Quillivant XR

QUILLIVANT XR- methylphenidate hydrochloride suspension, extended release
NextWave Pharmaceuticals, Inc

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including QUILLIVANT XR, 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 [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )].

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Pre-treatment Screening

Prior to treating children, adolescents, and adults with CNS stimulants including QUILLIVANT XR, 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)].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for QUILLIVANT XR use [see Boxed Warning, Warnings and Precautions ( 5.1), Drug Abuse and Dependence ( 9)].

2.2 General Dosing Information

Before administering the dose, VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least 10 seconds, to ensure that the proper dose is administered.

The recommended starting dose of QUILLIVANT XR for patients 6 years and above is 20 mg once daily in the morning. The dose may be titrated weekly in increments of 10 mg to 20 mg. Daily doses above 60 mg have not been studied and are not recommended. As with any CNS stimulant, during titration of QUILLIVANT XR, the prescribed dose should be adjusted, if necessary, until a well‑tolerated, therapeutic dose is achieved.

Pharmacologic treatment of ADHD may be needed for extended periods. Health care providers should periodically re-evaluate the long-term use of QUILLIVANT XR, and adjust dosage as needed.

Patients should be advised to avoid alcohol while taking QUILLIVANT XR [see Clinical Pharmacology ( 12.3)].

2.3 Administration Instructions

QUILLIVANT XR 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 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 [see Description ( 11), Clinical Pharmacology ( 12.3)].

2.5 Dose Reduction and Discontinuation

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 one-month period, the drug should be discontinued.

2.6 Reconstitution Instructions for the Pharmacist

QUILLIVANT XR is supplied as a powder for oral suspension which must be reconstituted with water prior to dispensing. Preparation instructions: Tap bottle until powder flows freely. Remove bottle cap, and add specified amount of water to the bottle (see Table 1 below). Fully insert bottle adapter into neck of bottle [see Instructions for Use, Figures F and G]. Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension.

Table 1. Product Reconstitution Instructions
Amount of drug in bottle Amount of water to add to bottle Final reconstituted volume (yield)
300 mg 53 mL 60 mL
600 mg 105 mL 120 mL
750 mg 131 mL 150 mL
900 mg 158 mL 180 mL

Store reconstituted QUILLIVANT XR at 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF). Dispense in original packaging (bottle in carton) with bottle adapter inserted and with enclosed oral dosing dispenser. QUILLIVANT XR is stable for up to 4 months after reconstitution.

3 DOSAGE FORMS AND STRENGTHS

Extended-release oral suspension (after reconstitution with water): 25 mg per 5 mL (5 mg per mL).

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Methylphenidate or other Components of QUILLIVANT XR

QUILLIVANT XR is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of QUILLIVANT XR. 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

QUILLIVANT XR is contraindicated during 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)].

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