Livensa
testosterone
Testosterone
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Livensa is and what it is used for
Before you use Livensa
How to use Livensa
Possible side effects
How to store Livensa
Further information
Medicinal product no longer authorised
Livensa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream. The testosterone in Livensa is the same hormone as that produced naturally in men and women.
After removal of the ovaries, testosterone drops to half of the levels compared to before the operation. Decrease in testosterone has been associated with low sexual desire, reduced sexual thoughts and reduced sexual arousal. All or any of these problems can cause personal distress or relationship difficulties. The medical term for this condition is Hypoactive Sexual Desire Disorder, also known as HSDD.
Livensa is used to treat HSDD.
Livensa is intended for use by women up to the age of 60 years who:
have a low sexual desire which is causing distress or concern, and
have had both of their ovaries removed, and
have had their womb removed (hysterectomy), and
are receiving estrogen therapy.
It may take longer than one month for you to notice an improvement. If you have not experienced a positive effect of Livensa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Livensa (see section ‘Further information’ at the end of this leaflet).
if you know that you have had in the past, currently have, or think that you might have, breast cancer or any other cancer which your doctor has described as being caused or stimulated by the female hormone estrogen, also called ‘estrogen-dependent’ cancers.
if you have other conditions that your doctor may consider not appropriate for the use of estrogen and/or testosterone.
if you have a history of heart, liver or kidney disease. Oedema may be a serious complication from high doses of testosterone, however, this is not expected from low dose of testosterone delivered by the Livensa patch.
if you have cancer of the lining of the womb (endometrial cancer), be aware that there is little information available on the effects of testosterone on the lining of the womb (endometrium).
if you are diabetic, as testosterone may lower blood glucose levels.
if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
If you have any of the above, tell your doctor before you start to use Livensa. Your doctor will advise you on what you should do.
The efficacy of Livensa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens’). Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Livensa.
If you stop estrogen therapy you must also stop using Livensa. Keep in mind that estrogens should be administered for the shortest possible duration.
Use Livensa only as long as you experience a positive effect of the treatment. There is no information on the safety of Livensa beyond 12 months.
There are limited data about the use in women above the age of 60. Livensa is intended for use by women up to the age of 60 years who have had both their ovaries and their womb removed.
Medicinal product no longer authorised
It is not known whether Livensa increases the risk of breast cancer and endometrium cancer. Your doctor will carefully monitor you with regard to breast cancer and endometrium cancer.
Livensa is not for use in children and adolescents.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Tell your doctor if you are taking blood-thinning (anticoagulant) treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Livensa is only indicated for women in their menopause after the ovaries and uterus have been removed. Do not use Livensa if you are, or suspect that you may be pregnant or are able to become pregnant, because it may cause harm to the unborn child.
Do not use Livensa in case of breast-feeding because it may cause harm to the child.
You can drive and use machines while using Livensa.
Always use Livensa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure of the instructions or if you want any more information. The usual dose is one patch twice weekly (each 3 to 4 days), see below ‘How and when to change your patch’. The active substance is released from the patch constantly over 3 to 4 days (corresponding to 300 micrograms per 24 hours) and is absorbed through your skin.
Stick the patch onto your lower abdomen, below your waist. Do not stick the patch on the breasts or bottom.
Make sure that your skin at the application site is:
clean and dry (free of lotions, moisturisers, and powders)
as smooth as possible (no major creases or skin folds)
not cut or irritated (free of rashes or other skin problems)
unlikely to be rubbed by clothing excessively
preferably free from hair.
When changing your patch, stick the new patch on to a different area of the skin of your abdomen, otherwise you are more likely to cause skin irritation.
Only one patch is to be worn at a time.
Medicinal product no longer authorised
If you are also using estrogen patches, make sure that the Livensa patch and the estrogen patch do not overlap.
For at least one week after removing a patch, do not place a new patch in the same area.
Medicinal product no longer authorised
You will need to change your patch every 3 to 4 days, which means using two patches each week. This will mean that you wear one patch for 3 days and the other for 4 days. Decide which two days each week you are going to change your patch, and change the patch on the same two days each week.
For example: If you decide to start treatment on a Monday, then you have to change your patch always on a Thursday and a Monday.
o Sunday + Wednesday
Monday + Thursday
Tuesday + Friday
Wednesday + Saturday
Thursday + Sunday
Friday + Monday
Saturday + Tuesday
As a reminder, mark on the outer carton your chosen patch-change days.
On the patch-change day, remove the used patch and immediately stick the new patch on to a different area of skin of your abdomen. Continue your treatment for as long as your doctor advises.
Fold the used patch in half, sticking the patch to itself, and discard it in a safe way in order to keep it away from children (e.g. in a rubbish bin). Medicines should not be disposed of via wastewater (do not flush it down the toilet). Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
You may shower, bath, swim and exercise as normal while wearing the patch. The patch is designed to remain in place during these times. However, do not scrub the area where the patch has been placed too hard.
Always make sure your patch is covered by clothing.
If a patch does begin to come off, you may be able to make it stick again by pressing on it firmly. If you cannot get the patch to stick successfully, remove the loose patch and use a new patch. Then continue with your regular schedule of patch-change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
If you have applied more than one patch at a time
Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Livensa. Overdosing with Livensa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
If you forget to change your patch
Change your patch as soon as you remember, and then continue with your regular schedule of patch- change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Returning to your regular schedule will help you remember when to change your patch.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Livensa can cause side effects, although not everybody gets them. Tell your doctor immediately:
Medicinal product no longer authorised
if you experience hair loss (a common side effect which may affect up to 1 in 10 people), enlargement of the clitoris (an uncommon side effect which may affect up to 1 in 100 people), an increase in the amount of hair on the chin or upper lip (a very common side effect which may affect more than 1 in 10 people), voice deepening or hoarseness (a common side effect), although these side effects may be mild. They are usually reversible if Livensa treatment is discontinued.
You should self assess for increased acne (a common side effect), increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of side effects of testosterone, which is the active substance in Livensa.
if you notice any skin reactions at the site of application (a very common side effect) such as redness, oedema, or blistering. In case of severe application site reaction, the treatment should be discontinued.
Most of them are mild in nature and reversible.
migraine
insomnia/inability to sleep properly
breast pain
weight gain
stomach pain
Most of them are mild in nature and reversible.
sinusitis (inflammation of nasal sinus)
abnormal clotting factor
hypersensitivity (allergic reactions)
increased appetite
agitation
anxiety
disturbance in attention
dysgeusia (distorted sense of taste)
impaired balance
hyperaesthesia (abnormal increase in sensitivity to stimuli of the senses)
oral paraesthesia (tingling or numb sensation in the mouth)
transient ischemic attack (mini stroke)
diplopia (double vision)
eye redness
palpitations (rapid and irregular heart beat)
nasal congestion
throat tightness
diarrhoea
dry mouth
nausea
eczema
increased sweating
rosacea (redness of the face)
arthritis
breast cyst
clitoral engorgement
genital pruritus (genital itching sensation)
vaginal burning sensation
anasarca (widespread swelling of the skin)
asthenia (lack of energy and strength)
chest tightness
chest discomfort
Medicinal product no longer authorised
abnormal blood fibrinogen (abnormal blood clotting)
increased heart rate
increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides (all measures of liver function).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Keep out of the reach and sight of children
Do not use Livensa after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater (do not flush it down the toilet) or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substance is testosterone. Each patch contains 8.4 mg of testosterone, releasing 300 micrograms of testosterone over 24 hours.
The other ingredients are: Sorbitan oleate, 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone co-polymer. Backing layer
Translucent polyethylene backing film printed with ink containing sunset yellow FCF (E110), latolrubine BK (E180) and copper phthalocyanine blue pigment.
Protective release liner Siliconised polyester film.
Livensa is a thin, clear, oval patch with T001 stamped on the back. Each patch is sealed in a sachet.
The following pack sizes are available: 2, 8 and 24 patches. Not all pack sizes may be marketed.
Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4
64331 Weiterstadt Germany
Warner Chilcott France
Parc d’activité de la Grande Brèche 5 rue Désir Prévost
91070 Bondoufle France
Medicinal product no longer authorised
Medicinal product no longer authorised
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Livensa remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
The off-label use is a safety risk. It is a CHMP concern that the data from the THIN (The Health Improvement Database) study suggests that approx 70% of the users are outside indication.
The CHMP decided that the MAH should continue to submit 6 monthly PSURs.
Medicinal product no longer authorised
Therefore, based on the safety profile in Livensa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.