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How to Take IGALMI

DEVELOPED TO HELP YOU
FEEL LESS AGITATED

No needles required
IGALMI is a mint-flavored film that is designed to stick under your tongue or behind your lower lip. Once dissolved in your mouth, the medicine is absorbed into your body.

How IGALMI works

The film is placed in your mouth (either under your tongue or behind your lower lip), allowing the medication to be absorbed into your bloodstream.

Dissolves inside your mouth

The film will stick in place and dissolve completely

Medicine is absorbed directly

Once the film is placed, the medicine will be absorbed directly through your mouth into your bloodstream

May start working
in as early as
20 minutes20 to 30 minutes*

Start feeling less agitated in a relatively short period of time

*20 minutes is based on results from the IGALMI clinical trial but was not a primary goal of the study.

Self-administered (with the supervision of a healthcare provider)

If your healthcare provider determines that IGALMI is right for you, you will be guided on the proper placement
in your mouth.

How to take IGALMI

1

IGALMI comes in a small, sealed pouch that is opened by the healthcare provider and given to you.

2

You will position the film in your mouth, either under your tongue or behind your lower lip. The film is designed to stick in place. Do not chew or swallow the film.

UNDER TONGUE
wait 15 minutes to eat or drink
OR
BEHIND LOWER LIP
wait 1 hour to eat or drink

Make sure you are adequately hydrated and sit or lie down after taking IGALMI. Tell your healthcare provider if you feel dizzy, lightheaded, or faint.

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.

What happens after taking IGALMI?

As you begin to feel less agitated, your healthcare provider will assess the underlying cause of your agitation and determine any other treatments you may need.

The next time you’re at a medical facility (such as the emergency room), do not hesitate to speak up and ask your healthcare provider if IGALMI, the mint-flavored film, can help.

Interested in sharing your experience with IGALMI? Apply to be a B.E.A.C.O.N. Program Ambassador.

Through the B.E.A.C.O.N. Program, you may have the opportunity to share your experience with IGALMI. Contact us by email at info@beacon-program.com or phone at 1-888-670-8240.

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IMPORTANT SAFETY INFORMATION

IGALMI can cause serious side effects, including:
  • Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. 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. Make sure you are adequately hydrated and sit or lie down after taking IGALMI. Tell your healthcare provider if you feel dizzy, lightheaded, or faint.

WHAT IS IGALMI?

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine that is placed under your tongue or behind your lower lip and is used for the acute treatment of agitation associated with bipolar disorder I or IIschizophrenia in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.

  • Heart rhythm changes (QT interval prolongation). You should not take IGALMI if you have an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, and if you are taking other drugs that affect your heart rhythm. Taking IGALMI if you have a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Tell your healthcare provider immediately if you feel faint or have heart palpitations.
  • Sleepiness/drowsiness. Do not do activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
  • Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.

The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.

These are not all the possible side effects of IGALMI. Speak with your healthcare provider for medical advice about side effects.

Tell your healthcare provider about your medical history, including if you suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. Tell your healthcare provider if you are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any drugs that lower your blood pressure, change your heart rate, or take anesthetics, sedatives, hypnotics, and opioids.

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.

Please see full Prescribing Information.

WHAT IS IGALMI?

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine that is placed under your tongue or behind your lower lip and is used for the acute treatment of agitation associated with bipolar disorder I or IIschizophrenia in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.