QuilliChew ER

QUILLICHEW ER- methylphenidate hydrochloride tablet, chewable, extended release
NextWave Pharmaceuticals, Inc

WARNING: ABUSE, MISUSE, AND ADDICTION

QuilliChew ER has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including QuilliChew ER, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

[see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2)].

1 INDICATIONS AND USAGE

QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to treating patients with QuilliChew ER, assess:

  • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ].
  • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating QuilliChew ER [see Warnings and Precautions (5.10)].

2.2 Recommended Dosage

The recommended starting dosage of QuilliChew ER for patients 6 years and above is 20 mg once daily orally in the morning. The dose may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. Daily doses above 60 mg have not been studied and are not recommended. As with any CNS stimulant, during titration of QuilliChew ER, the prescribed dose should be adjusted, if necessary, until a well-tolerated, therapeutic dose is achieved.

2.3 Administration Instructions

QuilliChew ER should be orally administered once daily in the morning with or without food [see Clinical Pharmacology (12.3)].

2.4 Switching from other Methylphenidate Products

If switching from other methylphenidate products, 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 [see Description (11), Clinical Pharmacology (12.3)].

2.5 Dosage Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reaction occur, reduce dosage, or, if necessary, discontinue QuilliChew ER. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue QuilliChew ER.

3 DOSAGE FORMS AND STRENGTHS

Extended-release chewable tablets:

20 mg equivalent of methylphenidate HCl available as a speckled, off-white, capsule-shaped coated tablet, debossed with “NP 12” on one side and functionally scored on the other side.

30 mg equivalent of methylphenidate HCl available as a speckled, light pink color, capsule-shaped coated tablet, debossed with “NP 13” on one side and functionally scored on the other side.

40 mg equivalent of methylphenidate HCl available as a speckled, dark pink to peach color, capsule-shaped coated tablet, debossed with “NP 14” on one side and plain (not scored) on the other side.

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Methylphenidate or other Components of QuilliChew ER

QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6.2)].

4.2 Monoamine Oxidase Inhibitors

QuilliChew ER is contraindicated during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI), because of the risk of hypertensive crisis [see Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Abuse, Misuse, and Addiction

QuilliChew ER has a high potential for abuse and misuse. The use of QuilliChew ER exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. QuilliChew ER can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including QuilliChew ER, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction.Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store QuilliChew ER in a safe place, preferably locked, and instruct patients to not give QuilliChew ER to anyone else. Throughout QuilliChew ER treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2 Risks to Patients with Serious Cardiac Disease

Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Avoid QuilliChew ER use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease.

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