DAYTRANA - methylphenidate patch 
Noven Therapeutics, LLC

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 10/2023

MEDICATION GUIDE

DAYTRANA® (day-TRON-ah)
(methylphenidate transdermal system) CII

Important: DAYTRANA is for use on the skin only.
What is the most important information I should know about DAYTRANA?

DAYTRANA may cause serious side effects, including:

  • Abuse, misuse, and addiction. DAYTRANA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of DAYTRANA, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of DAYTRANA or when it is used in ways that are not approved, such as snorting or injection.
    • Your healthcare provider should check your child's risk for abuse, misuse, and addiction before starting treatment with DAYTRANA and will monitor your child during treatment.
    • DAYTRANA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
    • Do not give DAYTRANA to anyone else. See "What is DAYTRANA?" for more information.
    • Keep DAYTRANA in a safe place and properly dispose of any unused medicine. See "How should I store DAYTRANA?" for more information.
    • Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.
    Your child's healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using DAYTRANA. Tell your child's healthcare provider if your child has any heart problems, heart disease or heart defects.
    Remove the DAYTRANA transdermal system (patch) and call your child's healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DAYTRANA.
  • Increased blood pressure and heart rate.
    Your child's healthcare provider should check your child's blood pressure and heart rate regularly during treatment with DAYTRANA.
  • Mental (psychiatric) problems, including:
    • new or worse behavior or thought problems
    • new or worse bipolar illness
    • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or manic symptoms
    Tell your child's healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression.
    Call your child's healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with DAYTRANA, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.
What Is DAYTRANA?

DAYTRANA is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. DAYTRANA may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD.

It is not known if DAYTRANA is safe and effective in children younger than 6 years.

DAYTRANA is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep DAYTRANA in a safe place to protect it from theft. Never give your DAYTRANA to anyone else because it may cause death or harm them. Selling or giving away DAYTRANA may harm others and is against the law.

Do not use DAYTRANA if your child:
  • is allergic to methylphenidate or any of the ingredients in DAYTRANA. See the end of this Medication Guide for a complete list of ingredients in DAYTRANA.
  • is taking, or has stopped taking withing the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)
Before using DAYTRANA, tell your child's healthcare provider about all of your child's medical conditions, including if your child:
  • has heart problems, heart disease, heart defects, or high blood pressure
  • has mental problems including psychosis, mania, bipolar illness, or depression, or has a family history of suicide bipolar illness, or depression
  • has seizures or have had an abnormal brain wave test (EEG)
  • has circulation problems in fingers or toes
  • has skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues)
  • has a history of vitiligo or a family history of vitiligo
  • has eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
  • has or had repeated movements or sounds (tics) or Tourettes syndrome, or have a family history of tics or Tourettes syndrome
  • is pregnant or plans to become pregnant. It is not known if DAYTRANA will harm the unborn baby. Tell your child's healthcare provider if your child becomes pregnant during treatment with DAYTRANA.
    • There is a pregnancy registry for females who are exposed to DAYTRANA during pregnancy. The purpose of the registry is to collect information about the health of women exposed to DAYTRANA and their baby. If your child becomes pregnant during treatment with DAYTRANA, talk to your child's healthcare provider about registering with the National Pregnancy Registry of Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
  • is breast feeding or plan to breast feed. DAYTRANA passes into breast milk. Talk to your child's healthcare provider about the best way to feed the baby during treatment with DAYTRANA.
  • a history of vitiligo and/or a family history of vitiligo
Tell your child's healthcare provider about all of the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

DAYTRANA and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with DAYTRANA. Your child's healthcare provider will decide if DAYTRANA can be taken with other medicines.

Especially tell your child's healthcare provider if your child takes:

  • blood pressure medicines (anti-hypertensive)

Know the medicines that your child takes. Keep a list of your child's medicines with you to show your child's healthcare provider and pharmacist when your child gets a new medicine. Do not start any new medicine while using DAYTRANA without first talking to your child's healthcare provider.

How should DAYTRANA be used?
  • See the detailed “Instructions for Use” at the end of this Medication Guide for information about the right way to apply, remove, and dispose of DAYTRANA.
  • Use DAYTRANA exactly as prescribed by your child's healthcare provider.
  • Your child's healthcare provider may change the dose if needed.
  • Apply DAYTRANA to the hip area 2 hours before an effect is needed and remove DAYTRANA within 9 hours after it is applied. Do not wear DAYTRANA longer than 9 hours a day.
  • If DAYTRANA falls off, a new patch may be applied to a different area of the same hip.
  • If you forget to apply DAYTRANA at your usual scheduled time each day, you may apply the patch later in the day. The patch should be removed at the usual time of day to lower the chance of side effects later in the day.
  • If your child has loss of appetite or trouble sleeping in the evening, ask your child's healthcare provider if your child can take the patch off earlier in the day.
  • Contact with water while bathing, swimming, or showering can make the patch not stick well.
  • Do not use bandages, tape, or other household adhesives (glue) to hold the patch onto the skin.
If your child uses too much DAYTRANA transdermal systems call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What should your child avoid while using DAYTRANA?
  • After applying the DAYTRANA patch, avoid exposing the application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds or other heat sources. Exposure to heat can cause too much medicine to pass into the body and cause serious side effects.
What are the possible side effects of DAYTRANA?

DAYTRANA may cause serious side effects, including:

  • See "What is the most important information I should know about DAYTRANA?"
  • Seizures. Your child's healthcare provider may stop treatment with DAYTRANA if your child has a seizure.
  • Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate. If your child develops priapism, get medical help right away.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynauds phenomenon). Signs and symptoms may include:
    • fingers or toes may feel numb, cool, or painful
    • fingers and toes may change color from pale, to blue, to red
    Tell your child's healthcare provider if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
    Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with DAYTRANA.
  • Slowing of growth (height and weight) in children. Your child should have their height and weight checked often during treatment with DAYTRANA. Your healthcare provider may stop your child’s DAYTRANA treatment if they are not growing or gaining weight as expected.
  • Eyes problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
  • New or worsening tics or worsening Tourette's syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourettes syndrome during treatment with DAYTRANA.
  • Loss of skin color. DAYTRANA may cause a persistent loss of skin-color where the patch is applied or around the patch application site. Loss of skin-color, in some cases, has been reported at locations on the skin far from any application site. The loss of skin-color may be permanent even after removing the patch or DAYTRANA is stopped. Call your healthcare provider right away if your child has changes in skin-color. DAYTRANA treatment may be stopped if your child has changes in skin color.
  • Allergic skin rash (contact sensitization). Stop using DAYTRANA and tell your child's healthcare provider right away if your child develops swelling or blisters at or around the application site. Your child may have a skin allergy to DAYTRANA. People who have skin allergies to DAYTRANA may develop an allergy to all medicines that contain methylphenidate, even methylphenidate medicines taken by mouth.
The most common side effects of DAYTRANA in children 6 to 12 years old include:
  • decreased appetite
  • trouble sleeping
  • nausea
  • vomiting
  • weight loss
  • tics
  • changes in mood
  • trouble eating
The most common side effects of DAYTRANA in children 13 to 17 years old include:
  • decreased appetite
  • nausea
  • trouble sleeping
  • weight loss
  • dizziness
  • stomach pain
  • trouble eating

DAYTRANA may also cause skin problems where it is applied (redness, small bumps, itching)

Your child's doctor may do certain blood tests while your child uses DAYTRANA.

These are not all the possible side effects of DAYTRANA.

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 DAYTRANA?
  • Store DAYTRANA at room temperature between 68° F to 77° F (20° C to 25° C).
  • Store DAYTRANA in a safe place, like a locked cabinet.
  • Do not store DAYTRANA in the refrigerator or freezer.
  • Keep DAYTRANA in their unopened pouches until you are ready to use them.
  • Use or throw away the patches within 2 months after you open the sealed tray or outer pouch.
  • Dispose of remaining, unused, or expired DAYTRANA by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, each unused patch should be removed from its individual pouch, separated from the protective liner, folded in half so that the sticky sides stick together, and flushed down the toilet. Put the pouch and liner in a container with a lid, close the container and throw away the container in the household trash. Do not flush the pouch and liner down the toilet. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
Keep DAYTRANA and all medicines out of the reach of children.

General information about the safe and effective use of DAYTRANA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DAYTRANA for a condition for which it was not prescribed. Do not give DAYTRANA to other people, even if they have the same symptoms. It may harm them and it is against the law.

You can ask your pharmacist or healthcare provider for information about DAYTRANA that is written for healthcare professionals.

What are the ingredients in DAYTRANA?
Active ingredient: methylphenidate
Inactive ingredients: acrylic adhesive, silicone adhesive

Manufactured by: Noven Pharmaceuticals, Inc., Miami, FL 33186
DAYTRANA® is a trademark of Noven Therapeutics, LLC.

For more information, go to www.daytrana.com, or call 1-877-567-7857.

Revised: 10/2023
Noven Therapeutics, LLC