Essential Precautions for Patients Taking Isotretinoin
Patients taking isotretinoin must strictly adhere to the iPLEDGE REMS program requirements, with pregnancy prevention being the most critical precaution due to the severe risk of birth defects. 1
Pregnancy Prevention Requirements
All patients must enroll in the iPLEDGE REMS program before starting isotretinoin 1
For patients who can become pregnant:
- Must have two negative pregnancy tests before starting therapy 1
- Must use two effective forms of contraception simultaneously for one month before, during, and for one month after treatment (unless committing to complete abstinence) 1
- Monthly pregnancy tests are required during treatment 2, 1
- Must obtain prescriptions within 7 days of pregnancy test specimen collection 1
For all patients:
Laboratory Monitoring
Baseline tests before starting isotretinoin:
Ongoing monitoring:
Medication Interactions
Avoid concurrent use of:
Use with caution with:
Dermatologic Precautions
- Avoid excessive sun exposure and use sunscreen due to increased photosensitivity 2
- Avoid waxing for hair removal as retinoids cause skin fragility 2
- Use liberal emollients for management of mucocutaneous dryness, which affects almost all patients 2
- Be aware of increased risk of minor skin infections (folliculitis, furunculosis) due to higher rates of S. aureus colonization 2
Mental Health Monitoring
- Patients and family members should be informed about monitoring for signs of depression, mood changes, or suicidal thoughts 1
- Signs of depression include sad mood, hopelessness, feelings of guilt, worthlessness, fatigue, difficulty concentrating, changes in sleep patterns or appetite, and suicidal thoughts 1
- Discontinue isotretinoin and contact the prescriber promptly if depression, mood disturbance, psychosis, or aggression develops 1
Special Considerations
- Elective cosmetic procedures (dermabrasion, laser resurfacing) should generally be delayed for 6-12 months after discontinuing isotretinoin 2
- Patients with diabetes should have more frequent monitoring of blood glucose levels 2
- Patients with a history of bone disorders or those on medications affecting bone metabolism should be monitored carefully 1
- Patients should avoid participation in sports with repetitive impact due to potential risk of fractures or delayed healing 1
Following these precautions is essential to minimize risks while maximizing the therapeutic benefits of isotretinoin for treating severe, recalcitrant acne.