Preview only show first 10 pages with watermark. For full document please download

Intuniv Faq (guanfacine) Answers To Some

   EMBED


Share

Transcript

Information about a nonstimulant treatment option for children and adolescents ages 6 to 17 with ADHD INTUNIV FAQ (guanfacine) Answers to some of the most frequently asked questions Ask your child’s doctor about a Starter Kit today! INTUNIV is a prescription medicine used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 to 17, either alone or in combination with ADHD stimulant medications. INTUNIV may cause serious side effects including low blood pressure, low heart rate, fainting, and sleepiness. 1 Q About ADHD ADHD is one of the most common childhood psychiatric disorders in the United States. Symptoms of ADHD may vary from child to child and must be present in two or more settings—such as at home and at school—continue for at least 6 months, and start before the age of 7. Symptoms may include inattention, hyperactivity, and impulsivity. The doctor will try to rule out other possible causes for your child’s symptoms. What is INTUNIV (guanfacine)? INTUNIV is a prescription medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 to 17, either alone or in combination with ADHD stimulant medications. INTUNIV is not a controlled substance. INTUNIV was shown to work in clinical studies lasting up to 8 weeks. Q Is INTUNIV right for everyone? No. Patients should not take INTUNIV if they are allergic to guanfacine or other ingredients in INTUNIV, or other products containing guanfacine. Tell the doctor about all medicines, vitamins, and herbal supplements your child is taking. A treatment plan for your child’s ADHD may include medication, behavior management, individual or family counseling, skills training, or other therapies. Q What are some of the side effects of INTUNIV? INTUNIV may cause serious side effects including low blood pressure, low heart rate, fainting, and sleepiness. The most common side effects of INTUNIV are sleepiness, tiredness, trouble sleeping, low blood pressure, nausea, stomach pain, and dizziness. 2 Please see Full Prescribing Information, including Patient Information. 3 Q Is INTUNIV (guanfacine) a stimulant? Q INTUNIV is not a stimulant and is not a controlled substance. INTUNIV has no known potential for abuse or dependence. Q You should know that your child should not drive or use machinery like lawn mowers or power tools until you know how INTUNIV affects your child. INTUNIV can slow thinking and motor skills. While taking INTUNIV, your child should not drink alcohol or take other medicines that can cause sleepiness or dizziness because these symptoms may get worse. Can INTUNIV be added to a stimulant? For some children, adding once-daily nonstimulant INTUNIV to their stimulant has been shown to provide more ADHD symptom improvement. Q Can INTUNIV help improve my child’s ADHD symptoms? Whether used alone or added to a stimulant, INTUNIV may help improve your child’s ADHD symptoms. INTUNIV was studied in clinical trials to treat ADHD. In some studies, it was used alone. In another, it was added to a stimulant. One 9-week study included 455 children who were on a stable stimulant dose for at least 4 weeks and had some improvement, but still had ADHD symptoms. These children then took either INTUNIV or a sugar pill with their stimulant. Doctors saw about 30% improvement in ADHD symptoms when INTUNIV was added to a stimulant compared with a sugar pill added to a stimulant. Q What should I tell the doctor before my child takes INTUNIV? What should be avoided while taking INTUNIV (guanfacine)? Patients should drink plenty of water and not get overheated while taking INTUNIV. Q How is INTUNIV given? Your child should take INTUNIV exactly as prescribed by the doctor. INTUNIV comes in 4 doses—1 mg, 2 mg, 3 mg, and 4 mg—and is taken once a day. The doctor should start your child with 1 mg and adjust the dose to find the one that’s right for your child. The right dose depends on your child’s weight and response to INTUNIV. It may take a few weeks to see improvement in your child’s ADHD symptoms. Do not change your child’s dose unless directed by the doctor. INTUNIV should be swallowed whole with liquid, without crushing, chewing, or breaking the tablet. INTUNIV should not be taken with a high-fat meal. Tell the doctor if your child cannot swallow INTUNIV whole. The doctor will regularly check your child’s blood pressure and heart rate. Before deciding if INTUNIV is an option for your child, the doctor needs to know if your child has low blood pressure, low heart rate, heart problems, has fainted, has liver or kidney problems, or has any other medical condition. Also tell the doctor if your child is pregnant or breast-feeding or plans to become pregnant or breast-feed. 4 Please see Full Prescribing Information, including Patient Information. 5 Q What other medications should I tell my child’s doctor about before my child takes INTUNIV (guanfacine)? Tell your child’s doctor about all of the medicines your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements. Save on INTUNIV (guanfacine) Get caregiver support, materials, and a great money-saving offer Ask the doctor today about the INTUNIV Starter Kit—a free resource that includes INTUNIV may affect the way other medicines work, and other medicines may affect how INTUNIV works. • Information about INTUNIV Especially tell your child’s doctor if your child takes • A trial sample offer • ketoconazole • A savings card that limits the cost of each prescription to just $15* • medicines that can affect enzyme metabolism • high blood pressure medicine • sedatives • benzodiazepines • barbiturates • antipsychotics Know the medicines your child takes. Keep a list of them and show it to your child’s doctor and pharmacist when your child is prescribed a new medicine. Q Can my child’s physician call in a refill for INTUNIV? INTUNIV is not a controlled substance. Your child’s physician can call in refills to the pharmacy if appropriate. 6 *The offer covers the amount above $15 up to a maximum of $115 per prescription, for up to 12 prescriptions. Restrictions may apply. Ask your child’s doctor about a Starter Kit today! If you don’t receive a Starter Kit, visit www.intuniv.com to get your savings coupon. Please see Full Prescribing Information, including Patient Information. 7 SUPPORT PROGRAM TM Instant Support Every Day Join today for free support and tools A little help can go a long way. That’s why we created the inTUNE Support ProgramTM — a support resource that provides free tools, materials, and more to help you every step of the way. After registering, you’ll receive • The Progress Tracker • The Refill Reminder Tool Shire Cares is a program that helps parents who need help paying for their child’s INTUNIV prescription. If your child doesn’t have prescription insurance or if you are having trouble affording your child’s prescription, Shire Cares may be able to help. Visit shirecares.com to learn more. •A  Doctor Discussion Guide • More information about INTUNIV and ADHD Visit intuniv.com today to learn more about INTUNIV (guanfacine) 8 Please see Full Prescribing Information, including Patient Information. 9 For more information visit intuniv.com Please see Full Prescribing Information, including Patient Information. 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. INTUNIV® is a registered trademark of Shire LLC. 1-800-828-2088 www.intuniv.com ©2013 Shire US Inc., Wayne, PA 19087 INT-05208 06/13