Qelbree is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older.

It is not known if this medicine is safe and effective in children less than 6 years of age.

Qelbree can cause serious side effects, including:

• Increased risk of suicidal thoughts or actions. Qelbree may increase suicidal thoughts and actions in children and adults with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed.
  How can I watch for and try to prevent suicidal thoughts and actions?
  • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you or your child develops suicidal thoughts or actions. This is very important when Qelbree treatment is started or when the dose is changed.
  • Call your healthcare provider right away if you or your child has any new or sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develops suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency help right away if you or your child has any of the following symptoms, especially if they are new, worse, or worry you:

• • attempts to commit suicide
  • new or worse depression
  • feeling very agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, being angry, or violent
  • an extreme increase in activity and talking (mania)
  • thoughts about suicide or dying
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

See Qelbree side effects for more information about side effects.

• Take Qelbree exactly as your healthcare provider tells you to take it.
• Take Qelbree 1 time each day with or without food.
• Swallow the capsules whole. Do not cut, crush, or chew the capsules.
• If the capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto a teaspoonful of applesauce.
• Swallow all the applesauce mixture right away, without chewing, or within 2 hours of mixing.
  
  • Do not chew the applesauce mixture.
  • Do not store applesauce mixture.
• Talk to your healthcare provider about what you should do if you or your child misses a dose.
• If you or your child takes too much or overdoses, call your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.

Usual Adult Dose for ADHD

- recommended starting dosage is 200 mg once daily. May titrate in increments of 200 mg weekly, to maximum recommended dosage of 600 mg once daily

Use: treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults

Usual Pediatric Dose for ADHD

- 6 to 11 years of age: Recommended starting dosage is 100 mg once daily. May titrate in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily
- 12 to 17 years of age: Recommended starting dosage is 200 mg once daily. May titrate after 1 week, by an increment of 200mg, to the maximum recommended dosage of 400 mg once daily

- Use: treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years and older

Do not take Qelbree if you or your child:

• takes a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you or your child takes an MAOI.
• stopped taking an MAOI in the last 14 days.
• takes alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, or theophylline.

Before taking Qelbree

Before starting treatment, tell your healthcare provider about all you or your child’s medical conditions, including if you or your child:

• has, or has a family history of, suicide, bipolar disorder, depression, mania or hypomania
• has blood pressure or heart rate problems
• has severe kidney problems. Your healthcare provider may lower the dose.
• has liver problems
• is pregnant or plans to become pregnant. Qelbree may cause harm to the mother when taken during pregnancy. You and your healthcare provider will decide if Qelbree should be taken during pregnancy.
  • Tell your healthcare provider right away if you or your child become pregnant or think they are pregnant during treatment with Qelbree.
  • There is a pregnancy registry for females who are exposed to Qelbree during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Qelbree and their baby. If you become pregnant while taking Qelbree, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications by calling 1-866-961-2388 or go to www.womensmentalhealth.org/preg.
• is breastfeeding or plans to breastfeed. It is not known if Qelbree passes into breastmilk. Talk to your healthcare provider about the best way to feed the baby during treatment.

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

Qelbree can cause serious side effects, including:

• See Important information
• Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate before starting and during treatment.
• Manic episodes. Manic episodes may happen in people with bipolar disorder who take Qelbree. Symptoms may include:
  • greatly increased energy
  • racing thoughts
  • unusually grand ideas
  • talking more or faster than usual
  • severe trouble sleeping
  • reckless behavior
  • excessive happiness or irritability
• Sleepiness and tiredness. See What should I avoid while taking Qelbree?

The most common side effects in children 6 to 17 years of age include:

• sleepiness
• tiredness
• vomiting
• irritability
• decreased appetite
• nausea
• trouble sleeping

The most common side effects in adults include:

• insomnia
• sleepiness
• nausea
• dry mouth
• headache
• tiredness
• decreased appetite
• constipation

Effects on weight. Your healthcare provider should check you or your child’s weight before starting, and during treatment.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.