ISOTRETINOIN
















  • Data from study where the average cumulative dose was 170 mg/kg
  • Reference [3]
Side effects Incidence
(% of patients)
Dry lips (cheilitis) 100%
Dry skin 100%
Nosebleeds 34%
Dry eyes 32%
Itching 32%
Retinoid dermatitis 32%
Joint aches 29%
Muscle aches 26%
Headaches 13%
Hair changes 11%
Nail changes 11%
Mood changes 8%
Vision changes 5%
Triglyceride levels > 300 mg/dl 5%



























  • * Price based on cost of thirty 40 mg capsules
  • Cannot be substitued for Accutane. Absorica LD is micronized isotretinoin, and it is not equivalent to Absorica on a mg-to-mg basis.
Isotretinoin
Name Dosage form Price*
Absorica® 10, 20, 25, 30, 35, 40 mg capsule $200 - $300
Absorica® LD 8, 16, 24, 32 mg capsule $700 - $800
Amnesteem® 10, 20, 40 mg capsule < $100
Claravis® 10, 20, 30, 40 mg capsule < $100
Myorisan® 10, 20, 30, 40 mg capsule < $100
Zenatane® 10, 20, 30, 40 mg capsule < $100



















PRESCRIBER INSTRUCTIONS
Male or female who cannot become pregnant
Initial visit
  • Step 1 - Give patient isotretinoin educational kit (male or female who cannot become pregnant) and obtain the unique patient ID number from the kit
  • Step 2 - Counsel patient on the side effects of isotretinoin. Counsel patient not to share the drug or donate blood.
  • Step 3 - Have patient sign the informed consent in the educational kit. Put signed consent in patient's medical record and give a copy to the patient.
  • Step 4 - Go online and register patient in the iPLEDGE® program (see iPLEDGE® website). You will need the ID number from the kit.
  • Step 5 - Prescribe one month of isotretinoin. Prescription can be filled for 30 days only. Prescription must be filled at a registered pharmacy.

Monthly follow-up visits
  • Step 1 - Counsel patient not to share the drug or donate blood
  • Step 2 - Go online and confirm that you have counseled the patient
  • Step 3 - Prescribe one month of isotretinoin. Prescription can be filled for 30 days only. Prescription must be filled at a registered pharmacy.
  • During the last month of therapy, confirm that patient knows not to donate blood for 30 days after their last dose. When isotretinoin is discontinued, it must be entered in the iPLEDGE® website.
Female who can become pregnant (see definition below)
Initial visit
  • Step 1 - Give patient isotretinoin educational kit (female who can become pregnant) and obtain the unique patient ID number from the kit
  • Step 2 - Counsel patient on the side effects of isotretinoin. Counsel patient on the teratogenic risks of isotretinoin and the contraception requirements of the iPLEDGE® program (see contraception below). If the provider wishes to refer a patient for counseling, there is a section in the educational kit that explains how to do this. Counsel patient not to share the drug or donate blood.
  • Step 3 - Have patient sign the two informed consents in the educational kit. Put signed consent in patient's medical record and give a copy to the patient.
  • Step 4 - Go online and register patient in the iPLEDGE® program (see iPLEDGE® website). You will need the ID number from the kit.
  • Step 5 - Perform urine or serum pregnancy test (CLIA-certified not necessary)
  • Step 6 - Confirm that patient is on 2 forms of approved contraception (see contraception below). Abstinence is another option and is discussed below (see abstinence).
  • Step 7 - Have patient follow-up in about 30 days

First follow-up visit
  • Step 1 - Confirm that patient has used 2 acceptable forms of birth control for last 30 days (see contraception below)
  • Step 2 - Order second pregnancy test (urine or serum, must be CLIA-certified). See second pregnancy test above for details on test timing.
  • Step 3 - Counsel patient on using 2 forms of birth control and not to share the drug or donate blood
  • Step 4 - Enter pregnancy results on iPLEDGE® website
  • Step 5 - Prescribe one month of isotretinoin. Prescription can be filled for 7 days only (day 1 is the day pregnancy test is collected). Prescription must be filled at a registered pharmacy.
  • IF PATIENT FAILS TO GET PRESCRIPTION FILLED WITHIN 7 DAYS - Patient must wait at least 19 days and repeat the second pregnancy test

Monthly follow-up visits
  • Step 1 - Confirm that patient has used 2 acceptable forms of birth control for last 30 days (see contraception below)
  • Step 2 - Order pregnancy test (urine or serum, must be CLIA-certified). See second pregnancy test above for details on test timing.
  • Step 3 - Counsel patient on using 2 forms of birth control and not to share the drug or donate blood.
  • Step 4 - Enter pregnancy results on iPLEDGE® website
  • Step 5 - Prescribe one month of isotretinoin. Prescription can be filled for 7 days only (day 1 is the day pregnancy test is collected). Prescription must be filled at a registered pharmacy.
  • Patient should have follow-up visit at the end of therapy and 30 days after her last dose. Pregnancy tests and reporting are required at these visits. Counsel patient not to donate blood and to use contraception for 30 days after her last dose. When isotretinoin is discontinued, it must be entered in the iPLEDGE® website.