Getting answers can help in making good decisions
Here, you’ll find frequently asked questions and answers on ADHD and EVEKEO, a medication for ADHD
After being diagnosed with ADHD, it’s very important to take an active role in managing the condition. One of the first ways to do that is to learn about ADHD and treatment options, including EVEKEO, so that you can meaningfully participate in discussions and decisions with the healthcare provider.
Here are some frequently asked questions—and answers to them—on ADHD and EVEKEO® CII (amphetamine sulfate tablets, USP):
FAQs about ADHD
+What are the symptoms of ADHD?
There are 3 ADHD types: ADHD predominantly inattentive, ADHD predominantly hyperactive-impulsive, and ADHD combined.
ADHD symptoms may change as you get older. In general, experts break down ADHD as follows1,2:
ADHD inattentive type (ADHD-I)
- At least 6 inattention symptoms for children age 16 and younger; at least 5 inattention symptoms for patients age 17 and older
— No close attention to detail, makes careless mistakes
— Difficulty maintaining attention
— Does not seem to listen
— Struggles to follow instructions
— Disorganized
— Avoids/Dislikes tasks that require sustained mental effort
— Loses items
— Easily distracted
— Forgetful
ADHD hyperactive-impulsive type (ADHD-HI)
- At least 6 hyperactive-impulsive symptoms for children age 16 and younger; at least 5 hyperactive-impulsive symptoms for patients age 17 and older
— Fidgets with hands and feet
— Difficulty staying seated
— Excessive physical energy
— Difficulty engaging in quiet activities
— Acts as if driven by a motor
— Excessive talking
— Blurts out answers before questions are fully asked
— Difficulty waiting or taking turns
— Interrupts or intrudes on others
ADHD combined type (ADHD-C)
- At least 6 inattention symptoms for children age 16 and younger; at least 5 inattention symptoms for patients age 17 and older AND
- At least 6 hyperactive-impulsive symptoms for children age 16 and younger; at least 5 hyperactive-impulsive symptoms for patients age 17 and older. People may be told they have 1 or both types of ADHD, which is called ADHD combined type
+People have told me ADHD isn't real. Is this true?
No. There are some people and organizations that continue to insist that ADHD is a “make-believe” condition, but this is simply not so. The National Institutes of Health, the Surgeon General of the United States, and a worldwide community of medical experts concluded that ADHD is a valid disorder that can have severe and lifelong consequences. More than 100 years of studies show that ADHD impacts emotional, social, academic, and work functioning on a daily basis. That's why it's so important to diagnose and treat ADHD as soon as possible.3
+How is ADHD diagnosed?
There is no single test to diagnose ADHD. A healthcare team will assess physical, social, academic, and emotional functioning levels. There are checklists that medical professionals use to help rate ADHD symptoms and rule out other conditions. A careful history from parents, teachers, and yourself (if you're old enough) will be taken. Once all the information is gathered, a manual called the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) will be used to see if you have ADHD. The DSM-5 contains a listing of criteria for every psychiatric disorder recognized by the US healthcare system. It is used by healthcare professionals only.1,2,4
+What causes ADHD?
No one knows exactly what causes ADHD. ADHD definitely affects the brain. Studies have shown that ADHD tends to run in families and is probably inherited. ADHD is not caused by anything you or your parents did wrong. Parenting styles and home environment can make ADHD better or worse, but they don't cause ADHD itself.5,6
ADHD is also not caused by food allergies, family problems, eating too much sugar, lack of discipline, laziness, or lack of motivation.3,5 Addressing these misperceptions is the first step for many families in moving forward with treatment for ADHD.
+Can ADHD be cured?
ADHD typically starts in childhood and can continue into adulthood.6 There is no cure for it yet.4 However, there are treatment options including EVEKEO for children with ADHD that can be used as part of an overall treatment program.6
+Why is medicine for ADHD needed?
ADHD symptoms put people at risk of facing problems at school or work, experiencing trouble relating to friends and family, becoming antisocial, and taking unnecessary risks that may result in serious injury. Medicines like EVEKEO can help by controlling ADHD symptoms in children, allowing those who take it to focus more clearly without being distracted or feeling like they have to move around a lot. About 70% to 80% of children who take an ADHD medicine respond positively.6
FAQs about EVEKEO
+How do I know if EVEKEO is the right choice?
To know if EVEKEO is the right choice, you and the healthcare provider should look at all your ADHD treatment options and discuss what’s most important to you in an ADHD treatment. EVEKEO is approved to treat ADHD in children ages 3 and up. And EVEKEO has adjustable dosing, so it can be taken once or twice a day and the dose can be increased or decreased depending on the specific needs of the pediatric patient with ADHD and the doctor’s directions.7
EVEKEO should not be taken without a prescription. People who should not take EVEKEO include those who have heart problems or hardening of the arteries, moderate to severe high blood pressure, thyroid problems, allergies to any of the ingredients in EVEKEO, a history of drug abuse, tension, or agitation or who have taken an antidepressant called a monoamine oxidase inhibitor (MAOI) within the past 14 days.7
+How do I know if the dose of EVEKEO is the right dose?
You and the doctor will work together to find the right dose. The doctor will start off with the lowest recommended dose based on age and then may increase the dose if ADHD symptoms are still present. Once EVEKEO has been taken for a while, the doctor may want to stop the medication for a short time to see if symptoms are still present. Medication should be stopped only if the doctor says to do so. Over time, the doctor may decide to decrease the dose to see if ADHD stays under control with less medicine. The EVEKEO dose should only be changed after a discussion with and direction from the doctor.7
+How will I know if EVEKEO is working?
After starting EVEKEO, you may notice feeling less distracted, and you may be better able to focus and pay attention. You may also start to see that EVEKEO is working if you notice improvements in school or at work, or in getting along with friends and family. If you don’t notice any difference in ADHD symptoms, talk with the doctor right away. The dose may need to be adjusted.
+What are the side effects of EVEKEO?
The most common side effects of EVEKEO include headache, stomach ache, trouble sleeping, decreased appetite, unpleasant taste, nervousness, dizziness, sexual problems (impotence in males), vomiting, itching, diarrhea or constipation, dry mouth, weight loss, and mood swings. These are not all the side effects of EVEKEO.7 For more information, see the Patient Medication Guide or ask the healthcare provider or pharmacist.
+How long should EVEKEO be taken?
ADHD can last a long time. The doctor will determine how long EVEKEO should be taken.
+Is there a discount available for EVEKEO?
Arbor Pharmaceuticals, the maker of EVEKEO, offers a way to save on an EVEKEO prescription. There’s a Free Trial Offer that provides up to 60 tablets at no cost if eligibility requirements are met, and an Instant Savings Program that helps to lower the co-pay or cover part of the cost of an EVEKEO prescription. These programs are available to patients who meet the eligibility requirements. Learn more.
References: 1. National Resource Center on ADHD: A program of CHADD. ADHD and the DSM 5. http://www.chadd.org/Portals/0/documents/ ADHD%20and%20the%20DSM%205%20Fact%20Sheet.pdf. Accessed May 23, 2016. 2. Centers for Disease Control and Prevention. Checklist: Signs and symptoms of attention-deficit/hyperactivity disorder (ADHD). http://www.cdc.gov/ncbddd/adhd/checklist.html. Accessed May 23, 2016. 3. National Resource Center on ADHD: A program of CHADD. About ADHD: Myths and misunderstandings. http://www.help4adhd.org/Understanding-ADHD/about-attention-deficit-hyperactivity-disorder/Myths-and-Misunderstandings.aspx. Accessed May 23, 2016. 4. National Institute of Mental Health. Attention Deficit/Hyperactivity Disorder. http://www.nimh.nih.gov/health/publications/attention-deficit-hyperactivity-disorder-easy-to-read/complete_34434.pdf. Accessed May 23, 2016. 5. Centers for Disease Control and Prevention. Facts about ADHD. http://www.cdc.gov/ncbddd/adhd/facts.html. Accessed May 23, 2016. 6. National Resource Center on ADHD: A program of CHADD. What we know 1. The disorder named ADHD. http://www.help4adhd.org/. Updated February 2008. Accessed May 23, 2016. 7. Evekeo [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC. 2023.
IMPORTANT SAFETY INFORMATION
Evekeo® (amphetamine sulfate tablets, USP) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:
- A sleep disorder called narcolepsy.
- Attention-Deficit Hyperactivity Disorder (ADHD) in children 3 to 16 years of age. Evekeo may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
- Exogenous obesity. Evekeo may be used as part of a short-term (a few weeks) weight reduction program for obesity in people who have not responded to other treatment.
IMPORTANT SAFETY INFORMATION
Evekeo® (amphetamine sulfate tablets, USP) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:
- A sleep disorder called narcolepsy.
- Attention-Deficit Hyperactivity Disorder (ADHD) in children 3 to 16 years of age. Evekeo may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
- Exogenous obesity. Evekeo may be used as part of a short-term (a few weeks) weight reduction program for obesity in people who have not responded to other treatment.
Evekeo is not for use in children under 3 years of age.
It is not known if Evekeo is safe and effective in children with exogenous obesity under 12 years of age.
Evekeo is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Evekeo in a safe place to protect it from theft. Never give your Evekeo to anyone else because it may cause death or harm them. Selling or giving away Evekeo may harm others and is against the law.
WARNING: ABUSE, MISUSE, AND ADDICTION
Amphetamine sulfate 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 amphetamine sulfate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing amphetamine sulfate, 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 amphetamine sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Do not take Evekeo if you or your child:
- are allergic to amphetamine products or any of the ingredients in Evekeo.
- are taking or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
What is the most important information I should know about Evekeo?
Evekeo may cause serious sides effects, including:
Abuse, misuse, and addiction. Evekeo has a high potential for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Evekeo, other amphetamine-containing medicines, and methylphenidate, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Evekeo or when it is used in ways 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 Evekeo and will monitor you or your child during treatment.
- Evekeo may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
- Do not give Evekeo to anyone else.
- 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 problems. 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 Evekeo. 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 Evekeo.
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 Evekeo.
Mental (psychiatric) problems can occur including:
- new or worsening behavior and thought problems.
- new or worsening 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 Evekeo, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.
Before taking Evekeo, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
- have heart problems, heart disease, heart defects, or high blood pressure.
- have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression.
- have seizures or have had an abnormal brain wave test (EEG).
- have circulation problems in fingers and toes.
- 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. It is not known if Evekeo will harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with Evekeo.
- are breastfeeding or plan to breastfeed. Evekeo passes into breast milk. You or your child should not breastfeed during treatment with Evekeo. Talk to your healthcare provider about the best way to feed the baby during treatment with Evekeo.
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Evekeo and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with Evekeo. Your healthcare provider will decide if Evekeo can be taken with other medicines.
- selective serotonin reuptake inhibitors (SSRIs)
- medicines used to treat migraine headaches called triptans
- lithium
- tramadol
- buspirone
- serotonin norepinephrine reuptake inhibitors (SNRIs)
- tricyclic antidepressants
- fentanyl
- tryptophan
- St. John’s Wort
Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine. Do not start any new medicine during treatment with Evekeo without talking to your healthcare provider first.
What should I avoid while taking Evekeo?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Evekeo affects you.
What are possible side effects of Evekeo?
Evekeo may cause serious side effects, including:
- Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Evekeo. Your healthcare provider may stop your child’s Evekeo treatment if they are not growing or gaining weight as expected.
- Seizures. Your healthcare provider may stop treatment with Evekeo if you or your child have a seizure.
- 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.
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 Evekeo.
- Serotonin syndrome. This problem may happen when Evekeo is taken with certain other medicines and may be life-threatening. 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, hallucinations, coma
- fast heartbeat
- flushing
- seizures
- sweating or fever
- loss of coordination
- confusion
- dizziness
- muscle stiffness or tightness
- changes in blood pressure
- high body temperature (hypothermia)
- 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 Evekeo.
The most common side effects of Evekeo include:
- headache
- stomachache
- trouble sleeping
- decreased appetite
- unpleasant taste
- nervousness
- dizziness
- sexual problems (impotence in males)
- vomiting
- itching
- diarrhea or constipation
- dry mouth
- weight loss
- mood swing
These are not all the possible side effects of Evekeo. Please see Full Prescribing Information for a full list.
The Important Safety Information does not include all the information needed to use Evekeo safely and effectively. Please see accompanying full Prescribing Information for Evekeo.
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
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