Intuniv

Take Intuniv exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The recommended dose range is 1 mg to 4 mg per day. 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• hallucinations;

• chest pain, fast or slow heartbeats; or

• a light-headed feeling, like you might pass out;

Common side effects may include:

• mild dizziness or drowsiness;

• dry mouth;

• constipation; or

• weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking guanfacine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with guanfacine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In the U.S.

• Intuniv
• Tenex

Available Dosage Forms:

• Tablet
• Tablet, Extended Release

Therapeutic Class: Antihypertensive

Pharmacologic Class: Alpha-2 Adrenergic Agonist

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Feeling tired or weak.
• Headache.
• Hard stools (constipation).
• Upset stomach.
• Not able to sleep.
• Belly pain.
• Feeling irritable.
• Throwing up.
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Intuniv® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].

General Instruction for Use

Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of guanfacine release. Do not administer with high fat meals, due to increased exposure.

Dose Selection

Take Intuniv orally once daily, either in the morning or evening, at approximately the same time each day. Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week.

In monotherapy clinical trials, there was dose- and exposure-related clinical improvement as well as risks for several clinically significant adverse reactions (hypotension, bradycardia, sedative events). To balance the exposure-related potential benefits and risks, the recommended target dose range depending on clinical response and tolerability for Intuniv® is 0.05-0.12 mg/kg/day (total daily dose between 1-7 mg) (See Table 1).

In the adjunctive trial which evaluated Intuniv® treatment with psychostimulants, the majority of patients reached optimal doses in the 0.05-0.12 mg/kg/day range. Doses above 4 mg/day have not been studied in adjunctive trials.

Switching from Immediate-Release Guanfacine to Intuniv®

If switching from immediate-release guanfacine, discontinue that treatment, and titrate with Intuniv® following above recommended schedule.

Do not substitute for immediate-release guanfacine tablets on a milligram-per-milligram basis, because of differing pharmacokinetic profiles. Intuniv® has significantly reduced Cmax (60% lower), bioavailability (43% lower), and a delayed Tmax (3 hours later) compared to those of the same dose of immediate-release guanfacine [see Clinical Pharmacology (12.3)].

Maintenance Treatment

Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of Intuniv®, and adjust weight-based dosage as needed. The majority of children and adolescents reach optimal doses in the 0.05-0.12 mg/kg/day range. Doses above 4 mg/day have not been evaluated in children (ages 6-12 years) and above 7 mg/day have not been evaluated in adolescents (ages 13-17 years) [see Clinical Studies (14)].

Discontinuation of Treatment

Following discontinuation of Intuniv®, patients may experience increases in blood pressure and heart rate [see Warnings and Precautions (5.4) and Adverse Reactions (6)]. Patients/caregivers should be instructed not to discontinue Intuniv® without consulting their health care provider. Monitor blood pressure and pulse when reducing the dose or discontinuing the drug. Taper the daily dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension.

 Missed Doses

When reinitiating patients to the previous maintenance dose after two or more missed consecutive doses, consider titration based on patient tolerability.

Dosage Adjustment with Concomitant Use of Strong and Moderate CYP3A4 Inhibitors or Inducers

Dosage adjustments for Intuniv® are recommended with concomitant use of strong and moderate CYP3A4 inhibitors (e.g., ketoconazole) or CYP3A4 inducers (e.g., carbamazepine) (Table 2) [see Drug Interactions (7)].

Controlled Substance

Intuniv® is not a controlled substance and has no known potential for abuse or dependence.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

No carcinogenic effect of guanfacine was observed in studies of 78 weeks in mice or 102 weeks in rats at doses up to 6.8 times the maximum recommended human dose of 0.12 mg/kg/day on a mg/m2 basis.

Mutagenesis

Guanfacine was not genotoxic in a variety of test models, including the Ames test and an in vitro chromosomal aberration test; however, a marginal increase in numerical aberrations (polyploidy) was observed in the latter study.

Impairment of Fertility

No adverse effects were observed in fertility studies in male and female rats at doses up to 22 times the maximum recommended human dose on a mg/m2 basis.

Intuniv® (in-TOO-niv)
(guanfacine)
Extended-Release Tablets

Read the Patient Information that comes with Intuniv® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is Intuniv®?

Intuniv® 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.

It is not known if Intuniv is safe and effective in children younger than 6 years of age.

Who should not take Intuniv®?

Do not take Intuniv if you are allergic to guanfacine or any of the ingredients in Intuniv. See the end of this leaflet for a complete list of ingredients in Intuniv.

What should I tell my doctor before taking Intuniv®?

Before you take Intuniv®, tell your doctor if you:

• have heart problems or a low heart rate
• have fainted
• have low or high blood pressure
• have liver or kidney problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Intuniv® will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Intuniv® passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking Intuniv®.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Intuniv®?

• 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 should I avoid while taking Intuniv®?

• 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.

What are the possible side effects of Intuniv®?

Intuniv® may cause serious side effects including:

• low blood pressure
• low heart rate
• fainting
• sleepiness
• withdrawal symptoms of increased heart rate and high blood pressure after suddenly stopping Intuniv® (which may be accompanied by headaches, feeling confused, nervousness, agitation, and tremors).

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Intuniv® include:

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

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Intuniv®. For more information, ask your doctor or pharmacist.

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

How should I store Intuniv®?

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

Keep Intuniv® and all medicines out of the reach of children.

General Information about the safe and effective use Intuniv®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Intuniv® for a condition for which it was not prescribed. Do not give Intuniv® to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about Intuniv®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Intuniv® that is written for health professionals.

For more information, go to www.Intuniv.com or call 1-800-828-2088.

What are the ingredients in Intuniv®?

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.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for Shire US Inc., 300 Shire Way, Lexington, MA 02421.

Intuniv® is a registered trademark of Shire LLC.

Revised: 7/2016

© 2016 Shire US Inc.

This product is covered by US patents including 6,287,599; 6,811,794.