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Find answers to common questions about Quillivant XR (methylphenidate HCl)

Quillivant XR is the first once-daily, extended-release liquid methylphenidate used for the treatment of ADHD. Quillivant XR is a central nervous system stimulant prescription liquid medicine that is taken by mouth once in the morning, with or without food. 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 may be used as part of a treatment program for ADHD that may include behavioral therapy or other therapies.

The “XR” stands for “eXtended Release.”

Quillivant XR uses technology to allow for a continuous release of methylphenidate throughout the day. This means that Quillivant XR only needs to be taken once each day in the morning.

The effectiveness of Quillivant XR was assessed in a laboratory classroom study. Teachers and raters used a rating scale (SKAMP) to evaluate the efficacy of Quillivant XR on attention and behavior in children with ADHD ages 6-12 years. Quillivant XR was given once daily in the morning for 4 to 6 weeks, where the right dose was identified for each patient. Patients randomly assigned to the Quillivant XR group remained on that dose for another week while others took a sugar syrup. At the end of the 1-week period each child's attention and behavior were measured. Quillivant XR was found effective at reducing the symptoms of ADHD at all measured times (45 minutes; 2, 4, 8, 10, and 12 hours after taking) compared to a sugar syrup.

The most common side effects for Quillivant XR and greater than placebo were mood swings, skin scratching, lack of sleep, involuntary rapid movement or speech, decreased appetite, vomiting, motion sickness, eye pain, and rash.

The most common adverse events reported during the study were decreased appetite, upper abdominal pain, affect lability, initial insomnia, insomnia, and headache.

Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.

Quillivant XR is banana-flavored.

Store Quillivant XR in a safe place at 59°F to 86°F (15°C to 30°C). Keep Quillivant XR and all medicines out of the reach of children.

Quillivant XR comes as a powder that your pharmacist will mix for you into a liquid. Depending on the prescription from your doctor, you will be given 1 or 2 bottles (containing the liquid form of Quillivant XR), with the bottle adapter already fully inserted by the pharmacist. You will also be given 1 oral dosing dispenser. Please refer to the Instructions for Use for a full description of each item.

  • Take Quillivant XR exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child
  • Take Quillivant XR once each day in the morning
  • 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
  • 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 healthcare 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
  • In case of poisoning, call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room

Take Quillivant XR exactly as prescribed by your doctor and as instructed by your pharmacist. Quillivant XR is taken once each day in the morning.

Quillivant XR was demonstrated to start working 45 minutes after taking. In a clinical study performed in a laboratory classroom, Quillivant XR was found effective at reducing the symptoms of ADHD in children ages 6-12 years at all measured times (45 minutes; 2, 4, 8, 10, and 12 hours after taking) compared to a sugar syrup.

Quillivant XR works in 45 minutes and keeps working for 12 hours after taking. That means that when taken at 7 am, Quillivant XR may be effective through evening. In a clinical study performed in a laboratory classroom, Quillivant XR was found effective at reducing the symptoms of ADHD in children ages 6-12 years at all measured times (45 minutes; 2, 4, 8, 10, and 12 hours after taking) compared to a sugar syrup.

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. Quillivant XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Selling or giving away Quillivant XR may harm others and is against the law. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

References: 1. Wigal SB, Childress AC, Belden HW, Berry SA. NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2013;23(1):3-10. 2. Quillivant XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ.

Important Safety Information

Quillivant® XR (methylphenidate HCI) is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Quillivant XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep Quillivant XR in a safe place to prevent abuse and misuse. 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.

See Additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Important Safety Information

Quillivant® XR (methylphenidate HCI) is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Quillivant XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep Quillivant XR in a safe place to prevent abuse and misuse. 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.

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. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Quillivant XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.

The following have been reported with the use of methylphenidate hydrochloride and other stimulant medicines:

  • Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Before starting Quillivant XR, tell your healthcare 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 during treatment with Quillivant XR.
  • Increase in blood pressure and heart rate.
    Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Quillivant XR.
  • Mental (psychiatric) problems, including new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms. Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call the doctor right away if there are any new or worsening mental symptoms during treatment.

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 the unborn baby. There is a pregnancy registry for females who are exposed to Quillivant XR 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 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 breastfeed.
  • Do not start any new medicine while taking Quillivant XR without talking to your healthcare provider first.

What should I avoid while taking Quillivant XR?

Quillivant XR should not be taken with MAOI medicines or 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.

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:

  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
    Call the doctor right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Quillivant XR.
  • 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.
  • 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.
  • 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.

Most Common side eff­ects 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.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is Quillivant XR?

Quillivant XR is a central nervous system stimulant prescription medicines. Quillivant XR is a chewable tablet.

Quillivant XR 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.

Please see Full Prescribing Information for Quillivant XR, including Boxed Warning about Abuse, Misuse and Addiction, and Medication Guide.

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