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Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a controlled multicenter, open label, non-comparative 90-day clinical study, 149 hypogonadal patients were treated with FORTESTA [see Clinical Studies]. Adverse reactions occurred in 22.8% (34/149) of patients. The most common adverse reaction reported in this study was skin reactions associated with the site of application (16.1%; 24/149) of which 79% (19/24) were mild, and the remainder were moderate (21%; 5/24) (Table 3).
Table 3 : Adverse Reactions Reported in > 1%
Patients in the US Phase 3 Clinical Trial of FORTESTA
|Adverse Reaction||Number (%) of Patients
N = 149
|Skin reaction||24 (16.1%)|
|Prostatic specific antigen increased||2 (1.3%)|
|Abnormal dreams||2 (1.3%)|
During the 90 day trial 5 patients (3.4%) discontinued treatment because of adverse reactions. These reactions were: 1 patient with contact dermatitis (considered probably related to FORTESTA application), 1 with application site reaction (considered probably related to FORTESTA application), 1 with gastrointestinal hypomotility (considered possibly related to FORTESTA application), 1 with severe dyspnea (considered not related to FORTESTA application), and 1 with moderate contusion (considered not related to FORTESTA application).
The following adverse reactions have been identified during post approval use of FORTESTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 4).
Table 4 : Adverse Drug Reactions from Post approval
Experience of FORTESTA by System Organ Class
|System Organ Class||Adverse Reaction|
|Blood and lymphatic system disorders||Polycythemia|
|Eye disorders||Vitreous detachment|
|Gastrointestinal disorders||Abdominal symptoms|
|General disorders and administrative site conditions||Application site erythema, irritation, pruritus, and swelling; fatigue, influenza like illness, and malaise.|
|Investigations||Decreased serum testosterone, increased hematocrit and hemoglobin|
|Musculoskeletal and connective tissue disorders||Pain in extremity|
|Nervous system disorders||Dizziness, headache, and migraine|
|Reproductive system and breast disorders||Erectile dysfunction, and priapism|
|Skin and subcutaneous tissue disorders||Allergic dermatitis, erythema, rash, and papular rash.|
|Vascular disorders||Venous thromboembolism|
Secondary Exposure To Testosterone In Children
Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirts and/or other fabric, such as towels and sheets [see WARNINGS AND PRECAUTIONS].
Read the Fortesta (testosterone gel) Side Effects Center for a complete guide to possible side effects
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements.
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
The concurrent administration of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
Drug Abuse And Dependence
FORTESTA contains testosterone, a Schedule III controlled substance as defined under the Anabolics Steroid Control Act.
Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects.
Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence is characterized by any three of the following:
- Taking more drug than intended
- Continued drug use despite medical and social problems
- Significant time spent in obtaining adequate amounts of drug
- Desire for anabolic steroids when supplies of the drugs are interrupted
- Difficulty in discontinuing use of the drug despite desires and attempts to do so
- Experience of a withdrawal syndrome upon discontinuation of anabolic steroid use.
Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.
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