* Pregnancy Test
    * Female patients of childbearing potential must have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Sotret prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue qualification of the patient for Sotret. The second pregnancy test (a confirmation test) must be done in a CLIA-certified laboratory. The interval between the two tests must be at least 19 days.
    * For patients with regular menstrual cycles, the second pregnancy test must be done during the first 5 days of the menstrual period and within 7 days following the office visit, immediately preceding the beginning of Sotret therapy and after the patient has used 2 forms of contraception for 1 month.
    * For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done within 7 days following the office visit, immediately preceding the beginning of Sotret therapy and after the patient has used 2 forms of contraception for 1 month.
    * Each month of therapy, patients must have a negative result from a urine or serum pregnancy test. A pregnancy test must be repeated each month, in a CLIA-certified laboratory, prior to the female patient receiving each prescription.


  * Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions. After consumption of alcohol, at least 36 hours should elapse before these determinations are made. It is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Sotret is established. The incidence of hypertriglyceridemia is 1 patient in 4 on isotretinoin therapy (see WARNINGS: Lipids).
  * Liver Function Tests: Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Sotret has been established (see WARNINGS: Hepatotoxicity).
  * Glucose: Some patients receiving isotretinoin capsules have experienced problems in the control of their blood sugar. In addition, new cases of diabetes have been diagnosed during isotretinoin capsule therapy, although no causal relationship has been established.
  * CPK: Some patients undergoing vigorous physical activity while on isotretinoin capsules therapy have experienced elevated CPK levels; however, the clinical significance is unknown. There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, transient elevations in CPK were observed in 12% of patients, including those undergoing strenuous physical activity in association with reported musculoskeletal adverse events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients, approximately half of the CPK elevations returned to normal within 2 weeks and half returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial.