Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Testavan 20 mg/g Transdermal gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Testosterone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Testavan is Testavan is a clear gel that contains testosterone, a male hormone produced naturally in your body. Testavan is used to replace testosterone in adult men when you do not produce enough natural testosterone – this is called "hypo-gonadism". The medicine helps to raise your testosterone to normal levels. What testosterone does Testosterone is made naturally in your body in your testicles.
- It helps produce sperm and to develop and maintain male features such as a deep voice and body hair.
- It is necessary for normal sexual function and sex drive.
- It also helps to maintain muscle size and strength. What Testavan is used for Testavan is used in men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical signs and symptoms such as:
- impotence
- infertility
- low sex drive
- tiredness
- depressive moods
- bone loss caused by low hormone level
- partial loss of secondary sex characteristics, such as changes in your voice, changes in the fat distribution and partial loss of face and body hair 2.
What you need to know before you take it
e Testavan
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Who can use Testavan
- Only men can use Testavan.
- Young men under the age of 18 years should not use this medicine.
- This medicine should not be used by females of any age.
- Do not allow women (especially women that are pregnant or breast-feeding) or children to come into contact with Testavan gel or the areas of skin where Testavan has been applied. Do not use Testavan:
- if you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6)
- if you have or are suspected of having prostate cancer
- if you have or are suspected of having breast cancer (a rare condition for men). Warnings and precautions Testosterone treatment can speed up the progress of pre-existing prostate cancer. Your doctor will do the necessary tests before you can use Testavan and do follow-up check by carrying out periodic blood tests and prostate examinations. Talk to your doctor before using Testavan, if you have or ever had any of the following:
- you have difficulty in passing water (urinating) due to an enlarged prostate gland
- you have bone cancer – your doctor will check your calcium levels
- you have high blood pressure, or if you are treated for high blood pressure, as Testavan may cause a rise in blood pressure
- you have severe heart, liver or kidney disease, as treatment with Testavan may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure (overload in the heart)
- you have ischaemic heart disease (which affects the supply of blood to the heart)
- blood clotting problems
- thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis blood clots in blood vessels)
- factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
- How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.
- you have epilepsy
- you have migraines
- you have breathing difficulties when you sleep – these are more likely to happen if you are overweight or have long term lung problems If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Testavan – using this medicine may make these conditions worse. If you develop reactions on your skin where you applied the Testavan, go back to your doctor to seek advice. It may be necessary to stop the treatment with Testavan. The following blood checks should be carried out by your doctor before and/or during the treatment: testosterone blood levels, full blood count. At the time of, and just after, the daily application of Testavan, do not apply moisturisers or sunscreen products to the area where you have put the gel How to prevent transfer of Testavan to someone else 2
Testavan can transfer to others by close skin-to-skin contact. This may result in increased testosterone levels in their body – this can be dangerous. This can happen from one contact – but it can also build up bit by bit with small amounts of contact over time.
- This is especially important for women and children – they normally only have low levels of testosterone in their bodies
- Pregnant women must not come into contact with Testavan. If your partner is pregnant you must be careful and protect her from any contact with the medicine and the application area. To stop the gel being transferred from your skin to someone else, you should:
- use the applicator to apply the medicine rather than your fingers
- wash your hands with water and soap straight away if you do get any Testavan on your hands
- cover where you have put the gel with clothing – once the gel has dried
- have a bath or shower, or wear clothing to cover the gel application site (such as a T-shirt), before having close skin-to-skin contact with anyone In order to improve the safety of your partner you should wash the area with soap for instance during a shower before having sexual intercourse or, if not possible, wear a T-shirt that covers the application site at the time of contact. What to do if someone else is exposed to Testavan If someone touches the gel or has skin-to-skin contact where you have put the gel, they should wash their area of skin with soap and water as soon as possible. The longer that the gel is in contact with the skin before washing, the greater the chance that the person will absorb some testosterone. If Testavan has been transferred to someone else, then look out for any changes in the body or behaviour of people close to you. If anyone close to you gets any of the following signs, they should see their doctor:
- acne
- deepening of the voice
- growth of facial or body hair
- changes in their monthly period
- early puberty, genital enlargement or changes in level of sexual behaviour of children Other medicines and Testavan Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription and herbal medicines. Testavan may affect how these medicines work and you may need to have your doses adjusted. In particular, tell your doctor or pharmacist if you are taking:
- Medicines to thin your blood (anti-coagulants) – Testavan may increase the effects of these drugs
- corticosteroids or any other medicines that may increase the production of these hormones. Both corticosteroids and Testavan may cause your body to hold on more water
- insulin to control your blood sugar levels (in diabetes); you may need to reduce your dose of insulin when you are in treatment with Testavan. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Testavan Pregnancy, breast-feeding and fertility Testavan is not intended for use by pregnant or breastfeeding women. If your partner is or becomes pregnant, you must follow the advice above under the heading 'How to prevent transfer of Testavan to someone else'.
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Pregnant women must avoid any skin contact with Testavan application sites in men. This medicine may cause damage to the unborn baby. In the event of contact, the area should be washed as soon as possible with soap and water. Breast-feeding women must avoid any contact with Testavanapplication sites in men. Sperm production may be reversibly suppressed with Testavan. Testavan contains propylene glycol This medicine contains propylene glycol, which may cause skin irritation. Testavan contains ethanol This medicine contains 538.70 mg alcohol (ethanol) in each 1.15 g dose which is equivalent to 468.40 mg/g (46.84 %w/w). It may cause burning sensation on damaged skin. 3.
How to take it
Testavan
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to use –
–
The recommended starting dose of Testavan is 23 mg testosterone (one pump press) applied once daily at approximately the same time each day preferably in the morning – but some patients may require a higher dose. The maximum recommended dose is 69 mg testosterone daily (three pump presses).
The correct dose of Testavan that you need will be decided by your doctor – they will do this by measuring two things regularly:
- the levels of testosterone in your blood
- How well the medicine is working for you. Talk to your doctor if you feel that the effects of the medicine is too strong or too weak. Using this medicine It is important that you read and follow these directions on how to use Testavan properly. Apply Testavan on your skin using the applicator. This is called "trans-dermal use" – the medicine goes through your skin into your body. Apply the medicine only to clean, dry, normal healthy skin on your shoulders or upper arms. Never apply Testavan to:
- your penis and testicles
- to skin that is broken or damaged -open sores, wounds or irritations. Supplies you will need
- Testavan gel pump kit. See Picture A.
- Box of tissues.
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Lid
Applicator
Pump Head
Pump
Picture A Note: Multipacks contain a lid on top of each pump head Priming your gel pump – first time only Before using a new Testavan pump, you need to get it ready to use. This is called "priming" the pump:
- Take off the applicator from the pump in the case of the single pack or take off the lid from the pump in the case of the multipack – See Picture B.
Picture B •
Prime the pump by pressing the pump head all the way down over a tissue. Repeat until gel appears. See Picture C.
Picture C
- Do not use any gel from priming because it might not be the right dose.
- Safely throw away the used tissues to prevent transferring to others including children or pets.
- Your Testavan pump is now ready to use.
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For daily dosing follow steps 1-4 Step 1: Preparing to apply your Testavan gel
- Select a clean, dry, normal healthy area of the skin on the upper arm and shoulder that would be covered by a short sleeve t-shirt. See Picture D.
- Use Testavan gel only on the upper arm and shoulder.
Picture D
- Take off the applicator from the pump See Picture E.
Picture E
- Take off the lid from the applicator See Picture F.
Picture F Step 2: Applying your Testavan gel • •
Hold the pump with the nozzle facing the applicator surface. Press the pump head all the way down once. See Picture G.
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Picture G
- Use the applicator to spread the gel evenly across one upper arm and shoulder, making sure not to get any gel on your hands. See Picture H.
- Clean up any spills with a tissue. Safely throw away used tissues to prevent transfer to others including children or pets.
Picture H
Find your dose as prescribed by your doctor in the table below. Dose
How to apply
23 mg
Apply one pump press as shown in Step 2 – do this once.
(1 pump press) 46 mg (2 pump presses) 69 mg (3 pump presses)
Apply one pump press as shown in Step 2. Repeat to apply another pump press – put on the opposite upper arm and shoulder. Apply one pump press as shown in Step 2. Repeat to apply one pump press – put on the opposite upper arm and shoulder. Repeat again to apply the third pump press to the first upper arm and shoulder that you used.
Step 3: Cleaning your Testavan applicator
- After use, clean the applicator with a tissue. See Picture I.
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Picture I
- Safely throw away used tissue. Be careful to prevent transfer to others including children or pets.
- REMEMBER to put the lid back on the applicator and put the applicator back on the pump. See Picture J.
Picture J •
Store the product safely and out of reach of children.
Step 4: After applying your Testavan
- Wash your hands with soap and water straight away, if you got gel on them.
- Testavan gel is flammable until dry. Let the Testavan gel dry before smoking or going near an open flame.
- Let the application site dry completely before getting dressed.
- Wear clothing that covers the application site at all times to prevent accidental transfer to others.
- Wait at least 2 hours before showering, swimming or bathing.
- Wash the application site with soap and water before any situation where skin-to-skin contact of the application site with another person is likely.
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If you use more Testavan than you should If you have applied too much medicine by mistake, wash the application area with soap and water as soon as you realise. Only use the amount of medicine prescribed by your doctor. If you feel irritable, nervous, gain weight, get long lasting or frequent erections – these may be signs that you are using too much. If you forget to use Testavan Do not use a double dose to make up for a forgotten dose.
- If your next dose is less than 12 hours away, do not take the missed dose. Then take your next dose as normal.
- If it is more than 12 hours until your next dose, take the dose that you have missed. Continue as normal the following day. If you stop using Testavan Talk to your doctor before you stop taking this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Common (may affect up to 1 in 10 people)
- skin irritation where the gel has been applied (including rash, dryness and redness)
- high levels of fats (triglycerides) in the blood
- increased blood pressure
- increased Prostatic Specific Antigen (PSA). PSA is a protein produced by the prostate, which can be used to detect prostate disease
- increased haematocrit (percentage of red blood cells in blood), identified by periodic blood tests Uncommon (may affect up to 1 in 100 people)
- Increased haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests
- Headache Other known undesirable effects associated with testosterone treatment include: acne, seborrhoea, baldness, sweating, increased body hair growth, skin tickling or numbness, headache, dizziness, nausea, hot flushes, fluid retention (such as swelling of ankles), weight gain, sleep apnoea, shortness of breath, hypersensitivity reactions, feeling sick/unwell, changes to your mood (such as aggression, hostility, nervousness, anxiety, depression), sleeplessness, muscular pain or cramp, development of breasts, increase in red blood cell count, decrease in red blood cells, blood clots, jaundice (liver problems which sometimes may be associated with yellowing of the skin and the whites of the eyes), abnormal liver function tests. Sex drive changes, erection increased, priapism (prolonged and painful erections), testis disorder, reduced number of sperm, difficulty passing urine, changes to your prostate gland, prostate cancer (there is no convincing evidence that testosterone replacement in hypogonadal men induces prostate cancer; however, testosterone therapy is to be avoided in men already known or thought to have prostate cancer). Prolonged testosterone administration may cause changes in the levels of salts (electrolytes) and water in the body. 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 9
via Yellow Card scheme, Website: 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 it
Testavan
Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the pump label and the outer carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Testavan contains The active substance is testosterone. The other excipients are: ethanol 96%, propylene glycol (E 1520), diethylene glycol monoethyl ether, carbomer 980, trolamine, disodium edetate, water. One gram of gel contains 20 mg testosterone. Each pump press delivers 1.15 g gel (1.25 ml) containing 23 mg of testosterone. What Testavan looks like and contents of the pack Testavan is a homogenous, translucent to slightly opalescent gel. The following pack sizes are available with or without a cap applicator and hygiene lid: Single packs containing 1 metering pump Multipacks containing 3 metering pumps Each pump contains 85.5 g Testavan gel and is capable of dispensing 56 metered doses. Marketing Authorisation Holder and Manufacturer The Simple Pharma Company UK Limited Suite 3, 4th Floor 1 Duchess Street London W1W 6AN UK Testavan 20 mg/g transdermal gel – PL 54460/0002 Manufactured by: Copea Pharma Europe Limited, Medici House, Unit 2, Ashbourne Manufacturing Park, Ashbourne, Co. Meath, A84 KH58, Ireland
CAP applicator: The Simple Pharma Company Limited, Ground Floor, 71 Lower Baggot St, Dublin D02 P593, Ireland
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This medicine is authorised in the Member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Italy, Liechtenstein, Lithuania, , Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland): Testavan Belgium, Croatia, , Greece, Hungary, Ireland,Latvia, Luxembourg, Slovenia: Testarzon
This leaflet was last revised in August 2023 Testavan is a trademark of Simple Pharma I Limited © 2021.
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Frequently asked questions about Testavan 20 mg/g Transdermal gel
How do I take Testavan 20 mg/g Transdermal gel?
Testavan 20 mg/g Transdermal gel comes as gel containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Testavan 20 mg/g Transdermal gel?
The active substance in Testavan 20 mg/g Transdermal gel is testosterone.
Are there equivalent medicines to Testavan 20 mg/g Transdermal gel?
Medicines with the same active substance, strength and form include: Tostran 20mg/g transdermal gel. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Testavan 20 mg/g Transdermal gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Testavan 20 mg/g Transdermal gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: testosterone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
4.2. Posology and method of administration
Posology
Adult men
The recommended starting dose of Testavan is 23 mg testosterone (one pump actuation) applied once daily. To ensure proper dosing, serum testosterone levels should be periodically measured and dose titrated to maintain eugonadal serum testosterone levels (see section 4.4.).
The serum testosterone level should be measured 2-4 hours after dosing approximately 14 days and 35 days after starting treatment or after a dose adjustment. If the serum testosterone concentration is below 17.3 nmol/L (500 ng/dL), the daily Testavan dose may be increased by 1 pump actuation. If the serum testosterone concentration exceeds 36.4 nmol/L (1050 ng/dL), the daily Testavan dose may be decreased by 1 pump actuation.
Dose titration should be based on both serum testosterone levels and the existence of clinical signs and symptoms related to testosterone deficiency.
Elderly
Same dose as for adults. However, it should be taken into account that physiologically testosterone levels are lower with increasing age (see section 4.4).
Maximum recommended dose
The maximum recommended dose is 69 mg testosterone per day, which is equivalent to 3 pump actuations.
Renal and hepatic impairment
There are no dedicated studies undertaken to demonstrate the efficacy and safety of this medicinal product in patients with renal or hepatic impairment. Therefore, testosterone replacement therapy should be used with caution in these patients (see section 4.4). After treatment with Testavan, testosterone levels are similar in subjects with mild or moderate renal impairment compared to subjects with normal renal function (see section 5.2).
Female population
Testavan is not indicated for use in women.
Paediatric population
Testavan is not indicated in children and has not been clinically evaluated in males under 18 years of age.
Method of administration
Transdermal use.
Testavan is a gel, which should be applied to the upper arm and shoulder, using the applicator. Patients should be instructed not to apply Testavan with fingers or hands.
Priming of new pump
To ensure correct dosing, patients should be instructed to prime each new pump before using it for the first time by pressing the pump head all the way down over a tissue paper until gel appears. Discard the initial gel and safely throw away the used tissue paper.
Administration
Testavan should be applied once daily at about the same time, preferably in the morning to clean, dry, intact skin of the upper arm and shoulder using the applicator. A lower amount of testosterone will be delivered if Testavan is applied to the abdomen or thigh and changing application site is therefore not recommended (see section 5.2).
To apply the gel after removal of the applicator lid, the pump head should be pressed all the way down once over the applicator head. Patients should be instructed to only make one pump actuation onto the applicator at a time. The applicator should be used to spread the gel evenly across the maximum surface area of one upper arm and shoulder, making sure not to get any gel on the hands. When more than one pump actuation is required to achieve daily dose, the procedure is repeated to the other upper arm and shoulder.
Dose
Application method
23 mg
(1 pump depression)
Apply one pump actuation to an upper arm and shoulder.
46 mg
(2 pump depressions)
Apply one pump actuation to an upper arm and shoulder.
Repeat to apply one pump depression to the opposite upper arm and shoulder.
69 mg
(3 pump depressions)
Apply one pump actuation to an upper arm and shoulder.
Repeat to apply one pump depression to the opposite upper arm and shoulder.
Repeat again to apply the third pump depression to the initial upper arm and shoulder.
Cleaning of the applicator
After use, the applicator should be cleaned with a tissue and the protective lid restored on top of the applicator. The used tissue paper should be safely thrown away and the product stored safely out of reach of children.
Following administration
If the gel was touched with the hands during the application procedure, patients should be instructed to wash their hands with water and soap immediately after applying Testavan.
Patients should be advised to let the application site dry completely before getting dressed.
Patients should be advised to wait at least 2 hours before showering, swimming or bathing to prevent reduced testosterone absorption (see section 4.4).
Wear clothing that covers the application side at all times to prevent accidental transfer to others.
4.3. Contraindications
• Hypersensitivity to the active substance, propylene glycol or to any of the excipients listed in section 6.1.
• Known or suspected carcinoma of the breast or the prostate
4.4. Special warnings and precautions for use
Testavan should be used only if male hypogonadism has been demonstrated and if other etiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone deficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction etc.) and confirmed by two separate blood testosterone measurements before initiating therapy with any testosterone replacement, including Testavan treatment.
Prior to initiation of testosterone replacement therapy, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer.
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 prostate specific antigen (PSA)) in patients receiving testosterone therapy at least annually and twice yearly in elderly patients and at risk patients (those with clinical or familial factors).
Testosterone levels should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.
Androgens may accelerate the progression of sub-clinical prostate cancer and benign prostatic hyperplasia.
Testavan should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. Regular monitoring of serum calcium concentrations is recommended in these patients.
Testavan is not a treatment for male sterility or impotence.
There is limited experience on the safety and efficacy of the use of Testavan in patients over 65 years of age. Currently, there is no consensus concerning age specific reference values for testosterone. However, it should be taken into consideration that the physiologically testosterone serum levels are lower with increasing age.
Testosterone may cause a rise in blood pressure and Testavan should be used with caution in men with hypertension.
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 this case, treatment must be stopped immediately.
Clotting disorders:
Testosterone should be used with caution in patients with thrombophilia, or risk factors for venous thromboembolism (VTE) as there have been post-marketing studies and reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy. In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.
Testosterone should be used with caution in patients with ischemic heart disease, epilepsy and migraine as these conditions may be aggravated.
There are published reports of increased risk of sleep apnoea in hypogonadal men treated with testosterone esters, especially in those with risk factors such as obesity or chronic respiratory disease.
If the patient develops a severe application site reaction, treatment should be reviewed and discontinued if necessary.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Testavan should not be used in women due to possible virialising effects.
As washing after Testavan administration reduces testosterone levels, patients are advised not to wash or shower for at least 2 hours after applying Testavan. When washing occurs up to 2 hours after the gel application, the absorption of testosterone may be reduced.
Testavan contains propylene glycol, which may cause skin irritation.
Testavan contains ethanol. This medicine contains 538.70 mg alcohol (ethanol) in each 1.15 g dose which is equivalent to 468.40 mg/g (46.84 %w/w). It may cause burning sensation on damaged skin.
Alcohol based products including Testavan are flammable; therefore avoid fire, flame or smoking until the gel has dried.
Potential for Transfer
If no precaution is taken, testosterone gel can be transferred to other persons by close skin to skin contact, resulting in increased testosterone serum levels and possibly adverse effects (e.g. growth of facial and/or body hair, acne, deepening of the voice, irregularities of the menstrual cycle) in case of repeat contact (inadvertent androgenisation).
The physician should inform the patient carefully about the risk of testosterone transfer and about safety instructions (see below). Testavan should not be prescribed in patients with a major risk of non-compliance with safety instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders).
This transfer is avoided by wearing clothes covering the application area or showering prior to contact.
As a result, the following precautions are recommended:
For the patient:
• use the cap applicator for hands-free administration to reduce the risk of secondary exposure to testosterone.
• if the gel was touched with the hands during the application procedure, wash hands thoroughly with soap and water after applying the gel.
• cover the application area with clothing once the gel has dried.
• shower before any situation in which skin to skin contact with another person is foreseen.
For people not being treated with Testavan:
• in the event of contact with an application area which has not been washed or is not covered with clothing, wash the area of skin onto which testosterone may have been transferred as soon as possible, using soap and water.
• report the development of signs of excessive androgen exposure such as acne or hair modification.
To improve partner safety, the patient should be advised for example to wear a T-shirt covering the application site during contact period, or to shower before sexual intercourse.
Furthermore, it is recommended to wear a T-shirt covering the application site during contact periods with children in order to avoid a contamination risk of children's skin.
Pregnant women must avoid any contact with Testavan application sites. In case of pregnancy of the partner, the patient must reinforce his attention to the precautions for use (see section 4.6).
Patients must be cautioned to minimise use of body lotion and sunscreen products at the area of application, at and just after application of Testavan gel.
Laboratory test interactions: Androgens may decrease concentrations of thyroxin-binding globulins, resulting in decreased total thyroxine (T4) serum concentration and increased resin uptake of triiodothyronine (T3) and T4. Free thyroid hormone concentration remains unchanged and there is no clinical evidence of thyroid dysfunction.
4.5. Interaction with other medicinal products and other forms of interaction
When androgens are given simultaneously with anticoagulants, the anticoagulant effects can increase. Patients receiving oral anticoagulants require close monitoring of their international normalized ratio (INR) especially when androgen treatment is started or stopped.
The concurrent administration of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may increase likelihood of oedema; thus these drugs should be administered with caution, particularly in patients with cardiac, renal or hepatic disease.
Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.
Interaction studies with body lotion and sunscreen products have not been performed.
4.6. Fertility, pregnancy and lactation
Testavan is intended for use by men only.
No clinical trials have been conducted with Testavan for assessment of male fertility. Spermatogenesis may be reversibly suppressed with Testavan (see section 5.3).
Pregnant women should avoid skin contact with Testavan application sites (see section 4.4).
In the event that unwashed or unclothed skin to which Testavan has been applied does come into direct contact with the skin of a pregnant woman, the general area of contact on the woman should be washed with soap and water immediately.
Testosterone may induce virilising effects on the foetus.
4.7. Effects on ability to drive and use machines
Testavan has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
a. Summary of the safety profile
The most commonly reported adverse reactions in phase 2 and phase 3 clinical trials lasting up to 9 months were application site reactions (4%) including: rash, erythema, pruritus, dermatitis, dryness, and skin irritation. The majority of these reactions were mild to moderate in severity.
b. Tabulated summary of adverse events
Adverse drug reactions reported in phase 2 and phase 3 clinical trials with Testavan are listed in the following table. All adverse reactions reported with a suspected relationship are listed by class and are listed according to the following frequency: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1.000 to < 1/100);
Testavan drug-related adverse reactions reported during clinical trials with more than one case (N=379)
MedDRA System Organ Class
Common ( ≥ 1/100 to <1/10)
Uncommon (≥ 1/1,000 to < 1/100)
General disorders and administration site conditions
Application site reaction (including rash, erythema, pruritus, dermatitis, dryness, and skin irritation)
Investigations
Blood triglycerides increased/hypertriglyceridaemia, PSA increased, haematocrit increased,
Haemoglobin increased
Vascular disorders
Hypertension
Nervous System Disorder
Headache
According to literature and spontaneous reporting from testosterone gels, other known undesirable effects are listed in the below table:
MedDRA System Organ Class
Adverse Reactions – Preferred term
Blood and lymphatic system disorders
Polycythaemia, anaemia
Psychiatric disorders
Insomnia, depression, anxiety, aggression, nervousness, hostility
Nervous system disorders
Headache, dizziness, paraesthesia
Vascular disorders
Hot flushes (vasodilation), deep vein thrombosis
Respiratory, thoracic and mediastinal disorders
Dyspnoea, sleep apnoea
Gastrointestinal disorders
Nausea
Skin and subcutaneous tissue disorders
Various skin reactions may occur including acne, seborrhoea and balding (alopecia), sweating, hypertrichosis
Musculoskeletal and connective tissue disorders
Musculoskeletal pain, muscle cramps
Renal and urinary disorders
Urination impaired, urinary tract obstruction
Reproductive system and breast disorders
Gynaecomastia, erection increased, testis disorder, oligospermia, benign prostatic hyperplasia, libido changes (therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism), prostate abnormalities, prostate cancer*)
General disorders and administration site conditions
Asthenia, malaise, application site reaction.
High dose or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema; hypersensitivity reactions may occur.
Investigations
Weight increase, elevated PSA, elevated haematocrit, red blood cell count increased or elevated haemoglobin
Metabolism and nutrition disorders
Electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment.
Hepatobiliary disorders
Jaundice and liver function test abnormalities.
* Data on prostate cancer risk in association with testosterone therapy are inconclusive.
Because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
No case of overdose with Testavan has been reported in clinical trials.
Symptoms
Clinical signs such as irritability, nervousness, weight gain, prolonged or frequent erection can indicate overexposure to androgen and serum testosterone levels should therefore be measured.
Treatment
Treatment of overdosage consists of discontinuation of Testavan together with appropriate symptomatic and supportive care.
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