DECAPEPTYL DEPOT 11.25 mg
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Package:
VIAL (powder for suspension): 1 x 11.25 mg + solvent.
Dosage:
1 vial administered every 12 weeks as a single I.M. injection.
Prescribing Restrictions:
Indications:
Prostatic cancer, lowering of sexual hormones.
Contra-Indications:
Hypersensitivity to triptorelin, LH-RH, other LH-RH agonist analogs or to any of the excipients. Patients with hormonal resistant prostate cancer. Patients with spinal cord compression secondary to prostate cancer metastases.
Special Precautions:
The injection site should be varied periodically. Intravascular injection must be strictly avoided. Must be administered under the supervision of a physician. Safety and efficacy has not been established in neonates, infants, children and adolescents, and should therefore not be used in these populations. Initially triptorelin causes transient increases 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 weeks 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. 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. Saturation levels of testosterone have been achieved by the end of the first month. After surgical castration, triptorelin does not induce any further decrease in serum testosterone levels. Caution is required in patients treated with anticoagulants. Diagnostic tests of pituitary gonadal function conducted during treatment and within 4 to 12 weeks after discontinuation of therapy with a LH-RH agonist may be misleading. Not indicated for use in females. Certain undesirable effects such as dizziness, somnolence, epileptic seizures and abnormal vision, could impair the ability to drive and use machines.
Side Effects:
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. See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.
