What does your patient need to know at the first visit?
Most important is what you need to know before the first visit. As the prescribing physician, you must be familiar with the iPLEDGE program. Because of the complexity of the program, consider identifying a physician in your area to refer patients if you are not going to be a regular prescriber of the medication.
If you are enrolled in iPLEDGE, let your patients (and/or their parents/guardians) know that there is a great deal of misinformation on the Internet. Reiterate that you and your staff are available to discuss their concerns. Also, give them reliable sources of information, such as the American Academy of Dermatology's patient information sheet as well as the Mayo Clinic's acne information. Drugs.com is another resource.
All patients—males, females who cannot become pregnant, and females of childbearing potential (FCBPs)—must be aware that this medication can cause birth defects if taken during pregnancy. They must be informed that the medication is not to be shared with anyone and that they should not give blood while taking this medication.
What treatment course do you recommend?
My evidence-based approach is a course of isotretinoin totaling a minimum of 150 mg per kilogram body weight. Do not give a more abbreviated course unless the patient has cleared early; even then I tend to complete 150 mg when possible. There is published evidence that pushing the course to a total of 220 mg per kilogram body weight results in a longer remission.
Generally, I do few laboratory tests other than pretreatment lipid panels as well as 1 or 2 follow-up lipid panels at monthly intervals. To comply with the iPLEDGE program, FCBP patients must have a monthly pregnancy test, which is reported on the iPLEDGE website before the patient can be prescribed the drug and receive the drug from a pharmacist who is participating in the iPLEDGE program.
One of the defects of the iPLEDGE system is that although only a 30-day supply of pills can be prescribed, it is difficult to always bring a patient back in exactly 30 days; for example, we work on a 4-week cycle and 30 days brings us into the next week or uncommonly the weekend when we do not see patients. Our male patients or females not of childbearing potential are not affected, but for our FCBP patients, it means usually scheduling visits at 35-day intervals because the pregnancy tests must be performed at minimum 28-day intervals and the prescription cannot be written and the pregnancy test recorded until after at least 30 days.
What are the side effects?
The common side effects are what you would expect from a medicine that is supposed to dry up the oil on your skin: dryness of the lips, mouth, and skin, as well as rashes due to the dryness. There also can be minor swelling of the eyelids or lips, nosebleeds, upset stomach, and thinning of the hair; dryness of the scalp may occur. I recommend using a little petroleum jelly inside the nostrils at night to counteract the dryness that leads to nosebleeds, and saline drops or gel for the eyes, especially for contact lens wearers.
Joint aches and pains have been reported, though I rarely see those effects in patients who are physically active such as those participating in competitive sports. Mood changes have been reported, including suicidal ideation.
What do you do if patients refuse treatment?
There is so much false information on the Internet about the dangers of isotretinoin, leaving some patients (and parents/guardians) too afraid to use it. I sympathize with this anxiety, but I do endeavor to point out that the birth defects occur only in women taking the drug while pregnant and have not been reported to occur after the drug is out of the patient's system.
Similarly, I point out that almost all of the evidence-based studies failed to confirm any association between the use of isotretinoin and depression, teenage suicide, and subsequent inflammatory bowel disease. Nonetheless, I mention these issues and recommend that the parents/guardians observe the teenager; in the case of adult patients, they themselves must be sensitive to symptoms.
Suggested Readings
American Academy of Dermatology Association. Position statement on isotretinoin. https://www.aad.org/Forms/Policies/Uploads/PS/PS-Isotretinoin.pdf. Published December 9, 2000. Updated November 13, 2010. Accessed May 18, 2017.
Blasiak RC, Stamey CR, Burkhart CN, et al. High-dose isotretinoin treatment and the rate of retrial, relapse, and adverse effects in patients with acne vulgaris. JAMA Dermatol. 2013;149:1392-1398.
