People with attention deficit hyperactivity disorder, also known as ADHD, can experience challenges doing day-to-day activities, and every day can look different. Azstarys (az-STAR-is) was approved in 2021 and is the first medicine of its kind that works quickly and over a long period of time to treat ADHD in adults and children 6 years old and older.
How Does It Work for ADHD?
ADHD is a brain disorder that affects a person’s behavior. Symptoms can include trouble paying attention, fidgeting, and not focusing. The condition happens in children and teenagers with many of these people carrying the disorder into adulthood. ADHD in children could affect how they perform in school and how they behave around others, including children and adults. ADHD in adults could affect their relationships with others and how they perform at work.
Azstarys is a central nervous system (CNS) stimulant that improves attention, hyperactivity, and impulsiveness. Stimulants boost the levels of certain brain chemicals, such as dopamine and norepinephrine, which can help manage ADHD symptoms.
How Do I Take It?
Azstarys is taken once a day in the morning, with or without food. The medicine comes as a capsule, which can be taken whole, sprinkled into water, or sprinkled onto applesauce. If you or your child are sprinkling the capsule into water or applesauce, open the capsule to release the contents inside of it. You can mix the contents of the capsule with 50 mL (2 ounces) of water or onto 2 tablespoons of applesauce. You or your child should swallow the applesauce or water mixture immediately or within 10 minutes of mixing. Do not store the applesauce or water and medicine mixture.
Azstarys comes in three doses: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, and 52.3 mg/10.4 mg capsule. The dosing can vary slightly depending on your age.
- Children between the ages of 6 and 12: Your health care provider may start your child on the 39.2 mg/7.8 mg once a day dose for about a week. The dose may either increase to 52.3 mg/10.4 mg once a day or decrease to 26.1 mg/5.2 mg once a day depending on how your child is tolerating the medicine and how well it is working for them.
- Children between the ages of 13 and 17 and adults: Your health care provider may start you or your child on the 39.2 mg/7.8 mg once a day dose for about a week to start treatment. Your health care provider may increase the dose to 52.3 mg/10.4 mg once a day depending on how you or your child is tolerating the medicine and how well it is working.
How Was It Studied for ADHD?
One clinical study was done to look at the safety and efficacy of Azstarys. People in this study were children between the ages of 6 and 12 years old who were diagnosed with ADHD. Children received either Azstarys at a starting dose of 39.2 mg/7.8 mg per day (where the dose could later be decreased to 26.1 mg/5.2 mg per day or increased to 52.3 mg/10.4 mg per day) or placebo containing no medicine for 7 days. The average age of children in the study was 10 years old, with a majority of the children being males (61.3%). The study also included children who were White Americans, African Americans, Asian Americans, those classified as “Multiracial” where they identified as more than one race, or those classified as “Other,” where their race wasn’t specified.
The study looked at classroom behavior in children to look at their attention and behavior over a 13 hour period of time. This was done by using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale, with the study looking at the change in the SKAMP scale from baseline to 13 hours. The scale looks at ADHD symptoms in a classroom setting, with a lower score showing an improvement in attention and behavior.
What Were the Benefits?
Children taking Azstarys had lower SKAMP scores compared to those taking placebo. This means that children taking Azstarys saw a greater improvement in their ADHD symptoms compared to placebo.
How Long Does It Take to Work?
In clinical studies, on average, Azstarys started working in 30 minutes and lasted for about 13 hours. Azstarys contains two medicines: dexmethylphenidate and serdexmethylphenidate. Dexmethylphenidate works quickly, while serdexmethylphenidate works slowly, to control symptoms throughout the day. Talk to your health care provider if you or your child do not see improvements in your/their ADHD symptoms, including improvement in attention, impulsiveness, or hyperactivity. Your health care provider may increase the dose of Azstarys or prescribe a different medicine.
What Are the Side Effects and How Can I Manage Them?
The most common side effects seen with Azstarys are:
- Decreased appetite
- Trouble sleeping
- Nausea
- Vomiting
- Upset stomach
- Stomach pain
- Weight loss
- Anxiety
- Dizziness
- Irritability
- Mood swings
- Fast heartbeat
- High blood pressure
Azstarys can affect you or your child’s appetite and can cause digestion problems. This can include a decrease in appetite, weight loss, nausea, vomiting, stomach pain, or upset stomach. It is important not to skip meals. Eating smaller, more frequent meals, alongside eating bland foods such as bread, plain crackers, and rice, may help you or your child eat throughout the day and lower stomach problems. It is important to stay hydrated and to drink plenty of water if you or your child is vomiting. Monitor your or your child’s weight while taking Azstarys. Azstarys may cause minor weight loss, but talk to your health care provider if you think you or your child is losing too much weight. If you experience nausea after taking Azstarys, try taking the medicine with food.
Azstarys can cause trouble sleeping. There are techniques that you or your child may be able to implement to help manage this. Drinking less caffeine, including soda or coffee, sticking to a sleep schedule, and limiting screen time before bedtime can help. It is also important that you or your child take Azstarys early in the morning. Taking the medicine too late in the day can worsen you or your child’s ability to sleep.
Azstarys can affect you or your child’s heart and cause your heart rate and your blood pressure to increase. Talk to your health care provider about how to best manage these symptoms. Your health care provider may monitor you or your child’s blood pressure and heart rate.
Azstarys can affect your mood and can cause you or your child to experience mood swings, become irritable, or have anxiety. Writing down how you are feeling, exercising, eating a well-balanced diet, and following a daily schedule can help with this.
Azstarys could cause you or your child to experience dizziness. Sit down or instruct your child to sit down right away if you/they start to feel dizzy to prevent falls.
Talk to your health care provider if any of these symptoms do not improve or get worse in either you or your child. Your health care provider may change the dose of Azstarys, change the medicine altogether, or prescribe medicines to help manage symptoms.
What Are Other Unique Considerations to Be Aware Of?
Azstarys is a schedule II medicine, which means it has a high chance of addiction, abuse, and misuse. There is also a risk of you or your child relying on the medicine (physical dependence). Your health care provider will monitor you or your child while on Azstarys. Do not share Azstarys with others.
Keep Azstarys in a safe, preferably locked place, and dispose of any unused medicine properly. You can dispose of any unused, expired, or remaining Azstarys by a medicine take-back program that is offered by the DEA or by going to a DEA-authorized collection site. If no take-back program or authorized collection site is available, mix Azstarys with dirt, cat litter, or coffee grounds, place it in a sealable plastic bag, and throw the bag away. Visit www.fda.gov/consumers/consumer-updates/where-and-how-dispose-unused-medicines for additional information on how to dispose of unused medicines.
What Type of Drug Interactions Can Happen?
Azstarys should not be taken with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI, as this can increase the risk of developing extremely high blood pressure (hypertensive crisis). MAOIs are used to treat Parkinson’s disease and depression. These medicines can include isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate).
Taking blood pressure medicines with Azstarys can cause blood pressure medicines not to work as well. Talk to your health care provider if you are taking any medicines for your blood pressure. Your health care provider may adjust the dose of your blood pressure medicine if needed.
Talk to your health care provider if you are undergoing surgery that will require you to receive anesthesia. It is not recommended that you take Azstarys the day you are receiving anesthesia. This can cause your blood pressure and heart rate to suddenly increase.
If you are taking risperidone, which is a medicine used for schizophrenia, bipolar disorder, and autism, with Azstarys, changes in the dose of either or both of these medicines can increase the risk of developing involuntary movements that you cannot control, also known as extrapyramidal symptoms (EPS).
Is There a Cost-Savings Program?
There is a copay savings offer available from the manufacturer that may allow you to pay as little as $0 for your first prescription of Azstarys and as little as $25 for each prescription after that. Whether you or your child are eligible depends on if you have commercial insurance. You can find out more at azstarys.com/savings-and-support or by calling 800-910-8432.
