What are the contraindications and monitoring parameters for Visanne (Dienogest)?

Contraindications and Monitoring Parameters for Visanne (Dienogest)

Visanne (dienogest) is contraindicated in women who are pregnant or may become pregnant, and women of reproductive potential must be counseled regarding the use of reliable methods of contraception. 1, 2

Contraindications

Absolute Contraindications:

• Pregnancy or women attempting to conceive 1, 2
• Breastfeeding women 1, 2
• Active or history of thromboembolic disorders (similar to other hormonal therapies) 1
• Uncontrolled hypertension 1
• Active/clinically significant liver disease 1
  • Child-Pugh Class B or C
  • Elevated liver enzymes (ALT/AST >3x upper limit of normal)
  • Total bilirubin >2x upper limit of normal
  • Active hepatitis or cirrhosis

Relative Contraindications:

• History of or current depression (use with caution due to potential mood effects) 1
• Severe renal dysfunction (use with caution) 1
• History of hormone-dependent malignancies 2
• Use with strong CYP3A4 inhibitors or inducers (may affect drug metabolism) 1

Monitoring Parameters

Baseline Assessment:

• Complete medical and gynecological history 2

  • Focus on risk factors for thromboembolic disease
  • Previous hormonal therapy responses
  • History of liver disease
  • History of depression or mood disorders

• Physical examination 2

  • Blood pressure measurement
  • Body weight assessment
  • Breast examination

• Laboratory tests 1, 2

  • Liver function tests (ALT, AST, bilirubin)
  • Complete blood count
  • Pregnancy test (must be negative before initiating therapy)
  • Consider lipid profile

Ongoing Monitoring:

• Bleeding patterns 2, 3

  • Abnormal uterine bleeding is common with dienogest (especially during initial months)
  • Bleeding intensity and frequency typically decrease over time
  • Document changes in bleeding patterns at each visit

• Pain assessment 2, 4

  • Monitor changes in endometriosis-related pain using visual analog scale
  • Evaluate effectiveness in reducing dysmenorrhea and pelvic pain

• Liver function 1

  • Periodic monitoring of liver enzymes, especially in first few months
  • More frequent monitoring if baseline values were elevated

• Blood pressure 1

  • Regular monitoring throughout treatment

• Mood changes 1

  • Assessment for depression or mood alterations
  • Particularly important in patients with history of depression

• Bone mineral density 4

  • Consider monitoring with long-term use (>1 year)
  • Especially important in adolescents and young adults

• Weight changes 2

  • Monitor at regular intervals

Special Considerations

• Contraceptive counseling 1, 2

  • Women must use reliable contraception during treatment
  • Dienogest at 2mg/day provides moderate ovulation inhibition but should not be relied upon for contraception alone 3

• Menstrual changes 2, 3

  • Patients should be counseled about potential irregular bleeding patterns
  • Bleeding typically decreases over time with continued use

• Drug interactions 1

  • Monitor for interactions with CYP3A4 inhibitors or inducers
  • May affect efficacy or side effect profile

• Discontinuation 3

  • Ovulation typically returns rapidly after treatment cessation
  • Consider alternative contraception if pregnancy is not desired

• Long-term therapy considerations 4

  • Dienogest may be used long-term until menopause in endometriosis patients
  • Ongoing monitoring becomes particularly important with extended use