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Drug Details

Decapeptyl SR 11.25mg

• Drug Class Description
  L 02 A E 04: Antineoplastic and immunomodulator Triptorelin is a synthetic decapeptide analogue of natural GnRH.
• Generic Name
  triptorelin acetate
• Presentation
  Powder for suspension for injection, sustained release formulation.
• Description
  Triptorelin (I.N.N.) 15mg, as triptorelin acetate. The vial contains an overage to ensure that a dose of 11.25mg is administered to the patient.
• Indications
  

  Treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration.

  Treatment of metastatic prostate cancer.

  As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.

  Treatment of endometriosis.

  Treatment of precocious puberty (onset before 8 years in girls and 10 years in boys).

• Adult Dosage
  

  Prostate cancer

  One intramuscular injection should be administered every 3 months.

  No dosage adjustment is necessary in the elderly.

  Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3mg) and as a 6-month treatment (Decapeptyl SR 22.5mg) for prostate cancer.

  Endometriosis

  One intramuscular injection should be administered every 3 months. The treatment must be initiated in the first five days of the menstrual cycle. Treatment duration depends on the initial severity of the endometriosis and the changes observed in the clinical features (functional and anatomical) during treatment. The maximum duration of treatment should be 6 months (two injections).

  A further course of treatment with Decapeptyl SR 11.25mg, or with other GnRH agonists, beyond 6 months should not be undertaken due to concerns about bone density losses.

  Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3mg) for endometriosis.

  Precocious puberty (before 8 years in girls and 10 years in boys)

  One intramuscular injection should be administered every 3 months.

  The treatment of children with Decapeptyl SR 11.25mg should be under the overall supervision of a paediatric endocrinologist or of a paediatrician or 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 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.

• Child Dosage
  Not applicable.
• Contra Indications
  

  Hypersensitivity to GnRH, its analogues or any other component of the medicinal product.

  Pregnancy and lactation

• Special Precautions
  

  The use of GnRH agonists may cause a 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. No specific data is available for patients with established osteoporosis or with risk factors for osteoporosis (e.g. chronic alcohol abuse, smokers, long-term therapy with drugs that reduce bone mineral density, e.g. anticonvulsants or corticosteroids, family history of osteoporosis, malnutrition, e.g. anorexia nervosa). Particular caution is therefore necessary since reduction in bone mineral density is likely to be more detrimental in these patients. Treatment with Decapeptyl SR 11.25mg 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.

  It should be confirmed that the patient is not pregnant before prescription of triptorelin.

  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.

  Mood changes, including depression have been reported. Patients with known depression should be monitored closely during therapy.

  Prostate cancer

  Initially, Decapeptyl SR 11.25mg, 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 orchidectomy (surgical castration) should be considered. 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, Decapeptyl SR 11.25mg does not induce any further decrease in serum testosterone levels.

  Long-term androgen deprivation either by bilateral orchidectomy or administration of GnRH agonists is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture.

  In addition, from epidemiological data, it has been observed that patients may experience metabolic changes (e.g. glucose intolerance), or an increased risk of cardiovascular disease during androgen deprivation therapy. However, prospective data did not confirm the link between treatment with GnRH agonists and an increase in cardiovascular mortality. Patients at high risk for metabolic or cardiovascular diseases should be carefully assessed before commencing treatment and their glucose, cholesterol and blood pressure adequately monitored during androgen deprivation therapy.

  Metabolic changes may be more severe in these high risk patients. Patients at high risk of metabolic or cardiovascular disease and receiving androgen deprivation therapy should be monitored at appropriate intervals not exceeding 3 months.

  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 agonists may therefore be misleading.

  Endometriosis

  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.

  In the majority of women, currently available data suggest that recovery of bone loss occurs after cessation of therapy.

  Used at the recommended dose, Decapeptyl SR 11.25mg causes constant hypogonadotropic amenorrhoea. If vaginal haemorrhage occurs after the first month, plasma oestradiol levels should be measured and if levels are below 50 pg/mL, possible organic lesions should be investigated.

  After withdrawal of treatment, ovarian function resumes and ovulation occurs approximately 5 months after the last injection. A non-hormonal method of contraception should be used throughout treatment including for 3 months after the duration of the last injection.

  Since menses should stop during Decapeptyl SR 11.25mg treatment, the patient should be instructed to notify her physician if regular menstruation persists.

  Precocious puberty

  Treatment of children with progressive brain tumours should follow a careful individual appraisal of the risks and benefits.

  In girls, initial ovarian stimulation at treatment initiation, followed by the treatment-induced oestrogen withdrawal, may lead, in the first month, to vaginal bleeding of mild or moderate intensity.

  After discontinuation of treatment the development of puberty characteristics will occur.

  Information with regards to future fertility is still limited. In most girls, regular menses will start on average one year after ending the therapy.

  Pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) and gonadotropin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia) should be precluded.

  Bone mineral density may decrease during GnRH agonist therapy for central precocious puberty. However, after cessation of treatment subsequent bone mass accrual is preserved, and peak bone mass in late adolescence does not seem to be affected by treatment.

  Slipped capital femoral epiphysis can be seen after withdrawal of GnRH agonist treatment. The suggested theory is that the low concentrations of oestrogen during treatment with GnRH agonists weaken the epiphysial plate. The increase in growth velocity after stopping the treatment subsequently results in a reduction of the shearing force needed for displacement of the epiphysis.

• Interactions
  

  Drugs which raise prolactin levels should not be prescribed concomitantly as they reduce the level of GnRH receptors in the pituitary.

  When Decapeptyl SR 11.25mg is co-administered with drugs affecting pituitary secretion of gonadotropins, caution should be exercised and it is recommended that the patient's hormonal status be supervised.

• Adverse Drug Reactions
  

  Clinical trials experience

  General tolerance in men

  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 (4%) and decreased libido (3%).

  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. The frequency of the adverse reactions is classified as follows: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000).

  System Organ Class	Very Common AEs	Common AEs	Uncommon AEs	Rare AEs	Additional post-marketing AEs
  	10%	1% -<10%	0.1% -<1%	0.01%-<0.1%
  Blood and lymphatic system disorders				Purpura
  Ear and labyrinth disorders			Tinnitus	Vertigo
  Endocrine disorders				Diabetes mellitus	Gynaecomastia
  Eye disorders				Abnormal sensation in eye Visual disturbance	Vision blurred
  Gastrointestinal disorders		Nausea	Abdominal pain Constipation Diarrhoea Vomiting	Abdominal distension Dry mouth Dysgeusia Flatulence
  General disorders and administration site conditions	Asthenia Hyperhidrosis	Fatigue Injection site erythema Injection site inflammation Injection site pain Injection site reaction Oedema	Lethargy Pain Rigors Somnolence	Chest pain Dysstasia Influenza like illness Pyrexia	Malaise
  Immune system disorders				Anaphylactic reaction Hypersensitivity	Hypersensitivity reaction
  Infections and infestations				Nasopharyngitis
  Investigations			Alanine aminotransferase increased Aspartate aminotransferase increased Blood creatinine increased Blood urea increased Weight increased	Blood alkaline phosphatase increased Body temperature increased Weight decreased	Blood pressure increased
  Metabolism and nutrition disorders			Anorexia Gout Increased appetite
  Musculoskeletal and connective tissue disorders	Back pain	Musculoskeletal pain Pain in extremity	Arthralgia Muscle cramp Muscular weakness Myalgia	Joint stiffness Joint swelling Musculoskeletal stiffness Osteoarthritis	Bone pain
  Nervous system disorders	Paraesthesia in lower limbs	Dizziness Headache	Paraesthesia	Memory impairment
  Psychiatric disorders			Depression Insomnia Irritability Mood swings	Confusional state Decreased activity Euphoric mood	Anxiety and Confusional state
  Reproductive system and breast disorders		Erectile dysfunction Loss of libido	Gynaecomastia Breast pain Testicular atrophy Testicular pain	Ejaculation failure
  Respiratory, thoracic and mediastinal disorders			Dyspnoea	Orthopnoea
  Skin and subcutaneous tissue disorders	Hyperhidrosis		Acne Alopecia Pruritus Rash	Blister	Angioneurotic oedema Urticaria
  Vascular disorders	Hot flush		Hypertension	Epistaxis Hypotension

  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. 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 in the risk of bone fracture.

  General tolerance in women

  As a consequence of decreased oestrogen levels, the most commonly reported adverse events (expected in 10% of women or more) were headache, decreased libido, sleep disorder, mood alterations, 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.

  The frequency of the adverse reactions is classified as follows: very common (1/10); common (1/100 to <1/10);

  System Organ Class	Very Common AEs	Common AEs	Additional post-marketing AEs
  	10%	1% - <10%
  Gastrointestinal disorders		Nausea Abdominal pain Abdominal discomfort	Diarrhoea Vomiting
  General disorders and administration site conditions		Injection site erythema Injection site inflammation Injection site pain	Pyrexia Malaise
  Investigations		Weight increased	Blood pressure increased
  Musculoskeletal and connective tissue disorders		Arthralgia Muscle spasms	Myalgia Muscular weakness
  Nervous system disorders	Headache Libido decreased		Dizziness
  Psychiatric disorders	Sleep disorder Mood altered		Depression Anxiety and Confusional state
  Reproductive system and breast disorders	Dyspareunia Dysmenorrhoea Genital haemorrhage (including menorrhagia, metrorrhagia) Libido decreased Ovarian hyperstimulation syndrome Ovarian hypertrophy Pelvic pain Vulvovaginal dryness	Breast pain	Amenorrhoea
  Skin and subcutaneous tissue disorders	Hyperhidrosis		Angioneurotic oedema Pruritus Rash Urticaria
  Vascular disorders	Hot flush
  Respiratory, thoracic and mediastinal disorders			Dyspnoea
  Eye disorders			Vision blurred Visual disturbance
  Ear and labyrinth disorders			Vertigo
  Immune system disorders			Hypersensitivity reaction

  At the beginning of treatment, the symptoms of endometriosis including pelvic pain and dysmenorrhoea are commonly exacerbated during the initial transient increase in plasma oestradiol levels. These symptoms are transient and usually disappear in one to two weeks.

  Genital haemorrhage including menorrhagia and metrorrhagia may occur in the month following the first injection.

  General tolerance in children

  The frequency of the adverse reactions is classified as follows: very common (1/10); common (1/100 to <1/10);

  System Organ Class	Very Common AEs	Common AEs	Additional post-marketing AEs
  	10%	1% - <10%
  Gastrointestinal disorders			Vomiting Abdominal pain Abdominal discomfort
  General disorders and administration site conditions		Pain Erythema Injection site erythema Injection site inflammation Injection site pain	Malaise
  Investigations			Blood pressure increased Weight increased
  Musculoskeletal and connective tissue disorders			Myalgia
  Nervous system disorders		Headache
  Psychiatric disorders			Affect lability Nervousness
  Reproductive system and breast disorders		Genital haemorrhage Vaginal bleeding
  Vascular disorders		Hot flush
  Respiratory, thoracic and mediastinal disorders			Epistaxis
  Eye disorders			Vision blurred Visual disturbance
  Skin and subcutaneous tissue disorders			Angioneurotic oedema Rash Urticaria
  Immune system disorders		Hypersensitivity reaction	Hypersensitivity reaction