Key takeaways:
In March 2022, Xelstrym (dextroamphetamine) became the first FDA-approved amphetamine patch to treat ADHD in adults and children at least 6 years of age.
Common side effects of Xelstrym include a smaller appetite, trouble sleeping, and headache. More serious side effects include dependence, heart problems, and serotonin syndrome.
Xelstrym will probably be available in the second half of 2022. We don’t know how much it will cost yet.
If you or your child has attention-deficit hyperactivity disorder (ADHD), you may be familiar with the medications that treat ADHD. The most common medical treatment for ADHD is a group of medications called stimulants.
In March 2022, the FDA approved a new stimulant treatment option for ADHD: Xelstrym (dextroamphetamine). Xelstrym is a transdermal patch, which means it delivers medication through your skin. It’s unique because it’s the only FDA-approved amphetamine patch.
Here, we’ll cover everything you need to know about Xelstrym — how it works, how effective it is, and the side effects you should watch out for.
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What is Xelstrym?
Xelstrym is a transdermal patch that treats ADHD. When you apply the patch, the medication is absorbed into your body through your skin. It’s FDA-approved for use in adults and children ages 6 and older.
Xelstrym is a stimulant medication. Prescription stimulants are divided into two categories: amphetamines (like Adderall) and methylphenidate (like Ritalin). Xelstrym is an amphetamine.
What makes Xelstrym unique?
Xelstrym is the first FDA-approved amphetamine patch that treats ADHD. The other prescription patch for ADHD is Daytrana (methylphenidate).
Daytrana is only approved to treat ADHD in children and teens age 6 to 17 years old. That makes Xelstrym the first patch to be FDA-approved to treat ADHD in adults.
How does Xelstrym work to treat ADHD?
It’s not completely clear how amphetamines like Xelstrym treat ADHD, but we know that they raise the amount of certain chemicals in the brain. These chemicals — norepinephrine and dopamine — help manage our mood and attention. People with ADHD have an altered amount of these chemicals in the brain.
Norepinephrine plays a role in regulating our attention span and response to stress. Dopamine affects how we react to rewarding experiences. A higher level of these chemicals in the body can lead to elevated alertness, energy, and attention, which may be how they help treat ADHD.
How is Xelstrym dosed?
Xelstrym is available in four different patch strengths:
4.5 mg
9 mg
13.5 mg
18 mg
For children ages 6 to 17 years old, it’s recommended to start with the 4.5 mg patch. For adults, the 9 mg patch is recommended as a starting dose.
In children, the dose can be raised gradually by 4.5 mg on a weekly basis. For most children and adults, the recommended maximum dose is 18 mg.
In people with severe kidney problems, the maximum dose is 13.5 mg. For those with kidney failure — also known as end stage renal disease (ESRD) — the maximum recommended dose is 9 mg.
Apply Xelstrym 2 hours before you want to see effects, and take it off within 9 hours of placing it. Don’t use more than one patch per 24 hours.
How do I apply the Xelstrym patch?
Xelstrym can be applied in these areas:
Hip
Upper arm
Chest
Upper back
The sides and back of your belly (between your ribs and hips)
Other tips for applying Xelstrym include:
To avoid skin irritation, change where you apply Xelstrym each time.
When applying, your skin should be dry without any skincare products on it.
Avoid placing Xelstrym on hairy areas of the body.
Avoid using external heat (like heating pads, electric blankets) where Xelstrym is placed. Heat can cause Xelstrym to be absorbed more quickly, which is dangerous.
If the edges of the patch peel off, press down on the patch to reattach it. If it comes off completely, apply a new patch.
Never use tape to attach the patch.
How effective is Xelstrym?
Xelstrym was studied in 6 to 17 year olds in a randomized controlled trial (RCT). An RCT is one of the best types of studies to determine if a medication works. Xelstrym was started in 110 children with ADHD. Their dose was raised as needed to manage ADHD symptoms. The study found that Xelstrym provided better control of ADHD symptoms compared to placebo (a patch with no medication in it).
At the time of Xelstrym’s FDA approval, there aren’t studies evaluating Xelstrym’s efficacy in adults. But another amphetamine — lisdexamfetamine — is well-studied in adults. Xelstrym is considered to be similar to lisdexamfetamine, so these studies were used to evaluate Xelstrym’s effectiveness in adults.
What are the known side effects of Xelstrym?
Like all medications, side effects may occur with Xelstrym. Side effects may vary between children and adults, but possible side effects include:
Smaller appetite than normal
Irritability
Stomach pain
Moodiness
Pain and itchiness where the patch was applied
Vomiting
Tiredness
Sudden, repetitive movements (tics)
Faster heart rate
Does Xelstrym have any serious side effects?
Xelstrym can cause serious side effects. It’s important to know about these risks so you know what to watch out for while you or your child is prescribed Xelstrym.
Potential for dependence and misuse
Prescription stimulants like Xelstrym are Schedule II controlled substances. Controlled substances have a high potential for dependence and misuse. There are no refills allowed on Schedule II prescriptions, which means you need a new prescription each time you run out.
In general, long-acting stimulants are less likely to cause dependence and misuse than short-acting ones. Long-acting medications are released into the blood gradually. This helps avoid the high that can occur when a medication is quickly absorbed into the bloodstream.
Slowed growth and weight loss
Stimulants have been linked to slowed growth and weight loss in children. In the study of Xelstrym, some children experienced weight loss. If your child isn’t growing or is losing weight on Xelstrym, talk to their healthcare provider.
Heart problems
Amphetamines may cause heart problems, including a heart attack or other life-threatening situations that can lead to death. This is more likely in adults and children who already have existing heart disease. It’s best to avoid Xelstrym if you or your child has existing heart issues, like an abnormal heart rhythm (like atrial fibrillation).
Mood changes
Stimulants can worsen symptoms (or cause new ones) in people who have an existing mental health condition like bipolar disorder. If you have any new or worsening symptoms (like hallucinations, delusions), you may need to stop Xelstrym. Talk to your healthcare provider immediately if you experience these symptoms.
Circulation problems
Stimulants can affect blood flow in the body. This makes it harder for blood to reach your fingers and toes (Raynaud’s phenomenon). Rarely, this can lead to open wounds (ulcers) in the fingers and toes. If you experience any discoloration, numbness, or pain in your fingers or toes, contact your healthcare provider immediately.
Serotonin syndrome
Serotonin syndrome can occur when serotonin levels are too high in the brain. Serotonin syndrome is rare, but it’s more likely when amphetamines are combined with other medications that also raise serotonin levels.
Examples include:
Monoamine oxidase inhibitors (MAOIs)
Selective serotonin reuptake inhibitors (SSRIs)
Serotonin norepinephrine reuptake inhibitors (SNRIs)
Tricyclic antidepressants (TCAs)
Serotonin syndrome symptoms include hallucinations, delirium, and fast heart rate. If you experience these symptoms, stop Xelstrym and other medications that raise serotonin. Contact your healthcare provider immediately.
Allergic skin reactions
If you or your child develop intense swelling or blisters where Xelstrym is placed, this may be a sign of a skin allergy to Xelstrym. Remove the patch and contact your healthcare provider immediately.
Does Xelstrym interact with other medications?
As mentioned above, Xelstrym can interact with medications that raise serotonin levels. But, it can also interact with other medications.
CYP2D6 inhibitors
CYP2D6 is an enzyme (protein) that changes some medications into their active form, including amphetamines. Medications that inhibit (block) CYP2D6 can cause high levels of Xelstrym in the body, making side effects more likely.
CYP2D6 inhibitors include:
SSRIs
Bupropion (Wellbutrin XL, Wellbutrin SR)
Diphenhydramine (Benadryl)
Ask your pharmacist if any of your medications are CYP2D6 inhibitors. If you’re taking a CYP2D6 inhibitor, your healthcare provider may start you at a lower dose of Xelstrym or raise your dose more gradually. If you experience symptoms of serotonin syndrome, stop Xelstrym and your CYP2D6 inhibitor. Contact your healthcare provider immediately.
Medications that make your urine more basic
Some medications can change the pH of your urine. The pH of a liquid is a measure of how acidic or basic it is. When your urine is more basic (a higher pH), levels of amphetamines can rise in the body. Avoid combining Xelstrym and medications that raise the pH of your urine. These include Cytra-K (potassium citrate/citric acid) and Urocit-K (potassium citrate).
How much will Xelstrym cost?
The manufacturer of Xelstrym — Noven Therapeutics — hasn't announced how much Xelstrym will cost. We’ll likely know more closer to when Xelstrym becomes available.
When will Xelstrym be available?
Noven Therapeutics announced that Xelstrym should be available in the second half of 2022. They haven’t specified a timeline otherwise.
The bottom line
Xelstrym is the first FDA-approved amphetamine patch to treat ADHD in adults and children over the age of 6. Common side effects of Xelstrym include a lower appetite, trouble sleeping, and headache. More serious side effects include abuse, heart problems, and serotonin syndrome. We don’t know how much Xelstrym will cost. It will likely be available in the second half of 2022.
Why trust our experts?
References
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