Visanne Special Precautions

Before starting Visanne treatment, pregnancy must be excluded. During treatment, patients are advised to use non-hormonal methods of contraception (eg, barrier method) if contraception is required.
Pregnancies that occur among users of progestogen-only preparations used for contraception (eg, minipill) are more likely to be ectopic than are pregnancies among users of combined oral contraceptives. Therefore, 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.
As Visanne is a progestogen-only preparation, it can be assumed that warnings and precautions for use of other progestogen-only preparations are also valid for the use of Visanne although not all of the warnings and precautions are based on respective findings in the clinical studies with Visanne.
If any of the conditions/risk factors mentioned as follows is present or deteriorates, an individual risk-benefit analysis should be done before Visanne is started or continued.
Circulatory Disorders: From epidemiological studies, there is little evidence for an association between progestogen-only preparations and an increased risk of myocardial infarction or cerebral thromboembolism. The risk of cardiovascular and cerebral events is rather related to increasing age, hypertension and smoking. In women with hypertension, the risk of stroke may be slightly enhanced by progestogen-only preparations.
Some studies indicate that there may be a slightly, but not statistically significant increased risk of venous thromboembolism (VTE) (deep venous thrombosis, pulmonary embolism) associated with the use of progestogen-only preparations. Generally recognized risk factors for VTE include a positive personal or family history (VTE in a sibling or a parent at a relatively early age), age, obesity, prolonged immobilization, major surgery or trauma. In case of long-term immobilization, it is advisable to discontinue the use of Visanne (in the case of elective surgery, at least 4 weeks in advance) and not to resume treatment until 2 weeks after complete remobilization.
The increased risk of thromboembolism in the puerperium must be considered. Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof.
Tumors: A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR=1.24) of having breast cancer diagnosed in women who are currently using oral contraceptives (OCs), mainly estrogen-progestogen preparations. The excess risk gradually disappears during the course of the 10 years after cessation of combined oral contraceptives (COC) use. Because breast cancer is rare in women <40 years, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. The risk of having breast cancer diagnosed in progestogen-only pill users is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
In rare cases, benign liver tumors and even more rarely, malignant liver tumors have been reported in users of hormonal substances eg, the one contained in Visanne. In isolated cases, these tumors have led to life-threatening intra-abdominal hemorrhages. A hepatic tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur in women taking Visanne.
Changes in Bleeding Pattern: Visanne treatment affects the menstrual bleeding pattern in the majority of women (see Adverse Reactions).
Uterine bleeding eg, 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.
Other Conditions: Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
Visanne generally does not appear to affect blood pressure in normotensive women. However, if a sustained clinically significant hypertension develops during the use of Visanne, it is advisable to withdraw Visanne and treat the hypertension.
Recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of Visanne.
Visanne may have a slight effect on peripheral insulin resistance and glucose tolerance. Diabetic women, especially those with a history of gestational diabetes mellitus, should be carefully observed while taking Visanne.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Visanne.
Persistent ovarian follicles (often referred to as functional ovarian cysts) may occur during the use of Visanne. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain.
Lactose: Each Visanne tablet contains lactose monohydrate 63 mg. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should consider the amount contained in Visanne.
Medical Examination: A complete medical history should be taken and a physical and gynecological examination should be performed prior to the initiation or reinstitution of the use of Visanne, guided by the contraindications (see Contraindications) and these should be repeated regularly during the use of Visanne. The frequency and nature of these assessments should be adapted to the individual woman but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, and should also include cervical cytology.
Effects on the Ability to Drive or Operate Machinery: Not known.
Impairment of Fertility: Based on available data, ovulation is inhibited in the majority of patients during treatment with Visanne. However, Visanne is not a contraceptive.
Visanne was not studied for contraceptive efficacy, but DNG 2 mg has been shown in a study involving 20 women to inhibit ovulation after 1 month of treatment.
If contraception is required, a non-hormonal method should be used.
Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with Visanne.
Use in lactation: Treatment with Visanne during lactation is not recommended. Physiochemical properties and animal data indicate excretion of dienogest in breast milk. A decision must be made whether to discontinue breastfeeding or to abstain from Visanne therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Use in children: Children and Adolescents: Visanne is not indicated in children prior to menarche. The safety and efficacy of Visanne in adolescents (menarche to 18 years) has not yet been established.
Use in the elderly: There is no relevant indication for the use of Visanne in the geriatric population.