Qelbree

Qelbree is a once-a-day treatment for attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. Qelbree is a non-stimulant ADHD medicine that may help to improve attention and reduce hyperactivity and impulsiveness.

Qelbree is thought to work by increasing levels of norepinephrine, a chemical messenger found in the brain, by blocking a protein called pre-synaptic norepinephrine transporter. ADHD has been associated with low levels of norepinephrine, leading to symptoms such as hyperactivity, impulsivity, and lack of attention, so increasing norepinephrine levels may reduce ADHD symptoms. Qelbree is classified as a selective norepinephrine reuptake inhibitor (NRI).

Qelbree’s FDA approval was received on April 2, 2021, and it is now indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. Qelbree contains the active ingredient (which is sometimes referred to as the generic name) viloxazine.

Qelbree directions: Qelbree capsules are taken once a day, with or without food. Swallow the capsule whole, and do not crush, chew, break, or open it. If you cannot swallow a capsule whole, open it and sprinkle the medicine onto a teaspoonful or tablespoonful of pudding or applesauce. Swallow the mixture right away without chewing, or within 15 minutes of mixing for pudding, or within 2 hours of mixing for applesauce.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your heart rate and blood pressure will need to be checked often.

If you or your child take too much Qelbree or overdose, call your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.

Some people have thoughts about suicide while taking this medicine, especially within the first few months of treatment or when the dose is changed. Stay alert to changes in your or your child's mood or symptoms. Report to your healthcare provider right away if there are any sudden changes in mood, behavior, thoughts, or feelings or if you or your child develops suicidal thoughts or actions.

See the Side Effects section for more information about side effects.

Some drugs should not be used with Qelbree. Your treatment plan may change if you also use:

• alosetron;
• duloxetine;
• ramelteon;
• tasimelteon;
• tizanidine; or
• theophylline.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Tell your doctor if you or anyone in your family has ever had:

• depression;
• bipolar disorder (manic depression);
• psychosis; or
• suicidal thoughts or actions.

Tell your doctor if you have ever had:

• heart problems;
• high blood pressure;
• liver disease; or
• severe kidney disease.

Pregnancy

Qelbree may be harmful when taken during pregnancy. Tell your doctor right away if a pregnancy occurs.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of viloxazine on the baby and the mother.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Qelbree passes into breastmilk. Ask your healthcare provider about the best way to feed the baby during treatment with this medicine.

Common Qelbree side effects

Common Qelbree side effects in adults are trouble sleeping, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation.

Common Qelbree side effects in pediatric patients are sleepiness, decreased appetite, tiredness, nausea, vomiting, trouble sleeping, and irritability.

These common side effects occurred in 5% or more of patients, at least twice the rate of patients taking a placebo.

Serious Qelbree side effects

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of a manic episode. Manic symptoms include racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, or being agitated or talkative.

This medicine can affect weight in children. Tell your doctor if your child loses weight or is not gaining weight at a normal rate.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Pediatric Qelbree Dose for Attention Deficit Disorder:

6 to 11 years Initial dose: 100 mg orally once a day Dose increases: May titrate in increments of 100 mg per week based on response and tolerability Maximum dose: 400 mg/day 12 to 17 years Initial dose: 200 mg orally once a day Dose increases: After 1 week, may titrate to 400 mg once a day based on response and tolerability Maximum dose: 400 mg/day

Usual Adult Qelbree Dose for Attention Deficit Disorder:

Adult patients: Initial dose: Recommended starting dosage is 200 mg once daily. Dose increases: May titrate in increments of 200 mg weekly to maximum recommended dosage of 600 mg once daily Maximum dose: 600 mg/day

Comments:

• Assess heart rate and blood pressure prior to initiating treatment.
• Screen patients for a personal or family history of suicide, bipolar disorder, and depression prior to initiating treatment.
• Pharmacologic treatment for Attention-Deficit Hyperactivity Disorder (ADHD) may be needed for extended periods; periodically reevaluate and adjust dosage as needed.

Qelbree is available in Extended-release capsules: 100 mg, 150 mg, and 200 mg.

Do not drive or operate heavy machinery until you know how this medicine will affect you. Qelbree may cause you to feel sleepy or tired.

Tell your healthcare provider about all the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Qelbree and other medicines may affect each other, causing possible serious side effects.

Your healthcare provider will decide if Qelbree can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• MAOIs
• alosetron
• duloxetine
• ramelteon
• tasimelteon
• tizanidine
• theophylline

Know the medicines you or your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when you or your child gets a new medicine.

Do not start any new medicine during treatment with Qelbree without first talking to your healthcare provider.

Not all possible interactions are listed here. For more information on interactions with Qelbree, click on the link below.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep all medicines out of the reach of children and pets.

Manufactured by: Catalent Pharma Solutions, LLC, 1100 Enterprise Drive, Winchester KY 40391, USA. Distributed by: Supernus Pharmaceuticals, Inc., Rockville, MD USA 20850.

Active ingredient: viloxazine

Inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, corn starch, ethylcellulose, FD&C Blue #1, FD&C Red #28, FD&C Yellow #5, FD&C Yellow #6, FD&C Yellow #10, gelatin, hypromellose, isopropyl alcohol, lactose monohydrate, medium chain triglycerides, oleic acid, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, talc, triacetin, titanium dioxide.