ARYNTA™ (lisdexamfetamine dimesylate) Oral Solution, CII
Indications and Usage
ARYNTA is a central nervous system (CNS) stimulant indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
- Moderate to severe binge eating disorder (BED) in adults.
Limitations of Use:
- The use of ARYNTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
- ARYNTA is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of ARYNTA for the treatment of obesity have not been established.
WARNING: ABUSE, MISUSE, AND ADDICTION
ARYNTA has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ARYNTA, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing ARYNTA, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout ARYNTA treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].
ADDITIONAL IMPORTANT SAFETY INFORMATION
Do not take ARYNTA if you or your child are:
- Allergic to amphetamine products or any of the ingredients in ARYNTA.
- Taking, or have stopped taking in the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI).
- Being treated with the antibiotic linezolid or intravenous methylene blue.
What are the possible side effects of ARYNTA?
ARYNTA may cause serious side effects, including:
- Abuse, misuse, and addiction: ARYNTA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ARYNTA, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ARYNTA or when it is used in ways that are not approved, such as snorting or injection.
- Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with ARYNTA and will monitor you or your child during treatment.
- ARYNTA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
- Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease.
- Your provider should check you or your child carefully for heart problems before starting treatment with ARYNTA. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
- Increased blood pressure and heart rate:
- Your healthcare provider should check you or your child's blood pressure and heart rate regularly during treatment with ARYNTA.
- Mental (psychiatric) problems:
- new or worse behavior and thought problems
- new or worse bipolar illness
- new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression.
- Slowing of growth (height and weight) in children: ARYNTA is not approved for use and is not recommended in pediatric patients below 6 years of age. Children should have their height and weight checked often during treatment with ARYNTA. ARYNTA treatment may be stopped if your child is not growing or gaining weight as expected.
- Circulation problems in fingers and toes (Peripheral Vasculopathy, including Raynaud's phenomenon): Signs and symptoms may include:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change color from pale, to blue, to red
Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
- Serotonin Syndrome: A potentially life-threatening problem called serotonin syndrome may happen when ARYNTA is taken with certain other medicines. Stop taking ARYNTA and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:
- agitation
- flushing
- coma
- loss of coordination
- dizziness
- seeing or hearing things that are not real (hallucination)
- high body temperature (hyperthermia)
- fast heartbeat
- seizures
- sweating
- confusion
- tremors, stiff muscles, or muscle twitching
- changes in blood pressure
- nausea, vomiting, diarrhea
- New or worsening tics or worsening Tourette's syndrome: Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette's syndrome during treatment with ARYNTA.
Before taking ARYNTA, tell your doctor about all your medical conditions, including if you or your child:
- Have heart problems, heart disease, heart defects, or high blood pressure, or have a family history of sudden death or heart rhythm problems
- Have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of suicide, bipolar illness, or depression
- Have circulation problems in fingers and toes
- Have kidney problems
- Have or had repeated movements or sounds (tics) or Tourette's syndrome, or have a family history of tics or Tourette's syndrome
- Are pregnant or plan to become pregnant. ARYNTA may harm the unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ARYNTA.
- Are breastfeeding or plan to breastfeed. ARYNTA passes into breast milk. You should not breastfeed during treatment with ARYNTA. Talk to your healthcare provider about the best way to feed the baby during treatment with ARYNTA.
Tell your healthcare provider about all the medicines that you or your child take, including:
- Prescription and over-the-counter medicines, vitamins, and herbal supplements.
- ARYNTA can affect the way other medicines work and other medicines may affect how ARYNTA works. Taking ARYNTA with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with ARYNTA.
The most common side effects of ARYNTA:
- In children 6 to 17 years and adults with ADHD include decreased or loss of appetite, diarrhea, dry mouth, trouble sleeping, stomach pain, anxiety, weight loss, dizziness, irritability, nausea, and vomiting.
- In adults with BED include dry mouth, decreased appetite, constipation, anxiety, trouble sleeping, increased heart rate, and feeling restless.
The Important Safety Information does not include all the information needed to use ARYNTA safely and effectively. Please see accompanying full Prescribing Information for ARYNTA.
To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
ARYNTA™ is a trademark of Azurity Pharmaceuticals, Inc.
©2026 Azurity Pharmaceuticals, Inc.
PP-ARY-6664-US-EN-v1 02/26
