Daytrana

Included as part of the "PRECAUTIONS" Section

• Noven Therapeutics, Llc

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Daytrana is excreted in human breast milk or if it will harm your nursing baby.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

Methylphenidate may also be used for purposes not listed in this medication guide.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• Do not use patches that are cut or do not look right.
• Wash your hands before and after use.
• Put patch on clean, dry, healthy skin on the hip. Do not put the patch on the waistline.
• Do not put on cuts, scrapes, eczema, or damaged skin.
• Put patch on in the morning and take off 9 hours later or as you have been told by the doctor.
• Put the patch in a new area each time you change the patch.
• Water from bathing, swimming, or showering can make the patch not stick well or fall off. If the patch falls off, do not touch the sticky side with your fingers.
• If the patch falls off, put on a new one on some other part of the same hip. Take the new patch off at the normal time.
• To gain the most benefit, do not miss doses.
• If you have been taking Daytrana for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
• Do not switch between different forms of Daytrana without first talking with the doctor.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine may cause nervousness, shakiness, and a fast heartbeat.
• If you are taking Daytrana and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.

What do I do if I miss a dose?

• You may apply the patch later in the day. Then take off the patch at your normal time of day.
• Do not put on 2 doses at the same time or extra doses.

Four dosage strengths are available:

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association 1994.

Daytrana is supplied in a sealed tray or outer pouch containing 30 individually pouched patches. See the chart below for information regarding available strengths.

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Do not store patches unpouched. Do not store patches in refrigerators or freezers.

Once the sealed tray or outer pouch is opened, use contents within 2 months. Apply the patch immediately upon removal from the individual protective pouch. For transdermal use only.

Advise patients to read the FDA-approved patient labeling (Medication Guide).
Information for Patients

Priapism

Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.4)]

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]

• Instruct patients beginning treatment with Daytrana about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red
• Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
• Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while using Daytrana
• Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Chemical Leukoderma

Advise patients of the possibility of a persistent loss of skin pigmentation at, around and distant from the application site. Advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur [see Warnings and Precautions (5.7)].

Parents and patients should be informed to apply Daytrana to a clean, dry site on the hip, which is not oily, damaged, or irritated. The site of application must be alternated daily. The patch should not be applied to the waistline, or where tight clothing may rub it.

If patients or caregivers experience difficulty separating the patch from the release liner or observe tearing and/or other damage to the patch during removal from the liner, the patch should be discarded according to the directions provided in this label, and a new patch should be applied [see Dosage and Administration (2.3)]. Patients or caregivers should inspect the release liner to ensure that no adhesive containing medication has transferred to the liner. If adhesive transfer has occurred, the patch should be discarded.

Daytrana should be applied 2 hours before the desired effect. Daytrana should be removed approximately 9 hours after it is applied, although the effects from the patch will last for several more hours. Daytrana may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.

The parent or caregiver should be encouraged to use the administration chart included with each carton of Daytrana to monitor application and removal time, and method of disposal. The Medication Guide included at the end of this insert also includes a timetable to calculate when to remove Daytrana, based on the 9 hour application time.

Patients or caregivers should avoid touching the adhesive side of the patch during application, in order to avoid absorption of methylphenidate. If they do touch the adhesive side of the patch, they should immediately wash their hands after application.

In the event that a patch does not fully adhere to the skin upon application, or is partially or fully detached during wear time, the patch should be discarded according to the directions provided in this label, and a new patch should be applied [see Dosage and Administration (2.3)]. If a patch is replaced, the total recommended wear time for that day should remain 9 hours, regardless of the number of patches used.

Patches should not be applied or re-applied with dressings, tape, or other common adhesives.

Exposure to water during bathing, swimming, or showering can affect patch adherence.

Do not cut patches. Only intact patches should be applied.

If there is an unacceptable duration of appetite loss or insomnia in the evening, taking the patch off earlier may be attempted before decreasing the patch dose.

Skin redness or itching is common with Daytrana and small bumps on the skin may also occur in some patients. If any swelling or blistering occurs the patch should not be worn and the patient should be seen by the prescriber. Patients or caregivers should not apply hydrocortisone or other solutions, creams, ointments, or emollients immediately prior to patch application, since the effect on patch adhesion and methylphenidate absorption has not been established. The potential adverse effects of topical corticosteroid use during treatment with Daytrana are unknown.

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Patients should be cautioned accordingly until they are reasonably certain that Daytrana does not adversely affect their ability to engage in such activities.

Patches should be stored at 25 degrees Celsius (77 degrees Fahrenheit) with excursions permitted that do not exceed 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) [see How Supplied/Storage and Handling (16)]. Patients or caregivers should be advised not to store Daytrana in the refrigerator or freezer.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Daytrana and should counsel them in its appropriate use. A patient Medication Guide is available for Daytrana. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186.

By: Noven Pharmaceuticals, Inc., Miami, FL 33186.

For more information call 1-877-567-7857 or visit www.Daytrana.com.

Dot Matrix™ is a trademark of Noven Pharmaceuticals, Inc.
Daytrana® is a registered trademark of Noven Therapeutics, LLC.

© 2009, 2013, 2015, 2016 Noven Pharmaceuticals, Inc.

This product is covered by US patents including for use with 6,905,016 and 8,186,506.

Last Modified: 01/2017

102086-17

MEDICATION GUIDE
Daytrana® (day-TRON-ah)
(methylphenidate transdermal system) CII

What is the most important information I should know about Daytrana?

Daytrana is a central nervous system (brain) stimulant medicine. Serious side effects have been reported with Daytrana or other stimulant medicines, including:

1. Heart problems, including:

• sudden death in people who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Your doctor should check you carefully for blood pressure and heart problems before you start and while you are using Daytrana.

Remove the Daytrana patch and call your doctor right away if you have any signs of heart problems such as:

• chest pain
• shortness of breath
• fainting

2. Mental (psychiatric) problems, including:

• new or worse aggressive behavior, hostility, anger, or irritability
• new or worse bipolar illness or mania (an extreme increase in activity or talking)
• new or worse psychosis (hearing or seeing things that are not real, being suspicious or distrustful, believing things that are not true)
• other unusual or extreme changes in behavior or mood

Tell your doctor right away if you have any new or worsening mental problems while using Daytrana.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red

• Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
• Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Daytrana

What Is Daytrana?

Daytrana is a prescription medicine used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people 6 to 17 years old. Daytrana is a central nervous system (brain) stimulant medicine. Daytrana may help you have better attention and less impulsive and hyperactive behavior. Daytrana is a patch that you apply to your skin on your hip. Daytrana is used as part of a total treatment program for ADHD that may also include counseling or other treatments.

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

Who should not use Daytrana?

Do not use Daytrana if you:

• are very anxious, tense, or agitated
• have glaucoma
• have tics (repeated movements or sounds that cannot be controlled)
• have Tourette's Syndrome or a family history of this syndrome
• are taking or have taken a monoamine oxidase inhibitor (MAOI) medicine within the past 2 weeks. Do not take a MAOI medicine for at least 2 weeks before using Daytrana. Ask your doctor or pharmacist if you are not sure if any of your medicines are MAOIs.
• are allergic to methylphenidate or any other ingredients in Daytrana. See "What are the ingredients in Daytrana?" for a complete list of ingredients.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my doctor before using Daytrana?

Before you start using Daytrana, tell your doctor if you have:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• seizures or have had an abnormal brain wave test (EEG)
• circulation problems in fingers or toes
• skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues)
• are pregnant or plan to become pregnant. It is not known if Daytrana will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast feeding or plan to breast feed. It is not known if Daytrana passes into your breast milk. You and your doctor should decide if you will use Daytrana or breastfeed.
• a history of vitiligo and/or a family history of vitiligo

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Daytrana and certain other medicines may affect each other, causing serious side effects.

Especially tell your doctor if you take:

• a monoamine oxidase inhibitor (MAOI) medicine See "Who should not take Daytrana?"
• medicines to treat depression
• medicines to treat seizures
• a blood pressure medicine
• a blood thinner medicine
• cold or allergy medicines that contain decongestants

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist. Do not start any new medicine while using Daytrana without talking to your doctor first.

How should I use Daytrana?

• Read the Patient Instructions for Use at the end of this Medication Guide that comes with your Daytrana for information about the right way to use Daytrana.
• Use Daytrana exactly as your doctor tells you to.
• Your doctor may change your dose if needed.
• Apply Daytrana to your hip 2 hours before an effect is needed.
• Do not wear Daytrana longer than 9 hours a day.
• Apply Daytrana to a different hip each day.
• Do not cut Daytrana patches.
• Parents or caregivers should apply and remove Daytrana for their child if the child is not responsible enough to do so.
• Your doctor may stop Daytrana treatment to check your ADHD symptoms.
• Your doctor may do certain blood tests and check your heart and blood pressure while you use Daytrana.
• If you forget to apply a patch in the morning, you may apply the patch later in the day. You should remove your patch at the usual time of day to lower the chance of side effects later in the day.
• If you have loss of appetite or trouble sleeping in the evening, ask your doctor if you can take the patch off earlier in the day.
• Contact with water while bathing, swimming, or showering can make the patch not stick well or make it fall off. If your patch falls off, do not touch the sticky side of the patch with your fingers. You may apply a new patch to a different area on the same hip. If you have to replace a patch that has fallen off, the total wear time for the first and second patch should not be more than a total of 9 hours in 1 day. Do not reapply the same patch that fell off.
• Do not wear your Daytrana patch longer than 9 hours.
• If you accidentally apply or wear more than 1 patch at a time, you have used too much Daytrana. Remove all patches, wash the application sites right away and call your doctor.
  • Call your Poison Control Center at 1-800-222-1222 -or go to the nearest hospital emergency room right away if you have:
    • vomiting
    • agitation
    • shaking
    • confusion or mental changes
    • see things that are not there (hallucinations)
    • sweating
    • redness in your face
    • headache
    • heartbeat changes

What should I avoid while using Daytrana?

• Do not put any medicine, cream, or lotion on your hip before you apply the Daytrana patch. Medicines, creams or lotions may affect how the patch sticks to your skin and how the medicine is absorbed from the patch.
• Do not use bandages, tape, or other household adhesives (glue) to hold the patch onto your skin.
• Do not use hair dryers, heating pads, electric blankets, heated water beds or other heat sources while wearing a Daytrana patch. Too much medicine can pass into your body and cause serious side effects.
• Do not drive, operate heavy machinery or do other dangerous activities until you know how Daytrana affects you.

What are 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. This usually happens in people with a history of seizures.
• Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
• Slowing of growth (weight and height). You should have your height and weight checked while using Daytrana.
• Loss of skin color (chemical leukoderma). 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 your skin-color may be permanent even after removing the patch or stopping use of Daytrana. Call your doctor immediately if you have changes in your skin-color.
• Allergic skin rash. Stop using Daytrana and see your doctor right away if you have swelling or blisters at or around the application site. You 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 those methylphenidate medicines that are taken by mouth.
• Eyesight changes or blurred vision

The most common side effects of Daytrana include:

• skin problems where you apply Daytrana (redness, small bumps, itching)
• poor appetite
• nausea
• vomiting
• stomach pain
• weight loss
• tics
• trouble sleeping
• mood swings
• dizziness

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

These are not all the possible side effects of Daytrana. 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 Daytrana?

• Store Daytrana at room temperature between 68° F to 77° F (20° C to 25° C).
• Do not store Daytrana in the refrigerator or freezer.
• Keep Daytrana patches 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.

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 that you have. It may harm them and it is against the law.

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

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

What are the ingredients in Daytrana?

Active ingredient: methylphenidate

Inactive ingredients: acrylic adhesive, silicone adhesive

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

Instructions for Use
Daytrana® (day-TRON-ah)
(methylphenidate transdermal system) CII

1. Daytrana Dosing Chart

Each carton of Daytrana contains a Daytrana Dosing Chart to help you keep track of your patch including:

• when you apply patch to the skin on your hip each morning
• when you remove the patch
• how and where you threw the Daytrana patch away

To use the Daytrana Dosing Chart, follow these instructions:

• Each day, when a new Daytrana patch is applied to your hip, write down the date and time that you applied the patch.
• Use the Daytrana schedule below so you can decide when to remove the patch. For example, if the patch is applied to the skin at 6:00 a.m., remove the patch at 3:00 p.m. on the same day. After you remove and throw away the patch, write down the time you removed the patch and how and where you threw it away.
• If the patch you placed on your child is missing, ask your child:
  • when the patch came off
  • how the patch came off
  • where the patch is

Daytrana Schedule for 9 Hour Dosing

2. Where to apply Daytrana

• Apply patch to your hip area. Do not put the patch near your waist. Clothing and movement may make your patch rub off (See Figure A).
• Use your other hip when you apply a new patch the next morning. Make sure there is no redness, small bumps or itching at the site where the patch is going to be applied.

Figure A

3. Before you apply Daytrana

Make sure your skin:

• Is clean (freshly washed), dry, and cool
• Does not have any powder, oil, or lotion
• Does not have any cuts and irritation (rashes, inflammation, redness, or other skin problems).

4. How to apply Daytrana

• Open the sealed tray or outer pouch and throw away the small packet (drying agent).
• Each patch is sealed in its own protective pouch.
• Carefully cut the protective pouch open with scissors, being careful not to cut the patch. Do not use patches that have been cut or damaged in any way (See Figure B).

Figure B

• Remove the patch from the protective pouch.
• Look at the patch to make sure it is not damaged. The patch should separate easily from the protective liner. Throw away the patch if the protective liner is hard to remove.

The Daytrana patch has 3 layers. The 3 layers are pictured below. The pictures show both sides of the patch:

                             Figure C                                                                  Figure D

Layers:

• Protective liner: The protective liner is the layer that you remove before you put the patch on (See Figure C).
• Adhesive with medicine: The adhesive with medicine is the layer that sticks to your skin (See Figure C).
• Outside backing: The outside backing is the layer that you see after you put the patch on your skin. The word "Daytrana" is printed on this layer (See Figure D).

• Apply the patch right away after you remove the patch from protective pouch.
• Hold the patch with the hard protective liner facing you. The word Daytrana will appear backwards.
• Gently bend the patch along the faint line and slowly peel half the liner, which covers the sticky surface of the patch (See Figure E).

Figure E

• Avoid touching the sticky side of the patch with your fingers.
• If you accidentally touch the sticky side of the patch, apply the patch, then wash your hands right away so that the medicine does not go into the skin on your hands.
• Using the other half of the protective liner as a handle, apply the sticky side of the patch to the selected area of the child's hip (See Figure F).

Figure F

• Press the sticky side of the patch firmly into place and smooth it down.
• While you are still holding the sticky side down, gently fold back the other half of the patch.
• Hold an edge of the remaining protective liner and slowly peel it off (See Figure G).

Figure G

• After the protective liner is removed, there should not be any adhesive (glue) sticking to the liner.

Figure H

• Press the entire patch firmly into place with the palm of your hand over the patch for about 30 seconds (See Figure H).
• Make sure that the patch firmly sticks to your skin.
• Gently rub the edges of the patch with your fingers to make sure the patch sticks to your skin.
• Wash your hands after you apply your patch.
• Write the time you applied your patch on the dosing chart on the carton. Use the dosing schedule so you know what time you should remove your patch.

5. How to remove and throw away Daytrana

• When you remove the patch, peel it off slowly. If the patch is too sticky on your skin and you need something to help you remove it:
  • Gently apply an oil-based product (petroleum jelly, olive oil, or mineral oil) to the patch edges. Gently spread the oil underneath the patch edges.
  • Apply an oil-based product or lotion to your skin if any adhesive (glue) remains after you remove your patch. This will gently loosen and remove any adhesive that is left over.
  • If you still can not easily remove the patch, ask your doctor or pharmacist about what to do for this problem.
• Fold the used Daytrana patch in half and press it together firmly so that the sticky side sticks to itself. Flush the used patch down the toilet or put the patch in a container with a lid right away.
• Do not flush the protective pouches or the protective liners down the toilet. These items should be thrown away in a container with a lid.
• Wash your hands after you handle the patch.
• After you remove the patch and throw the patch away, write down the time on the dosing chart.
• Safely throw away any unused Daytrana patches that are left over from the prescription as soon as they are no longer needed.
  To safely throw away the patches:
  • Remove the leftover patches from their protective pouches and remove the protective liners.
  • Either fold the patches in half with the sticky sides together, and flush the patches down the toilet, or
  • Throw the patches away in a container with a lid.

Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186.

By: Noven Pharmaceuticals, Inc., Miami, FL 33186.
© 2009, 2013, 2015, 2016 Noven Pharmaceuticals, Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 01/2017

102086-17

PRINCIPAL DISPLAY PANEL - NDC 68968-5552-3 - 10 mg 30 Count Carton

PRINCIPAL DISPLAY PANEL - NDC 68968-5553-3 - 15 mg 30 Count Carton

PRINCIPAL DISPLAY PANEL - NDC 68968-5554-3 - 20 mg 30 Count Carton

PRINCIPAL DISPLAY PANEL - NDC 68968-5555-3 - 30 mg 30 Count Carton