompanied by fever, coughing, dyspnea, abnormal chest X-ray, etc. may occur (< 0.1%), the patient's condition should be closely observed. If any abnormality is observed, appropriate measures, such as treatment with adrenal cortical hormones, should be taken.
Since anaphylaxis may occur (< 0.1%), careful inquiry should be made, and close observation should be made after the administration of ENANTONE. If any abnormality is observed, appropriate measures should be taken.
Hepatic dysfunction or jaundice, with increased AST (GOT), ALT (GPT) etc., may occur (frequency unknown). Therefore, close observation should be made, and if any abnormality is observed, appropriate measures should be taken.
Development or aggravation of diabetes may occur (frequency unknown). If any abnormality is observed, appropriate measures should be taken.
Pituitary apoplexy has been reported in patients with pituitary adenoma (frequency unknown). Therefore, if headache, vision impairment, visual field disorder, etc. are observed immediately after the first dose of ENANTONE, appropriate measures, such as surgical treatment, should be taken after conducting examination.
Thromboembolic event, such as myocardial infarction, cerebral infarction, venous thrombosis, pulmonary embolism, may occur (frequency unknown). Therefore, close observation should be made, and if any abnormality is observed, appropriate measures, such as discontinuation of administration, should be taken.
Endometriosis, Uterine Myoma, Premenopausal Breast Cancer: Since a depressed state like climacteric disturbance resulting from estrogen reducing effect of ENANTONE may occur (0.1% - < 5%), the patient's condition should be closely observed.
Prostate cancer: Since a depressed state may occur (< 0.1%), the patient's condition should be closely observed.
Elevation of serum testosterone level due to the stimulating effect of ENANTONE on the pituitary-gonad system may bring about a transient aggravation of bone pain, ureteral obstruction or spinal cord compression (≥ 5%). If any of such symptoms occurs, appropriate measures, such as pertinent symptomatic treatment, should be taken.
Since cardiac failure may occur (0.1 - < 5%), close observation should be made. If any abnormality is observed, appropriate measures, such as discontinuation of administration, should be taken.
Clinically significant adverse reactions: Endometriosis, uterine myoma, premenopausal breast cancer, central precocious puberty: See Table 8.

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Prostate Cancer: See Table 9.

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Enantone 3-Month DPS 11.25 mg: Undesirable effects are mainly due to the specific pharmacological action of the medicinal product, that is, the endocrine changes caused by the product (suppression of testosterone secretion in men and menopausal similar to hypoestrogenism in women).
The following undesirable effects are based on the clinical trials experience and post-marketing experience. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), not known (the frequency cannot be defined on the basis of the available data).
All patient populations: See Table 10.

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All adult populations: See Table 11.

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Adult women: The most recurrent undesirable effects are associated with hypoestrogenism. Oestrogen levels return to normal when treatment is stopped. The state of hypoestrogenism leads to a slight reduction of bone density during the treatment, which is sometimes not reversible (see Precautions). (See Tables 12, 13 and 14.)

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Vaginal haemorrhage may occur during the therapy as a result of acute degeneration of the submucosal fibroids (see Precautions).
Adult men: In the early stage of therapy there is a short-term increase in sex hormone levels ("Flare-up" phenomenon). Adverse events that may occur particularly at the beginning of treatment include urinary tract obstruction (as urinary symptoms); bone pain, weakness in the lower extremities, and paraesthesia (as neurological symptoms) may also occur in patients with compression of the spinal column (see Precautions). (See Table 15.)

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Paediatric population: In the early stage of therapy there is a short-term increase in sex hormone levels ("Flare-up" phenomenon) followed by a drop to the values of the prepuberal range. Adverse events, particularly at the start of treatment, may occur due to this pharmacological effect. (See Table 16.)

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Enantone 6-Month DPS 30 mg: Administration of ENANTONE 6 MONTH DPS regularly leads to an initial short-term increase in the serum level of testosterone (Flare phenomenon), potentially resulting in a transient exacerbation of certain disease symptoms. The treatment may lead to onset or increase of urinary tract obstruction and its consequences (e.g., haematuria). In patients with bone metastasis bone pain may occur. In patients with bone marrow suppression, muscle weakness, myasthenia of the leg, and lymphedema may occur. This exacerbation of symptoms usually subsides spontaneously on continued therapy with ENANTONE 6 MONTH DPS, without leading to the need to discontinue ENANTONE 6 MONTH DPS.
Due to suppression of sex hormones adverse reactions may be observed. Frequencies of adverse reactions are defined in the following categories: 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), not known (cannot be estimated from the available data). (See Table 17.)

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Note: Response to ENANTONE 6 MONTH DPS can be verified by monitoring serum testosterone, acid phosphatase, and PSA levels. Specifically, there occurs an initial temporary rise in the testosterone level at the start of treatment, followed by a decrease within a period of two weeks. After two to four weeks testosterone levels are reached similar to those observed after bilateral orchiectomy and persisting in the castration range throughout the entire treatment period.
In the initial phase of therapy with ENANTONE 6 MONTH DPS, a transient rise in acid phosphatase may occur. However, acid phosphatase values usually return to normal or near-normal within a few weeks.
In case of very common occurring tip abscesses testosterone levels should be monitored, as a possible elevation of testosterone may result from inadequate leuprorelin absorption from the depot.