VISANNE 2/MG TAB 28/TAB

Indications

Approved Uses

Treatment of endometriosis

Off-Label Uses

Adenomyosis; heavy menstrual bleeding (including bleeding associated with endometriosis/adenomyosis) and dysmenorrhea/pelvic pain related to these conditions.

Dosage & Administration

Dosing by Condition

Endometriosis: 2 mg orally once daily continuously (no breaks), starting on any day of the menstrual cycle.

Initial Dose

2mg orally once daily, can be started on any day of the menstrual cycle.

Maintenance Dose

2mg orally once daily, taken continuously without any break.

Maximum Dose

2mg orally once daily

Children's Dosage

Not intended for use before menarche. Safety and efficacy have been studied in adolescents, but it may affect bone mineral density.

How to Take

Take 1 tablet (dienogest 2 mg) orally once daily at about the same time each day; swallow with water; may be taken with or without food; take continuously every day without any tablet-free interval and start the next pack the day after finishing the previous pack.

Side Effects

Common Side Effects

Headache, breast discomfort, nausea, acne, weight gain, menstrual irregularities (spotting, breakthrough bleeding, amenorrhea), depressed mood, hot flushes.

Side Effect Frequency

Very common (>10%): uterine bleeding disturbances (e.g., irregular/abnormal bleeding), headache, breast discomfort/pain. Common (1-10%): depressed mood, acne, nausea, weight gain. (Amenorrhea is also commonly reported as part of bleeding pattern changes.)

Safety & Warnings

Warnings & Precautions

Not a contraceptive-if contraception is needed, use non-hormonal methods and avoid concomitant hormonal contraceptives; discontinue and evaluate if thrombotic event occurs or if jaundice/clinically significant liver dysfunction develops; monitor/advise regarding mood changes or depression; expect and monitor irregular bleeding patterns; consider bone health (BMD may decrease with prolonged use), especially in adolescents/other osteoporosis risk groups; use caution in patients with thromboembolic risk factors, hypertension, or diabetes.

Special Populations

Pregnancy

Contraindicated

Children

Not intended for use before menarche. Safety and efficacy have been studied in adolescents, but it may affect bone mineral density.

Elderly

Not indicated in postmenopausal women; no specific data for elderly use

Storage & Patient Advice

Stopping the Medicine

May be stopped at any time without tapering; ovarian function/bleeding patterns typically recover after stopping, and endometriosis symptoms may recur-discuss with prescriber before discontinuation if stopping due to adverse effects or lack of control.

Patient Counseling

Take 1 tablet daily at the same time with no breaks between packs, even if bleeding occurs. Not a contraceptive-use non-hormonal contraception if pregnancy prevention is needed. Expect irregular bleeding/spotting especially early. Seek care for severe mood changes/depression, signs of thrombosis (leg swelling/pain, chest pain, shortness of breath), severe headache, or jaundice/severe abdominal pain. Tell clinicians about all medicines/herbals (especially CYP3A4 inducers like St John’s wort) and avoid grapefruit.

Monitoring Requirements

Monitor blood pressure periodically; assess mood/depression; perform routine gynecologic follow-up (including breast/pelvic exam as clinically indicated); monitor for abnormal uterine bleeding and anemia if heavy/prolonged; check liver function if symptoms/signs of hepatic dysfunction occur; consider bone health/BMD risk assessment in patients with osteoporosis risk factors or prolonged therapy.

Pharmacology

Mechanism of Action

Synthetic progestin (progesterone receptor agonist) that suppresses endometriotic lesion growth mainly by creating a hypoestrogenic/progestogenic environment (reducing estradiol-driven proliferation) and exerting direct anti-proliferative/anti-inflammatory effects on endometrial tissue; ovulation may be inhibited in some patients but it is not a reliable contraceptive.

Onset of Action

Bleeding pattern changes can occur within the first weeks; improvement in endometriosis-associated pain typically occurs over several weeks and may take up to ~3 months for maximal benefit.

Duration of Effect

Clinical effect is maintained with continuous once-daily dosing; missed doses can reduce suppression and increase breakthrough bleeding.

Half-Life

Approximately 9-10 hours.

Bioavailability

Approximately 91%.

Metabolism

Extensively metabolized in the liver primarily by CYP3A4 (oxidation/hydroxylation followed by conjugation) to pharmacologically inactive metabolites.

Excretion

Excreted mainly as metabolites via urine and feces (predominantly renal excretion of metabolites).

Product Information

Available Dosage Forms

Tablet

Composition per Dose

Each tablet: 2 mg dienogest

OTC Alternatives

No OTC alternative

Hormone Type

Progesterone

Method

Oral

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