Testosterone Undecanoate 250mg/Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER 2792
19.04.16[3]
Nebido® 1000 mg/4 ml, solution for injection
(Testosterone undecanoate)
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is available using the above name, but will be referred to as Nebido throughout this leaflet.
What is in this leaflet:
1. What Nebido is and what it is used for
2. What you need to know before you are given Nebido
3. How to use Nebido
4. Possible side effects
5. How to store Nebido
6. Contents of the pack and other information
1. WHAT NEBIDO IS AND WHAT IT IS USED FOR
Nebido contains testosterone, a male hormone, as the active ingredient. Nebido is injected into a muscle in your body. There it can be stored and gradually released over a period of time.
Nebido is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). These should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:
- impotence
- infertility
- low sex drive
- tiredness
- depressive moods
- bone loss caused by low hormone levels
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NEBIDO Do NOT use Nebido
- if you are allergic to testosterone undecanoate or any of the other ingredients of this medicine (listed in section 6)
- if you have ever had androgen-dependent cancer or suspected cancer of the prostate or of the breast
- if you have or have ever had a liver tumour Nebido is not intended for use in women.
Nebido is not for use in children and adolescents. There is no data available on the use of Nebido in males under 18 years of age.
Warnings and precautions
Talk to your doctor before using Nebido if you have or have ever had:
- epilepsy
- heart, kidney or liver problems
- migraine
- temporary interruptions in your breathing during sleep (apnoea), as these may get worse
- cancer, as the level of calcium in your blood may need to be tested regularly
- blood clotting problems
If you are suffering from severe heart, liver or kidney disease, treatment with Nebido may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
Tell your doctor if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure.
If your liver is not working
No formal studies have been performed in patients with liver impairment.
You will not be prescribed Nebido if you have ever had a liver tumour (see “Do not use Nebido").
Elderly patients (65 years or older)
There is no need for your doctor to adjust the dose if you are over 65 (see “Medical examination/follow up”).
Muscle building and drug tests
Nebido is not suitable for building muscles in healthy individuals or for increasing physical strength.
Nebido might lead to positive results in drug tests.
Medical examination/Follow-up
Male hormones may increase the growth of prostate cancer and enlarged prostate glands (benign prostatic hypertrophy). Before your doctor injects Nebido, he/she will examine you to check that you do not have prostate cancer.
Your doctor will regularly examine your prostate and breast, especially if you are elderly. He/she will also take regular blood samples.
Following the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed to occur.
Other medicines and Nebido
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription. The doctor may need to adjust the dose if you are using any of the following:
- the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): Nebido may increase the risk of water retention, especially if your heart and liver are not working properly
- tablets that thin your blood (anticoagulants)
If you are diabetic, it may be necessary to adjust your insulin.
Nebido may also affect the results of some laboratory tests (e.g. thyroid gland). Tell your doctor or the laboratory staff that you are using Nebido.
Pregnancy, breast-feeding and fertility
Nebido is not for use in women and must not be used in pregnant or breastfeeding women.
Testosterone replacement therapy may reversibly reduce spermatogenesis. Driving and using machines
Nebido has no effect on your ability to drive or use machines.
3. HOW TO USE NEBIDO
Your doctor will inject Nebido (1 ampoule) very slowly into a muscle. He/she will give you the injections every 10 to 14 weeks. This is enough to maintain sufficient testosterone levels without leading to a build-up of testosterone in the blood.
Nebido is strictly for intramuscular injection. Special care will be taken to avoid injection into a blood vessel (see "Notes on handling the OPC (One-Point-Cut) ampoule”).
The following information is intended for medical or healthcare professionals only:
The solution for intramuscular injection is to be visually inspected prior to use and only clear solutions free from particles should be used.
The contents of an ampoule are to be injected intramuscularly immediately after opening the ampoule.
The medicinal product is for single use only and any unused solution should be discarded.
Administration
Special care must be given to avoid intravasal injection.
As with all oily solutions, Nebido must be injected strictly intramuscularly and very slowly. Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Treatment is usually supportive, e.g. by administration of supplemental oxygen.
Suspected anaphylactic reactions after Nebido injection have been reported.
POM
PL 20636/2792
Start of treatment
Your doctor will measure your blood testosterone levels before starting treatment and during the early stages of treatment. Your doctor may give you the second injection after only six weeks in order to quickly reach the necessary testosterone level. This will depend on your symptoms and testosterone levels.
Maintaining your Nebido levels during treatment
The injection interval should always be within the recommended range of 10 to 14 weeks.
Your doctor will measure your testosterone levels regularly at the end of an injection interval to make sure it is at the right level. If the level is too low, your doctor may decide to give you injections more often. If your testosterone levels are high, your doctor may decide to give you injections less often. Do not miss your injection appointments. Otherwise, your optimum level of testosterone will not be maintained.
If you think that the effect of Nebido is too strong or too weak, talk to your doctor.
If you used more Nebido than you should
Symptoms of having too much Nebido include:
- irritability
- nervousness
- weight gain
- long-lasting or frequent erections
Tell your doctor, if you have any of these. Your doctor will inject it less often or will stop treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are acne and pain where the injection is given.
Common side effects (may affect up to 1 in 10 patients):
- abnormally high levels of red blood cells
- weight gain
- hot flushes
- acne
- enlarged prostate and associated problems
- various reactions where the injection was given (e.g. pain, bruising, or irritation)
Uncommon side effects (may affect up to 1 in 100 patients):
- allergic reaction
- increased appetite, changes in blood test results (e.g. increased blood sugars or fats)
- depression, emotional disorder, insomnia, restlessness, aggression, or irritability
- headache, migraine, or tremor
- cardiovascular disorder, high blood pressure, or dizziness
- bronchitis, sinusitis, cough, shortness of breath, snoring, or voice problems
- diarrhoea, or nausea
- changes in liver test results
- hair loss, or various skin reactions (e.g. itching, reddening, or dry skin)
- joint pain, pain in limbs, muscle problems (e.g. spasm, pain or stiffness), or an increase in the blood substance creatine phosphokinase
- urinary tract disorders (e.g. decreased flow of urine, urinary retention, urge to pass urine at night)
- prostatic disorders (e.g. prostatic intraepithelial neoplasia, or hardening or inflammation of the prostate), changes in sexual appetite, painful testicles, painful, hardened or enlarged breasts, or increased levels of male and female hormones
- tiredness, general feeling of weakness, excessive sweating, or night sweats
The oily liquid Nebido may reach the lungs (pulmonary microembolism of oily solutions) which can in rare cases lead to signs and symptoms such as cough, shortness of breath, feeling generally unwell, excessive sweating, chest pain, dizziness, “pins and needles”, or fainting. These reactions may occur during or immediately after the injection and are reversible.
Suspected anaphylactic reactions after Nebido injection have been reported.
In addition to the side effects listed above the following have been reported following treatment with preparations containing testosterone: nervousness, hostility, brief interruptions in breathing during sleep, various skin reactions including dandruff and oily skin, more frequent erections, and very rare cases of yellowing of the skin and eyes (jaundice).
Treatment with high doses of testosterone preparations commonly stops or reduces sperm production, although this returns to normal after treatment ceases. Testosterone replacement therapy of poorly functioning testicles (hypogonadism) can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema (swelling due to fluid retention).
For testosterone products in general a common risk of increased red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), were observed by periodic blood tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NEBIDO
Keep out of the sight and reach sight of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Nebido contains
Each ml of solution contains 250mg Testosterone undecanoate equivalent to 157.9mg Testosterone. One ampoule contains 1000 mg testosterone undecanoate.
The other ingredients are benzyl benzoate and refined castor oil.
What Nebido looks like and contents of the pack
Nebido is available as a brown glass ampoule containing a clear yellowish oily solution.
The contents of the packs are:
1 brown ampoule with 4 ml solution for injection.
Manufacturer
Manufactured by Bayer Pharma AG, MullerstraUe 178, D-13353 Berlin, Germany. Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 19.04.16[3]
Nebido is a trademark of Bayer Intellectual Property GmbH.
poule:
Warnings
Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial factors).
Besides laboratory tests of the testosterone concentrations in patients on long-term androgen therapy the following laboratory parameters should be checked periodically: haemoglobin, haematocrit, and liver function tests and lipid profile.
In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.
Notes on handling the OPC (One-Point-Cut) am There is a pre-scored mark beneath the coloured point on the ampoule eliminating the need to file the neck. Prior to opening, ensure that any solution in the upper part of the ampoule flows down to the lower part. Use both hands to open; while holding the lower part of the ampoule in one hand, use the other hand to break off the upper part of the ampoule in the direction away from the coloured point.
Testosterone undecanoate 250 mg/ml, solution for injection
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is available using the above name, but will be referred to as Testosterone undecanoate throughout this leaflet.
What is in this leaflet:
1. What Testosterone undecanoate is and what it is used for
2. What you need to know before you are given Testosterone undecanoate
3. How to use Testosterone undecanoate
4. Possible side effects
5. How to store Testosterone undecanoate
6. Contents of the pack and other information
1. WHAT TESTOSTERONE UNDECANOATE IS AND WHAT IT IS USED FOR
Testosterone undecanoate contains testosterone, a male hormone, as the active ingredient. Testosterone undecanoate is injected into a muscle in your body. There it can be stored and gradually released over a period of time.
Testosterone undecanoate is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). These should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:
- impotence
- infertility
- low sex drive
- tiredness
- depressive moods
- bone loss caused by low hormone levels
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TESTOSTERONE UNDECANOATE
Do NOT use Testosterone undecanoate
- if you are allergic to testosterone undecanoate or any of the other ingredients of this medicine (listed in section 6)
- if you have ever had androgen-dependent cancer or suspected cancer of the prostate or of the breast
- if you have or have ever had a liver tumour Testosterone undecanoate is not intended for use in women.
Testosterone undecanoate is not for use in children and adolescents. There is no data available on the use of Testosterone undecanoate in males under 18 years of age.
Warnings and precautions
Talk to your doctor before using Testosterone undecanoate if you have or have ever had:
- epilepsy
- heart, kidney or liver problems
- migraine
- temporary interruptions in your breathing during sleep (apnoea), as these may get worse
- cancer, as the level of calcium in your blood may need to be tested regularly
- blood clotting problems
If you are suffering from severe heart, liver or kidney disease, treatment with Testosterone undecanoate may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
Tell your doctor if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure.
If your liver is not working
No formal studies have been performed in patients with liver impairment.
You will not be prescribed Testosterone undecanoate if you have ever had a liver tumour (see “Do not use Testosterone undecanoate”).
Elderly patients (65 years or older)
There is no need for your doctor to adjust the dose if you are over 65 (see “Medical examination/follow up”).
Muscle building and drug tests
Testosterone undecanoate is not suitable for building muscles in healthy individuals or for increasing physical strength.
Testosterone undecanoate might lead to positive results in drug tests.
Medical examination/Follow-up
Male hormones may increase the growth of prostate cancer and enlarged prostate glands (benign prostatic hypertrophy). Before your doctor injects Testosterone undecanoate, he/she will examine you to check that you do not have prostate cancer.
Your doctor will regularly examine your prostate and breast, especially if you are elderly. He/she will also take regular blood samples.
Following the use of hormonal substances such as androgen compounds, cases of benign (non-cancerous) and malignant (cancerous) liver tumours have been observed to occur.
Other medicines and Testosterone undecanoate
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription. The doctor may need to adjust the dose if you are using any of the following:
- the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): Testosterone undecanoate may increase the risk of water retention, especially if your heart and liver are not working properly
- tablets that thin your blood (anticoagulants)
If you are diabetic, it may be necessary to adjust your insulin.
Testosterone undecanoate may also affect the results of some laboratory tests (e.g. thyroid gland). Tell your doctor or the laboratory staff that you are using Testosterone undecanoate.
Pregnancy, breast-feeding and fertility
Testosterone undecanoate is not for use in women and must not be used in pregnant or breast-feeding women.
Testosterone replacement therapy may reversibly reduce spermatogenesis.
Driving and using machines
Testosterone undecanoate has no effect on your ability to drive or use machines.
3. HOW TO USE TESTOSTERONE UNDECANOATE
Your doctor will inject Testosterone undecanoate (1 ampoule) very slowly into a muscle. He/she will give you the injections every 10 to 14 weeks. This is enough to maintain sufficient testosterone levels without leading to a build-up of testosterone in the blood.
The following information is intended for medical or healthcare professionals only:
The solution for intramuscular injection is to be visually inspected prior to use and only clear solutions free from particles should be used.
The contents of an ampoule are to be injected intramuscularly immediately after opening the ampoule.
The medicinal product is for single use only and any unused solution should be discarded.
Administration
Special care must be given to avoid intravasal injection.
As with all oily solutions, Testosterone undecanoate must be injected strictly intramuscularly and very slowly. Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Treatment is usually supportive, e.g. by administration of supplemental oxygen.
Suspected anaphylactic reactions after Testosterone undecanoate injection have been reported.
POM
PL 20636/2792
Testosterone undecanoate is strictly for intramuscular injection. Special care will be taken to avoid injection into a blood vessel (see “Notes on handling the OPC (One-Point-Cut) ampoule”).
Start of treatment
Your doctor will measure your blood testosterone levels before starting treatment and during the early stages of treatment. Your doctor may give you the second injection after only six weeks in order to quickly reach the necessary testosterone level. This will depend on your symptoms and testosterone levels.
Maintaining your Testosterone undecanoate levels during treatment
The injection interval should always be within the recommended range of 10 to 14 weeks.
Your doctor will measure your testosterone levels regularly at the end of an injection interval to make sure it is at the right level. If the level is too low, your doctor may decide to give you injections more often. If your testosterone levels are high, your doctor may decide to give you injections less often. Do not miss your injection appointments. Otherwise, your optimum level of testosterone will not be maintained.
If you think that the effect of Testosterone undecanoate is too strong or too weak, talk to your doctor.
If you used more Testosterone undecanoate than you should
Symptoms of having too much Testosterone undecanoate include:
- irritability
- nervousness
- weight gain
- long-lasting or frequent erections
Tell your doctor, if you have any of these. Your doctor will inject it less often or will stop treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are acne and pain where the injection is given.
Common side effects (may affect up to 1 in 10 patients):
- abnormally high levels of red blood cells
- weight gain
- hot flushes
- acne
- enlarged prostate and associated problems
- various reactions where the injection was given (e.g. pain, bruising, or irritation)
Uncommon side effects (may affect up to 1 in 100 patients):
- allergic reaction
- increased appetite, changes in blood test results (e.g. increased blood sugars or fats)
- depression, emotional disorder, insomnia, restlessness, aggression, or irritability
- headache, migraine, or tremor
- cardiovascular disorder, high blood pressure, or dizziness
- bronchitis, sinusitis, cough, shortness of breath, snoring, or voice problems
- diarrhoea, or nausea
- changes in liver test results
- hair loss, or various skin reactions (e.g. itching, reddening, or dry skin)
- joint pain, pain in limbs, muscle problems (e.g. spasm, pain or stiffness), or an increase in the blood substance creatine phosphokinase
- urinary tract disorders (e.g. decreased flow of urine, urinary retention, urge to pass urine at night)
- prostatic disorders (e.g. prostatic intraepithelial neoplasia, or hardening or inflammation of the prostate), changes in sexual appetite, painful testicles, painful, hardened or enlarged breasts, or increased levels of male and female hormones
- tiredness, general feeling of weakness, excessive sweating, or night sweats
Warnings
Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial factors).
Besides laboratory tests of the testosterone concentrations in patients on long-term androgen therapy the following laboratory parameters should be checked periodically: haemoglobin, haematocrit, and liver function tests and lipid profile.
In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.
The oily liquid Testosterone undecanoate may reach the lungs (pulmonary microembolism of oily solutions) which can in rare cases lead to signs and symptoms such as cough, shortness of breath, feeling generally unwell, excessive sweating, chest pain, dizziness, “pins and needles”, or fainting. These reactions may occur during or immediately after the injection and are reversible.
Suspected anaphylactic reactions after Testosterone undecanoate injection have been reported.
In addition to the side effects listed above the following have been reported following treatment with preparations containing testosterone: nervousness, hostility, brief interruptions in breathing during sleep, various skin reactions including dandruff and oily skin, more frequent erections, and very rare cases of yellowing of the skin and eyes (jaundice).
Treatment with high doses of testosterone preparations commonly stops or reduces sperm production, although this returns to normal after treatment ceases. Testosterone replacement therapy of poorly functioning testicles (hypogonadism) can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema (swelling due to fluid retention).
For testosterone products in general a common risk of increased red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), were observed by periodic blood tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TESTOSTERONE UNDECANOATE
Keep out of the sight and reach sight of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Testosterone undecanoate contains
Each ml of solution contains 250mg Testosterone undecanoate equivalent to 157.9mg Testosterone. One ampoule contains 1000 mg testosterone undecanoate.
The other ingredients are benzyl benzoate and refined castor oil.
What Testosterone undecanoate looks like and contents of the pack
Testosterone undecanoate is available as a brown glass ampoule containing a clear yellowish oily solution.
The contents of the packs are:
1 brown ampoule with 4 ml solution for injection.
Manufacturer
Manufactured by Bayer Pharma AG, MullerstraUe 178, D-13353 Berlin, Germany. Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 19.04.16[3]
Notes on handling the OPC (One-Point-Cut) ampoule: There is a pre-scored mark beneath the coloured point on the ampoule eliminating the need to file the neck. Prior to opening, ensure that any solution in the upper part of the ampoule flows down to the lower part.
Use both hands to open; while holding the lower part of the ampoule in one hand, use the other hand to break off the upper part of the ampoule in the direction away from the coloured point.