Amnesteem (Isotretinoin) - Indications and Dosage

INDICATIONS AND USAGE

SEVERE RECALCITRANT NODULAR ACNE

Amnesteem is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition², means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, Amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Amnesteem is indicated only for those females who are not pregnant, because isotretinoin can cause severe birth defects (see boxed CONTRAINDICATIONS AND WARNINGS).

A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. ^1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis and Premature Epiphyseal Closure).

DOSAGE AND ADMINISTRATION

Amnesteem should be administered with a meal (see PRECAUTIONS: Information for Patients and Prescribers).

The recommended dosage range for Amnesteem is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day⁸, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects -- 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 dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Amnesteem with food will significantly decrease absorption. Before upward dose adjustments are made, the patient should be questioned about their compliance with food instructions.

The safety of once daily dosing with Amnesteem has not been established. Once daily dosing is not recommended.

If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. 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 doses, has not been studied, and is not recommended. It is important that Amnesteem be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Amnesteem on bone loss is unknown (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).

Contraceptive measures must be followed for any subsequent course of therapy (see boxed CONTRAINDICATIONS AND WARNINGS).

Information for Pharmacists

Amnesteem must only be dispensed in no more than a 30-day supply and only on presentation of an isotretinoin prescription with a yellow self-adhesive isotretinoin qualification sticker within 7 days of the qualification date. REFILLS REQUIRE A NEW WRITTEN PRESCRIPTION WITH A YELLOW SELF-ADHESIVE ISOTRETINOIN QUALIFICATION STICKER WITHIN 7 DAYS OF THE QUALIFICATION DATE. No telephone or computerized prescriptions are permitted. An Amnesteem Medication Guide must be given to the patient each time Amnesteem is dispensed, as required by law. This Amnesteem Medication Guide is an important part of the risk management program for the patient.

HOW SUPPLIED

Soft gelatin capsules, 10 mg (reddish brown), imprinted I10.

- Cartons of 30 containing 3 Prescription Paks of 10

capsules NDC 62794-611-93

- Cartons of 100 containing 10 Prescription Paks of 10

capsules NDC 62794-611-88

Soft gelatin capsules, 20 mg (reddish brown and cream), imprinted I20.

- Cartons of 30 containing 3 Prescription Paks of 10

capsules NDC 62794-612-93

- Cartons of 100 containing 10 Prescription Paks of 10

capsules NDC 62794-612-88

Soft gelatin capsules, 40 mg (orange-brown), imprinted I40.

- Cartons of 30 containing 3 Prescription Paks of 10

capsules NDC 62794-614-93

- Cartons of 100 containing 10 Prescription Paks of 10

capsules NDC 62794-614-88

Storage

Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.