QELBREE

QELBREE- viloxazine hydrochloride capsule, extended release
Supernus Pharmaceuticals, Inc

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behavior were reported in pediatric patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] .

1 INDICATIONS AND USAGE

Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

2 DOSAGE AND ADMINISTRATION

2.1 Important Considerations Prior to Initiating Treatment

  • Assess heart rate and blood pressure prior to initiating treatment with Qelbree, following increases in dosage, and periodically while on therapy [see Warnings and Precautions (5.2)] .
  • Prior to initiating treatment with Qelbree, screen patients for a personal or family history of suicide, bipolar disorder, and depression [see Warnings and Precautions (5.3)].

2.2 Recommended Dosage

Pediatric patients 6 to 11 years of age

The recommended starting dosage for pediatric patients 6 to 11 years of age is 100 mg orally once daily. Dosage may be titrated in increments of 100 mg at weekly intervals to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.

Pediatric patients 12 to 17 years of age

The recommended starting dosage for pediatric patients 12 to 17 years of age is 200 mg orally once daily. After 1 week, dosage may be titrated by an increment of 200 mg to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Qelbree and adjust dosage as needed.

2.3 Administration Information

Administer Qelbree orally with or without food [see Clinical Pharmacology (12.3)] . Do not cut, crush, or chew the capsules.

Swallow Qelbree capsules whole or open the capsule and sprinkle the entire contents over a teaspoonful of applesauce. Consume all the sprinkled applesauce in its entirety, without chewing, within 2 hours; do not store for future use.

2.4 Dosage Recommendations in Patients with Renal Impairment

In patients with severe renal impairment (eGFR < 30 mL/min/1.73m 2), the recommended starting dosage is 100 mg once daily. Dosage may be titrated in weekly increments of 50 to 100 mg once daily, to a maximum recommended dosage of 200 mg once daily.

No dosage adjustment is recommended in patients with mild to moderate (eGFR of 30 to 89 mL/min/1.73m 2) renal impairment [see Use in Specific Populations (8.6)] .

3 DOSAGE FORMS AND STRENGTHS

Qelbree (viloxazine extended-release capsules) are available as:

100 mg: yellow opaque body and cap (printed “SPN” on the cap, “100” on the body)

150 mg: lavender opaque body and cap (printed “SPN” on the cap, “150” on the body)

200 mg: light green opaque body and cap (printed “SPN” on the cap, “200” on the body)

4 CONTRAINDICATIONS

Qelbree is contraindicated in patients:

  • receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuing an MAOI, because of an increased risk of hypertensive crisis [see Drug Interactions (7.1)] .
  • receiving concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range [see Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors

In clinical studies, higher rates of suicidal thoughts and behavior were reported in pediatric patients with ADHD treated with Qelbree than in patients treated with placebo. Among 1019 patients exposed to Qelbree 100 mg to 400 mg in short-term trials, a total of nine patients (0.9%) reported suicidal ideation (N=6), behavior (N=1) or both (N=2). Eight patients reported suicidal ideation or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS), a validated scale that assesses suicide risk. An additional patient treated with Qelbree reported suicidal behavior during the clinical trials, but did not report it on the C-SSRS. Among 463 patients treated with placebo in these studies, two patients (0.4%) reported suicidal ideation on the C-SSRS. No patients treated with placebo reported suicidal behavior. No completed suicides occurred in these trials.

Patients treated with Qelbree had higher rates of insomnia and irritability [see Adverse Reactions (6.1)] . Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, there is a concern that these and other symptoms such as depressed mood, anxiety, agitation, akathisia, mania, hypomania, panic attacks, impulsive behavior, and aggression may represent precursors to emerging suicidal ideation or behavior. Thus, patients being treated with Qelbree should be observed for the emergence of such symptoms.

Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Consider changing the therapeutic regimen, including possibly discontinuing Qelbree, in patients who are experiencing emergent suicidal thoughts and behaviors or symptoms that might be precursors to emerging suicidal ideation or behavior, especially if these symptoms are severe or abrupt in onset, or were not part of the patient’s presenting symptoms. Advise family members or caregivers of patients to monitor for the emergence of suicidal ideation or behavior, and to report such symptoms immediately to the healthcare provider.

5.2 Blood Pressure and Heart Rate Increases

Qelbree can cause an increase in heart rate and diastolic blood pressure.

In a clinical study in patients 6 to 11 years of age, 34/154 (22%) of patients treated with Qelbree 100 mg daily had a ≥20 beat per minute (bpm) increase in heart rate at any time point in the clinical trial, compared to 15/159 (9%) of patients who received placebo. This finding was observed in 84/268 (31%) who received the 200 mg daily dosage, compared to 39/262 (15%) of patients in the placebo group, and in 28/100 (28%) of patients who received the 400 mg daily dosage, compared to 24/103 (23%) of patients who received placebo.

In a clinical study in patients 12 to 17 years of age, 22/99 (22%) of patients treated with Qelbree 200 mg daily had a ≥20 bpm increase in heart rate at any time point in the clinical trial, compared to 15/104 (14%) of patients who received placebo. This finding was observed in 69/205 (34%) who received the 400 mg daily dosage, compared to 35/201 (17%) of patients in the placebo group. In patients 12 to 17 years of age, 52/205 (25%) of patients treated with Qelbree 400 mg daily had a ≥ 15 mmHg increase in diastolic blood pressure at any time in the clinical trial, compared to 26/201 (13%) of patients in the placebo group.

Assess heart rate and blood pressure prior to initiating treatment with Qelbree, following increases in dosage, and periodically while on therapy [see Dosage and Administration (2.1)] .

5.3 Activation of Mania or Hypomania

Noradrenergic drugs, such as Qelbree, may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression [see Dosage and Administration (2.1)].

5.4 Somnolence and Fatigue

Qelbree can cause somnolence and fatigue. In the short-term, placebo-controlled clinical trials in pediatric patients with ADHD, somnolence (including lethargy and sedation) was reported in 16% of Qelbree-treated patients compared to 4% of placebo-treated patients. Fatigue was reported in 6% of Qelbree-treated patients, compared to 2% of placebo-treated patients [see Adverse Reactions (6.1)] .

Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by Qelbree.

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