Camcevi · 4.4 Special warnings and precautions for use · 1

HOS-287659 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Adverse reactions seen with leuprorelin-containing medicinal products are mainly subject to the specific pharmacological action of leuprorelin, namely increases and decreases in certain 5 hormone levels. The most commonly reported adverse reactions are hot flashes, nausea, malaise and fatigue and transient local irritation at the site of injection. Mild or moderate hot flashes occur in approximately 58% of patients. Tabulated list of adverse reactions The following undesirable effects were reported during clinical studies with leuprorelin- containing medicinal products for injection in patients with advanced prostate carcinoma. Undesirable effects are classified, by frequency, as very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1 000, <1/100), rare (≥1/10 000, <1/1 000) and very rare (<1/10 000), not known (cannot be estimated from the available data). Table 1: Undesirable effects reported for leuprorelin-containing medicinal products for injection Infections and infestations common nasopharyngitis uncommon urinary tract infection, local skin infection Blood and lymphatic system disorders common haematology changes, anaemia Metabolism and nutrition disorders uncommon aggravated diabetes mellitus Psychiatric disorders uncommon abnormal dreams, depression, decreased libido Nervous system disorders uncommon dizziness, headache, hypoaesthesia, insomnia, taste disturbance, smell disturbance, vertigo rare abnormal involuntary movements not known idiopathic intracranial hypertension (pseudotumor cerebri) (see section 4.4) Cardiac disorders uncommon QT prolongation (see sections 4.4 and 4.5), myocardial infarction (see section 4.4) Vascular disorders very common hot flashes uncommon hypertension, hypotension rare syncope, collapse Respiratory, thoracic and mediastinal disorders uncommon rhinorrhoea, dyspnoea not known interstitial lung disease Gastrointestinal disorders common

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HOS-287665 · has-adverse-reaction-information · PDF-Seite 19

Summary of the safety profile Adverse reactions seen with leuprorelin-containing medicinal products are mainly subject to the specific pharmacological action of leuprorelin, namely increases and decreases in certain hormone levels. The most commonly reported adverse reactions are hot flashes, nausea, malaise and fatigue and transient local irritation at the site of injection. Mild or moderate hot flashes occur in approximately 58% of patients. 19 Tabulated list of adverse reactions The following undesirable effects were reported during clinical studies with leuprorelin- containing medicinal products for injection in patients with advanced prostate carcinoma. Undesirable effects are classified, by frequency, as very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1 000, <1/100), rare (≥1/10 000, <1/1 000) and very rare (<1/10 000), not known (cannot be estimated from the available data). Table 1: Undesirable effects reported for leuprorelin-containing medicinal products for injection Infections and infestations common nasopharyngitis uncommon urinary tract infection, local skin infection Blood and lymphatic system disorders common haematology changes, anaemia Metabolism and nutrition disorders uncommon aggravated diabetes mellitus Psychiatric disorders uncommon abnormal dreams, depression, decreased libido Nervous system disorders uncommon dizziness, headache, hypoaesthesia, insomnia, taste disturbance, smell disturbance, vertigo rare abnormal involuntary movements not known idiopathic intracranial hypertension (pseudotumor cerebri) (see section 4.4) Cardiac disorders uncommon QT prolongation (see sections 4.4 and 4.5), myocardial infarction (see section 4.4) Vascular disorders very common hot flashes uncommon hypertension, hypotension rare syncope, collapse Respiratory, thoracic and mediastinal disorders uncommon rhinorrhoea, dyspnoea not known interstitial lung disease Gastrointestinal disorders common

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HOS-287655 · has-contraindication-information · PDF-Seite 3

CAMCEVI is contraindicated in women and paediatric patients. Hypersensitivity to the active substance, to other GnRH agonists or to any of the excipients listed in section 6.1. Patients who previously underwent orchiectomy (as with other GnRH agonists, leuprorelin does not result in further decrease of serum testosterone in case of surgical castration). As sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases (see also section 4.4).

HOS-287661 · has-contraindication-information · PDF-Seite 17

CAMCEVI is contraindicated in women and paediatric patients. Hypersensitivity to the active substance, to other GnRH agonists or to any of the excipients listed in section 6.1. Patients who previously underwent orchiectomy (as with other GnRH agonists, leuprorelin does not result in further decrease of serum testosterone in case of surgical castration). As sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases (see also section 4.4).

HOS-287654 · has-indication-information · PDF-Seite 2

CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

HOS-287660 · has-indication-information · PDF-Seite 16

CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

HOS-287663 · has-interaction-information · PDF-Seite 19

No pharmacokinetic drug-drug interaction studies have been performed. There have been no reports of any interactions of leuprorelin with other medicinal products. Since androgen deprivation treatment may prolong the QT interval, the concomitant use of leuprorelin with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).

HOS-287657 · has-interaction-information · PDF-Seite 5

No pharmacokinetic drug-drug interaction studies have been performed. There have been no reports of any interactions of leuprorelin with other medicinal products. Since androgen deprivation treatment may prolong the QT interval, the concomitant use of leuprorelin with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).

HOS-287658 · has-pregnancy-information · PDF-Seite 5

CAMCEVI is contraindicated in women. Based on findings in animals and mechanism of action, leuprorelin may impair fertility in males of reproductive potential (see section 5.3).

HOS-287664 · has-pregnancy-information · PDF-Seite 19

CAMCEVI is contraindicated in women. Based on findings in animals and mechanism of action, leuprorelin may impair fertility in males of reproductive potential (see section 5.3).

HOS-287656 · has-warning-information · PDF-Seite 3

Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit/risk ratio including the potential for Torsade de pointes prior to initiating leuprorelin. Periodic monitoring of electrocardiograms and electrolytes should be considered. Cardiovascular diseases Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving GnRH agonists should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. 3 Transient testosterone flare Leuprorelin, like other GnRH agonists, causes a transient increase in serum concentrations of testosterone, dihydrotestosterone and acid phosphatase during the first week of treatment. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, haematuria, or ureteral or bladder outlet obstruction (see section 4.8). These symptoms usually subside on continuation of therapy. Additional administration of an appropriate antiandrogen should be considered beginning 3 days prior to leuprorelin therapy and continuing for the first two to three weeks of treatment. This has been reported to prevent the sequelae of an initial rise in serum testosterone. Following surgical castration, leuprorelin does not lead to a further decrease in serum testosterone levels in male patients. Bone density Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with GnRH agonists (see section 4.8). Antiandrogen therapy significantly increases the risk for fractures owing to osteoporosis. Only limited data is available on this issue. Fractures owing to osteoporosis were observed in 5% of patients following 22 months of pharmacological androgen deprivation therapy and in 4% of patients following 5 to 10 years of treatment. The risk for fractures owing to osteoporosis is generally higher than the risk for

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HOS-287662 · has-warning-information · PDF-Seite 17

Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit/risk ratio including the potential for Torsade de pointes prior to initiating leuprorelin. Periodic monitoring of electrocardiograms and electrolytes should be considered. Cardiovascular diseases Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving GnRH agonists should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. 17 Transient testosterone flare Leuprorelin, like other GnRH agonists, causes a transient increase in serum concentrations of testosterone, dihydrotestosterone and acid phosphatase during the first week of treatment. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, haematuria, or ureteral or bladder outlet obstruction (see section 4.8). These symptoms usually subside on continuation of therapy. Additional administration of an appropriate antiandrogen should be considered beginning 3 days prior to leuprorelin therapy and continuing for the first two to three weeks of treatment. This has been reported to prevent the sequelae of an initial rise in serum testosterone. Following surgical castration, leuprorelin does not lead to a further decrease in serum testosterone levels in male patients. Bone density Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with GnRH agonists (see section 4.8). Antiandrogen therapy significantly increases the risk for fractures owing to osteoporosis. Only limited data is available on this issue. Fractures owing to osteoporosis were observed in 5% of patients following 22 months of pharmacological androgen deprivation therapy and in 4% of patients following 5 to 10 years of treatment. The risk for fractures owing to osteoporosis is generally higher than the risk fo

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