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1 X 11.25 mg
The recommended dose of Decapeptyl Depot is 11.25 mg triptorelin (1 vial) administered every twelve weeks as a single intramuscular injection. The lyophilized microgranules are to be reconstituted using only 2 ml sterile water for injection (see section 6.5 Instructions for use and handling and disposal). The injection site should be varied periodically. Since Decapeptyl Depot 11.25 mg is a suspension of microgranules, inadvertent intravascular injection should be strictly avoided. No dosage adjustment is necessary for patients with renal or hepatic impairment. Decapeptyl Depot 11.25 mg must be administered under the supervision of a physician. Safety and efficacy of Decapeptyl Depot 11.25 mg has not been established in neonates, infants, children and adolescents, therefore Decapeptyl Depot 11.25 mg is not indicated for use in these populations.
Decapeptyl Depot 11.25 mg is indicated for lowering of sexual hormones and for the treatment of advanced hormone-dependent prostate cancer.
Decapeptyl Depot 11.25 mg is contraindicated in patients with hypersensitivity to triptorelin, LH-RH (luteinizing hormone – releasing hormone), other LH-RH agonist analogues or to any of the excipients of Decapeptyl Depot 11.25 mg. Decapeptyl Depot 11.25 mg is not indicated for patients with hormone independent prostate cancer. Decapeptyl Depot 11.25 mg is contraindicated in patients presenting with spinal cord compression or evidence of spinal metastases.
Initially triptorelin causes transient increase in serum testosterone levels. As a consequence, isolated cases of transient worsening of signs and symptoms of prostate cancer may occasionally develop during the first week of treatment. A small number of patients may experience a temporary increase in bone pain, which can be managed symptomatically. Isolated cases of spinal cord compression or urethral obstruction have been observed. If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered. Careful monitoring is indicated during the first weeks of treatment, particularly in patients suffering from vertebral metastases and/or from urinary tract obstruction. During the initial phase of treatment, consideration should be given to the additional administration of a suitable anti-androgen to counteract the initial rise in serum testosterone levels and the worsening of clinical symptoms. Once the castration levels of testosterone have been achieved by the end of the first month, they are maintained for as long as the patients receive their injection every twelve weeks. The effectiveness of treatment can be monitored by measuring serum levels of testosterone and prostate specific antigen. After surgical castration triptorelin does not induce any further decrease in serum testosterone levels therefore Decapeptyl Depot 11.25 mg should not be used after orchiectomy. Caution is required in patients treated with anticoagulants, due to the potential risk of hematomas at the site of injection. Administration of triptorelin in therapeutic doses results in suppression of the pituitary gonadal system. Normal function is usually restored after treatment is discontinued. Diagnostic tests of pituitary gonadal function conducted during treatment and after discontinuation of therapy with LH-RH agonist may therefore be misleading
The most commonly observed adverse events were due to its expected physiological effects.
Very common: Hot flushes, reduced size of genitalia, impotence, decreased libido.
Common: Injection site pain, edema, asthenia, fatigue, back pain, gynecomastia, constipation, weight increase, skeletal pain, tumor flare, urinary incontinence, micturition frequency, urinary retention, dysuria. May be associated with increased bone loss and may lead to osteoporosis and increased risk of bone fracture. May also lead to an incorrect diagnosis of bone metastases.
For full details see prescribing information.
No interactions have been reported between Decapeptyl Depot 11.25 mg and other medicinal products. In the absence of relevant data and as a precaution, hyperprolactinaemic medicinal products should not be prescribed concomitantly with Decapeptyl Depot 11.25 mg since hyperprolactinemia reduces the number of pituitary LH-RH receptors. There is a potential risk of haematomas at the site of injection in patients treated with anticoagulants.
Pregnancy and Lactation
Decapeptyl Depot 11.25 mg is not indicated for use in females. Animal studies have shown effects on reproductive parameters.
The pharmaceutical properties of Decapeptyl Depot 11.25 mg and its route of administration make accidental or intentional overdose unlikely. There is no human experience of overdose. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentration and on the reproductive tract will be evident with higher doses of Decapeptyl Depot 11.25 mg. If overdose occurs, this should be managed symptomatically.