ctive Potential
Infertility
During treatment with large doses of exogenous androgens, including JATENZO,spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitarytesticularaxis [see Warnings and Precautions (5.8)], possibly leading to adverse effects onsemen parameters including sperm count. Reduced fertility is observed in some men takingtestosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also beenreported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence(9.2)]. With either type of use, the impact on fertility may be irreversible.
8.4 Pediatric Use
The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not beenestablished. Improper use may result in acceleration of bone age and premature closure ofepiphyses.
8.5 Geriatric Use
There have not been sufficient numbers of geriatric patients involved in controlled clinicalstudies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of agediffers from younger subjects. No patients over 65 years of age were enrolled in the 4-monthefficacy and safety clinical study utilizing JATENZO. Additionally, there is insufficient longtermsafety data in geriatric patients utilizing JATENZO to assess the potentially increased risk
of cardiovascular disease and prostate cancer.
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
JATENZO contains testosterone undecanoate, which is a Schedule III controlled substance asdefined under the Controlled Substances Act.
9.2 Abuse
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewardingpsychological and physiological effects. Abuse and misuse of testosterone are seen in male andfemale adults and adolescents. Testosterone, often in combination with other anabolicandrogenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abusedby athletes and bodybuilders. There have been reports of misuse by men taking higher doses oflegally obtained testosterone than prescribed and continuing testosterone despite adverse eventsor against medical advice.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenicsteroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy,congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatricmanifestations, including major depression, mania, paranoia, psychosis, delusions,hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks,convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization,deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrualirregularities.
The following adverse reactions have been reported in male and female adolescents: prematureclosure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and mayinclude abuse of other agents, it is not always possible to reliably estimate their frequency orestablish a causal relationship to drug expo |
