Vyvanse (Page 6 of 7)

17 PATIENT COUNSELING INFORMATION

See Medication Guide

17.1 Information on Medication Guide

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Vyvanse and should counsel them in its appropriate use. A patient Medication Guide is available for Vyvanse. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is attached to the package insert.

17.2 Controlled Substance Status/Potential for Abuse, Misuse, and Dependence

Patients should be advised that Vyvanse is a federally controlled substance because it can be abused or lead to dependence. Additionally, it should be emphasized that Vyvanse should be stored in a safe place to prevent misuse and/or abuse. Patient history (including family history) of abuse or dependence on alcohol, prescription medicines, or illicit drugs should be evaluated [see Drug Abuse and Dependence (9)].

17.3 Serious Cardiovascular Risks

Patients should be advised of serious cardiovascular risk (including sudden death, myocardial infarction, stroke, and hypertension) with Vyvanse. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation [see Warnings and Precautions (5.1)].

17.4 Psychiatric Risks

Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression. Additionally, stimulant therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.2)].

17.5 Growth

Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted. [see Warnings and Precautions (5.6)].

17.6 Pregnancy

Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during treatment [see Dosage and Administration (2) and Use in Specific Populations (8.1)].

17.7 Nursing

Patients should be advised not to breast feed if they are taking Vyvanse [see USE IN SPECIFIC POPULATIONS (8.3) ].

17.8 Impairment in Ability to Operate Machinery or Vehicles

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.

Pharmacist: Medication Guide to be dispensed to patients

Manufactured for: Shire US Inc., Wayne, PA 19087

Made in USA

For more information call 1-800-828-2088

Vyvanse^® is a trademark of Shire LLC

©2011 Shire US Inc.

US Pat No. 7,105,486 and US Pat No. 7,223,735

Last Modified: 08/2011

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

VYVANSE^®

(lisdexamfetamine dimesylate) CII

Read the Medication Guide that comes with Vyvanse before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Vyvanse.

What is the most important information I should know about Vyvanse? Vyvanse is a stimulant medicine. The following have been reported with use of stimulant medicines. 1. Heart-related problems: • sudden death in patients 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 have 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 Vyvanse.Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Vyvanse.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 Vyvanse. 2. Mental (Psychiatric) problems:All Patients • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostilityChildren and Teenagers • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or 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 Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is Vyvanse?

Vyvanse is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Vyvanse may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Vyvanse should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Vyvanse?

Vyvanse should not be taken if you or your child:

• have heart disease or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• have an eye problem called glaucoma
• are very anxious, tense, or agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• is sensitive to, allergic to, or had a reaction to other stimulant medicines

Vyvanse has not been studied in children less than 6 years old.

Vyvanse may not be right for you or your child. Before starting Vyvanse tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette’s syndrome
• liver or kidney problems
• thyroid problems
• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Vyvanse be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and non-prescription medicines, vitamins, and herbal supplements. Vyvanse 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 Vyvanse.

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

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• anti-psychotic medicines
• lithium
• blood pressure medicines
• seizure medicines
• narcotic pain medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

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

How should Vyvanse be taken?

• Take Vyvanse exactly as prescribed. Vyvanse comes in 6 different strength capsules. Your doctor may adjust the dose until it is right for you or your child.
• Take Vyvanse once a day in the morning.
• Vyvanse can be taken with or without food.
• From time to time, your doctor may stop Vyvanse treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Vyvanse. Children should have their height and weight checked often while taking Vyvanse. Vyvanse treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Vyvanse or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Vyvanse?

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

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

Common side effects include:

• upper belly pain
• dizziness
• irritability
• nausea
• weight loss
• decreased appetite
• dry mouth
• trouble sleeping
• vomiting

Vyvanse may affect your or your child’s ability to drive or do other dangerous activities.

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

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Vyvanse?

• Store Vyvanse in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from light.
• Keep Vyvanse and all medicines out of the reach of children.

General information about Vyvanse

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vyvanse for a condition for which it was not prescribed. Do not give Vyvanse 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 Vyvanse. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Vyvanse that was written for healthcare professionals. For more information about Vyvanse, please contact Shire US Inc. at 1-800-828-2088.

What are the ingredients in Vyvanse?

Active Ingredient: lisdexamfetamine dimesylate

Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, Yellow Iron Oxide.

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

©2011 Shire US Inc.

US Pat No. 7,105,486 and US Pat No. 7,223,735

Last Modified: 08/2011