s are reported voluntarily from a population of uncertain size, it is notalways possible to reliably estimate their frequency or establish a causal relationship to drugexposure.
Cardiovascular Disorders: myocardial infarction, stroke [see Warnings and Precautions (5.3)]
Vascular Disorders: Venous thromboembolism [see Warnings and Precautions (5.5)]
7 DRUG INTERACTIONS
7.1 Insulin
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 necessitate a decrease in the dose of anti-diabetic medication.
7.2 Oral Vitamin K Antagonist AnticoagulantsChanges in anticoagulant activity may be seen with androgens; therefore, more frequentmonitoring of international normalized ratio (INR) and prothrombin time are recommended inpatients taking warfarin, especially at the initiation and termination of androgen therapy.
7.3 Corticosteroids
The concurrent use of testosterone with corticosteroids may result in increased fluid retentionand requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
7.4 Medications that May Also Increase Blood Pressure
Some prescription medications and nonprescription analgesic and cold medications contain drugsknown to increase blood pressure. Concomitant administration of these medications withJATENZO may lead to additional increases in blood pressure [see Boxed Warning and Warningsand Precautions (5.1)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
JATENZO is contraindicated in pregnant women. Testosterone is teratogenic and may causefetal harm based on data from animal studies and its mechanism of action [see Contraindications(4) and Clinical Pharmacology (12.1)]. Exposure of a female fetus to androgens may result invarying degrees of virilization. In animal developmental studies, exposure to testosterone inutero resulted in hormonal and behavioral changes in offspring and structural impairments ofreproductive tissues in female and male offspring. These studies did not meet current standardsfor nonclinical development toxicity studies.
Data
Animal Data
In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnantanimals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacementtherapy resulted in structural impairments in both female and male offspring. Structuralimpairments observed in females included increased anogenital distance, phallus development,empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, andincreased ovarian follicular recruitment. Structural impairments seen in male offspring includedincreased testicular weight, larger seminal tubular lumen diameter, and higher frequency ofoccluded tubule lumen. Increased pituitary weight was seen in both sexes.
Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring.
Hypertension was observed in pregnant female rats and their offspring exposed to dosesapproximately twice those used for testosterone replacement therapy.
8.2 Lactation
Risk Summary
JATENZO is not indicated for use in women.
8.3 Females and Males of Reprodu |
