Dosing
The recommended starting daily dose of Testim is 5 g of gel (1 tube) containing 50 mg of testosterone. Morning serum testosterone levels should be measured approximately 14 days after initiation of therapy to ensure normal male serum testosterone levels (>300 ng/dL) are achieved. If the serum testosterone concentration remains below the normal range, or if the desired clinical response is not achieved, the daily Testim dose may be increased to 10 g (2 tubes) as instructed by the physician.
Application
Patients should be directed to apply Testim every day as part of their morning routine to help raise their testosterone levels.
Four steps for using Testim:
- Patients should apply Testim at the same time every day, after a morning shower. Their skin should be clean and dry before they use Testim.
- Patients should tap the tube a few times, then gently pierce the seal of the tube with the cap. They should then squeeze the entire contents into their hands. Used tubes should be discarded where they will be out of the reach of children, to avoid accidental exposure.
- Next, patients should immediately apply gel to the area of their shoulders and upper arms that will be covered by a short sleeved T-shirt. Patients should rub the gel onto their skin for several seconds until the gel is dry. This helps ensure that Testim will enter their system, so they may get the benefits Testim is designed to provide. Instruct them to let Testim dry before they put on their shirt.
- After patients apply Testim, they should wash their hands thoroughly with soap and water. This helps prevent transferring Testim to someone else's skin. As well, they must wear clothing over the application sites after the gel has dried, because the testosterone in Testim must not come in contact with women and children. If patients anticipate direct skin-to-skin contact, they must wash the application sites thoroughly with soap and water.
Other important reminders for patients:
- Do not apply Testim to genitals
- Avoid skin contact with open sores, wounds, or irritations
- Store Testim at room temperature and out of the reach of children
- Keep Testim in a safe, convenient place where it will be seen and used every day
Read about who should be screened for low testosterone »
Read about diagnosing and monitoring your patients »
Indication
Testim 1% (testosterone gel) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Important Safety Information
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Androgens are contraindicated in men with cancer of the breast or known or suspected cancer of the prostate. Testim is not indicated for women and must not be used in women. Pregnant and nursing women should avoid skin contact with Testim application sites on men. Testosterone may cause fetal harm, or harm a breast-feeding baby.
Testim should not be used in patients with known hypersensitivity to testosterone or any of the ingredients in Testim, including soy.
Men treated with androgens may be at an increased risk for prostate cancer, or the development or worsening of benign prostatic hyperplasia.
Testim is not meant for use in women. If you are pregnant, may become pregnant, or are breast-feeding, Testim may harm your unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area where Testim has been applied.
Virilization can occur in women and children secondarily exposed to testosterone. To minimize the potential for secondary exposure to testosterone from Testim-treated skin, patients should wash their hands thoroughly and immediately with soap and water after application of Testim and should cover the application site(s) with clothing after the gel has dried. Prior to any situation in which direct skin-to-skin contact is anticipated, patients should wash the application sites thoroughly with soap and water so as to remove any testosterone residue.
Other risks associated with the use of testosterone include: edema with or without congestive heart failure, gynecomastia, and potentiation of sleep apnea. Large doses of testosterone may suppress spermatogenesis.
The most common adverse events occurring with the use of Testim include: application site reaction, increase in hematocrit/hemoglobin, headache, and increase in blood pressure.
Please see Full Prescribing Information and Medication Guide.