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Progestogen (4th Generation, Anti-Endometriotic) Pregnancy: CONTRAINDICATED — suppress ovulation but also potentially teratogenic; effective contraception not required (dienogest itself suppresses ovulation) but pregnancy test recommended if amenorrhoea

Dienogest

Brand names: Visanne, Zalkya

Adult dose

Dose: 2 mg once daily continuously (no treatment-free interval)
Route: Oral
Frequency: Once daily continuously
Max: 2 mg/day
Endometriosis treatment; continuous dosing — amenorrhoea may develop; can be used long-term; superior to placebo and comparable to GnRH agonists in pain reduction without bone loss

Paediatric dose

Dose: Not established for <12 years; limited data in adolescents N/A/kg
Route: Oral
Frequency: N/A
Max: 2 mg/day if used in adolescents (specialist)
Some specialist centres use off-label in adolescent endometriosis ≥12 years

Dose adjustments

Renal

No dose adjustment required

Hepatic

Contraindicated in liver disease (current or history)

Paediatric weight-based calculator

Some specialist centres use off-label in adolescent endometriosis ≥12 years

Clinical pearls

  • Dienogest vs GnRH agonists (GARDA trial): comparable efficacy for endometriosis-related pain without the bone mineral density loss seen with leuprorelin — ESHRE guideline endorses dienogest as first-line medical management for endometriosis
  • Unique pharmacology: partial oestrogen receptor agonism locally allows maintenance of moderate local E2 without systemic oestrogenic effects — this local effect suppresses endometriotic implants without inducing full surgical menopause
  • No add-back therapy required (unlike GnRH agonists) — suitable for longer-term use (>6 months) without bone density monitoring as standard
  • Irregular bleeding in first 3 months is the main reason for discontinuation — counsel patients thoroughly; amenorrhoea usually develops with continued use and should be presented as a benefit, not an adverse effect
  • MHRA approved for endometriosis; NICE NG73 recommends progestogen therapy as one of the options; dienogest is preferred over older progestogens (medroxyprogesterone, norethisterone) in current ESHRE guidance due to more targeted anti-endometriotic mechanism

Contraindications

  • Thromboembolism (current or history)
  • Ischaemic heart disease or stroke
  • Undiagnosed vaginal bleeding
  • Known/suspected sex-hormone-sensitive malignancies
  • Severe liver disease

Side effects

  • Irregular bleeding/spotting (most common — especially first 3 months)
  • Amenorrhoea (develops in many with prolonged use)
  • Headache
  • Breast discomfort
  • Mood changes
  • Weight gain
  • Bone density — minimal loss (less than GnRH agonists)

Interactions

  • CYP3A4 inducers (rifampicin, carbamazepine) — reduce dienogest levels; reduced efficacy
  • St John's Wort — induces CYP3A4; reduce dienogest levels

Monitoring

  • Symptom response (pain scores)
  • Menstrual pattern
  • Blood pressure
  • BMD (only if additional risk factors or prolonged use >2 years)

Reference: BNFc; BNF 90; GARDA trial (Strowitzki et al. Fertil Steril 2010); ESHRE Endometriosis Guideline (2022); NICE NG73; SPC Visanne; Schindler et al. Maturitas 2011. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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