Inositol Plus

CONTRAINDICATIONS AND WARNINGS

Myorisan ® must not be used by female patients who are or may become pregnant. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking Myorisan ® 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 Myorisan ® 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 Myorisan ®, Myorisan ® 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 Myorisan’s ® teratogenicity and to minimize fetal exposure, Myorisan ® is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This REMS is called iPLEDGE ®. Myorisan ® must only be prescribed by prscribers who are enrolled and activated with the iPLEDGE REMS. Myorisan ® must only be

dispensed by a pharmacy enrolled and activated with iPLEDGE, and must only be dispensed to patients who are enrolled and meet all the requirements of iPLEDGE. ( see

PRECAUTIONS ).

INFORMATION FOR PHARMACISTS

Access the iPLEDGE REMS system via the internet ( www.ipledgeprogram.com ), telephone (1-866-495-0654) to obtain an authorization and the "do not dispense to patient after" date. Myorisan ® must only be dispensed in no more than a 30-day supply.

REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.

A Myorisan ® Medication Guide must be given to the patient each time Myorisan ® is dispensed, as required by law. This Myorisan ® Medication Guide is an important part of the risk management program for the patient.