Shire plc has announced that the US Food and Drug Administration (FDA) has approved Mydayis, a once-daily treatment comprised of 3 different types of drug-releasing beads, for patients aged ≥13 years with attention deficit hyperactivity disorder (ADHD). Shire plc is headquartered in Lexington, MA.

Indications: Mydayis is a central nervous system (CNS) stimulant indicated for the treatment of ADHD in patients aged ≥13 years.

Dosage/administration: The maximum dose in pediatric patients with severe renal impairment is 12.5 mg daily. In adult patients with severe renal impairment, the maximum dose should not exceed 25 mg daily. Use in pediatric and adult patients with end-stage renal disease is not recommended. Patients are advised to take consistently either with or without food. Mydayis should be administered upon awakening because the effects may last up to 16 hours and there is the potential for insomnia.

Adverse reactions: The most common adverse reactions in pediatric patients (≥13 years) with ADHD are insomnia, decreased appetite, decreased weight, irritability, and nausea. In adults, the most common adverse reactions are insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety.