MYDAYIS

Warning

High potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Contraindications

• Known hypersensitivity to amphetamine or other components of MYDAYIS
• Concomitant treatment with monoamine oxidase inhibitors

Adverse Reactions

• Insomnia
• Decreased appetite
• Decreased weight
• Irritability
• Nausea
• Abdominal pain upper

General Guidance

Dosage may be adjusted in increments of 12.5 mg no sooner than weekly, based on the therapeutic needs and response of the patient

Pregnancy

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MYDAYIS during pregnancy
• The limited available data from published literature and postmarketing reports on use of amphetamine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

Pediatric Use

• The safety and effectiveness of MYDAYIS in pediatric patients with ADHD ages 13 to 17 years have been established
• The safety and effectiveness of MYDAYIS have not been established in pediatric patients ages 12 years and younger

Geriatric Use

• Clinical studies of MYDAYIS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
• In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy