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Evaluations Prior to Prescribing and Use of Amnesteem: o In patients who can get pregnant, only prescribe Amnesteem after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing Amnesteem o Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests.

Recommended dosage is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks

Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day in two divided doses with food.

Once daily dosing is not recommended.

If a dose is missed, just skip that dose. Do not take two doses at the same time.

See the Full Prescribing Information for the recommended duration of use

2.1 Evaluations

Prior to Prescribing and Use of Amnesteem In patients who can get pregnant, only prescribe Amnesteem after verification and documentation that they are not pregnant. For the detailed requirements prior to prescribing Amnesteem, see Use in Specific Populations. Prior to Amnesteem use in all patients, complete the following laboratory testing:

A fasting lipid profile including triglycerides.

Liver function tests.

2.2 Recommended

Dosage The recommended dosage range for Amnesteem is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks (see Tables 1 and 2, respectively).

Table 1: Amnesteem: Recommended Divided Doses (0.5 mg/kg/day dosage) Body Weight First Dose Second Dose 40 kg 10 mg 10 mg 50 kg 12.5 mg 12.5 mg 60 kg 15 mg 15 mg 70 kg 17.5 mg 17.5 mg 80 kg 20 mg 20 mg 90 kg 22.5 mg 22.5 mg 100 kg 25 mg 25 mg Table 2: Amnesteem: Recommended Divided Doses (1 mg/kg/day dosage) Body Weight First Dose Second Dose 40 kg 20 mg 20 mg 50 kg 25 mg 25 mg 60 kg 30 mg 30 mg 70 kg 35 mg 35 mg 80 kg 40 mg 40 mg 90 kg 45 mg 45 mg 100 kg 50 mg 50 mg 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 Amnesteem in divided doses with food, as tolerated (see Table 3).

Table 3: Amnesteem: Recommended Divided Doses (2 mg/kg/day dosage) Body Weight First Dose Second Dose 40 kg 40 mg 40 mg 50 kg 50 mg 50 mg 60 kg 60 mg 60 mg 70 kg 70 mg 70 mg 80 kg 80 mg 80 mg 90 kg 90 mg 90 mg 100 kg 100 mg 100 mg The safety and effectiveness of once daily dosing with Amnesteem has not been established and is not recommended. If a dose of Amnesteem is missed, just skip that dose. Do not take two doses of Amnesteem at the same time.

2.3 Recommended

Duration of Use A 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 Amnesteem. 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 Amnesteem in patients who have completed skeletal growth. The use of another course of Amnesteem treatment is not recommended before a two-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 Amnesteem, even in low dosages, has not been studied, and is not recommended. The effect of long-term use of Amnesteem on bone loss is unknown.