Dyanavel XR

Warning

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

Contraindications

• Patients known to be hypersensitive to amphetamine, or other components of Adzenys XR-ODT
• Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs

Adverse Reactions

• Loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever in pediatric patients
• Dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections in adults

General Guidance

Adjust dosage according to the therapeutic needs and response of the patient

Pregnancy

• Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Nonteratogenic effects, such as vasoconstriction and premature delivery, have been reported

Nursing Mothers

• Breastfeeding is not recommended during treatment with Adzenys XR-ODT
• Amphetamine is present in human milk at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage

Pediatric Use

• The safety and effectiveness of Adzenys XR-ODT have been established in pediatric patients with ADHD ages 6 to 17 years
• Long-term growth suppression has been reported in pediatric patients

Geriatric Use

• Adzenys XR-ODT has not been studied in the geriatric population