Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
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.
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).
The maximum recommended dose is 69 mg testosterone per day, which is equivalent to 3 pump actuations.
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).
Testavan is not indicated for use in women.
Testavan is not indicated in children and has not been clinically evaluated in males under 18 years of age.
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.
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 2 additional pump actuations and safely throw away the used tissue paper.
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. |
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.
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.
No case of overdose with Testavan has been reported in clinical trials.
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 of overdosage consists of discontinuation of Testavan together with appropriate symptomatic and supportive care.
3 years.
This medicinal product does not require any special storage conditions.
Testavan is supplied in a multidose container consisting of a metering pump with a laminate foil pouch in a bottle, and is provided with a cap applicator with a hygienic lid. The pump is composed of polypropylene, ethylene propylene diene monomer and stainless steel and the pouch is a polyethylene/polyethylene terephthalate/aluminium/polyethylene laminate encased in a rigid polypropylene bottle.
The product is available in packs of one multidose container. Each pump contains 85.5 g Testavan gel and is capable of dispensing 56 metered doses.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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