Amnesteem is a prescription medication used to treat the most severe form of acne called nodular acne. Amnesteem belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.
This medication comes in capsule form and is usually taken twice daily, with food. Amnesteem may be taken for four or five months. A longer period of use is not recommended.
Common side effects of Amnesteem include dry skin, chapped lips, dry eyes, or dry nose causing nosebleeds. Amnesteem can also cause birth defects, miscarriages, or premature births.
Because Amnesteem can cause birth defects, patients, doctors, and pharmacies must be registered with a special distribution program called the iPLEDGE program.
CONTRAINDICATIONS AND WARNINGS
Amnesteem must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Amnesteem in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
Birth defects which have been documented following Amnesteem exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.
Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
If pregnancy does occur during treatment of a female patient who is taking Amnesteem, Amnesteem must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
Because of Amnesteem’s teratogenicity and to minimize fetal exposure, Amnesteem is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Amnesteem must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Amnesteem must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE
