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 * QUILLIVANT XR PRESCRIBING INFORMATIONPI AND MEDICATION GUIDEMG
 * QUILLICHEW ER PRESCRIBING INFORMATIONPI AND MEDICATION GUIDEMG







TREATMENT OPTIONS FOR PATIENTS 6 YEARS AND OLDER WITH ADHD


METHYLPHENIDATE PRODUCTS THAT OFFER PERSONALIZED DOSING AND MICROTITRATION


SCROLL DOWN AND LEARN MORE ABOUT QUILLIVANT AND QUILLICHEW IN 60 SECONDS


QUILLIVANT XR® (METHYLPHENIDATE HCL): MICROTITRATION (2-4 ML) PROVIDES DOSING
FLEXIBILITY IN A LIQUID METHYLPHENIDATE

 * Developed with LiquiXR® technology
 * Starting dose 20 mg (4 mL) once daily in the morning, with or without food1
 * Adjust the dose in 10-mg (2 mL) to 20-mg (4 mL) increments once a week1
 * Maximum daily dose 60 mg (12 mL)1

IMAGE IS FOR ILLUSTRATIVE PURPOSE ONLY.

After reconstitution by the pharmacist: 5 mL of Quillivant XR equals 25 mg
methylphenidate HCl.

Quillivant XR prescribing guide1

Dosing/titrationDispenseTake once daily in the morning with or without food20
mg/day600-mg bottle (120 mL)4 mL10 mg/day300-mg bottle (60 mL)2 mL30
mg/day900-mg bottle (180 mL)6 mL40 mg/day2 x 600-mg bottle (total 240 mL)8 mL50
mg/day2 x 750-mg bottle (total 300 mL)10 mL60 mg/day
(Maximum dose)2 x 900-mg bottle (total 60 mL)12 mL

PRESCRIBING 2 BOTTLES WITH DIFFERENT NDC NUMBERS WHEN JUST 1 BOTTLE COULD BE
USED TO FILL THE PRESCRIPTION MAY RESULT IN EXTRA OUT-OF-POCKET OR COPAY COSTS
FOR YOUR PATIENTS.

ALWAYS SHAKE BOTTLE FOR 10+ SECONDS BEFORE ADMINISTRATION

The concentration of Quillivant XR is 25 mg per 5 mL (5 mg/mL) in all bottle
sizes.

IMPORTANT DOSING CONSIDERATIONS

 * Prior to treatment, assess for the presence of cardiac disease (i.e., perform
   a careful history, family history of sudden death or ventricular arrhythmia,
   and physical exam) and risk for abuse
 * After prescribing, maintain careful prescription records, educate patients
   about abuse, and monitor for signs of abuse and overdose
 * Periodically reevaluate the need for Quillivant XR use
 * If paradoxical aggravation of symptoms or other adverse effects occur, reduce
   dosage, or, if necessary, discontinue the drug
 * Quillivant XR should be periodically discontinued to assess the child’s
   condition. If improvement is not observed after appropriate dosage adjustment
   over a 1-month period, the drug should be discontinued

IF SWITCHING FROM OTHER METHYLPHENIDATE PRODUCTS TO QUILLIVANT XR2:

 * Discontinue that treatment and titrate with Quillivant XR using the above
   titration schedule
 * Do not substitute for other methylphenidate products on a
   milligram‑per‑milligram basis because of different methylphenidate base
   compositions and differing pharmacokinetic profiles

ADHD, ATTENTION DEFICIT HYPERACTIVITY DISORDER.


SMOOTH PK PROFILE

Quillivant XR—no peaks throughout the day after initial onset

Mean d-methylphenidate plasma concentration-time profiles1


With the use of LiquiXR technology, Quillivant XR has approximately 20%
immediate-release and 80% extended-release methylphenidate.

STUDY DETAILS

Following a single, 60-mg oral dose of Quillivant XR for extended-release oral
suspension, in 28 healthy adult subjects in a crossover study under fasting
conditions, d-methylphenidate mean (±SD) peak plasma concentrations of 13.6
(±5.8) ng/mL occurred at a median time of 5.0 hours after dosing. The relative
bioavailability of Quillivant XR compared with methylphenidate immediate-release
(IR) oral solution (2 x 30 mg, q6h) is 95%.1

SD, STANDARD DEVIATION.


QUILLICHEW ER OFFERS FLEXIBLE TITRATION AND MAY BE CHEWED OR SWALLOWED WHOLE

For patients that need a methylphenidate tablet, consider choosing QuilliChew ER

 * Starting dose 20 mg once daily in the morning, with or without food3

 * Available in 20-mg, 30-mg, and 40-mg tablets3
 * 20-mg and 30-mg tablets are scored to allow the dose to be titrated in weekly
   increments of 10 mg, 15 mg, or 20 mg3

 * Maximum daily dose is 60 mg/day3

TABLETS ARE NOT ACTUAL SIZE.

11 Dose options—QuilliChew ER prescribing guide4,5

Dosing/titrationWrite 30-day prescriptionTake once daily in the morning with or
without food20 mg/dayThirty 20-mg tabletsOne tablet10 mg/dayFifteen 20-mg
tabletsHalf of one tablet15 mg/dayFifteen 30-mg tabletsHalf of one tablet25
mg/dayFifteen 20-mg tablets and
fifteen 30-mg tabletsHalf of a 20-mg tablet and half a 30-mg tablet30
mg/dayThirty 30-mg tabletsOne tablet35 mg/dayThirty 20-mg tablets and
fifteen 30-mg tabletsOne 20-mg tablet and half a 30-mg tablet40 mg/dayThirty
40-mg tabletsOne tablet45 mg/dayForty-five 30-mg tabletsOne 30-mg tablet and
half a 30-mg tablet50 mg/daySeventy-five 20-mg tabletsTwo 20-mg tablets and half
a 20-mg tablet55 mg/dayThirty 40-mg tablets and
fifteen 30-mg tabletsOne 40-mg tablet and half a 30-mg tablet60 mg/daySixty
30-mg tabletsTwo 30-mg tablets

IMPORTANT DOSING CONSIDERATIONS

 * Prior to treatment, assess for the presence of cardiac disease (i.e., perform
   a careful history, family history of sudden death or ventricular arrhythmia,
   and physical exam) and risk for abuse
 * After prescribing, maintain careful prescription records, educate patients
   about abuse, and monitor for signs of abuse and overdose
 * Periodically reevaluate the need for QuilliChew ER use
 * If paradoxical aggravation of symptoms or other adverse effects occur, reduce
   dosage, or, if necessary, discontinue the drug
 * QuilliChew ER should be periodically discontinued to assess the child’s
   condition. If improvement is not observed after appropriate dosage adjustment
   over a 1-month period, the drug should be discontinued

IF SWITCHING FROM OTHER METHYLPHENIDATE PRODUCTS TO QUILLICHEW ER3:

 * Discontinue that treatment and titrate with QuilliChew ER using the above
   titration schedule
 * Do not substitute for other methylphenidate products on a
   milligram-per-milligram basis, because of different methylphenidate base
   compositions and differing pharmacokinetic profiles


METHYLPHENIDATES DESIGNED WITH YOUR PATIENTS INDIVIDUALIZED NEEDS IN MIND

For Patients 6 years and older with ADHD

Proven EfficacyYesYesFormulationLiquidTabletDosing OptionsMicrotitration
2-4 mLMost in an extended-release methylphenidate tabletLiquiXR®
Technology✔✔Copay Assistance✔✔

There are no data on the effectiveness or safety in patients switched from one
of the above treatments to the other.

 * Quillivant XR is the first once-daily, extended release, liquid
   methylphenidate1,6,7
    * For newly diagnosed patients 6 years and older with ADHD who need extended
      symptom control with proven efficacy
    * Offers the ability to start with a low dose and titrate in small
      increments

 * QuilliChew ER provides proven efficacy in a tablet
    * Available in a tablet to cover the most important parts of a
      patient’s day3
    * Most dosing options of any extended-release methylphenidate tablet
    * May be chewed or swallowed whole

Learn more about Quillivant XR and QuilliChew ER and our co-pay savings and
support programs

Click to Learn More


IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Quillivant XR, QuilliChew ER, other
methylphenidate-containing products, and amphetamines, have a high potential for
abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor
for signs of abuse and dependence while on therapy.

 * Quillivant XR and QuilliChew ER are contraindicated:
    * in patients known to be hypersensitive to methylphenidate or other
      components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions
      such as angioedema and anaphylactic reactions have been reported.
    * during treatment with monoamine oxidase inhibitors (MAOIs), and also
      within 14 days following discontinuation of treatment with an MAOI because
      of the risk of hypertensive crisis.

 * Sudden death, stroke, and myocardial infarction have occurred in adults
   treated with CNS stimulants at recommended doses. Sudden death has occurred
   in pediatric patients with structural cardiac abnormalities and other serious
   cardiac problems, and in adults taking CNS stimulants at recommended doses
   for ADHD. Avoid use in patients with known structural cardiac abnormalities,
   cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or
   other serious cardiac problems. Further evaluate patients who develop
   exertional chest pain, unexplained syncope, or arrhythmias during treatment
   with Quillivant XR or QuilliChew ER.
 * CNS stimulants cause an increase in blood pressure (mean increase
   approximately 2 - 4 mm Hg) and heart rate (mean increase approximately
   3 - 6 bpm). Some individuals may have larger increases. Monitor all patients
   for hypertension and tachycardia.
 * Use of stimulants may cause psychotic or manic symptoms in patients with no
   prior history, or exacerbation of symptoms in patients with pre-existing
   psychiatric illness. Evaluate for bipolar disorder prior to Quillivant XR or
   QuilliChew ER use.
 * Cases of painful and prolonged penile erections and priapism have been
   reported with methylphenidate products. Immediate medical attention should be
   sought if signs or symptoms of prolonged penile erections or priapism are
   observed.
 * Stimulants used to treat ADHD are associated with peripheral vasculopathy,
   including Raynaud's phenomenon. Signs and symptoms are usually intermittent
   and mild; however, very rare sequelae include digital ulceration and/or soft
   tissue breakdown. Careful observation for digital changes is necessary during
   treatment with ADHD stimulants.
 * CNS stimulants have been associated with weight loss and slowing of growth
   rate in pediatric patients. Growth should be monitored during treatment with
   stimulants, including Quillivant XR and QuilliChew ER. Patients who are not
   growing or gaining weight as expected may need to have their treatment
   interrupted.
 * QuilliChew ER contains phenylalanine, a component of aspartame, and can be
   harmful to patients with phenylketonuria (PKU).
 * Based on accumulated data from other methylphenidate products, the most
   common (≥5% and twice the rate of placebo) adverse reactions are:
    * Abdominal pain
    * Affect lability
    * Anxiety
    * Appetite decreased
    * Blood pressure increased
    * Dizziness
    * Dyspepsia
    * Insomnia
    * Irritability
    * Nausea
    * Tachycardia
    * Vomiting
    * Weight decreased

 * There is limited experience with Quillivant XR and QuilliChew ER in
   controlled trials.
 * Quillivant XR: The most common (≥2% in the Quillivant XR group and greater
   than placebo) adverse reactions reported in the Phase 3 controlled study
   conducted in 45 ADHD patients (ages 6-12 years) in Quillivant XR compared to
   placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation
   (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite
   (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and
   rash (2%, 0%).
 * QuilliChew ER: The most common (≥2% in the QuilliChew ER group and greater
   than placebo) adverse reactions reported in the Phase 3 controlled study
   conducted in 90 pediatric subjects (ages 6-12 years) in QuilliChew ER
   compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo),
   aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%),
   headache (2.4%, 0%), and weight decreased (2.4%, 0%).
 * CNS stimulant medications, such as Quillivant XR and QuilliChew ER, can cause
   vasoconstriction and thereby decrease placental perfusion. No fetal and/or
   neonatal adverse reactions have been reported with the use of therapeutic
   doses of methylphenidate during pregnancy; however, premature delivery and
   low birth weight infants have been reported in amphetamine-dependent mothers.
 * The developmental and health benefits of breastfeeding should be considered
   along with a mother’s clinical need for Quillivant XR and QuilliChew ER and
   any potential adverse effects on the breastfed infant from Quillivant XR and
   QuilliChew ER or from the underlying maternal condition. Monitor
   breastfeeding infants for adverse reactions, such as agitation, insomnia,
   anorexia, and reduced weight gain.


INDICATION

Quillivant XR and QuilliChew ER are central nervous system (CNS) stimulants
indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Please see Full Prescribing Information for Quillivant XR, including Boxed
Warning regarding Abuse and Dependence.

Please see Full Prescribing Information for QuilliChew ER, including Boxed
Warning regarding Abuse and Dependence.




THIS PROGRAM IS SPONSORED BY TRIS PHARMA, INC.
QUILLIVANT XR AND QUILLICHEW ER ARE REGISTERED TRADEMARKS OF NEXTWAVE
PHARMACEUTICALS, INC.
©2019 TRIS PHARMA, INC. ALL RIGHTS RESERVED.    QUI.297.PR    12/19

© 2019, NUMEDIS

--------------------------------------------------------------------------------

References:

 1. Quillivant XR [package insert]. Tris Pharma, Inc.; 2018.
 2. Herman BK, King TR, Kando JC, Pardo A. Poster presented at: 2018 NEI
    Congress; November 7‑11, 2018; Orlando, FL.
 3. QuilliChew ER [package insert]. Tris Pharma, Inc.; 2018.
 4. Dyanavel XR [package insert]. Tris Pharma, Inc.; 2019.
 5. Childress AC, Kando JC, King TR, Pardo A, Herman BK. Early-onset efficacy
    and safety pilot study of amphetamine extended-release oral suspension in
    the treatment of children with attention-deficit/hyperactivity disorder. J
    Child Adolesc Psychopharmacol. 2019 Feb;29(1):2‑8.
    doi: 10.1089/cap.2018.0078.
 6. Aptensio XR [package insert]. Rhodes Pharmaceuticals L.P.; 2017.
 7. Concerta [package insert]. Janssen Pharmaceuticals, Inc.; 2017.




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