XELSTRYM^®
(dextroamphetamine)
transdermal system, CII

Abuse, misuse, and addiction: XELSTRYM is a federally controlled substance (CII) because it contains dextroamphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep XELSTRYM in a safe place to protect it from theft. Never sell or give your XELSTRYM to anyone else because it may cause death or harm to them and it is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Do not use XELSTRYM if you or your child are:

• Allergic to amphetamine or any of the ingredients in XELSTRYM. See the end of the Medication Guide for a complete list of ingredients in XELSTRYM.
• Taking or have taken within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or the intravenous medicine called methylene blue.

XELSTRYM can cause serious side effects, including:

• Risks for people with serious heart disease. Sudden death as happened in people who have heart defects or other serious heart disease. Your healthcare provider (HCP) should check you or your child carefully for heart problems before starting treatment with XELSTRYM. Tell your HCP if you or your child have any heart problems, heart disease, or heart defects. Call your HCP or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with XELSTRYM.
• Increased blood pressure and heart rate. Your HCP should check you or your child’s blood pressure and heart rate regularly during treatment with XELSTRYM.
• Mental (psychiatric) problems. Including new or worse behavior and thought problems; new or worse bipolar illness; new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real); or new manic symptoms. Tell your HCP about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Call your HCP right away if you or your child have any new or worsening mental symptoms or problems during treatment with XELSTRYM, especially hearing, seeing or believing things that are not real, or new manic symptoms.

• Slowing of growth (height or weight) in children. Children should have their height and weight checked often while on XELSTRYM. Your HCP may stop treatment with XELSTRYM if your child is not growing or gaining height or weight as expected.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Fingers or toes may feel numb, cool, or painful. Fingers or toes may change color from pale, to blue, to red. Tell your HCP if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your HCP right away if you or your child have any signs of unexplained wounds appearing on fingers or toes while using XELSTRYM.
• Serotonin syndrome. Symptoms such as agitation, fast heartbeat, flushing, seizures, coma, sweating, loss of coordination, confusion, dizziness, tremors, stiff muscles, muscle twitching, seeing or hearing things that are not real (hallucinations), changes in blood pressure, high body temperature (hyperthermia), nausea, vomiting, or diarrhea may occur. Stop using XELSTRYM and call your HCP or go to the emergency room if symptoms occur. Serotonin syndrome may occur if XELSTRYM is taken with certain medicines and may be life-threatening.
• Allergic skin rash (contact sensitization). Stop using XELSTRYM and tell your HCP right away if you or your child develop swelling or blisters at or around the application site.
• Application site reactions. Reactions have happened while wearing XELSTRYM and after removing it. Symptoms include pain, itching, burning feeling, redness, discomfort, or swelling at the application site. Call your HCP if you or your child develop any application site reactions that do not resolve on their own.
• New or worsening tics or worsening Tourette’s syndrome. Tell your HCP if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with XELSTRYM.

Before taking XELSTRYM tell your HCP about all the medications you take and any medical conditions including if you:

• Are pregnant or plan to become pregnant. It is not known if XELSTRYM may harm your unborn baby. There is a pregnancy registry for women who are exposed to XELSTRYM during pregnancy. The purpose of the registry is to collect information about the health of women exposed to XELSTRYM and their babies. For more information on registering with the National Pregnancy Registry for Psychiatric Medications call 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/othermedications/
• Are breastfeeding or plan to breastfeed. XELSTRYM can pass into your milk. Do not breastfeed while taking XELSTRYM. Talk to your doctor about the best way to feed your baby if you take XELSTRYM.

What should I avoid while using XELSTRYM?

• Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how XELSTRYM affects you.
• Avoid exposing the application site to direct external heat sources such as hair dryers, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds, as exposure to heat can cause too much medicine to pass into your body and cause serious side effects.

The most common side effects of XELSTRYM include:

• • decreased appetite
  • trouble sleeping
  • stomach pain
  • nausea
  • increased blood pressure
  • headache
  • muscle twitching (tics)
  • vomiting
  • irritability
  • increased heart rate

Please read the Medication Guide and Full Prescribing Information including the Boxed Warning.

To report suspected Adverse Reactions, contact Noven at 800-455-8070 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.