IMPORTANT SAFETY INFORMATION

Contraindications

• Known hypersensitivity to amphetamine or other ingredients in Adzenys XR-ODT. Angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products.
• Taking a monoamine oxidase inhibitor (MAOI), or have taken an MAOI within the past 14 days. Hypertensive crisis can occur.

Warnings and Precautions

• Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Adzenys XR-ODT treatment.
• Blood Pressure and Heart Rate Increases: CNS stimulants can cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Consider this before prescribing and monitor blood pressure and pulse.
• Psychiatric Adverse Reactions: CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychosis. Assess for bipolar disorder prior to treatment.
• Long-Term Suppression of Growth: Closely monitor weight and height in pediatric patients treated with Adzenys XR-ODT. Treatment may need to be interrupted.
• Peripheral Vasculopathy, including Raynaud’s Phenomenon: Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary.
• Serotonin Syndrome: Increased risk may occur when amphetamines are co-administered with serotonergic agents (such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or triptans), and during overdosage situations. If it occurs, discontinue Adzenys XR-ODT and initiate supportive treatment.
• Potential for Overdose Due to Medication Errors: Substitution and dispensing errors with other amphetamine products could occur, leading to possible overdosage. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine base compositions and differing pharmacokinetic profiles.

Adverse Reactions

The most common adverse reactions (≥5% and with a higher incidence than placebo) were:

• Children (ages 6 - 12): loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.
• Adolescents (ages 13 - 17): loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
• Adults: dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections.

Pregnancy and Lactation

Based on animal data, may cause fetal harm. Amphetamines, such as Adzenys XR-ODT, can increase the risk of premature delivery, and infants born to amphetamine dependent mothers have an increased risk of low birth weight.

Breastfeeding is not recommended during treatment with Adzenys XR-ODT.

INDICATION

Adzenys XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

REFERENCE: 1. Adzenys XR-ODT [package insert]. Grand Prairie, TX: Neos Therapeutics, Inc
Adderall XR® is a registered trademark of Shire LLC, a Takeda Company.

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