Important Safety Information
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Adzenys XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Patients should not take Adzenys XR-ODT if they are:
- Hypersensitive 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.
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, nervousness, and weight loss.
- Adults: dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections.
Pregnancy and Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal data, Adzenys XR-ODT may cause fetal harm. Breastfeeding is not recommended during treatment.