Micronizeddosage

Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD: In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing ABSORICA/ABSORICA LD Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests. ABSORICA is not substitutable with ABSORICA LD because of different bioavailability and recommended dosage.

Recommended dosage for: o ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses. Once daily dosing is not recommended. If a dose of ABSORICA/ABSORICA LD is missed, just skip that dose. Do not take two doses of ABSORICA/ABSORICA LD at the same time.

2.1 Evaluations

Prior To Prescribing and Use of ABSORICA/ABSORICA LD In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant. For the detailed requirements prior to prescribing ABSORICA/ABSORICA LD, see Use in Specific Populations. Prior to ABSORICA / ABSORICA LD use in all patients, complete the following laboratory testing: A fasting lipid profile including triglycerides. Liver function tests.

2.2 Recommended

Dosage ABSORICA is not substitutable with ABSORICA LD.

The recommended dosage of: ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 1). ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 2). To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. Swallow capsules whole. Do not split, crush, chew, or suck on the capsules. During treatment, the dosage may be adjusted according to response of the disease and/or adverse reactions, some of which may be dose-related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dosage adjustments up to 2 mg/kg/day for ABSORICA (1.6 mg/kg/day for ABSORICA LD) in divided doses, as tolerated. The safety and effectiveness of once daily dosing with ABSORICA/ABSORICA LD has not been established and is not recommended. If a dose of ABSORICA/ABSORICA LD is missed, just skip that dose. Do not take two doses of ABSORICA/ ABSORICA LD at the same time.

Table 1: ABSORICA Daily Dosage by Body Weight1 Body Total Daily Dosage (mg) 1 Weight 0.5 mg/kg 1 mg/kg 2 mg/kg 40 kg 50 kg 60 kg 70 kg 80 kg 90 kg 100 kg 20 25 30 35 40 45 50 40 50 60 70 80 90 100 80 100 120 140 160 180 200 1 Administer in two divided doses with or without meals Table 2: ABSORICA LD Daily Dosage by Body Weight1 Body Total Daily Dosage (mg) 1 Weight 0.4 mg/kg 0.8 mg/kg 1.6 mg/kg 40 kg 50 kg 60 kg 70 kg 80 kg 90 kg 100 kg 16 20 24 28 32 36 40 32 40 48 56 64 72 80 64 80 96 112 128 144 160 1 Administer in two divided doses with or without meals

2.3 Recommended

Duration of Use A normal course of treatment is 15 to 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, may discontinue ABSORICA/ABSORICA LD. After a period of 2 months or more off treatment, and if warranted by persistent or recurring severe nodular acne, may initiate a second course of ABSORICA/ABSORICA LD in patients who have completed skeletal growth. The use of another course of ABSORICA/ABSORICA LD treatment is not recommended before a 2-month waiting period because the patient’s acne may continue to improve after a 15 to 20-week course of treatment. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of ABSORICA/ABSORICA LD, even in low dosages, has not been studied, and is not recommended. The effect of long-term use of ABSORICA/ABSORICA LD on bone loss is unknown.