Medication Guide

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

What is the most important information I should know about QUILLIVANT XR?

QUILLIVANT XR may cause serious side effects, including:

• Abuse, misuse, and addiction. QUILLIVANT XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of QUILLIVANT XR, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of QUILLIVANT XR or when it is used in ways that are 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 QUILLIVANT XR and will monitor you or your child during treatment.

• QUILLIVANT XR may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.

• Do not give QUILLIVANT XR to anyone else. See “What is QUILLIVANT XR?” for more information.

• Keep QUILLIVANT XR in a safe place and properly dispose of any unused medicine. See “How should I store QUILLIVANT XR?” for more information.

• 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 disease. 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 QUILLIVANT XR.

Tell your health care provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room 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.

• Increased blood pressure and heart rate.

  Your health care provider should check your or your child’s blood pressure and heart rate regularly during treatment with QUILLIVANT XR.

• Mental (Psychiatric) problems:

• new or worse behavior and thought problems
• new or worse bipolar illness
• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

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

Call your health care provider 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.

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 people with ADHD.

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

QUILLIVANT XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.Keep QUILLIVANT XR in a safe place to protect it from theft. Never give your QUILLIVANT XR to anyone else, because it may cause death or harm them. Selling or giving away QUILLIVANT XR may harm others and is against the law.

Do not take QUILLIVANT XR if you or your child:

• are allergic to methylphenidate hydrochloride, or any of the ingredients in QUILLIVANT XR. See the end of this Medication Guide for a complete list of ingredients in QUILLIVANT XR.
• are taking or have taken within the past 14 days a type of anti-depression medicine called a monoamine oxidase inhibitor (MAOI).

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

• heart problems, heart disease, heart defects, or high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• circulation problems in fingers and toes
• have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• if you are pregnant or plan to become pregnant. It is not known if QUILLIVANT XR will harm your unborn baby. Talk to your health care provider if you are pregnant or plan to become pregnant.
  • There is a pregnancy registry for females who are exposed to ADHD medications during pregnancy. The purpose of the registry is to collect information about the health of females exposed to QUILLIVANT XR and their baby. If you or your child becomes pregnant during treatment with QUILLIVANT XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
• if you are breastfeeding or plan to breast feed. QUILLIVANT XR passes into your breast milk. You and your healthcare provider should decide if you will take QUILLIVANT XR or breast feed.

Tell your health care provider 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 health care provider will decide whether QUILLIVANT XR can be taken with other medicines.

Especially tell your health care provider if you or your child takes:

• anti-depression medicines including MAOIs

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your health care provider and pharmacist. Do not start any new medicine while taking QUILLIVANT XR without talking to your health care provider first.

How should QUILLIVANT XR be taken?

• Read the step-by-step instructions for using QUILLIVANT XR extended-release suspension at the end of this Medication Guide.

• Take QUILLIVANT XR exactly as prescribed. Your health care provider may adjust the dose, if needed, until it is right for you or your child. During dose adjustment, you or your child may still have ADHD symptoms.
• QUILLIVANT XR should be used with the oral dosing dispenser provided with the product. If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.
• Check and make sure that the QUILLIVANT XR bottle contains liquid medicine. If QUILLIVANT XR is in powder form, do not use it. Return it to your pharmacist.
• Check and make sure that the bottle adapter was fully inserted into the bottle by the pharmacist. If the bottle adapter is not fully inserted, insert the adapter into the bottle.
• Take QUILLIVANT XR 1 time each day in the morning. QUILLIVANT XR is an extended-release suspension. It releases medicine into your body throughout the day.
• QUILLIVANT XR can be taken with or without food. Taking QUILLIVANT XR with food may shorten the time it takes for the medicine to start working.
• Your health care provider may do regular checks of the blood, heart, and blood pressure while taking QUILLIVANT XR.
• Children should have their height and weight checked often while taking QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if a problem is found during these check-ups.
• If a dose is missed, you or your child should talk to your health care provider about dosing.

If you or your child take too much QUILLIVANT XR, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking QUILLIVANT XR?

• QUILLIVANT XR should not be taken with MAOI medicines. Do not start taking QUILLIVANT XR if you stopped taking an MAOI in the last 14 days.
• Do not drink alcohol while taking QUILLIVANT XR. This may cause a faster release of your methylphenidate dose.

What are the possible side effects of QUILLIVANT XR?

QUILLIVANT XR may cause serious side effects, including:

• 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:

• Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because priapism can cause long lasting damage, it should be checked by a health care provider right away.
• 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, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with QUILLIVANT XR.

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if your child is not gaining weight or height.

• Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.

• 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 QUILLIVANT XR.

The most common side effects of QUILLIVANT XR include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings
• fast heart beat
• increased blood pressure

These are not all the possible side effects of QUILLIVANT XR.

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?

• Store QUILLIVANT XR at 59°F to 86°F (15°C to 30°C).
• Store QUILLIVANT XR in a safe place, like a locked cabinet.
• Dispose   of remaining, unused, or expired QUILLIVANT XR by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix QUILLIVANT XR with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away QUILLIVANT XR in the household trash. Visit http://www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
• Keep QUILLIVANT XR and all medicines out of the reach of children.

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.

You can ask your pharmacist or healthcare provider for information about QUILLIVANT XR that is written for healthcare professionals.

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.

Distributed by:

Manufactured by:

 Tris Pharma, Inc.

Monmouth Junction, NJ 08852

For more information, go to www.quillivantxr.com or call (732)-940-0358.

This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com

This Medication Guide has been approved by the U.S. Food and Drug Administration.                 Revised:  10/2023