Dienogest

Use is associated with irregular menstrual bleeding (eg, amenorrhea, infrequent or frequent bleeding, prolonged bleeding) and may be aggravated in some women (eg, those with fibroids). Bleeding patterns generally show a reduced intensity over time. If bleeding irregularities continue with prolonged use, appropriate diagnostic measures should be taken to rule out endometrial pathology (eg, endometrial sampling, pelvic ultrasound). Consider discontinuation of therapy with prolonged heavy bleeding. Pretreatment menstrual bleeding patterns return within 2 months of therapy discontinuation.

Dienogest has been associated with plateauing and loss of bone mineral density (BMD) which may not be completely reversible; BMD loss may be greater with prolonged use of dienogest and the effects may be of greater concern during adolescence and periods of bone accretion. It is not known if use of dienogest during adolescence will decrease peak bone mass and increase the risk of osteoporosis. A mean decrease in BMD in the lumbar spine of 1.2% has been observed in patients 12 to Risks/benefits of therapy in adolescents should be evaluated prior to initiating therapy and regularly during therapy. BMD monitoring should be considered in adolescent females as clinically appropriate. In a small study of adult patients, a reduction in mean bone mineral density was not observed 6 months after initiating therapy though long term data are not available. Risk assessment should also be performed in women of any age at increased risk of osteoporosis; adequate calcium and vitamin D intake should be encouraged in females of all ages.

Breast cancer is a hormonal sensitive tumor and the prognosis for women with a current or recent history of breast cancer may be worse with combination hormonal contraceptive use (Curtis 2016). Data are insufficient to determine if progestin only preparations also increase this risk. Routine breast examinations are recommended during therapy. Use is contraindicated with known or suspected sex-hormone-dependent malignancy.

May impair glucose tolerance; use caution in women with diabetes or a history of gestational diabetes mellitus.

May occur occasionally; women with a history of chloasma should avoid sun or ultraviolet radiation exposure during therapy.

Patients with a prior history of cholestatic jaundice during pregnancy or due to the use of sex steroids should discontinue use of dienogest if cholestatic jaundice reoccurs during therapy.

Rare cases of benign and malignant hepatic tumors have been reported with use.

Persistent ovarian cysts which are often asymptomatic may occur during therapy.

Patients with a prior history of pruritus during pregnancy or due to use of sex steroids should discontinue dienogest therapy if pruritus reoccurs during therapy.

Progestin-only therapy has been associated with a slight but non-significant increase risk of VTE in some studies; discontinue therapy promptly with suspicion or symptoms of a thrombotic event. Discontinue use in patients with prolonged immobilization and at least 4 weeks prior to elective surgery; may resume therapy 2 weeks after complete remobilization. The risk of thromboembolism may be increased immediately postpartum. Disease-related concerns:

Use with caution in patients with multiple risk factors for cardiovascular disease (eg, older age, hypertension, hypercholesterolemia, morbid obesity, diabetes, women who smoke); use of progestin only preparations may increase the risk of cardiovascular disease (Curtis 2016). Use is contraindicated in women with a history of or current arterial and cardiovascular disease. Discontinue if clinically significant hypertension develops during therapy.

Use with caution in patients with depression; discontinue use with onset of clinically relevant depression or with aggravation of pre-existing depression.

Use is contraindicated in patients with a history of or current severe hepatic disease. Special populations:

Not indicated for use in the geriatric population.

Not for use prior to menarche.

The risk of cardiovascular side effects and the risk of bone mineral density decline is increased in women who smoke cigarettes. Women should be advised not to smoke. Other warnings/precautions:

Not intended for use as a contraceptive.