Frequently asked questions
Answers to the most commonly asked questions on Testavan® .
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Background information on Testavan®
What is Testavan® indicated for?
Testavan® is a testosterone replacement therapy indicated for the treatment of adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.[1]
Is Testavan® available over-the-counter?
Testavan is not available over the counter. It is available as a prescription-only medication and is indicated for adult mal hypogonadism, confirmed by clinical features and biochemical tests.
Which patients are likely to benefit from treatment with Testavan®?
Testavan® is indicated for the treatment of adult males (≥18-years-old) with hypogonadism.[1]
Efficacy
Are the efficacy results for Testavan® comparable with other available treatments?
In the phase III, open-label studies, 76-86% of hypogonadal men responded to Testavan® treatment; response was defined as restoration of physiological serum testosterone levels of 300 - 1,050 nm/dL. Treated individuals demonstrated statistically significant improvements in sexual function, fatigue and quality of life (p<0.0001).[2] [3]
While there are currently no head-to-head data, indirect comparison indicates Testavan® is comparable to other available TRTs including other topical gels. [2-5]
What is the bioavailability of Testavan® compared with other topical TRT gels?
Testavan® has demonstrated greater bioavailability and faster absorption than leading competitors, Testim® 1%, Androgel® 1%, Fortesta® 2% and Axiron® 2%, as demonstrated in a phase 1, open-label, multiple dose clinical study. [6] Further, Testavan demonstrated comparable average serum testosterone concentrations (12.8 - 17.5 nmol/L) with Testim® 1%, Androgel® 1%, Fortesta® 2% and Axiron® 2%. [5]
Please note, at present no head-to-head data directly compares Testavan® and other topical TRTs. As such, caution should be exercised when comparing treatment options due to differences in study design, endpoints and baseline patient characteristics.
Safety and tolerability
What are the most common adverse events associated with Testavan®?
The most common adverse events were application site reactions, occurring in 4.4% of participants, and primarily included rash, erythema, dryness, pruritus, and skin irritation. The majority of these events were mild-to-moderate in severity. [1-3] [7]
Other reported adverse events include increased blood triglycerides, increased prostate specific antigen, increased haematocrit, hypertension, increased haemoglobin and headache. [1]
Please refer to the Testavan® Summary of Product Characteristics for the full list of adverse events.
Are there other associated health risks to consider?
The relationship between TRT and cardiovascular disease remains unclear and therefore caution should be exercised in patients who have severe cardiac insufficiency or ischemic heart disease due to potential treatment complications. No cardiac instances have been reported and linked to Testavan use. [1]
Increased prostate specific antigen (PSA) and increased hematocrit levels have been reported following treatment with Testavan®, however substantial increases (defined as >54%) were either rare or not reported.
There is no strong evidence associating any TRT with increased risk of developing prostate cancer.
There is also the risk of transfer of the product from the individual for whom is was prescribed or a secondary person. Caution should be taken to avoid this including covering the application site with clothing and washing hands immediately after use. There have been some reported cases of hyperandrogenism in women and precocious puberty in children as a result of secondary transference. [10]
Dosing and administration
8. What are the available doses of Testavan®?
Testavan® gel contains 20 mg/g testosterone. The dose of testosterone delivered with one
pump actuation is 1.15 g (1.25 mL); equivalent to 23 mg of testosterone. [1]
The recommended starting dose of Testavan® is 23 mg/day testosterone, one pump actuation [1.15 g/1.25 mL of gel]). [1]
Testavan® dose may be adjusted to 46 mg/day testosterone (two pump actuations) or
69 mg/day testosterone (three pump actuations; maximum recommended dose) to ensure
that physiological levels of testosterone (300–1050 ng/dL) are maintained. [1]
9. How frequently can the dose of Testavan® be modified?
Available doses of Testavan are outlined above.
Dose modifications should be based on:[1]
- Serum testosterone levels measured 2–4 hours after Testavan® administration on approximately Days 14 and 35 after starting treatment or after a dose adjustment.
-Presentation of clinical signs and symptoms associated with testosterone deficiency.
10. Can a physician start treatment with two actuations of Testavan® (46 mg/daytestosterone)?
It is recommended that the starting dose of Testavan® is 23 mg/day testosterone, one pump actuation [1.15 g/1.25 mL of gel]). [1]
Doses may be modified up to 69 mg/day and should be based on: [1]
- Serum testosterone levels measured 2–4 hours after Testavan® administration on approximately Days 14 and 35 after starting treatment or after a dose adjustment.
-Presentation of clinical signs and symptoms associated with testosterone deficiency.
Learn more on administration here.
Please refer to the SmPC for further information.
Storage and care
11. How should Testavan® be stored?
Testavan® does not require any special storage conditions, however the product should notbe frozen.
It should be stored in a safe place, out of reach and sight of children.
Testavan® has a shelf life of 3 years.
Patients should not use Testavan® after the expiry date which is shown on the packaging.
12. How should the applicator be maintained and cleaned?
The applicator should be cleaned using a tissue which should then be discarded immediately after use to prevent second-person transfer. Following cleaning, the user should replace the protective lid back on the applicator and the applicator placed back on the pump.
Dose modifications should be based on:[1]
The applicator should be stored in a safe place, out of reach and sight of children.
References
1. Testavan® Summary of Product Characteristics. Available from : https://www.medicines.org.uk/emc/product/13936/smpc . Last accessed : August 2022
2. Cunningham G, et al.. Endocr Pract. 2017;23(5):557–65
3. Belkoff L, et al. Andrologia 2018;50(1):e12801
4. Luthy K, et al. J Nurse Pract 2017;13(4):241–9
5. Arver S, et al. Andrology 2018;6:396-407
6. Olsson H, et al. Clin Pharmacol Drug Dev 2014;3(5):358–64
7. Efros M, et al. Andrologia 2016;48(6):637–45
8. Dohle G, et al. EAU Guidelines on Male Hypogonadism 2018.Available at:http://uroweb.org/guideline/male-hypogonadism/.
9. Khera M, et al. Diagnosis and Treatment of Testosterone Deficiency:
Recommendations from the Fourth International Consultation for Sexual Medicine
(ICSM 2015). J Sex Med 2016;13(12):1787–804.
10. Michael G. Miller, Alan D. Rogol & Troy L. ZumBrunnen. Current Medical Research
and Opinion. 2012. 28:2, 267-269