Azmiro

AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [ see Dosage and Administration ( 2.2 ) ].
• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [ see Dosage and Administration (2.2) ]. Limitations of Use
• Safety and efficacy of AZMIRO in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
• Safety and efficacy of AZMIRO in pediatric patients below the age of 12 years have not been established [ see Use in Specific Populations ( 8.4 ) ]. AZMIRO is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ): Limitations of Use:
• Safety and efficacy of AZMIRO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established ( 1 ).
• Safety and effectiveness in pediatric patients below the age of 12 years have not been established ( 8.4 ).

AZMIRO is contraindicated in:

• Known hypersensitivity to AZMIRO or to any of its components [see Description ( 11 )]. Hypersensitivity, including skin manifestations and anaphylactoid reactions have been reported [ see Adverse Reactions ( 6.2 ) ].
• Men with carcinoma of the breast or known or suspected carcinoma of the prostate gland [ see Warnings and Precautions ( 5.3 ) ].
• Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [ see Use in Specific Populations ( 8.1 ) ].
• Known hypersensitivity to AZMIRO or any of its components, skin manifestations and anaphylactoid reactions have been reported ( 4 )
• Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ).