Adult: 2 mg once daily. Doses must be taken continuously regardless of any vaginal bleeding. May initiate therapy on any day of menstrual cycle.
What are the brands available for Dienogest in Malaysia?
Visanne
Hepatic Impairment
Severe: Contraindicated.
Administration
Dienogest May be taken with or without food.
Contraindications
Undiagnosed abnormal vaginal bleeding; active venous thromboembolic disorder; history of or current arterial and CV disease (e.g. MI, ischaemic heart disease, cerebrovascular accident); presence or history of hepatic neoplasia (benign or malignant); diabetes mellitus with vascular involvement; known or suspected sex hormone-dependent malignancy. Current or history of severe hepatic impairment (where LFTs have not returned to normal). Pregnancy and lactation.
Special Precautions
Patient with risk factors for VTE (e.g. personal or family history of VTE, obesity, prolonged immobilisation, major trauma), risk factors for CV disease and cerebral events (e.g. hypertension, smoking); risk factors for osteoporosis; diabetes or history of gestational diabetes; history of extrauterine pregnancy or tube function impairment; history of depression; history of chloasma gravidarum; history of cholestatic jaundice and pruritus during pregnancy or due to the use of sex steroids. Patients undergoing surgery. Any hormonal contraception must be discontinued prior to treatment initiation; if contraception is needed, non-hormonal contraception (e.g. barrier method) should be used.
Adverse Reactions
Significant: Irregular menstrual bleeding (e.g. amenorrhoea, prolonged bleeding, frequent or infrequent bleeding), BMD loss, chloasma, persistent ovarian cyst; risk of thromboembolic disorders; depression; may impair glucose tolerance; recurrence of cholestatic jaundice or pruritus in patients with history of these conditions during pregnancy or previous use of sex steroids. Rarely, benign and malignant hepatic tumours. Gastrointestinal disorders: Nausea, abdominal pain and distension, flatulence, vomiting. General disorders and administration site conditions: Asthenia. Investigations: Increased weight. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, migraine. Psychiatric disorders: Sleep disorder, nervousness, loss of libido, mood alteration, irritability, anxiety. Reproductive system and breast disorders: Breast discomfort, uterine or vaginal bleeding, including spotting. Skin and subcutaneous tissue disorders: Acne, alopecia. Vascular disorders: Hot flushes.
Patient Counseling Information
Ensure adequate intake of calcium and vitamin D. Avoid exposure to sunlight or UV light during treatment, particularly if at risk of developing chloasma. If contraception is required, women of childbearing potential must use non-hormonal methods of contraception (e.g. barrier method) during treatment.
Monitoring Parameters
Verify pregnancy status prior to starting therapy. Perform adequate diagnostic measures (e.g. endometrial sampling) to rule out malignancy, if necessary, in all cases of undiagnosed abnormal vaginal bleeding. Monitor blood pressure; BMD in patients at risk for osteoporosis (before treatment and as clinically indicated). Assess for signs and symptoms of depression and endometrial-related pain.
Drug Interactions
Diminished therapeutic effect with CYP3A4 inducers (e.g. phenytoin, barbiturates, carbamazepine, rifampicin, oxcarbazepine, felbamate, griseofulvin). May increase exposure with strong and moderate CYP3A4 inhibitors (e.g. ketoconazole, erythromycin).
Food Interaction
Diminished therapeutic effect with St. John's wort. May increase exposure with grapefruit juice.
Lab Interference
May interfere with the results of certain laboratory tests including glucose tolerance, serum folate, coagulation and fibrinolysis, lipoprotein levels, and liver, thyroid, adrenal and renal function.
Action
Description: Mechanism of Action: Dienogest, a nortestosterone derivative, is a steroid with antiandrogenic properties that has no significant androgenic, mineralocorticoid or glucocorticoid activity. It exerts a strong progestogenic effect in the uterus, decreasing estradiol production and thereby suppressing the trophic effects of estradiol on both eutopic and ectopic endometrium. Continuous administration of dienogest leads to hypoestrogenic, hypergestagenic endocrine environment, which causes decidualisation and subsequent atrophy of endometriotic lesions. Pharmacokinetics: Absorption: Rapidly and almost completely absorbed. Bioavailability: Approx 91%. Time to peak plasma concentration: Approx 1.5 hours. Distribution: Volume of distribution: 40 L. Plasma protein binding: Approx 90% non-specifically to albumin. Metabolism: Metabolised in the liver mainly by CYP3A4 into inactive metabolites. Excretion: Via urine (mainly as inactive metabolites). Elimination half-life: Approx 9-10 hours.
Chemical Structure
Dienogest Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 68861, Dienogest. https://pubchem.ncbi.nlm.nih.gov/compound/Dienogest. Accessed Aug. 27, 2025.
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