Usual Adult Dose for Acne

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
Maximum dose: Up to 2 mg/kg/day
Duration of therapy: Up to 20 weeks

Comments:

• Patients should take some formulations of this drug with food.
• Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
• Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
• Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
• The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.

Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Usual Pediatric Dose for Acne

12 years or older:

• Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
• Maximum dose: 2 mg/kg/day
• Duration of therapy: Up to 20 weeks

Comments:

• Patients should take some formulations of this drug with food.
• Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
• Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
• Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
• The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.

Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Suspected hepatitis or patients with liver function test elevations that do not normalize: Discontinue use; etiologies should be further investigated.

Dose Adjustments

• Patients may discontinue treatment if the total nodule count has reduced by at least 70% before completing the 15 to 20-week treatment.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for products containing isotretinoin. It includes a medication guide, elements to assure safe use, and implementation system. For additional information: www.fda.gov/REMS

US BOXED WARNING:
BIRTH DEFECTS (Pregnancy Category X): This drug should not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking this drug in any amount, even for short periods of time; potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following exposure include abnormalities of the face, eyes (including microphthalmia, facial dysmorphia, cleft palate), ears (including anotia, micropinna, small/absent external auditory canals), skull, central nervous system (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit), cardiovascular system, thymus gland abnormality, and parathyroid gland deficiency. Cases of IQ scores less than 85 with/without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.

• If pregnancy does occur during treatment, this drug must be discontinued immediately and the patient should be referred to an obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling.
• This drug is only available through a restricted program under a REMS called iPLEDGE(TM). Under the REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Female patients of reproductive potential should be tested for pregnancy before receiving the first prescription, within the first 5 days of the menstrual period (patients with regular menstrual periods) OR immediately preceding the beginning of treatment (patients with amenorrhea/irregular cycles/using a contraceptive method that precludes withdrawal bleeding), AND during each month of treatment. Some experts recommend obtaining an additional test 5 weeks after the discontinuation of treatment.
• Capsules should be swallowed with a full glass of liquid.

Storage requirements:

• Keep away from others not prescribed this drug, including children.
• Store at 20 to 25C; protect from light.

General:

• Due to high teratogenicity and to minimize fetal exposure, this drug is available only through a special restricted distribution program called iPLEDGE (TM). Prescribers, pharmacies, and wholesalers must be registered and activated with the iPLEDGE program in order to prescribe, dispense, or distribute this drug. This drug must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. This registration process ensures that prescribers, pharmacists, and patients agree to assume specific responsibilities to ensure that patients do not become pregnant while taking this drug and do not get prescribed the medicine if they are pregnant. Further details on iPLEDGE are available at www.ipledgeprogram.com or by calling 1-866-495-0654.
• Female patients must pick up their prescription within 7 days of being filled, and all prescriptions should be limited to a 30-day supply.

Monitoring:

• Embryofetal: Pregnancy tests in female patients of reproductive potential
• Hepatic: Liver function tests at baseline and then at weekly to biweekly intervals until the response is established.
• Metabolic: Fasting lipid and blood glucose levels at baseline and then at weekly to biweekly intervals until the response is established.

Patient advice:

• Inform patients that this drug may decrease night vision, and they should use caution when driving or operating machinery.
• Patients should be told to avoid donating blood during and up to 1 month after discontinuation of treatment.
• Patients should be instructed to report new/unusual changes in vision, hearing, headaches, mood or depression, abdominal pain or diarrhea.
• Patients should be advised to avoid sharing this drug with anyone, even those with similar conditions.
• Female patients of reproductive potential should be instructed regarding pregnancy testing (per local protocol), and should be told to use at least 2 forms of birth control during and at least 1 month after treatment. Female patients of reproductive potential who have unprotected intercourse any time 1 month before, during, or 1 month after treatment should contact their healthcare provider immediately.

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