TM Owner Endo Pharmaceuticals
Testim 1% Gel
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Indications & Clinical Uses
- Testim 1% testosterone gel, supplied in 5 g unit-dose tubes (50 mg testosterone per tube), is FDA-approved testosterone replacement therapy (Endo USA, Inc., USA) for adult men with conditions that cause a deficiency or absence of natural testosterone, including primary hypogonadism (a testicular problem) and hypogonadotropic hypogonadism (a pituitary/hypothalamic problem).
- Safety and effectiveness of Testim for age-related low testosterone ('low T' of ageing alone, without an underlying medical cause) have not been established, and it is not approved for use in women or in males under 18.
- Testim is self-applied once daily to clean, dry skin of the shoulders or upper arms, and it must be distinguished from injectable, intramuscular, and other testosterone formulations, which have different dosing and monitoring requirements.
Side Effects
- Testim carries a boxed warning: virilization (early puberty-like changes, such as enlarged genitals, increased body hair, or aggressive behaviour) has been reported in children secondarily exposed to testosterone gel through skin contact with an unwashed or unclothed application site on a treated man.
- The most common effects are application-site skin reactions and a rise in red blood cell count (haematocrit).
- Other reactions include headache, raised blood pressure, and breast tenderness or enlargement (gynaecomastia).
- Report leg pain, swelling, redness or unexpected shortness of breath urgently, as these can signal a blood clot.
- Cover the application site with clothing once the gel has dried, and wash your hands after applying.
Precautions & Warnings
- Testim is contraindicated in men with breast cancer or known or suspected prostate cancer, and must not be used by pregnant women or allowed to contact a pregnant partner's skin, as testosterone can harm an unborn baby.
- Your doctor checks prostate-specific antigen (PSA) and performs a prostate exam before starting and periodically during treatment, and monitors haematocrit and blood pressure, since Testim is not suitable for uncontrolled high blood pressure.
- It may worsen benign prostatic hyperplasia (enlarged prostate) symptoms and can increase the risk of blood clots.
- Children and women must avoid all contact with unwashed or unclothed treated skin.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you use.
- Testosterone in Testim can lower blood glucose in people with diabetes, so insulin or other diabetes medicine doses may need adjusting, and blood sugar should be checked more closely after starting or stopping treatment.
- Testim can increase the blood-thinning effect of warfarin and similar anticoagulants, so INR is monitored more frequently, particularly when starting or changing the Testim dose.
- Corticosteroids used together with Testim can increase fluid retention.
- Always wash your hands after applying the gel and let it dry fully before dressing or contact with others.
References
Frequently Asked Questions
Testim (testosterone gel) treats low testosterone in adult men caused by primary or hypogonadotropic hypogonadism - a testicular or pituitary problem. It is not approved for age-related low testosterone alone, and it is not used in women or in males under 18.
You apply Testim once daily to clean, dry skin of your shoulders or upper arms, using the amount your doctor prescribes. Let the gel dry fully before dressing, and wash your hands afterward to avoid transferring testosterone to other people.
Testim carries a boxed warning: children can develop early puberty-like changes if they touch an unwashed treated area on a man using Testim. Common effects include skin reactions where applied and a rise in red blood cell count. Report leg swelling or breathlessness urgently.
Avoid letting children or women touch unwashed or unclothed skin where you applied Testim, since testosterone can transfer and cause harm to them. Testim is avoided in men with prostate or breast cancer, and it must not be used during pregnancy.
Before and during Testim treatment, your doctor checks your PSA and prostate, red blood cell count (haematocrit), and blood pressure. These tests help catch prostate changes, blood thickening, or high blood pressure early, so testing continues at intervals throughout treatment.
Testosterone gels like Testim can reduce sperm production and fertility with long-term use. Discuss family planning with your doctor before starting, since treatment is often continued long term for confirmed hypogonadism, with regular blood tests guiding any future dose changes.
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