Intuniv

What is Intuniv?

• Intuniv (Guanfacine) is a central alpha2A-adrenergic receptor agonist used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

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Guanfacine

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Guanfacine molecule ball

What are the uses of this medicine?

• Intuniv (Guanfacine) is a prescription medicine used to treat the symptoms of attention deficit hyperactivity disorder (ADHD). INTUNIV may be used alone or with ADHD stimulant medicines.
• INTUNIV® is not a central nervous system (CNS) stimulant.

How does this medicine work?

• Guanfacine is a central alpha2A-adrenergic receptor agonist.
• Guanfacine is not a central nervous system (CNS) stimulant.
• The mechanism of action of guanfacine in ADHD is not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of a hypersensitivity reaction to INTUNIV or its inactive ingredients, or other products containing guanfacine.

What drug interactions can this medicine cause?

• INTUNIV® may affect the way other medicines work, and other medicines may affect how INTUNIV® works.

Especially tell your doctor if you take:

• ketoconazole
• medicines that can affect enzyme metabolism
• high blood pressure medicine
• sedatives
• benzodiazepines
• barbiturates
• antipsychotics

• Strong and moderate CYP3A4 inhibitors increase guanfacine exposure. Decrease INTUNIV® to 50% of target dosage when coadministered with strong and moderate CYP3A4 inhibitors.
• Strong and moderate CYP3A4 inducers decrease guanfacine exposure. Based on patient response, consider titrating INTUNIV dosage up to double the target dosage over 1 to 2 weeks.

Is this medicine FDA approved?

• Guanfacine was approved for medical use in the United States in 1986.

How should this medicine be used?

Recommended dosage:

• 1 mg to 7 mg (0.05-0.12 mg/kg target weight based dose range) once daily in the morning or evening based on clinical response and tolerability.
• Begin at a dose of 1 mg once daily and adjust in increments of no more than 1 mg/week.
• Do not substitute for immediate-release guanfacine tablets on a mg-per-mg basis, because of differing pharmacokinetic profiles.
• If switching from immediate-release guanfacine, discontinue that treatment and titrate with INTUNIV® as directed.
• When discontinuing, taper the dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension.

Administration:

• Take INTUNIV® exactly as your doctor tells you.
• Your doctor may change your dose. Do not change your dose of INTUNIV® without talking to your doctor.
• Do not stop taking INTUNIV® without talking to your doctor.
• Try not to miss your dose of INTUNIV®. If you miss a dose of INTUNIV®, take the next dose at your regular time. If you miss 2 or more doses, talk to your doctor, as you may need to restart INTUNIV® with a lower dose.
• Do not take a double dose to make up for a missed dose.
• INTUNIV® should be taken 1 time a day in the morning or in the evening, either alone or in combination with an ADHD stimulant medicine that your doctor may prescribe. Your doctor will tell you when to take INTUNIV® and when to take your ADHD stimulant medication.
• INTUNIV® should be swallowed whole with a small amount of water, milk, or other liquid.
• Do not crush, chew, or break INTUNIV®. Tell your doctor if you cannot swallow INTUNIV® whole.
• Do not take INTUNIV® with a high-fat meal.
• Your doctor will check your blood pressure and heart rate while you take INTUNIV®.
• If you take too much INTUNIV®, call your local Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 1 mg, 2 mg, 3 mg and 4 mg

This medicine is available in fallowing brand namesː

• INTUNIV

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleepiness
• tiredness
• trouble sleeping
• low blood pressure
• nausea
• stomach pain
• dizziness
• dry mouth
• irritability
• vomiting
• slow heart rate

INTUNIV® may cause serious side effects including:

• low blood pressure
• low heart rate
• fainting
• sleepiness
• increased blood pressure and heart rate after suddenly stopping INTUNIV (rebound hypertension).

What special precautions should I follow?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how INTUNIV® affects you. INTUNIV® can slow your thinking and motor skills.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking INTUNIV® until you talk with your doctor. INTUNIV® taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not become dehydrated or overheated. This may increase your chance of having low blood pressure or fainting while taking INTUNIV.
• Do not suddenly stop INTUNIV. Tell your healthcare provider if you have been vomiting and cannot take INTUNIV, you may be at risk for rebound hypertension.
• Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated.
• Cardiac Conduction Abnormalities may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• drowsiness
• lethargy
• bradycardia
• Miosis of the pupils

Management of overdosage:

• Management of INTUNIV® overdose should include monitoring for and the treatment of initial hypertension, if that occurs, as well as hypotension, bradycardia, lethargy and respiratory depression.
• Children and adolescents who develop lethargy should be observed for the development of more serious toxicity including coma, bradycardia and hypotension for up to 24 hours, due to the possibility of delayed onset hypotension.

Can this medicine be used in pregnancy?

• It is not known if INTUNIV® will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• There is a pregnancy registry for females who are exposed to ADHD medications, including INTUNIV, during pregnancy.
• The purpose of the registry is to collect information about the health of females exposed to INTUNIV and their baby.
• If you or your child becomes pregnant during treatment with INTUNIV, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at 1-866-961-2388.

Can this medicine be used in children?

• The safety and efficacy of INTUNIV® in geriatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: guanfacine hydrochloride
• Inactive ingredients: hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glycerol behenate. In addition, the 3 mg and 4 mg tablets also contain green pigment blend PB-1763.

Who manufactures and distributes this medicine?

Distributed by: Takeda Pharmaceuticals America, Inc. Lexington, MA

• INTUNIV® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.

What should I know about storage and disposal of this medication?

• Store INTUNIV® between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Intuniv
• FDA Intuniv

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