Decapeptyl Depot 22.5 mg

/ Ferring Pharmaceuticals

Posology: The usual dosage is one intramuscular injection of Decapeptyl Depot 22.5mg every 24 weeks under medical supervision.
Since Decapeptyl Depot 22.5 mg is a suspension of microgranules, intravascular
injection must be strictly avoided.
Decapeptyl Depot 22.5 mg may only be administered by doctors or medical personnel.
The injection site should be varied periodically.
Paediatric population: Precocious puberty (before 8 years in girls and 10 years in boys).
The treatment of children with Decapeptyl Depot 22.5 mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or an endocrinologist with expertise in the treatment of central precocious puberty.
Treatment should be stopped around the physiological age of puberty in boys and girls and should not be continued in girls with a bone maturation of more than 12-13 years.
There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13-14 years.
Treatment monitoring
Prostate cancer: The efficacy of treatment can be monitored by measuring serum levels of testosterone and prostate specific agent (PSA) and by subjective evaluation (symptomatic improvement e.g. urinary symptoms, cancer pain etc).
Special dosage recommendations (refers to all dosages if not specified otherwise):
Elderly patients: The dose does not have to be adapted to age.
The medicine is not indicated for post-menopausal women.
Hepatic or renal impairment: The dose does not have to be adjusted for patients suffering from limited hepatic or renal function.

Decapeptyl Depot 22.5 mg is indicated for symptomatic treatment of advanced
hormone-dependent prostate cancer. As an alternative treatment, if orchiectomy or the administration of oestrogens are not indicated or are unacceptable to the patient.
Decapeptyl Depot 22.5 mg is also indicated for the treatment of central precocious puberty (CPP) in children 2 years and older with an onset of CPP before 8 years in girls and 10 years in boys.

Hypersensitivity to LH-RH, triptorelin, other GnRH analogues or any of the excipients.
Prostate cancer: If the tumor is not hormone-dependent or after surgical castration.
In patients with spinal cord compression caused by metastases of their prostate cancer.

See prescribing information for full details.

General information: Allergic reactions have been observed in isolated cases shortly after the injection of triptorelin, but these regressed with conventional treatment.
The most commonly observed undesirable effects during triptorelin treatment where attributable to its expected physiological effects: initial increase in testosterone level, followed by almost complete suppression of testosterone. These effects, which were observed very frequently, included hot flushes, facial, flushing (particularly at the start treatment), impotence and decreased libido.
The following undesirable effects, for which a causal connection with the treatment was at least considered possible have been reported, although a causal connection is often difficult to determine in patients with metastatic cancer.
See prescribing information for full details.

Particular caution is required when triptorelin is co-administered with drugs affecting pituitary secretion of gonadotrophins, and monitoring of the patient’s hormonal status is recommended.
Cytochrome P450 (CYP) enzymes are unlikely to be involved in the metabolism and elimination of triptorelin. Moreover, in vitro data has been shown that triptorelin is neither an inhibitor nor an inducer of CYP and that is not a substrate or an inhibitor of P-glycoprotein (P-gp) either. Drug interaction with triptorelin are therefore unlikely.

Decapeptyl Depot 22.5mg is not indicated for use in women.

The pharmaceutical properties of triptorelin and its mode of administration make accidental or intentional overdose unlikely. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentration and on the reproductive system will occur, even at elevated doses of triptorelin. Any overdosage should be treated symptomatically.