Drugs List

Therapeutic Indications

Uses

Advanced prostate cancer: adjuvant to radiotherapy
Locally advanced non metastatic prostate cancer
Metastatic prostate cancer
Precocious puberty in boys under 10 years of age : treatment
Sexual deviation - in male
Treatment of endometriosis
Treatment of precocious puberty - onset under 8 years in girls

Decapeptyl SR 11.25mg
Locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration Metastatic prostate cancer
Endometriosis
Precocious puberty - onset before 8 years in girls and 10 years in boys As adjuvant treatment:
To radiotherapy in patients with high-risk localised or locally advanced prostate cancer To radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression
Prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

Decapeptyl SR 22.5mg
Locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration Metastatic prostate cancer
Central precocious puberty (CPP) - onset before 8 years in girls and 10 years in boys As adjuvant treatment:
To radiotherapy in patients with high-risk localised or locally advanced prostate cancer To radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression
Prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

Salvacyl 11.25mg
Decreasing sexual drive in adult men with severe sexual deviation via the reversible reduction of testosterone to castrate levels

Administration

For intramuscular injection only.

The injection site should be varied periodically.

Contraindications

Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Children with progressive brain neoplasm
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Cardiovascular disorder
Depression
Electrolyte imbalance
History of torsade de pointes
Metabolic disorder
Osteoporosis
Spinal cord compression
Spinal metastasis
Urinary obstruction

Correct electrolyte disorders before treatment
Not effective following surgical removal of testes
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all age groups
Not all available products are licensed for all uses
Prostate cancer: Prophylaxis of flare with anti-androgen is recommended
Treatment to be prescribed under the supervision of a specialist
Vary injection site during prolonged therapy
Exclude pregnancy prior to initiation of treatment
Measure bone density in at risk patients prior to therapy
Consider monitoring ECG in patients at risk of QT prolongation
If metrorrhagia occurs measure plasma estradiol levels
Monitor bone status in long term therapy
Monitor closely patient with depression
Monitor serum electrolytes
Prostate cancer: Disease flare may occur at beginning of treatment
Advise patient to report any new or worsening depression/suicidal ideation
Advise patient to report sudden headache, vomiting or visual disturbances
May cause loss of bone mineral density
Spinal cord compression may occur
Ureteric obstruction may occur
May affect results of some laboratory tests
Hypersexuality: Consider introducing anti-androgens before discontinuing
Endometriosis: Maximum treatment duration 6 months
Female: Non-hormonal contraception required during and after treatment
Advise patient on diet and exercise to minimise bone loss
Advise patient to report regular menstruation if it persists during therapy
Menstruation stops during treatment
Pubertal development will resume after cessation of therapy

Use may be associated with bone loss, and can lead to osteoporosis, with an increased risk of fractures. Use with caution in patients with metabolic bone disease or other risk factors for osteoporosis. Consider treatment or prophylaxis of osteoporosis where appropriate.
Use of a bisphosphonate in men, in combination with triptorelin may reduce bone loss. In women, most patients will recover bone loss after cessation of treatment. Peak bone mass in adolescence does not seem to be affected by treatment. Consider additional measures to counteract loss of bone mineral density.

Modification to patient lifestyle including smoking cessation, moderation of alcohol consumption and regular weight bearing exercise are recommended. Adequate dietary calcium and vitamin D intake should also be maintained in long term therapy.

In rare cases treatment with triptorelin may unmask a pituitary cell adenoma. Patients may present with symptoms of pituitary apoplexy (sudden headache, vomiting, visual impairment and ophthalmoplegia).

Patients at a high risk of metabolic or cardiovascular disease should be carefully monitored before and during treatment.

An increase in lymphocyte count may be detected during treatment.

Prostate cancer
Triptorelin causes a transient increase in serum testosterone levels. As a result, symptoms of prostate cancer may worsen. Consider administering an additional anti-androgen.

Spinal cord compression or urethral obstruction have been observed with the use of gonadotrophin-releasing hormone (GnRH) agonists. Treatment for such complications should continue as normal. In extreme cases, surgical castration should be considered. After surgical castration, triptorelin will not contribute to further decreases in serum testosterone. After castration levels of testosterone have been achieved (by the end of the first month of treatment), they are maintained as long as patients receives their injection in line with their treatment program.

Endometriosis
Non-hormonal contraception should be used throughout the treatment and for 3 months after duration of the last injection.

Treatment with triptorelin will cause a persistent hypogonadotropic amenorrhoea. If metrorrhagia occurs, other than in the first month, plasma estradiol levels should be measured. If the level is less than 50 pg/ml, possible associated organic lesions should be sought.
After withdrawal of treatment, ovarian function resumes. Function expected to return approximately 5 months after the last injection.

Precocious puberty
Exclude pseudo-precocious puberty (e.g. gonadal or adrenal tumour or hyperplasia) and gonadotrophin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia) before treatment.

In girls at initiation of treatment, ovarian stimulation followed by oestrogen withdrawal will occur. This may lead to mild to moderate vaginal bleed in the first month.

After finalising therapy, development of puberty characteristics will occur. Information regarding future fertility is still limited. In most girls, menses will start on average one year after discontinuing therapy.

Slipped capital femoral epiphysis may be seen after withdrawal of treatment.

Sexual deviation
Treatment should be initiated and controlled by a psychiatrist and must be administered under medical supervision. Give treatment in combination with psychotherapy.

Triptorelin causes a transient increase in serum testosterone levels. As a result, there may be an increase in sexual drive. Consider administering an additional anti-androgen.

Evaluation of effect is essentially clinical and an assessment of each patient should be carried out regularly, for example, before each injection. If there is doubt about the effect, serum testosterone levels may be measured.

Pregnancy and Lactation

Pregnancy

Triptorelin is contraindicated in pregnancy.

Gonadotrophin-releasing hormone (GnRH) agonists are associated with a theoretical risk of abortion or foetal abnormality.

At the time of writing, there are no adequate data available on the use of triptorelin in human pregnancy. Limited data available on the inadvertent use of triptorelin during pregnancy did not indicate an increased risk of congenital malformations. However, long term follow up studies on development are far too limited.

Research conducted in animals has not indicated direct or indirect harmful effects with respect to pregnancy or post-natal development, but there are indications for foetotoxicity and delayed parturition.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Triptorelin is contraindicated in breastfeeding.

The manufacturer suggests triptorelin is not recommended for use in breastfeeding.

It is not known whether triptorelin is excreted in human breast milk. It is unlikely to be excreted in breast milk due to its high molecular weight.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Abnormal sensation in eye
Acne
Alopecia
Anaphylaxis
Angioedema
Anorexia
Anxiety
Arthralgia
Asthenia
Back pain
Blistering
Blurred vision
Bone pain
Breast pain
Chest pain
Confusion
Constipation
Decrease in bone mineral density
Depression
Diabetes mellitus
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Dysstasia
Epistaxis
Erectile dysfunction
Euphoria
Failure of ejaculation
Fatigue
Fever
Flatulence
Gout
Gynaecomastia
Headache
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypotension
Impaired memory
Increase in alkaline phosphatase
Increase in blood urea or creatinine
Increase in serum ALT/AST
Increased appetite
Increased risk of fractures
Influenza-like symptoms
Injection site reactions
Insomnia
Irritability
Joint disorder
Lability of affect
Lethargy
Malaise
Mood changes
Muscle cramps
Muscle weakness
Myalgia
Nasopharyngitis
Nausea
Oedema
Orthopnoea
Osteoarthritis
Osteoporosis
Pain
Painful extremities
Paraesthesia
Prolongation of QT interval
Pruritus
Purpura
Rash
Reduced libido
Rigors
Rise in body temperature
Somnolence
Stiffness
Testicular atrophy
Testicular pain
Tinnitus
Tumour flare
Urticaria
Vertigo
Visual disturbances
Vomiting
Weight changes

Presentation

Injections of triptorelin (as embonate/pamoate).

Drugs List

Therapeutic Indications

Uses

Advanced prostate cancer: adjuvant to radiotherapy
Locally advanced non metastatic prostate cancer
Metastatic prostate cancer
Precocious puberty in boys under 10 years of age : treatment
Sexual deviation - in male
Treatment of endometriosis
Treatment of precocious puberty - onset under 8 years in girls

Decapeptyl SR 11.25mg
Locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration Metastatic prostate cancer
Endometriosis
Precocious puberty - onset before 8 years in girls and 10 years in boys As adjuvant treatment:
To radiotherapy in patients with high-risk localised or locally advanced prostate cancer To radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression
Prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

Decapeptyl SR 22.5mg
Locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration Metastatic prostate cancer
Central precocious puberty (CPP) - onset before 8 years in girls and 10 years in boys As adjuvant treatment:
To radiotherapy in patients with high-risk localised or locally advanced prostate cancer To radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression
Prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

Salvacyl 11.25mg
Decreasing sexual drive in adult men with severe sexual deviation via the reversible reduction of testosterone to castrate levels

Dosage

This is the monograph for triptorelin as embonate/pamoate.

For information relating to other forms of triptorelin, for example triptorelin as acetate, please consult the separate product information.

Adults

Children

Administration

For intramuscular injection only.

The injection site should be varied periodically.

Contraindications

Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Children with progressive brain neoplasm
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Cardiovascular disorder
Depression
Electrolyte imbalance
History of torsade de pointes
Metabolic disorder
Osteoporosis
Spinal cord compression
Spinal metastasis
Urinary obstruction

Correct electrolyte disorders before treatment
Not effective following surgical removal of testes
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all age groups
Not all available products are licensed for all uses
Prostate cancer: Prophylaxis of flare with anti-androgen is recommended
Treatment to be prescribed under the supervision of a specialist
Vary injection site during prolonged therapy
Exclude pregnancy prior to initiation of treatment
Measure bone density in at risk patients prior to therapy
Consider monitoring ECG in patients at risk of QT prolongation
If metrorrhagia occurs measure plasma estradiol levels
Monitor bone status in long term therapy
Monitor closely patient with depression
Monitor serum electrolytes
Prostate cancer: Disease flare may occur at beginning of treatment
Advise patient to report any new or worsening depression/suicidal ideation
Advise patient to report sudden headache, vomiting or visual disturbances
May cause loss of bone mineral density
Spinal cord compression may occur
Ureteric obstruction may occur
May affect results of some laboratory tests
Hypersexuality: Consider introducing anti-androgens before discontinuing
Endometriosis: Maximum treatment duration 6 months
Female: Non-hormonal contraception required during and after treatment
Advise patient on diet and exercise to minimise bone loss
Advise patient to report regular menstruation if it persists during therapy
Menstruation stops during treatment
Pubertal development will resume after cessation of therapy

Use may be associated with bone loss, and can lead to osteoporosis, with an increased risk of fractures. Use with caution in patients with metabolic bone disease or other risk factors for osteoporosis. Consider treatment or prophylaxis of osteoporosis where appropriate.
Use of a bisphosphonate in men, in combination with triptorelin may reduce bone loss. In women, most patients will recover bone loss after cessation of treatment. Peak bone mass in adolescence does not seem to be affected by treatment. Consider additional measures to counteract loss of bone mineral density.

Modification to patient lifestyle including smoking cessation, moderation of alcohol consumption and regular weight bearing exercise are recommended. Adequate dietary calcium and vitamin D intake should also be maintained in long term therapy.

In rare cases treatment with triptorelin may unmask a pituitary cell adenoma. Patients may present with symptoms of pituitary apoplexy (sudden headache, vomiting, visual impairment and ophthalmoplegia).

Patients at a high risk of metabolic or cardiovascular disease should be carefully monitored before and during treatment.

An increase in lymphocyte count may be detected during treatment.

Prostate cancer
Triptorelin causes a transient increase in serum testosterone levels. As a result, symptoms of prostate cancer may worsen. Consider administering an additional anti-androgen.

Spinal cord compression or urethral obstruction have been observed with the use of gonadotrophin-releasing hormone (GnRH) agonists. Treatment for such complications should continue as normal. In extreme cases, surgical castration should be considered. After surgical castration, triptorelin will not contribute to further decreases in serum testosterone. After castration levels of testosterone have been achieved (by the end of the first month of treatment), they are maintained as long as patients receives their injection in line with their treatment program.

Endometriosis
Non-hormonal contraception should be used throughout the treatment and for 3 months after duration of the last injection.

Treatment with triptorelin will cause a persistent hypogonadotropic amenorrhoea. If metrorrhagia occurs, other than in the first month, plasma estradiol levels should be measured. If the level is less than 50 pg/ml, possible associated organic lesions should be sought.
After withdrawal of treatment, ovarian function resumes. Function expected to return approximately 5 months after the last injection.

Precocious puberty
Exclude pseudo-precocious puberty (e.g. gonadal or adrenal tumour or hyperplasia) and gonadotrophin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia) before treatment.

In girls at initiation of treatment, ovarian stimulation followed by oestrogen withdrawal will occur. This may lead to mild to moderate vaginal bleed in the first month.

After finalising therapy, development of puberty characteristics will occur. Information regarding future fertility is still limited. In most girls, menses will start on average one year after discontinuing therapy.

Slipped capital femoral epiphysis may be seen after withdrawal of treatment.

Sexual deviation
Treatment should be initiated and controlled by a psychiatrist and must be administered under medical supervision. Give treatment in combination with psychotherapy.

Triptorelin causes a transient increase in serum testosterone levels. As a result, there may be an increase in sexual drive. Consider administering an additional anti-androgen.

Evaluation of effect is essentially clinical and an assessment of each patient should be carried out regularly, for example, before each injection. If there is doubt about the effect, serum testosterone levels may be measured.

Pregnancy and Lactation

Pregnancy

Triptorelin is contraindicated in pregnancy.

Gonadotrophin-releasing hormone (GnRH) agonists are associated with a theoretical risk of abortion or foetal abnormality.

At the time of writing, there are no adequate data available on the use of triptorelin in human pregnancy. Limited data available on the inadvertent use of triptorelin during pregnancy did not indicate an increased risk of congenital malformations. However, long term follow up studies on development are far too limited.

Research conducted in animals has not indicated direct or indirect harmful effects with respect to pregnancy or post-natal development, but there are indications for foetotoxicity and delayed parturition.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Triptorelin is contraindicated in breastfeeding.

The manufacturer suggests triptorelin is not recommended for use in breastfeeding.

It is not known whether triptorelin is excreted in human breast milk. It is unlikely to be excreted in breast milk due to its high molecular weight.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Abnormal sensation in eye
Acne
Alopecia
Anaphylaxis
Angioedema
Anorexia
Anxiety
Arthralgia
Asthenia
Back pain
Blistering
Blurred vision
Bone pain
Breast pain
Chest pain
Confusion
Constipation
Decrease in bone mineral density
Depression
Diabetes mellitus
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Dysstasia
Epistaxis
Erectile dysfunction
Euphoria
Failure of ejaculation
Fatigue
Fever
Flatulence
Gout
Gynaecomastia
Headache
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypotension
Impaired memory
Increase in alkaline phosphatase
Increase in blood urea or creatinine
Increase in serum ALT/AST
Increased appetite
Increased risk of fractures
Influenza-like symptoms
Injection site reactions
Insomnia
Irritability
Joint disorder
Lability of affect
Lethargy
Malaise
Mood changes
Muscle cramps
Muscle weakness
Myalgia
Nasopharyngitis
Nausea
Oedema
Orthopnoea
Osteoarthritis
Osteoporosis
Pain
Painful extremities
Paraesthesia
Prolongation of QT interval
Pruritus
Purpura
Rash
Reduced libido
Rigors
Rise in body temperature
Somnolence
Stiffness
Testicular atrophy
Testicular pain
Tinnitus
Tumour flare
Urticaria
Vertigo
Visual disturbances
Vomiting
Weight changes

Effects on Laboratory Tests

Suppression of the pituitary gonadal system occurs with therapeutic doses of triptorelin, which may give misleading results in relevant diagnostic tests.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Decapeptyl SR 11.25mg powder and solvent for suspension for injection. Ipsen Ltd. Revised July 2017.
Summary of Product Characteristics: Decapeptyl SR 22.5mg powder and solvent for suspension for injection. Ipsen Ltd. Revised December 2016.
Summary of Product Characteristics: Salvacyl 11.25mg powder for suspension for injection. Ipsen Ltd. Revised April 2016.