EVEKEO- amphetamine sulfate tablet 
Arbor Pharmaceuticals

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MEDICATION GUIDE
Evekeo® (amphetamine sulfate tablets, USP)

Read this Medication Guide before you or your child starts taking Evekeo and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about you or your child's treatment.

What is the most important information I should know about Evekeo tablets?

Evekeo is a stimulant medicine. Some people have had the following problems when taking stimulant medicines such as Evekeo:

1.
Heart-related problems:
  • sudden death in people who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Evekeo.

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with Evekeo.

Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Evekeo.

2.
Mental (Psychiatric) problems including:

In children, teenagers, and adults:

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

In Children and Teenagers who have psychiatric problems, new psychotic symptoms such as:

  • hearing voices
  • seeing things that are not real
  • believing things that are not true
  • being suspicious
  • new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Evekeo, especially:

  • seeing or hearing things that are not real
  • believing things that are not real
  • being suspicious
3.
Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon].
  • 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 have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Evekeo.

What is Evekeo?

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 is against the law.

Tell your doctor if you or your child has (or has a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Evekeo?

Do not take Evekeo if you or your child:

What should I tell my doctor before taking Evekeo?

Before you or your child takes Evekeo, tell your doctor if you or your child has or if there is a family history of:

Tell your doctor if:

Tell your doctor about all the medicines that you or your child takes, including prescription and nonprescription 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 adjusted while taking Evekeo.

Your doctor will decide whether Evekeo can be taken with other medicines.

Especially tell your doctor if you or your child takes:

Know the medicines that you or your child takes.

Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

Do not start any new medicine while taking Evekeo without talking to your doctor first.

How should I take Evekeo?

What should I avoid while taking Evekeo?

Do not drive, operate 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:

See "What is the most important information I should know about Evekeo?" for information on reported heart and mental problems.

Other serious side effects include:

The most common side effects of Evekeo include:

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects of Evekeo. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Arbor Pharmaceuticals, LLC, Medical Information at 1-866-516-4950 or FDA at 1-800-FDA-1088.

How should I store Evekeo?

General information about the safe and effective use of Evekeo.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Evekeo for a condition for which it was not prescribed. Do not give Evekeo to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Evekeo. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Evekeo that was written for healthcare professionals.

For more information about Evekeo, please contact Arbor Pharmaceuticals, LLC at 1-866-516-4950.

What are the ingredients in Evekeo?

Active Ingredient: amphetamine sulfate

Inactive Ingredients: crospovidone, silicified microcrystalline cellulose, and stearic acid. The 10 mg tablets also contain FD&C Blue #1.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Arbor Pharmaceuticals, LLC
Atlanta, GA 30328

AM-MG-07

Rev. 04/19

Revised: 3/2021
Arbor Pharmaceuticals