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.

Learn more about the causes of ADHD.

+Can ADHD be cured?

ADHD typically starts in childhood and can continue into adulthood.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.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 30 tablets at no cost if eligibility requirements are met, and an Instant Savings Program that helps to lower the copay 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. 

IMPORTANT SAFETY INFORMATION

Evekeo (amphetamine sulfate tablets, USP) is a federally controlled substance (CII) with a high risk of abuse or dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Evekeo may harm others and is illegal.

INDICATION

Evekeo® (amphetamine sulfate tablets, USP) is a prescription medicine for the treatment of narcolepsy, attention deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short term adjunct in a regimen of weight reduction.

IMPORTANT SAFETY INFORMATION

Evekeo (amphetamine sulfate tablets, USP) is a federally controlled substance (CII) with a high risk of abuse or dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Evekeo may harm others and is illegal.

Do not take Evekeo if you or your child:

  • has a history of advanced heart disease or hardening of the arteries, moderate to severe high blood pressure, hyperthyroidism, known hypersensitivity or other serious cardiac problems that may place you or your child at increased vulnerability to the sympathomimetic effects of a stimulant drug
  • is very anxious, tense or agitated
  • has a history of drug abuse
  • is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI)
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

Warnings and Precautions

Serious heart problems can occur when taking stimulant medicines, such as Evekeo, and can include:

  • sudden death in people who have heart problems or heart defects
  • sudden death, stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems including heart defects, abnormal heart rhythm, high blood pressure, disease known as cardiomyopathy, coronary artery disease, or a family history of these problems or sudden cardiac death. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath or fainting while taking Evekeo.

Mental (psychiatric) problems can occur including:

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

New aggressive behavior or psychotic symptoms can occur in children and teenagers such as:

  • seeing things or hearing voices
  • believing things that are not true
  • being suspicious
  • new manic problems

Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had or about a family history of suicide, bipolar illness or depression, new or worsening aggressive behavior or hostility. Call your doctor right away if you or your child has any new or worsening mental symptoms while taking Evekeo.


Circulation problems in fingers and toes:

  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your doctor if you or your child has any numbness, pain, color change, or sensitivity to temperature in your fingers and toes or a family history of health conditions including circulation problems in fingers and toes. Call your doctor right away if you or your child has any signs of unexplained wounds appearing on fingers and toes while taking Evekeo.


Evekeo may cause serious side effects including:

  • slowing of growth (height and weight) in children, seizures, eyesight changes or blurred vision, and serotonin syndrome. Serotonin syndrome can be life threatening and happens when Evekeo is taken with certain medicines. Symptoms include agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, nausea or vomiting, diarrhea, and muscle stiffness or tightness

The most common side effects reported with 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

Talk to your doctor if you or your child have side effects that are bothersome or do not go away, if you or your child is pregnant, plan on becoming pregnant, or are breast-feeding, about all health conditions (or a family history of), and about the medicines you or your child take. Your doctor will decide whether Evekeo can be taken with other medicines and if Evekeo is right for your child.

For additional safety information, consult the Evekeo full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.