What is the recommended dose of Sevista (Ormeloxifene) for treating mastalgia?

Recommended Dose of Sevista (Ormeloxifene) for Mastalgia

The recommended dose of Ormeloxifene (Sevista/Centchroman) for treating mastalgia is 30 mg orally once daily for 12 weeks, based on multiple clinical trials demonstrating significant pain reduction with this regimen. 1, 2

Standard Dosing Protocol

• Initial treatment: 30 mg orally once daily for 12 weeks 3, 2
• Alternative regimen: 30 mg on alternate days for 3 months has also been studied with good results 4
• The once-daily regimen appears to provide faster and more consistent pain relief, particularly for cyclical mastalgia 2

Expected Treatment Response

• Rapid onset: 90% of patients experience significant pain reduction (VAS score dropping from 10 to 3) within the first week of treatment 4
• Complete response rates:
  • 66% for cyclical mastalgia at 1 week 2
  • 40% for noncyclical mastalgia at 1 week 2
  • 92% for cyclical mastalgia at 12 weeks 2
  • 80% for noncyclical mastalgia at 12 weeks 2
• Overall response rate: 88% at 12 weeks, with sustained effect of 85% at 24 weeks post-treatment 2

Clinical Positioning

Ormeloxifene should be considered as first-line pharmacologic therapy for moderate to severe mastalgia after conservative measures (reassurance, proper bra fitting) have failed. 1, 2

• It is more effective than topical NSAIDs for severe cases 1
• Comparable efficacy to tamoxifen but with a different side effect profile 3
• Particularly effective for cyclical mastalgia, with faster response than noncyclical patterns 2

Critical Safety Considerations and Side Effects

Important contraindications and monitoring requirements:

• Common side effects include dizziness, menstrual irregularities, and development of ovarian cysts 3
• Ovarian cyst development is a significant concern, occurring in a notable proportion of patients 3
• Contraindicated in pregnancy, women planning pregnancy, and breastfeeding mothers (as with other SERMs) 5
• Not recommended during prolonged immobilization or in patients with history of thromboembolic events (extrapolating from other SERM safety profiles) 5

Duration and Follow-up

• Treatment duration: 12 weeks is the standard treatment period 3, 2
• Post-treatment observation: Monitor for 12 weeks after cessation to assess sustained relief 3, 2
• Partial relapse: Some patients may experience partial pain recurrence after stopping treatment, though many maintain significant improvement 3
• Consider retreatment if symptoms recur after the observation period 2

Practical Implementation

Start with 30 mg once daily rather than alternate-day dosing for optimal results:

• Once-daily dosing provides more consistent pain relief 2
• Alternate-day dosing (30 mg every other day) may be considered if side effects occur with daily dosing 4
• Monitor for ovarian cyst development with pelvic ultrasound if menstrual irregularities develop 3
• Assess pain severity using Visual Analog Scale (VAS) at baseline, 1 week, 4 weeks, 12 weeks, and 24 weeks 2

Comparison to Alternative Treatments

Ormeloxifene offers advantages over traditional hormonal therapies:

• Similar efficacy to tamoxifen 10 mg daily but with different side effect profile 3
• Fewer androgenic or severe menopausal side effects compared to danazol 1
• More effective than dopamine agonists for mastalgia 1
• However, the frequency of ovarian cyst development is a significant concern that must be discussed with patients 3

Licensing and Availability Considerations

Note that Ormeloxifene is not licensed in all countries:

• Currently used extensively in India for mastalgia treatment 1
• Not licensed in the United Kingdom or United States as of the most recent evidence 1
• Where unavailable, tamoxifen 10 mg daily remains the most effective alternative with established safety profile 6