TESTOSTERONE UNDECANOATE 250MG/ML SOLUTION FOR INJECTION
Active substance(s): TESTOSTERONE UNDECANOATE / TESTOSTERONE UNDECANOATE / TESTOSTERONE UNDECANOATE
Nebido® 1000 mg/4 ml, solution for
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
- 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:
- low sex drive
- 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 androgen-dependent cancer or suspected cancer of the
prostate or of the breast
- if you have or 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:
- heart, kidney or liver problems
- 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
- blood clotting problems
- high blood pressure or if you are treated for high blood pressure, as
testosterone may cause a rise in blood pressure.
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.
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.
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
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 information is intended for healthcare professionals
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.
- 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
- blood-thinning tablets (coumarin derived oral anticoagulants) since this
can increase the risk of bleeding. Your doctor will check the dose.
- medicines used to treat diabetes. It may be necessary to adjust the dose
of your blood sugar reducing medicine. Like other androgens,
testosterone may increase the effect of insulin.
Please be sure to inform your doctor if you suffer from a disturbance
of blood clotting, because this is important for your doctor to know before
deciding to inject Nebido.
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 and breast-feeding
Nebido is not for use in women and must not be used in pregnant or breastfeeding women.
Treatment with high doses of testosterone preparations commonly may
reversibly stop or reduce sperm production (see also under “Possible side
Driving and using machines
Nebido has no observed 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
Nebido is strictly for intramuscular injection. Special care will be taken to
avoid injection into a blood vessel (see “Notes on handling the OPC (OnePoint-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
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
If you use more Nebido than you should
Symptoms of having too much Nebido include:
- 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
Common side effects (may affect up to 1 in 10 patients):
- abnormally high levels of red blood cells
- weight gain
- hot flushes
- enlarged prostate and associated problems
- various reactions where the injection was given (e.g. pain, bruising, or
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
- 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 increased creatine phosphokinase in the blood
- 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
- tiredness, general feeling of weakness, excessive sweating, or night sweats
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
Suspected anaphylactic reactions after Nebido injection have been
Rare side effects (may affect up to 1 in 1000 patients):
- 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
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, increased hair growth, 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. 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
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
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
The contents of the packs are:
1 brown ampoule with 4 ml solution for injection.
Manufacturer and Product Licence Holder
Manufactured by Bayer Pharma AG, Müllerstraße 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) 28.01.17
Nebido is a trademark of Bayer Intellectual Property GmbH.
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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)
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
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.