What surveillance is recommended for patients on norethindrone (progestin) therapy?

Norethindrone Surveillance Recommendations

Patients on norethindrone therapy should have blood pressure monitoring at baseline and follow-up visits, liver function tests at baseline and periodically during treatment, and regular assessment for side effects including menstrual irregularities and systemic symptoms. 1, 2

Baseline Monitoring

• Pregnancy test prior to initiation (norethindrone is contraindicated in pregnancy - Category X) 1
• Blood pressure measurement 1
• Baseline liver function tests (ALT, AST) due to risk of transaminitis 3
• Assessment of contraindications including history of:
  • Breast cancer 4
  • Thromboembolic disorders 2
  • Cardiovascular disease risk factors 2

Ongoing Monitoring

General Surveillance Schedule

• Clinical review annually for stable patients, with more frequent monitoring during initial therapy 4, 2
• Blood pressure monitoring at each follow-up visit 1
• Assessment of menstrual patterns and bleeding irregularities 2
  • Irregular bleeding is a common side effect and reason for discontinuation 5

Laboratory Monitoring

• Liver function tests periodically, especially for patients on higher doses (≥10 mg daily) 3
  • Consider monitoring every 3-6 months initially, then annually if stable 4
• No routine monitoring of lipid profiles is required but may be considered as norethindrone can occasionally affect HDL levels 2

Symptom-Based Monitoring

• Assess for headaches/migraines - consider discontinuation if new pattern that is recurrent, persistent, or severe 2
• Monitor for gastrointestinal symptoms (nausea, vomiting, diarrhea) which may reduce hormone absorption 2, 3
• Evaluate for signs of decreased milk production in nursing mothers 2

Special Considerations

• For patients with endometriosis using norethindrone for symptom management:

  • Monitor for symptom relief (pain reduction) 6
  • More vigilant liver function monitoring may be needed, as transaminitis has been reported in this population 3
  • Complete resolution of transaminitis typically occurs within 1-12 months after discontinuation 3

• For patients using norethindrone for heavy menstrual bleeding:

  • Assess bleeding patterns regularly 5
  • Monitor for effectiveness in controlling bleeding episodes 5

Patient Education

• Instruct patients to take medication at the same time every day for maximum effectiveness 2
• Advise patients to report prolonged episodes of bleeding, amenorrhea, or severe abdominal pain 2
• Inform patients about potential side effects, particularly menstrual irregularities 2
• Counsel on the need for backup contraception if a dose is missed by 3 or more hours 2

Discontinuation Considerations

• Most common reasons for discontinuation include irregular bleeding (54.5%) and systemic side effects 5
• Fertility typically returns rapidly after discontinuation 2
• If transaminitis occurs, discontinuation typically results in normalization of liver function tests 3