Oligest Special Precautions

As dienogest is a progestogen-only preparation it can be assumed that the special warnings and precautions for use of progestogen-only preparations are also valid for the use of dienogest although not all of the warnings and precautions are based on respective findings in the clinical studies with dienogest.
If any of the conditions/risk factors mentioned as follows is present or deteriorates, an individual risk-benefit analysis should be done before treatment with dienogest can be started or continued.
Changes in Bleeding Pattern: The majority of patients treated with dienogest experience with irregular menstrual bleeding pattern e.g. amenorrhea, infrequent or frequent bleeding, prolonged bleeding. And may be aggravated in some patients. 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 e.g. endometrial sampling, pelvic ultrasound. Consider discontinuation of therapy with prolonged heavy bleeding. Pretreatment menstrual bleeding patterns return within 2 months of therapy discontinuation.
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. Rather, the risk of cardiovascular and cerebral events is related to increasing age, hypertension, and smoking. The risk of stroke may be increased in patients with hypertension. Discontinue if clinically significant hypertension develops during therapy.
Use with caution in patients with risk factors for venous thromboembolism (VTE) including, personal or family history (VTE in a sibling or a parent at a relatively early age), obesity, prolonged immobilization, major surgery, or major trauma.
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 using estrogen-progestogen preparations. The excess risk gradually disappears during the course of the 10 years after cessation of combined OC (COC) use. There are insufficient data specific to progestin-only preparations. However, breast cancer is a hormonal-sensitive tumor and prognosis for patients with a current or recent history of breast cancer may be worse with contraceptive use.
In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of hormonal substances.
Osteoporosis: Bone Mineral Density (BMD) in Adult Women: Endogenous estrogen levels are moderately decreased during treatment with dienogest.
Currently, long-term data on bone mineral density (BMD) and risk of fractures in users of dienogest are not available.
BMD was assessed in 21 adult patients before and after 6 months of treatment with dienogest and there was no reduction of mean BMD.
Bone Mineral Density in Adolescent Females: The use of dienogest in adolescents (12 to 18 years) over a treatment period of 12 months was associated with a mean decrease in BMD in the lumbar spine of 1.2%. Follow-up measurement at 6 months after the treatment in a subgroup with decreased BMD values showed that the mean BMD was increased to -0.6%. After cessation of treatment, BMD increased towards pre-treatment levels in majority of these patients.
In adolescent patients, the use of dienogest has been associated with plateauing and loss of BMD which may not be completely reversible. Loss of BMD is of particular concern during adolescence and early adulthood, as this is a critical period of bone accretion. BMD loss may be greater with increasing duration of use. It is unknown if BMD decrease in this population will reduce peak bone mass and increase the risk for fracture in later life.
Risk/benefits of therapy in adolescents should be evaluated prior to initialing therapy and regularly during therapy. (See Additional Information on Special Populations: Pediatric Population under Dosage & Administration and Pharmacology: Pharmacodynamics under Actions.)
In patients who are at an increased risk of osteoporosis a careful risk-benefit assessment should be performed before starting dienogest because endogenous estrogen levels are moderately decreased during treatment with dienogest. (See Pharmacology: Pharmacodynamics under Actions.)
Adequate intake of calcium and Vitamin D, whether from the diet or from supplements, is important for bone health in women of all ages.
Other Conditions: Patients who have a history of depression should be carefully observed and the drug should be discontinued if the depression recurs to a serious degree.
Dienogest generally does not appear to affect blood pressure in normotensive women. However, if a sustained clinically significant hypertension develops during the use of dienogest, it is advisable to withdraw dienogest and treat the hypertension.
Patients with a prior history of cholestatic jaundice and/or pruritus during pregnancy or due to the use of sex steroids should discontinue use of dienogest if cholestatic jaundice and/or pruritus reoccurs during therapy.
Dienogest may impair glucose tolerance. Diabetic women, especially those with a history of gestational diabetes mellitus, should be carefully observed while taking dienogest. Chloasma may occasionally occur, especially in women with a history of chloasma. Patients should avoid exposure to the sun or ultraviolet radiation whilst taking dienogest.
Persistent ovarian follicles (often referred to as functional ovarian cysts) which are often asymptomatic may occur during therapy.
Lactose: Each OLIGEST tablet contains 102.9 mg of lactose monohydrate. 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 OLIGEST.
Effects on Ability to Drive and Use Machines: No effects on the ability to drive and use machines have been observed in users of products containing dienogest.