YOUR QUESTIONS ABOUT IGALMI ANSWERED

Agitation related to bipolar disorder I or IIschizophrenia is a feeling of uneasiness that may be expressed verbally or physically through a number of symptoms (like restlessness or feeling wound up). These symptoms can
be mild, moderate, or severe. If agitation starts to escalate, medical attention may be required to help
reduce it.

IGALMI is the first and only FDA approved sublingual film used in the acute treatment of agitation related to bipolar disorderschizophrenia in adults. Limitations of Use: The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose.

IGALMI is a sublingual, mint-flavored film taken to reduce agitation related to bipolar disorderschizophrenia.

During a clinical study of patients with bipolar disorder I or IIschizophrenia, IGALMI was shown to begin reducing agitation in as early as 20 minutes.20 to 30 minutes. In the clinical study, agitation was significantly less than placebo, beginning at 20 minutes for the 180 mcg dose and 30 minutes for the 120 mcg dose. Your results may vary.

IGALMI has peppermint oil as an ingredient, giving it a mint flavor.

Once your healthcare provider hands you the IGALMI film, you have a couple options on where you can position it in your mouth:

• Place the film under your tongue, or
• Place the film behind your lower lip

The film will stick in place. Your healthcare provider will be able to assist you with any questions you may have about placement.

Do not eat or drink for at least 15 minutes if placed under the tongue, and 1 hour if placed behind the lower lip. You may be asked to have a seat or lay down to prevent you from falling in case you get dizzy.

After taking IGALMI, your healthcare provider will monitor your vital signs and alertness, as well as check for any possible side effects. They may ask you to remain seated or lying down to reduce the risk of falling in case you feel dizzy.

Your healthcare provider will be with you and will help direct you on proper placement of the film when you are ready to take it.

There’s a chance you may feel drowsy after taking IGALMI. During clinical studies, some patients even fell asleep. But patients who fell asleep could be woken up.

You should not participate in activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.

There are side effects you may experience when taking IGALMI. The most common side effects included:

In clinical studies, the majority of side effects were mild to moderate in severity. These are not all the possible side effects.

See additional possible side effects listed in the Important Safety Information below.

Speak with your healthcare professional for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You can also contact BioXcel Therapeutics, Inc. at
1-833-201-1088 or medinfo@bioxceltherapeutics.com.

IGALMI may not be appropriate to take if you are expecting. Please notify your healthcare provider about your pregnancy right away.

Please tell your healthcare provider if you are nursing, as there is not enough research to indicate potential effects on your child.

IGALMI is typically taken as a single film, or your healthcare provider may decide to only give you half, based on your medical history.

Whether or not you need a second dose will depend on your healthcare provider’s assessment of
your agitation.

You can only receive IGALMI under the supervision of a healthcare provider.

This answer varies for everyone. If you or a loved one can recognize that your agitation related to bipolar disorderschizophrenia is escalating, you should seek medical intervention before it is out of your control. You can either contact your healthcare provider, call 9-1-1, or head to your nearest medical facility.

IMPORTANT: If you haveor your loved one has suicidal thoughts, call 9-8-8 or 9-1-1 or go to the emergency room immediately.

Yes. When seeking emergency medical attention for agitation, you are encouraged to discuss treatment options that you feel comfortable with—or are interested in trying—like IGALMI. Your healthcare provider can also answer any additional questions you may have about IGALMI.

Please note, IGALMI may not be available at every medical facility.

De-escalation is a method used in an emergency situation to help people experiencing agitation related to bipolar disorderschizophrenia begin to calm down. It involves staff simply speaking with you in a non-challenging way to help you begin to safely calm down on your own.

Once you’re ready, your healthcare provider may use medication to further reduce feelings of agitation.

IGALMI can help significantly reduce your agitation related to bipolar disorderschizophrenia.

IGALMI is taken under the supervision of a healthcare provider who will monitor your vital signs (like blood pressure and heart rate) and alertness after you take IGALMI to prevent you from falling or fainting.

As you feel less agitated, your healthcare provider may then want to assess the underlying cause of your agitation to determine any other treatments you may need. You should not do any activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.