QUILLIVANT  XR- methylphenidate hydrochloride powder, for suspension 
NextWave Pharmaceuticals, Inc.

----------

Medication Guide

QUILLIVANT™ XR (\kwil-ə-vant\)
(methylphenidate hydrochloride)
for extended-release oral suspension CII

Read this Medication Guide that comes with QUILLIVANT XR 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 your or your child's treatment with QUILLIVANT XR.

What is the most important information I should know about QUILLIVANT XR?
The following have been reported with use of methylphenidate hydrochloride and other 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 QUILLIVANT XR.
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with QUILLIVANT XR.
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 QUILLIVANT XR.
2. Mental (Psychiatric) problems:
All Patients
  • new or worse behavior and thought problems
  • new or worse bipolar illness
Children 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 QUILLIVANT XR, especially seeing or hearing things that are not real, believing things that are not real, or are 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 the 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 QUILLIVANT XR.

What is QUILLIVANT XR?

QUILLIVANT XR is a central nervous system stimulant prescription medicine. QUILLIVANT XR is a liquid medicine that you take by mouth. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QUILLIVANT XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

QUILLIVANT XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep QUILLIVANT XR in a safe place to prevent misuse and abuse. Selling or giving away QUILLIVANT XR 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.

It is not known if QUILLIVANT XR is safe and effective in children under 6 years of age.

Who should not take QUILLIVANT XR?

QUILLIVANT XR should not be taken if you or your child:

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

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. QUILLIVANT XR 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 QUILLIVANT XR.

Your doctor will decide whether QUILLIVANT XR 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.

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

How should QUILLIVANT XR be taken?

What are possible side effects of QUILLIVANT XR?

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

Other serious side effects include:

Common side effects include:

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 QUILLIVANT XR?

General information about the safe and effective use of QUILLIVANT XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QUILLIVANT XR for a condition for which it was not prescribed. Do not give QUILLIVANT XR 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 QUILLIVANT XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about QUILLIVANT XR that was written for healthcare professionals. For more information, please contact NextWave Pharmaceuticals, Inc., at 1-800-206-8115 or visit the website at www.quillivantxr.com.

What are the ingredients in QUILLIVANT XR?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.

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

Logo

LAB-0657-4.1

December 2013

Revised: 12/2013
Document Id: c0aeb2b0-7e04-43a2-9650-448517734ec3
Set id: e0157005-6e3e-4763-b910-9eb0937608c9
Version: 8
Effective Time: 20131217
 
NextWave Pharmaceuticals, Inc.