Qelbree

Approved Indications

Qelbree is specifically approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD). It is used to manage symptoms in the following groups:

• Children and Adolescents: It is used for pediatric patients between the ages of 6 and 17 years.
• Adults: It is approved for use in adults aged 18 years and older.

How It Is Used

As a non-stimulant medication, Qelbree provides an alternative for patients who may not tolerate or respond well to stimulant treatments. It is intended to help manage the core symptoms of ADHD, including:

• Difficulty focusing or paying attention.
• Hyperactivity or excessive physical movement.
• Impulsivity or acting without thinking.

Healthcare providers often prescribe this medication as part of a comprehensive treatment program. This program may also include psychological, educational, and social therapies to address the behavioral aspects of ADHD.

Mechanism of Action

Qelbree is classified as a selective norepinephrine reuptake inhibitor (SNRI). While many medications used for attention deficit hyperactivity disorder (ADHD) are stimulants, Qelbree is a non-stimulant option that affects brain chemistry differently.

The medication works by targeting a neurotransmitter called norepinephrine. Neurotransmitters are chemical messengers that allow nerve cells to communicate with each other. Norepinephrine is specifically involved in regulating:

• Attention and focus
• Alertness
• Impulse control
• Hyperactivity

In the brain, Qelbree blocks the process where norepinephrine is reabsorbed back into the nerve cells. By preventing this reuptake, the medication increases the amount of norepinephrine available in the spaces between cells. This higher concentration of the chemical is thought to improve the brain's ability to process information and control behavior.

Although the precise mechanism of how viloxazine (the active ingredient in Qelbree) treats ADHD is not fully established, its effect on norepinephrine levels is considered the primary way it helps manage symptoms.

Common Side Effects

Common side effects may vary depending on whether the medication is taken by a child or an adult. Frequently reported side effects include:

• Sleepiness, drowsiness, or fatigue
• Decreased appetite
• Nausea and vomiting
• Trouble sleeping (insomnia)
• Irritability
• Headache
• Dry mouth
• Constipation

Serious Side Effects

While less common, some side effects require immediate medical attention. Contact a healthcare provider right away if you experience:

• Suicidal thoughts or behaviors: New or worsening thoughts of harming yourself, particularly in children and teenagers.
• Heart and blood pressure changes: Significant increases in heart rate or blood pressure.
• Manic episodes: Symptoms such as greatly increased energy, racing thoughts, reckless behavior, or severe trouble sleeping, especially in individuals with bipolar disorder.
• Allergic reactions: Signs like a skin rash, hives, or swelling of the face, lips, or tongue.

Suicidal Thoughts and Behaviors

Qelbree has a boxed warning for an increased risk of suicidal thoughts and actions in children and adolescents. Patients starting treatment should be monitored closely for any worsening of symptoms, new or sudden changes in mood, or suicidal behavior. This risk is highest during the first few months of treatment or when the dose is changed. Families and caregivers should stay alert for signs such as agitation, irritability, or unusual changes in behavior.

Contraindications

• MAOIs: This medication must not be taken with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI. Taking these together can cause a serious and potentially life-threatening reaction.
• CYP1A2 Substrates: Qelbree should not be used with certain medications that are sensitive substrates of the CYP1A2 enzyme or those with a narrow therapeutic range, such as theophylline or tizanidine, as it can significantly increase the levels of these drugs in the body.

Heart Rate and Blood Pressure

Treatment can lead to increases in heart rate and blood pressure. Healthcare providers typically measure these levels before starting the medication and periodically during treatment. Caution is advised for patients with pre-existing cardiovascular conditions that could be worsened by increases in blood pressure or heart rate.

Activation of Mania or Hypomania

There is a risk of activating mania or hypomania, particularly in individuals with bipolar disorder. Patients should be screened for bipolar disorder before starting treatment to assess the risk of a manic episode. Symptoms may include greatly increased energy, severe trouble sleeping, racing thoughts, or unusually grand ideas.

Somnolence and Fatigue

Somnolence (sleepiness) and fatigue are common side effects. Patients are advised to use caution when performing activities that require mental alertness, such as driving or operating heavy machinery, until they are certain the medication does not impair their ability to do so safely.

Pregnancy

There is currently limited data on the use of Qelbree in pregnant women. In animal studies, viloxazine was associated with developmental issues and fetal harm when administered at high doses. Because human data is insufficient, the medication should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks to the fetus.

A pregnancy exposure registry is available to monitor outcomes for individuals who take Qelbree while pregnant. Patients and healthcare providers are encouraged to report exposures to help improve understanding of the drug's effects during pregnancy.

Breastfeeding

It is not known whether viloxazine is excreted in human breast milk, nor is it known how the drug might affect a breastfed infant or milk production. If you are breastfeeding, your healthcare provider can help you weigh the benefits of treatment against the potential risks to your baby.

Available Forms

Qelbree is supplied as extended-release capsules for oral use. These capsules are designed to release the active ingredient gradually into the body.

Administration Options

The medication is taken by mouth. The capsules can be used in the following ways:

• Swallowed whole with or without food.
• Opened and the entire contents sprinkled onto a small amount of soft food, such as applesauce.

If the capsule is opened and sprinkled, the mixture should be swallowed immediately without chewing the pellets to ensure the medication is released properly.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Qelbree for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is approved for use in pediatric patients 6 to 17 years of age and in adults.

Boxed Warning

Qelbree carries a boxed warning because clinical trials indicated that some patients experienced an increase in suicidal thoughts and actions while taking the medication. This risk is present in both children and adults. Healthcare providers and caregivers should monitor patients closely for any unusual changes in behavior, worsening depression, or suicidal ideation, particularly during the start of treatment or following dosage adjustments.

Controlled Substance Status

Qelbree is not a controlled substance. Unlike stimulant medications frequently prescribed for ADHD, it is not considered to have a high potential for abuse or physical dependence.

Additional Regulatory Information

The FDA requires that a Medication Guide be distributed with each prescription. This guide outlines serious potential side effects, including the risk of suicidal thoughts, increased blood pressure, and increased heart rate. Patients with a history of certain mental health conditions or those taking specific types of antidepressants, such as monoamine oxidase inhibitors (MAOIs), are advised of significant contraindications and warnings by the FDA.

Insurance and Brand Status

Qelbree is a brand-name medication, and there is currently no generic version of viloxazine available. Brand-name drugs typically cost more than generic equivalents. The final price often depends on an individual's insurance plan and whether the drug is included on the plan's formulary.

Factors Influencing Price

Several factors can affect the out-of-pocket cost for this medication:

• Insurance Coverage: Copayments and coinsurance amounts vary significantly between different private insurance plans and government programs.
• Pharmacy Choice: Prices for the same medication can differ between retail pharmacies and mail-order services.
• Dosage: The prescribed strength and quantity of the medication may impact the total cost.

Financial Assistance

Because Qelbree is a brand-name drug, the manufacturer may offer savings cards or coupons to help eligible patients reduce their copayments. Additionally, patient assistance programs may be available for those who are uninsured or meet specific financial criteria. Patients are encouraged to check with their healthcare provider or the manufacturer's website for current assistance options.