An antineoplastic - It treats severe acne that has not responded to other therapy like antibiotics
FDA Alerts
Special Alerts:
[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Isotretinoin, http://www.fda.gov/medwatch/safety/2006/accutane_ipledge.pdf, http://www.fda.gov/cder/drug/infopage/accutane/default.htm and http://www.fda.gov/cder/drug/infopage/accutane/FAQ200610.pdf.
Has been used alone and in combination with a psoralen and UVA light (PUVA therapy) in the treatment of psoriasis†.†
Neoplasms
Has been used in the prevention, treatment, and adjunctive treatment of various cutaneous and extracutaneous malignant neoplasms† (of epithelial origin); however, the specific role of isotretinoin, if any, not established.†
Dosage and Administration
General
Severe Nodular Acne
Individualize dosage according to severity of the disease, the patient’s weight, and/or appearance of adverse effects (e.g., dose-related cheilitis or hypertriglyceridemia).
Prior to increasing isotretinoin dosage, ascertain whether patient has been compliant with instructions on taking the drug with food since failing to do so will substantially decrease absorption of the drug.
Transient exacerbation (or flare) of acne may occur during the first weeks of therapy, but this initial exacerbation usually subsides by 4–6 weeks.
If a patient misses a dose, the next dose should not be doubled.
Do not exceed recommended dosage and duration of treatment.
Administration
Restricted Distribution
Distribution of isotretinoin is restricted because of known, severe teratogenic effects. (See Boxed Warning and see Fetal/Neonatal Morbidity and Mortality under Cautions.)
A centralized risk management program, called iPLEDGE, for Accutane® (isotretinoin) and all generic isotretinoin preparations was approved by FDA; this program replaced previous restricted distribution programs sponsored by various manufacturers. The program requires registration of wholesalers, prescribers, pharmacies, and patients; all must agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense, or use isotretinoin.
The iPLEDGE program strengthened processes to ensure appropriately timed and properly documented pregnancy testing and counseling of patients before, during, and following isotretinoin therapy; the program is computer based and uses verifiable, trackable links between prescriber, patient, pharmacy, and wholesaler in a single registry to control prescribing, distribution, dispensing, and patient use of isotretinoin.
To obtain detailed information on all requirements for patients (e.g., contraception, pregnancy testing), prescribing clinicians (e.g., program enrollment, patient registration, patient education), and dispensing pharmacists (e.g., obtaining dispensing authorization, providing patient medication guides), see the iPLEDGE program website at http://www.ipledgeprogram.com.
To facilitate pregnancy testing and counseling in accordance with the iPLEDGE program, clinicians must not prescribe more than a 30-day supply of drug. Telephone, fax, and electronic transmission (e.g., e-mail) of prescriptions are permitted. Refills require a new prescription and another authorization from the iPLEDGE program; automatic refills are not allowed.
Pharmacists must dispense prescriptions prior to the date specified by the iPLEDGE system (7 days from the office visit date) and record this date on the prescription bag sticker. Patients must pick up prescriptions no later than this date; if not picked up by that date, pharmacists must return the drug to stock.
Oral Administration
Administer orally twice daily with meals; once-daily dosing not recommended.
To decrease the risk of esophageal irritation, swallow capsules whole with a full glass of liquid; do not suck or chew the capsules.
Dosage
Pediatric Patients
Severe Nodular Acne
Oral
Adolescents ≥12 years of age: usual initial dosage is 0.5–1 mg/kg daily given in 2 divided doses with food. Adjust subsequent dosage after ≥2 weeks of treatment according to individual tolerance and response, using the lowest possible effective dosage.
Usual duration of therapy: 15–20 weeks; discontinue therapy sooner if the total number of cysts has been reduced by more than 70%.
A second course of therapy may be initiated if severe nodular acne persists and it is thought that the patient could benefit from further treatment; optimum interval between initial and subsequent courses of isotretinoin therapy has not been defined for adolescents who have not completed skeletal growth.
Adults
See the MEDWATCH notification at the beginning of the monograph.
Severe Nodular Acne
Oral
Usual initial dosage: 0.5–1 mg/kg daily given in 2 divided doses with food. Adjust subsequent dosage after ≥2 weeks of treatment according to individual tolerance and response, using the lowest possible effective dosage. If disease is severe or is mainly evident on the chest and back, instead of the face, dosages up to 2 mg/kg daily may be required.
Usual duration of therapy: 15–20 weeks; discontinue therapy sooner if the total number of cysts has been reduced by more than 70%.
A second course of therapy may be initiated if severe nodular acne persists and it is thought that the patient could benefit from further treatment; however, at least 2 months should elapse between courses in adults to assess the degree of improvement and the need for further therapy.
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