ARYNTA - lisdexamfetamine dimesylate oral solution
Azurity Pharmaceuticals, Inc.
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| MEDICATION GUIDE ARYNTATM (AH-RIN-TAH) (lisdexamfetamine dimesylate) Oral Solution, CII |
| What is the most important information I should know about 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. • Do not give ARYNTA to anyone else. See "What is ARYNTA?" for more information. • Keep ARYNTA in a safe place and properly dispose of any unused medicine. See "How should I store ARYNTA?" for more information. • 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 healthcare 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. Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with ARYNTA. • 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, including: • 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. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with ARYNTA, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. |
| What is ARYNTA?
ARYNTA is a central nervous system (CNS) stimulant prescription medicine used for the treatment of: • Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. ARYNTA may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. • Moderate to severe binge eating disorder (BED) in adults. ARYNTA may help reduce the number of binge eating days in people with BED. ARYNTA is not recommended for use in children under 6 years of age with ADHD. ARYNTA is not for weight loss. It is not known if ARYNTA is safe and effective for the treatment of obesity. It is not known if ARYNTA is safe and effective for use in children with BED. ARYNTA is a federally controlled substance (CII) because it contains lisdexamfetamine dimesylate that can be a target for people who abuse prescription medicines or street drugs. Keep ARYNTA in a safe place to protect it from theft. Never give your ARYNTA to anyone else because it may cause death or harm them. Selling or giving away ARYNTA may harm others and is against the law. |
| Do not take ARYNTA if you or your child are:
• allergic to amphetamine products or any of the ingredients in ARYNTA. See the end of this Medication Guide for a complete list of ingredients in ARYNTA. • taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI). • being treated with the antibiotic linezolid or intravenous methylene blue. |
| Before taking ARYNTA, tell your healthcare provider about all 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. o There is a pregnancy registry for women who are exposed to ARYNTA during pregnancy. If you become pregnant during treatment with ARYNTA, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/adhd-medications/. • 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. Especially tell your healthcare provider if you or your child take: • selective serotonin reuptake inhibitors (SSRIs) • serotonin norepinephrine reuptake inhibitors (SNRIs) • medicines used to treat migraine headaches called triptans • tricyclic antidepressants • lithium • fentanyl • tramadol • tryptophan • buspirone • St. John's Wort Keep a list of all medicines to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if ARYNTA can be taken with other medicines. Do not start any new medicine during treatment with ARYNTA without talking to your healthcare provider first. |
| How should ARYNTA be taken?
• Read the Instructions for Use for detailed instructions about how to measure and take a dose of ARYNTA. • Take ARYNTA exactly as prescribed by your or your child’s healthcare provider. • Your healthcare provider may change the dose if needed. • Take ARYNTA 1 time each day in the morning with or without food. • Taking ARYNTA in the afternoon may cause trouble sleeping. • If you or your child take too much ARYNTA, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
| What are the possible side effects of ARYNTA?
ARYNTA may cause serious side effects, including: • See "What is the most important information I should know about ARYNTA?" • Slowing of growth (height and weight) in children. 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: o fingers or toes may feel numb, cool, painful o 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. Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with ARYNTA. • 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 • fast heartbeat • flushing • seizures • coma • sweating • loss of coordination • confusion • dizziness • tremors, stiff muscles, or muscle twitching • seeing or hearing things that are not real (hallucination) • changes in blood pressure • high body temperature (hyperthermia) • 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. The most common side effects of ARYNTA in children 6 to 17 years old and adults with ADHD include: • loss of appetite (anorexia) • anxiety • decreased appetite • weight loss • diarrhea • dizziness • dry mouth • irritability • trouble sleeping • nausea • stomach pain • vomiting The most common side effects of ARYNTA in adults with BED include: • dry mouth • trouble sleeping • decreased appetite • increased heart rate • constipation • feeling jittery • anxiety These are not all the possible side effects of ARYNTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| How should I store ARYNTA?
• Store ARYNTA at room temperature between 68°F to 77°F (20°C to 25°C). • Store ARYNTA in a safe place (like a locked cabinet). • Keep the container tightly closed. • Throw away (discard) any remaining ARYNTA 30 days after first opening the bottle. • Dispose of remaining, unused, or expired ARYNTA by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix ARYNTA with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the solution in a container such as a sealed plastic bag and throw away ARYNTA in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep ARYNTA and all medicines out of the reach of children. |
| General information about the safe and effective use of ARYNTA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ARYNTA for a condition for which it was not prescribed. Do not give ARYNTA to other people, even if they have the same symptoms that you have. It may harm them and it is against the law. You can ask your pharmacist or healthcare provider for information about ARYNTA that is written for healthcare professionals. |
| What are the ingredients in ARYNTA?
Active ingredient: lisdexamfetamine dimesylate Inactive ingredients: dibasic sodium phosphate dihydrate, methylparaben sodium, monobasic sodium phosphate dihydrate, propylparaben sodium, propylene glycol, saccharin sodium, hydrochloric acid, sodium hydroxide and purified water. Manufactured for: Azurity Pharmaceuticals, Inc. Woburn, MA 01801 This products labeling may have been updated. For current Full Prescribing Information, please visit www.arynta.com. PN: #####-##### Rev: 04; 12/2025 |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 12/2025