Sotret 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 definition,2 means “many” as opposed to “few or several” nodules.

Because of significant adverse effects associated with its use, Sotret should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

In addition, Sotret is indicated only for those female patients who are not pregnant, because Sotret 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 capsules.

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).

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Suppurative inflammation -- A pathologic process consisting in the formation of pus.

Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Hyperostosis -- Increase in the mass of bone per unit volume.

PREMATURE EPIPHYSEAL CLOSURE --

See Boxed CONTRAINDICATIONS AND WARNINGS.

Sotret may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.

No mechanism of action has been established for these events (see ADVERSE REACTIONS: Psychiatric).

Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin.

Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need.

Therefore, prior to initiation of Sotret therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation maybe necessary.

Signs and symptoms of depression, as described in the brochure (“Recognizing Psychiatric Disorders in Adolescents and Young Adults”), include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment.

Patients should stop Sotret and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit.

Discontinuation of Sotret therapy may be insufficient; further evaluation may be necessary.

While such monitoring may be helpful, it may not detect all patients at risk.

Patients may report mental health problems or family history of psychiatric disorders.

These reports should be discussed with the patient and/or the patient’s family.

A referral to a mental health professional may be necessary.

The physician should consider whether Sotret therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of isotretinoin therapy.