What are the off-label uses of Visanne (Dienogest) beyond endometriosis?

From the Guidelines

Dienogest (Visanne) is used off-label for the treatment of acne vulgaris, among other conditions, due to its anti-androgenic properties. The use of Visanne for acne treatment is supported by its classification as a fourth-generation progestin, which includes drospirenone and dienogest, known for their antiandrogenic effects 1. These properties make Visanne a potential option for managing acne, particularly in women who may also benefit from its contraceptive effects or have conditions like polycystic ovary syndrome (PCOS) that often involve acne and hormonal imbalances. Key points to consider when using Visanne off-label for acne include:

• Its mechanism of action, which involves reducing ovarian androgen production and increasing sex hormone-binding globulin, thereby reducing free testosterone that can exacerbate acne 1.
• The typical dosage for Visanne in the treatment of endometriosis is 2mg daily, but the dosage for off-label uses like acne may need to be adjusted based on individual patient response and side effects.
• Potential side effects, such as irregular bleeding, headaches, breast tenderness, and mood changes, which are common in the first few months of treatment and should be monitored by a healthcare provider.
• The importance of regular follow-up to assess the efficacy of Visanne for acne treatment and to manage any adverse effects that may arise. Given the moderate certainty evidence supporting the use of combined oral contraceptives (which include progestins like dienogest) for acne treatment 1, Visanne can be considered a viable off-label option for patients with acne vulgaris, especially when hormonal factors are suspected to play a role in the condition's pathogenesis.

From the Research

Off-Label Uses of Visanne (Dienogest)

• Visanne (Dienogest) is primarily indicated for the treatment of endometriosis, but research suggests its potential off-label uses include:
  • Treatment of primary dysmenorrhea: Studies 2, 3 have demonstrated the efficacy and safety of dienogest in relieving pain associated with primary dysmenorrhea.
  • Treatment of secondary dysmenorrhea: Research 3 has also shown that dienogest can effectively relieve pain in patients with secondary dysmenorrhea.
• The dosage of dienogest for these off-label uses may vary, with studies suggesting:
  • 1 mg/day as an effective and well-tolerated dose for primary dysmenorrhea 2, 3.
  • 2 mg/day as a potentially effective dose, but with a higher incidence of irregular uterine bleeding 2.

Safety and Efficacy

• Dienogest has been shown to be generally well-tolerated, with common side effects including irregular uterine bleeding and spotting 2, 3.
• The safety profile of dienogest is similar to that of other hormonal treatments, with no significant differences in terms of clinically relevant side effects 4.

Clinical Evidence

• Studies 5, 6, 4, 2, 3 provide evidence for the efficacy and safety of dienogest in the treatment of endometriosis and its potential off-label uses.
• Further research is needed to fully establish the efficacy and safety of dienogest for off-label uses, but current evidence suggests its potential as a therapeutic option for patients with primary and secondary dysmenorrhea.