Luprodex Special Precautions

Cardiovascular disease: 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 physicians should assess the benefit risk ratio. 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.
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 physicians should assess the benefit risk ratio.
Transient testosterone flare: Leuprorelin acetate 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. These symptoms usually subside on continuation of therapy.
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. The risk for fractures owing to osteoporosis is generally higher than the risk for pathological fractures.
Pituitary apoplexy has been reported after the administration of GnRH-agonists and was presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention is required.
Hyperglycemia and diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported after receiving GnRH agonists.
Convulsions: Post marketing reports of convulsions have been observed in patients on leuprorelin acetate with or without a history of predisposing factors.
Hepatic dysfunction and jaundice with elevated liver enzyme have been reported. Therefore, close observation should be made and appropriate measures taken if necessary.
Spinal fracture, paralysis and hypotension have been reported.
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as leuprorelin. Patients should be informed accordingly and treated as appropriate if symptoms occur.
When considering the preoperative treatment of fibroids it is mandatory to confirm the diagnosis of fibroids and exclude an ovarian mass, either visually by laparoscopy or by ultrasonography or other investigative technique, as appropriate, before administering Leuprorelin acetate.
The patients should be warned of severe bleeding following the administration of Leuprorelin acetate as a consequence of the acute degeneration of the fibroids.
Leuprorelin acetate may cause an increase in uterine cervical resistance, which may result in difficulty in dilating the cervix for intrauterine surgical procedure.
Men: Patients with urinary obstruction and patients with metastatic vertebral lesions should begin Leuprorelin acetate therapy under close supervision for the first few weeks of treatment.
Women: Since menstruation should stop with effective doses of Leuprorelin acetate, the patient should notify her physician if regular menstruation persists.
In girls with central precocious puberty: Before starting the therapy, a precise diagnosis of idiopathic and/or neurogenic central precocious puberty is necessary.
Pediatric Use: Experience with Leuprorelin acetate (Depot) for treatment of endometriosis has been limited to women 18 years of age and older.