Essential information

Visanne^® product description: Each tablet contains 2 mg dienogest. For oral use.

Therapeutic indication: Treatment of endometriosis. Treatment can be started on any day of the menstrual cycle. Tablets should be taken continuously without regard to vaginal bleeding.

Contraindications: Active venous thromboembolic disorder, arterial and cardiovascular disease, present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease), diabetes mellitus with vascular involvement, presence or history of severe hepatic disease as long as liver function values have not returned to normal, presence or history of liver tumors (benign or malignant), known or suspected sex hormone dependent malignancies, undiagnosed vaginal bleeding, hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use: Before starting treatment, pregnancy must be excluded. During treatment, patients are advised to use non-hormonal methods of contraception (e.g. barrier method) if contraception is required. In women with a history of extrauterine pregnancy or an impairment of tube function, the use of Visanne^® should be decided on only after carefully weighing the benefits against the risks. Treatment should be stopped if there are symptoms of an arterial or venous thrombotic event or suspicion thereof. Slightly increased risks of breast cancer diagnosed in women who are currently using oral contraceptives mainly estrogen-progestogen preparations, in rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported. Visanne^® treatment affects the menstrual bleeding pattern in the majority of women. Uterine bleeding, for example in women with adenomyosis uteri or uterine leiomyomata, may be aggravated with the use of Visanne^®. If bleeding is heavy and continuous over time, this may lead to anemia (severe in some cases). Discontinuation of Visanne^® should be considered in such cases. Use in adolescents over a treatment period of 12 months was associated with a mean decrease in bone mineral density (BMD) in the lumbar spine of 1.2%. After cessation of treatment, BMD increased again. The benefits of Visanne^® against the possible risks of use in each individual adolescent patient should weigh also taking into account the presence of significant risk factors for osteoporosis. No BMD decrease was observed in adults. Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. Visanne^® should be discontinued in case of sustained clinically significant hypertension, recurrence of cholestatic jaundice and/or pruritus. Diabetic women should be carefully observed. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation, persistent ovarian follicles may occur during the use of Visanne^®. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain.

Long-term safety: A long-term post-approval observational active surveillance study was conducted to investigate the incidence of first-time occurrence or worsening of clinically relevant depression and occurrence of anemia. A total of 27,840 women with a newly prescribed hormonal therapy for endometriosis were enrolled in the study and followed up for up to 7 years. A total of 3,023 women started with a prescription for dienogest 2 mg and 3,371 patients started with other approved endometriosis drugs. The overall adjusted hazard ratio for new occurrences of anemia comparing the dienogest patients with the patients on other approved endometriosis drugs was 1.1 (95% CI: 0.4–2.6). The adjusted hazard ratio for depression risk comparing dienogest and other approved endometriosis drugs was 1.8 (95% CI: 0.3–9.4). A slightly increased risk of depression in dienogest users compared with users of other approved endometriosis drugs could not be excluded.

Undesirable effects: Undesirable effects are more common during the first months after the start of treatment with Visanne^® and subside with continued treatment. There may be changes in bleeding pattern, such as spotting, irregular bleeding or amenorrhea. The following undesirable effects have been reported in users of Visanne^®. The most frequently reported undesirable effects under treatment with Visanne^® are headache (9.0%), breast discomfort (5.4%), depressed mood (5.1 %) and acne (5.1 %).