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It is used for hormone replacement in men who are not able to produce enough testosterone (hypogonadism). To decrease this risk, carefully follow all directions for the proper use of this drug. Children should avoid contact with any unwashed or unclothed area where the medication has been applied. RxList does not provide medical advice, diagnosis or treatment. Dose titrations on Days 14, 35, and 60 resulted in mean (SD) Cavg and Cmax for final doses of 10 mg to 70 mg on Day 90 shown in Table 5. The percentages of patients with Cmax greater than 1500 ng/dL, and between 1800 and 2499 ng/dL on Day 90 were 5.4% and 1.6%, respectively. The secondary endpoint was the percentage of patients with Cmax above 3 pre-determined limits.
The metered dose pump is capable of dispensing 120 metered pump actuations. To obtain a full first dose, it is necessary to prime the canister pump. In addition, serum testosterone concentration should be assessed periodically thereafter. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. Prior to initiating, FORTESTA confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range.
In patients treated with FORTESTA, 77.5% (100/129) had Cavg within the normal range on Day 90. The primary endpoint was the percentage of patients with Cavg within the normal range (greater than or equal to 300 ng/dL and less than or equal to 1140 ng/dL) on Day 90. On the other thigh, the application site was washed with liquid soap and warm tap water, dried, and then wiped using dry sponges. Two (2) hours after the application of FORTESTA onto each inner thigh, one thigh was wiped using dry sponges. A mean (SD) of 0.002 (0.006) mg of residual testosterone (ie, 99.8% reduction compared to when hand was not washed) was recovered after washing hands with liquid soap and warm tap water.
Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. Fortesta is a clear, colorless, odorless, gel containing testosterone. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Fortesta. Fortesta may cause serious adverse reactions in nursing infants. The starting dose of Fortesta is 40 mg (4 pumps) applied topically once daily in the morning. We have also independently evaluated relevant literature and data for possible post-marketing adverse events.
Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease see ADVERSE REACTIONS. Androgens, including FORTESTA, may promote retention of sodium and water. Long-term therapy with testosterone enanthate has produced multiple hepatic adenomas. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
This medication may raise your blood pressure. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Redness/irritation at the application site and acne may occur.