Loading…
GONAPEPTYL DEPOT is a brand name for Triptorelin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Men: Treatment of hormone dependent locally advanced or metastatic prostate cancer. Women: Preoperative reduction of myoma size to reduce the symptoms of bleeding and pain in women with symptomatic uterine myomas. Symptomatic endometriosis confirmed by laparoscopy when suppression of the ovarian hormonogenesis is…
Verbatim from this product's MHRA label. Tap a section to expand.
The product should only be used under the supervision of an appropriate specialist having requisite facilities for regular monitoring of response. The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.
6. Following reconstitution, the suspension has to be injected immediately. g. into the skin of the abdomen, the buttock or thigh) or deep intramuscularly. The injection site should be changed each time. 75 mg triptorelin. In order to continually suppress testosterone levels, it is important to comply with a 4-weekly administration.
75 mg triptorelin. The treatment must be initiated in the first 5 days of the cycle.
Children:
Dosing at the beginning of treatment should be based on body weight, one injection of triptorelin should be injected on days 0, 14, and 28. Thereafter one injection every 4 weeks. Should the effect be insufficient, the injections may be given every 3 weeks.
Dosing should be based on body weight according to the table. 75 mg (full dose) Note for specific patient groups: - There is no need to adjust the dose for the elderly. - According to current data, dose reduction or prolongation of the dosage interval in patients with impaired renal function is not necessary.
Duration of administration - Prostate carcinoma:
Treatment with GONAPEPTYL Depot is usually a long-term therapy. - Uterine myomas and endometriosis: The duration of treatment depends on the initial degree of severity of endometriosis and on the evolution of its clinical manifestations (functional and anatomical) and on the evolution of the volume of the uterine myomas, determined by ultrasonography during treatment.
Normally, the maximum attainable result is achieved after 3 to 4 injections. 4). - Central precocious puberty (CPP): Treatment should be stopped if a bone maturation of older than 12 years in girls and older than 13 years in boys has been achieved.
Adverse experiences reported among patients treated with triptorelin during clinical trials and from post-marketing surveillance are shown below. As a consequence of decreased testosterone or oestrogen levels, most patients are expected to experience adverse reactions, with hot flushes being the most frequently reported (30% in men and 75-100% in women).
Additionally, impotence and decreased libido should be expected in 30-40% of male patients, while bleeding/spotting, sweating, vaginal dryness and/or dyspareunia, decrease in libido, headache and mood changes are expected in more than 10% of women.
g. urinary obstruction, skeletal pain due to metastases, compression of the spinal cord, muscular fatigue and lymphatic oedema of the legs). In some cases urinary tract obstruction decreases the kidney function. Neurological compression with asthenia and paraesthesia in the legs has been observed.
General tolerance in men (refer to Special Warnings and Precautions for use) As seen with other GnRH agonist therapies or after surgical castration, the most commonly observed adverse events related to triptorelin treatment were due to its expected pharmacological effects: Initial increase in testosterone levels, followed by almost complete suppression of testosterone.
These effects included hot flushes (50%), erectile dysfunction and decreased libido. The following adverse reactions, considered as at least possibly related to triptorelin treatment, were reported. Most of these are known to be related to biochemical or surgical castration.
5) decreased Triptorelin causes a transient increase in circulating testosterone levels within the first week after the initial injection of the sustained release formulation. With this initial increase in circulating testosterone levels, a small percentage of patients (≤ 5%) may experience a temporary worsening of signs and symptoms of their prostate cancer (tumour flare), usually manifested by an increase in urinary symptoms (< 2%) and metastatic pain (5%), which can be managed symptomatically.
General:
The use of GnRH agonists may cause reduction in bone mineral density. In men, preliminary data suggest that the use of a bisphosphonate in combination with a GnRH agonist may reduce bone mineral loss. g. g. anticonvulsants or corticoids, family history of osteoporosis, malnutrition).
Rarely, treatment with GnRH agonists may reveal the presence of a previously unknown gonadotroph cell pituitary adenoma. These patients may present with a pituitary apoplexy characterised by sudden headache, vomiting, visual impairment and ophthalmoplegia.
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as triptorelin. Patients should be informed accordingly and treated as appropriate if symptoms occur. Mood changes have been reported.
Patients with known depression should be monitored closely during therapy.
Men:
Initially, triptorelin, like other GnRH agonists, causes a 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 weeks of treatment.
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. A small number of patients may experience a temporary worsening of signs and symptoms of their prostate cancer (tumour flare) and temporary increase in cancer related pain (metastatic pain), which can be managed symptomatically.
As with other GnRH agonists, 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 (surgical castration) should be considered.
General:
Known hypersensitivity to triptorelin, poly-(d,l lactide coglycolide), dextran, or to any of the excipients. Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue. In women: - Pregnancy - Lactation period
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Triptorelin in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
These symptoms are transient and usually disappear in one to two weeks. Isolated cases of exacerbation of disease symptoms, either urethral obstruction or spinal cord compression by metastasis have occurred. Therefore, patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy (see Special warnings and special precautions for use).
The use of GnRH agonists, to treat prostate cancer may be associated with increased bone loss and may lead to osteoporosis and increases the risk of bone fracture. General tolerance in women (refer to Special Warnings and Precautions for use) As a consequence of decreased oestrogen levels, the most commonly reported adverse events (expected in 10% of women or more) were headache, libido decreased, sleep disorder, mood changes, dyspareunia, dysmenorrhoea, genital haemorrhage, ovarian hyperstimulation syndrome, ovarian hypertrophy pelvic pain, abdominal pain, vulvovaginal dryness, hyperhidrosis, hot flushes and asthenia.
The following adverse reactions, considered as at least possibly related to triptorelin treatment, were reported. Most of these are known to be related to biochemical or surgical castration. MedDRA System Organ Class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Not known Women Immune system disorders Hypersensitivity Anaphylactic reaction Psychiatric disorders Libido decreased, mood changes, sleep disorder Depressed mood, depression […]
Careful monitoring is indicated during the first weeks of treatment, particularly in patients suffering from vertebral metastasis, at the risk of spinal cord compression, and in patients with urinary tract obstruction. After surgical castration, triptorelin does not induce any further decrease in serum testosterone levels.
Long-term androgen deprivation either by bilateral orchiectomy or administration of GnRH analogues is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture. Androgen deprivation therapy may prolong the QT interval.
g. glucose intolerance, fatty liver), or an increased risk of cardiovascular disease during androgen deprivation therapy. However, prospective data did not confirm the link between treatment with GnRH analogues and an increase in cardiovascular mortality.
Patients at high risk for metabolic or cardiovascular diseases should be carefully assessed before commencing treatment and adequately monitored during androgen deprivation therapy. Administration of triptorelin in therapeutic doses result 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 GnRH analogues may therefore be misleading. g. laparoscopy).
It should be confirmed that the patient is not pregnant before prescription of triptorelin. Since menses should stop during GONAPEPTYL Depot treatment, the patient should be instructed to notify her physician if regular menstruation persists.
Loss of bone mineral density The use of GnRH agonists is likely to cause reduction in bone mineral density averaging 1% per month during a six month treatment period. Every 10% reduction in bone mineral density is linked with about a two to three times increased fracture risk.
For this reason, therapy without addback treatment should not exceed a duration of 6 months. After withdrawal of treatment, the bone loss is generally reversible within 6 - 9 months. In the majority of women, currently available data suggest that recovery of bone loss occurs after cessation of therapy.
g. g. g. anorexia nervosa). Since reduction in bone mineral density is likely to be more detrimental in these patients, treatment with triptorelin should be considered on an individual basis and only be initiated if the benefits of treatment outweigh the risk following a very careful appraisal.
Consideration should be given to additional measures in order to counteract loss of bone mineral density.
Uterine myomas and endometriosis:
A supervening metrorrhagia in the course of treatment is abnormal (apart from the first month) and should lead to verification of plasma oestrogen level. Should this level be less than 50 pg/ml, possible associated organic lesions should be sought.
g. menstrual bleeding will resume after 7-12 weeks after the final injection. Non-hormonal contraception should be used […]