Progesterone

Progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. Progesterone vaginal insert is a progesterone indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women( 1 ).

Progesterone vaginal insert should not be used in individuals with any of the following conditions:

• Previous allergic reactions to progesterone or any of the ingredients of progesterone vaginal insert [see Description ( 11 )]
• Known missed abortion or ectopic pregnancy
• Liver disease
• Known or suspected breast cancer
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events
• Previous allergic reactions to progesterone or any of the ingredients of progesterone vaginal insert ( 4 )
• Known missed abortion or ectopic pregnancy ( 4 )
• Liver disease ( 4 )
• Known or suspected breast cancer ( 4 )
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events ( 4 )

• Life-threatening arterial or venous thromboembolic disorders may occur during hormone treatment, including treatment with progesterone vaginal insert. Discontinue progesterone vaginal insert if any of these are suspected ( 5.1 )
• Observe patients with a history of depression closely. Consider discontinuation if symptoms worsen ( 5.2 )
• Progesterone vaginal insert is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert ( 5.3 )

5.1Cardiovascular or Cerebrovascular Disorders

The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. progesterone vaginal insert should be discontinued if any of these are suspected.