`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`200533Orig1s000
`
`
`REMS
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`

`

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`
`
`Initial Date of Approval: August 25, 2011
`
`NDA 200533
`NUCYNTA® ER (tapentadol) tablets
`Opioid analgesic
`Janssen Pharmaceuticals, Inc.
`Titusville, NJ 08560
`1-800-526-7736
`
` 
`
`RISK EVALUATION AND MITIGATION STRATEGY (REMS)
`I.
`GOALS
`The goals of the NUCYNTA® ER REMS are:
`
`• To inform patients and healthcare professionals about the potential for abuse, misuse,
`overdose, and addiction to NUCYNTA® ER.
`• To
`inform patients and healthcare professionals about
`NUCYNTA® ER.
`
`the safe use of
`
`
`REMS ELEMENTS
`II.
`Medication Guide
`A.
`In accordance with 21CFR208.24 a Medication Guide will be dispensed with each
`NUCYNTA® ER prescription.
`
`This Medication Guide is part of the REMS and is appended.
`
`Elements to Assure Safe Use
`B.
`1. Healthcare professionals who prescribe NUCYNTA® ER will receive training.
`
`a.
`
`Janssen Pharmaceuticals, Inc. will ensure that training will be provided to healthcare
`professionals who prescribe NUCYNTA® ER. To become trained, each prescriber
`will be provided with the NUCYNTA® ER educational materials. Training will
`address the following:
`
`i. Proper patient selection;
`
`ii. Appropriate NUCYNTA® ER dosing and administration;
`
`iii. General principles of safe opioid use including information about opioid abuse
`and how to identify patients who are at risk for addiction;
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`iv. Potential abuse, misuse, overdose, and addiction from exposure to opioids,
`including NUCYNTA® ER;
`
`v. Risks of NUCYNTA® ER including:
`
`1. The risk of overdose caused by exposure to an essentially immediate-release
`form of tapentadol by consuming split, broken, chewed, crushed, or dissolved
`NUCYNTA® ER tablets;
`
`2. The risk of overdose in patients who have not developed tolerance to the
`sedating or respiratory-depressant effects of opioids when using an initial dose
`of NUCYNTA® ER greater than 50 mg twice daily (total daily dose of
`100 mg);
`
`3. The risk of addiction from exposure to NUCYNTA® ER
`
`vi. Information to counsel patients on the need to store opioid analgesics safely out of
`the reach of children and household acquaintances, and the need to properly
`dispose of unused drugs when no longer needed by the patient and not to share
`drugs with anyone for any reason; and
`
`vii. The importance of dispensers providing each patient a Medication Guide with
`each prescription and instructing the patient to read it.
`
`b. Janssen Pharmaceuticals, Inc. will ensure that within 3 weeks after approval of the
`NUCYNTA® ER REMS, a Dear Healthcare Professional letter will be mailed to
`prescribers most experienced in treating chronic pain with opioid agonists, including
`pain specialists, physiatrists, and primary care physicians. This letter is designed to
`convey and reinforce the risks of abuse, misuse, overdose, and addiction of
`NUCYNTA® ER as well as the need to complete the NUCYNTA® ER REMS
`Education Program. This letter will be available on the Janssen Pharmaceuticals, Inc.
`website (www.NUCYNTAERREMS.com) for a time period of 1 year from the date
`of the mailing.
`
`c. The mailings will also include the following NUCYNTA® ER REMS training
`materials:
`
`i. A copy of the full Prescribing Information (PI)
`
`ii. NUCYNTA® ER Medication Guide
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`iii. Prescribing NUCYNTA® ER Healthcare Professional Education Program: A
`Guide for Healthcare Professionals Who Intend to Prescribe NUCYNTA® ER
`
`iv. NUCYNTA® ER Education Confirmation Form
`
`d. Additional printed training material will be available through field-force distribution
`and by calling
`the
`toll-free number at
`Janssen Pharmaceuticals,
`Inc.
`(1-800-526-7736).
`
`e. The
`training material will
`www.NUCYNTAERREMS.com.
`
`also
`
`be
`
`available
`
`for
`
`download
`
`at
`
`f. Janssen Pharmaceuticals, Inc. will maintain a list of all prescribers who have
`completed the NUCYNTA® ER REMS Education Program.
`
`Prescribers will be re-trained every two years or following substantial changes to the
`NUCYNTA® ER REMS.
` Substantial changes may
`include changes
`to
`the
`NUCYNTA® ER Full Prescribing Information, NUCYNTA® ER Medication Guide, or
`NUCYNTA® ER REMS that require substantial modification of the educational
`materials.
`
`The following materials are part of the REMS and are appended:
`
`• Dear Healthcare Professional Letter,
`• Prescribing NUCYNTA® ER Healthcare Professional Education Program: A Guide
`for Healthcare Professionals Who Intend to Prescribe NUCYNTA® ER, NUCYNTA®
`ER Education Confirmation Form, and
`• NUCYNTA® ER REMS website screenshots.
`
`Implementation System
`C.
`Because NUCYNTA® ER can be approved without the Elements to Assure Safe Use
`described under FDCA 505-1(f)(3)(B), (C), and (D) of the Act, an implementation
`system is not required.
`
`Timetable for Submission of Assessments
`D.
`Janssen Pharmaceuticals, Inc. will submit REMS Assessments to the FDA every 6
`months for the first year from the date of approval of the REMS, and annually thereafter.
`To facilitate inclusion of as much information as possible while allowing reasonable time
`to prepare the submission, the reporting interval covered by each assessment will
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`conclude no earlier than 60 days before the submission date for that assessment. Janssen
`Pharmaceuticals, Inc. will submit each assessment so that it will be received by the FDA
`on or before the due date.
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`APPENDIX 1
`
`MEDICATION GUIDE
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`5
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`MEDICATION GUIDE
`
`NUCYNTA® ER (new-SINN-tah E-R) C-II
`
`(tapentadol)
`
`extended-release oral tablets
`
`
`
`Important:
`
`Keep NUCYNTA® ER in a safe place away from children. Accidental use by a
`child is a medical emergency and can result in death. If a child accidentally
`takes NUCYNTA® ER, get emergency help right away.
`
`Read the Medication Guide that comes with NUCYNTA® ER before you start
`taking it and each time you get a new prescription. There may be new information.
`This Medication Guide does not take the place of talking to your doctor about your
`medical condition or your treatment. Talk to your doctor if you have any questions.
`
`What is the most important information I should know about NUCYNTA® ER?
`
`1. NUCYNTA® ER overdose can cause life-threatening breathing
`problems that can lead to death.
`
`• Take NUCYNTA® ER exactly as prescribed by your doctor.
`
`• NUCYNTA® ER is not for use for short-term pain relief from injuries or
`surgery.
`
`• NUCYNTA® ER is not for use to treat pain that you only have once in a
`while (“as needed”).
`
`• Swallow NUCYNTA® ER tablets whole. Do not break, split, chew,
`dissolve, or crush NUCYNTA® ER tablets before swallowing, or
`inject the contents. If NUCYNTA® ER is taken in this way, the
`tapentadol in NUCYNTA® ER may be released too fast. This is
`dangerous. It may cause you to have trouble breathing and
`lead to death.
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`•
`
`If you cannot swallow NUCYNTA® ER tablets whole, tell your doctor.
`You will need a different pain medicine.
`
`• Do not drink alcohol, or use prescription or non-prescription medicines
`that contains alcohol while you are being treated with NUCYNTA® ER.
`Alcohol can cause very high levels of tapentadol in your blood and you
`can die due to an overdose of tapentadol.
`
`•
`
`It is important to stay under the care of your doctor while taking
`NUCYNTA® ER.
`
`2. Prevent theft, misuse, or abuse. Keep NUCYNTA® ER in a safe place to
`protect it from being stolen. NUCYNTA® ER can be a target for people
`who misuse or abuse prescription medicines or street drugs.
`
`3. Never give NUCYNTA® ER to anyone else, even if they have the same
`symptoms you have. It may harm them or even cause death. Selling
`or giving away this medicine is against the law.
`
`What is NUCYNTA® ER?
`
`• NUCYNTA® ER is a prescription medicine that contains the opioid (narcotic)
`pain medicine tapentadol. The medicine in NUCYNTA® ER is slowly released
`over time. If you split, break, chew, dissolve, or crush NUCYNTA® ER
`before swallowing, or inject the contents, the tapentadol may be
`released too fast and you may overdose. See “What is the most
`important information I should know about NUCYNTA® ER?”
`
`• NUCYNTA® ER is a strong opioid pain medicine. NUCYNTA® ER is used in
`adults to treat moderate to severe pain that continues around-the-clock and
`is expected to last for a long period of time.
`
`• NUCYNTA® ER is not for use for short-term pain relief from injuries or
`surgery.
`
`• NUCYNTA® ER is not for use to treat pain that you only have once in a while
`(“as needed”).
`
`• NUCYNTA® ER is a federally controlled substance (CII) because it
`contains strong opioid pain medicine that can be a target for people who
`abuse prescription medicines or street drugs.
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`•
`
`It is not known if NUCYNTA® ER is safe and works in children less than 18
`years of age. NUCYNTA® ER should not be used in children.
`
`Who should not take NUCYNTA® ER?
`
`Do not take NUCYNTA® ER if you:
`
`• have trouble breathing or lung problems such as severe asthma, wheezing, or
`shortness of breath.
`• have a bowel blockage called paralytic ileus.
`•
`take a monoamine oxidase inhibitor (MAOI) medicine or have taken
`an MAOI medicine within the last 14 days. Ask your doctor or pharmacist
`if any of your medicines is a MAOI.
`• are allergic to tapentadol or any of the ingredients in NUCYNTA® ER. See the
`end of this Medication Guide for a complete list of ingredients in NUCYNTA®
`ER.
`
`
`What should I tell my doctor before taking NUCYNTA ER?
`
`NUCYNTA® ER may not be right for you.
`
`Before taking NUCYNTA® ER, tell your doctor if you:
`
`• have trouble breathing or lung problems such as asthma, wheezing, or
`shortness of breath
`• have had a head injury or a brain problem
`• have liver or kidney problems
`• have adrenal gland problems, such as Addison’s disease
`• have thyroid problems
`• have convulsions or seizures
`• have pancreas or gallbladder problems
`• have problems urinating or prostate problems
`• have constipation
`• have severe scoliosis that affects your breathing
`• have low blood pressure
`• have or had a drinking problem or alcoholism or a family history of this
`problem
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`• have mental problems including depression, anxiety, or hallucinations (seeing
`or hearing things that are not really there)
`• have or had drug abuse or addiction problems or a family history of this
`problem
`• plan to have surgery
`• are pregnant or plan to become pregnant.
`If you take NUCYNTA® ER right before your baby is born, your baby could
`have breathing problems.
`If you take NUCYNTA® ER regularly before your baby is born, your newborn
`baby may have withdrawal symptoms, because his/her body has become
`used to the medicine.
`
`Symptoms of withdrawal in a newborn baby may include:
`o
`irritability
`o crying more than usual
`o shaking (tremors)
`o
`jitteriness
`o breathing faster than normal
`o diarrhea or more stools than normal
`o vomiting
`o
`fever
`• are breastfeeding. You should not breastfeed while taking NUCYNTA® ER.
`Talk to your doctor about the best way to feed your baby if you take
`NUCYNTA® ER.
`
`Tell your doctor about all the medicines you take, including prescription and
`nonprescription medicines, vitamins, and herbal supplements. Some medicines may
`cause serious or life-threatening medical problems when taken with NUCYNTA® ER.
`Sometimes, the doses of certain other medicines and NUCYNTA® ER need to be
`changed.
`
`Especially tell your doctor if you take:
`
`• Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and
`Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants,
`tramadol, and triptan medicines. See “What are the possible side effects of
`NUCYNTA® ER?”
`• Other medicines that make you sleepy such as:
`
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`o other pain medicines
`o antidepressant medicines, including those listed above
`o sleeping pills
`o antihistamines
`o anti-anxiety medicines
`o muscle relaxants
`o anti-nausea medicines
`o
`tranquilizers
`
`Do not take NUCYNTA® ER if you take a monoamine oxidase inhibitor
`(MAOI) medicine. See "Who should not take NUCYNTA® ER?"
`Do not take any new medicine while using NUCYNTA® ER until you have talked to
`your doctor or pharmacist. They will tell you if it is safe to take other medicines while
`you are taking NUCYNTA® ER. Ask your doctor if you are not sure if your
`medicine is one of the listed above.
`
`Know the medicines you take. Keep a list of them to show your doctor and
`pharmacist when you get a new medicine.
`
`How should I take NUCYNTA® ER?
`
`• Take NUCYNTA® ER exactly as prescribed by your doctor. Do not
`change the dose unless your doctor tells you to.
`• Your doctor may change your dose after seeing how NUCYNTA® ER affects
`you.
`• You can take NUCYNTA® ER with or without food.
`• Swallow NUCYNTA® ER whole. You must take NUCYNTA® ER one tablet at
`a time, with enough water to make sure that you completely swallow the
`tablet right away. Do not soak, lick, or wet the tablet before putting it in your
`mouth.
`• Do not break, split, chew, dissolve, or crush NUCYNTA® ER tablets
`before swallowing, or inject the contents. If you cannot swallow tablets,
`tell your doctor. See “What is the most important information I should know
`about NUCYNTA® ER?”
`• If you miss a dose, take it as soon as possible. If it is almost time for your
`next dose, skip the missed dose and go back to your regular dosing schedule.
`Do not take 2 doses at the same time unless your doctor tells you to.
`If you are not sure about your dosing call your doctor.
`• If you take too much NUCYNTA® ER or overdose, get emergency help
`right away.
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`• Call your doctor if your pain is not well controlled while taking NUCYNTA® ER.
`• Follow your doctor’s instructions about how to slowly stop taking NUCYNTA®
`ER to help prevent uncomfortable withdrawal symptoms.
`
`What should I avoid while taking NUCYNTA® ER?
`
`• Do not drive, operate machinery, or do other dangerous activities,
`until you know how NUCYNTA® ER affects how alert you are. NUCYNTA® ER
`can make you sleepy.
`
`
`
`What are the possible side effects of NUCYNTA® ER?
`
`NUCYNTA® ER can cause serious side effects including:
`
`• Life-threatening breathing problems. Call your doctor right away or
`get emergency medical help if you:
`o have trouble breathing
`o have extreme drowsiness with slowed breathing
`o have shallow breathing (little chest movement with breathing)
`o
`feel faint, dizzy, confused, or have other unusual symptoms
`o have a seizure
`• Decreased blood pressure. This can make you feel dizzy and faint if you
`get up too fast from sitting or lying down. Low blood pressure is more likely
`to happen if you take other medicines that can also lower your blood
`pressure. Severe low blood pressure can happen if you lose blood or take
`certain other medicines.
`• Serotonin syndrome. Serotonin syndrome is a rare, life-threatening
`condition that could happen if you take NUCYNTA® ER with SSRIs, SNRIs,
`MAOIs, triptans, tricyclic antidepressants, tramadol, or certain other
`medicines. Serotonin syndrome can cause death. See “What should I tell my
`doctor before taking NUCYNTA® ER?”
`You or someone else should call your doctor or get medical help right away if
`you have any of these symptoms:
`o you feel agitated or restless, or have hallucinations
`o you pass out (become unconscious). Serotonin syndrome can cause
`you to go into coma
`o you have a fast heartbeat or feel overheated
`o you have heavy sweating that is not due to activity, or loss of
`coordination
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`You may have nausea, vomiting, or diarrhea with any of the symptoms listed
`above.
`• NUCYNTA® ER could cause seizures in people who are at risk for
`having seizures or who have epilepsy. If you have a seizure while
`taking NUCYNTA® ER, stop taking NUCYNTA® ER and call your doctor
`right away.
`• Physical Dependence. Do not stop taking NUCYNTA® ER or any other opioid
`without talking to your doctor. You could become sick with uncomfortable
`withdrawal symptoms because your body has become used to these
`medicines. Physical dependence is not the same as drug addiction.
`• There is a chance of abuse or addiction with NUCYNTA® ER. The chance
`is higher if you are, or have been addicted to or abused other medicines,
`street drugs, or alcohol, or if you have a history of mental problems.
`The most common side effects with NUCYNTA® ER are:
`
`• nausea
`
`•
`
`constipation
`
`• headache
`
`• dizziness
`
`•
`
`sleepiness
`
`Constipation (not enough or hard bowel movements) is a common side effect of pain
`medicines (opioids), including NUCYNTA® ER, and is unlikely to go away without
`treatment. Talk to your doctor about dietary change, and the use of laxatives
`(medicines to treat constipation) and stool softeners to prevent or treat constipation
`while taking NUCYNTA® ER.
`
`Talk to your 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 NUCYNTA® ER. For a complete list, 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 NUCYNTA® ER?
`
`• Keep NUCYNTA® ER in a safe place away from children.
`• Keep NUCYNTA® ER in the container it comes in.
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`• Store NUCYNTA ER between 68°F to 77°F (20°C to 25°C). Keep NUCYNTA ER
`tablets dry.
`• After you stop taking NUCYNTA® ER, flush the unused tablets down
`the toilet.
`
`General information about NUCYNTA® ER
`
`Medicines are sometimes prescribed for purposes other than those listed in a
`Medication Guide. Do not use NUCYNTA® ER for a condition for which it was not
`prescribed. Do not give NUCYNTA® ER to other people, even if they have the same
`symptoms you have. It may harm them and even cause death. Sharing NUCYNTA®
`ER is against the law.
`
`This Medication Guide summarizes the most important information about NUCYNTA®
`ER. If you would like more information, talk with your doctor. You can ask your
`doctor or pharmacist for information about NUCYNTA® ER that is written for
`healthcare professionals. For more information about NUCYNTA® ER call 1-800-526-
`7736 or go to www.NUCYNTAERREMS.com.
`
`What are the ingredients in NUCYNTA® ER?
`
`Active Ingredient: tapentadol HCl
`
`Inactive ingredients: polyethylene oxide, hypromellose, polyethylene glycol and
`alpha-tocopherol (vitamin E).
`
`The film coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol,
`talc, and the colorant FD&C Blue #2 aluminum lake is used for 100-, 150-, 200-, and
`250-mg strengths; and additionally, yellow iron oxide is used in 150-mg tablets.
`
`Printing inks for all strengths contain shellac glaze and propylene glycol. The 50,
`100, 150, and 200 mg tablet printing ink also contains black iron oxide. The 250 mg
`tablet printing ink also contains titanium dioxide.
`
`This Medication Guide has been approved by the U.S. Food and Drug Administration.
`
`Manufactured by:
`Janssen Ortho, LLC
`Gurabo, PR 00778
`
`Manufactured for:
`Janssen Pharmaceuticals, Inc.
`Titusville, NJ 08560
`
`
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`Issued: August 2011
`
`© Janssen Pharmaceuticals, Inc. 2011
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`APPENDIX 2
`
`DEAR HEALTHCARE PROFESSIONAL LETTER
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`15
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`
`
`Important Drug Warning
`Risk of potential abuse, misuse, overdose, and addiction for NUCYNTA® ER
`(tapentadol) extended-release oral tablets C-II
`
`[Date]
`
`Dear Healthcare Professional:
`
`Janssen Pharmaceuticals, Inc. is introducing NUCYNTA® ER, an extended-release
`formulation of tapentadol indicated for the management of moderate to severe chronic
`pain in adults when a continuous, around-the-clock opioid analgesic is needed for an
`extended period of time.
`
`NUCYNTA® ER has a Risk Evaluation and Mitigation Strategy (REMS) to educate
`prescribers about the potential abuse, misuse, overdose and addiction from exposure to
`NUCYNTA® ER. The Food and Drug Administration (FDA) determined that a REMS
`was necessary for NUCYNTA® ER to ensure that the benefits of the drug outweigh the
`risks.
`
`Prior to prescribing NUCYNTA® ER, prescribers are encouraged to review the
`NUCYNTA® ER Healthcare Professional Educational Program and complete the
`NUCYNTA® ER Education Confirmation Form.
`
`You may complete and submit the NUCYNTA® ER Education Confirmation Form
`electronically at www.NUCYNTAERREMS.com or fax the completed form to Janssen
`Pharmaceuticals, Inc. at 1-800-282-7832. A confirmation of receipt will be emailed or
`faxed to you.
`
`The goals of the REMS for NUCYNTA® ER are:
`• Goal 1: To inform patients and healthcare professionals about the potential for
`abuse, misuse, overdose, and addiction to NUCYNTA® ER
`• Goal 2: To inform patients and healthcare professionals about the safe use of
`NUCYNTA® ER
`
`
`NUCYNTA® ER contains tapentadol, a mu-opioid agonist and a Schedule II controlled
`substance with an abuse liability similar to other opioid analgesics. NUCYNTA® ER can
`be abused in a manner similar to other opioid agonists, legal or illicit. These risks should
`be considered when prescribing or dispensing NUCYNTA® ER in situations where the
`prescribing healthcare professional or dispensing pharmacist is concerned about an
`increased risk of misuse, abuse, or diversion.
`
`NUCYNTA® ER is contraindicated in:
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`• Patients who have impaired pulmonary function such as significant respiratory
`depression, acute or severe bronchial asthma or hypercapnia in unmonitored
`settings or the absence of resuscitative equipment.
`• Patients who have or are suspected of having paralytic ileus
`• Patients who are receiving monoamine oxidase (MAO) inhibitors or the use of
`MAO inhibitors within the last 14 days
`• Patients with a known hypersensitivity to the active substance, tapentadol, or any
`component of the product.
`
`
`NUCYNTA® ER is NOT intended for use as an as needed analgesic.
`
`NUCYNTA® ER is NOT indicated for the management of acute or post operative pain.
`
`Serious adverse reactions which may be associated with NUCYNTA® ER therapy in
`clinical use are those observed with opioid analgesics, including respiratory depression,
`impaired mental and physical abilities, seizures and additive CNS depressive effects
`when used in conjunction with alcohol, other opioids, or illicit drugs. The most common
`adverse events (≥10%) were nausea, dizziness, constipation, headache and somnolence.
`
`The co-administration of alcohol with NUCYNTA ER may result in increased serum
`levels and a potentially fatal overdose of tapentadol. Patients must not consume alcoholic
`beverages while using NUCYNTA® ER.
`
`Refer to the full prescribing information, with boxed warning for detailed safety
`information
`
`Prescribing and Dispensing
`Refer to the full prescribing information for detailed prescribing and dispensing information.
`
`Selection of patients for treatment with NUCYNTA® ER is governed by the same
`principles that apply to the use of similar opioid analgesics. Physicians should
`individualize treatment in every case, using non-opioid analgesics, opioids on an as
`needed basis and/or combination products, and chronic opioid therapy in a progressive
`plan of pain management such as outlined by the World Health Organization and
`Federation of State Medical Boards Model Guidelines.
`
`When prescribing and dispensing opioid products, such as NUCYNTA® ER, healthcare
`professionals should adopt behaviors that decrease the likelihood of abuse and misuse of
`the opioid product. Examples of these behaviors include proper assessment of the patient,
`periodic re-evaluation of therapy, proper dispensing, and correct storage, handling and
`disposal of the opioid drug. Also, healthcare professionals are advised to keep careful
`record-keeping of prescribing information, including quantity, frequency, and renewal
`requests.
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`The starting dose of NUCYNTA® ER in patients currently not taking opioid analgesics is
`50 mg twice a day (approximately every 12 hours). Individually titrate the dose within
`the therapeutic range of 100 mg to 250 mg twice daily. Titrate patients to adequate
`analgesia with dose increases of 50 mg no more than twice daily every 3 days. The
`maximum allowed daily dose of NUCYNTA® ER is 250 mg twice daily (500 mg as a
`total daily dose).
`
`There are no adequate data on the direct conversions from other opioids to
`NUCYNTA® ER. The initial dose of NUCYNTA® ER in patients previously taking other
`opioids is 50 mg twice daily, titrated to an effective and tolerable dose within the
`therapeutic range of 100 mg to 250 mg twice daily. Do not exceed a total daily dose of
`NUCYNTA® ER of 500 mg.
`
`Patients receiving NUCYNTA® (immediate release formulation) may be converted to
`NUCYNTA® ER by using the equivalent total daily dose of NUCYNTA® and dividing it
`into two equal doses separated by approximately 12 hour intervals.
`
`Pain relief and adverse reactions should be frequently assessed. In clinical practice,
`titration of the total daily dose of NUCYNTA® ER should be based upon the amount of
`supplemental opioid utilization, severity of the patient’s pain, and patient’s ability to
`tolerate NUCYNTA® ER. Patients should be titrated to a dose proving a meaningful
`improvement of pain with acceptable tolerability.
`
`When discontinuing NUCYNTA® ER, potential withdrawal symptoms may be reduced
`by tapering the dose of NUCYNTA® ER.
`
`Safe Administration
`Refer to the full prescribing information for detailed safety information
`
`NUCYNTA® ER tablets are to be swallowed whole, one at a time, and are not to be split,
`broken, chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or
`crushed NUCYNTA® ER tablets could lead to rapid release and absorption of a
`potentially fatal dose of tapentadol. Patients should not pre-soak, lick or otherwise wet
`the tablet prior to placing into their mouth. Tablets must be taken one at a time with
`enough water to ensure complete swallowing immediately after placing in their mouth.
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`Abuse and Dependence
`Refer to the full prescribing information for detailed safety information
`
`Abuse may occur by taking intact tablets without legitimate purpose, by crushing or
`snorting the crushed formulation or by injecting a solution from the crushed formulation.
`The risk of fatal overdose is further increased when tapentadol is abused concurrently
`with alcohol or other CNS depressants, including other opioids.
`
`Patient Counseling
`Patients should be counseled about the importance of storing opioid analgesics including
`NUCYNTA® ER, safely and out of the reach of children, other household members,
`visitors and pets.
`
`Patients should be instructed against use by individuals other than the patient, for whom
`it was prescribed, as such inappropriate use may have severe medical consequences,
`including death.
`
`You are strongly advised to discuss the risk associated with NUCYNTA® ER with your
`patients and/or their caregivers and encourage them to read the Medication Guide. This
`Medication Guide contains important information on the safe and effective use of
`NUCYNTA® ER. The NUCYNTA® ER Medication Guide should be provided to patients
`each time NUCYNTA® ER is dispensed.
`
`Medication Guide
`
`Enclosed with this letter, you will find the NUCYNTA® ER Medication Guide.
`Pharmacists and other healthcare professionals who dispense NUCYNTA® ER have a
`responsibility to provide a Medication Guide directly to each patient or caregiver with
`each prescription according to Federal law 21 CFR 208.24(e). Additional copies of the
`NUCYNTA® ER Medication Guide
`are
`available
`by
`download
`from
`www.NUCYNTAERREMS.com, by contacting our Customer Communications Center at
`1-800-526-7736 or by asking your NUCYNTA® ER representative.
`
`Education Materials
`Also enclosed, you will find a copy of the Prescribing NUCYNTA® ER Healthcare
`Professional Education Program: A Guide for Healthcare Professionals Who Intend to
`Prescribe NUCYNTA® ER, which contains information about the appropriate use of
`NUCYNTA® ER and information that can be shared when you counsel patients or their
`caregivers on the appropriate use, possible risks, and safe storage of NUCYNTA® ER.
`The Education Program also includes information on:
`• General opioid risks
`• Appropriate patient selection
`• Appropriate dosing and administration
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`• Possible side effects and safety risks
`• Risks associated with concomitant drug and alcohol use
`• How to identify drug abuse and patients at risk for addiction
`• Recommendations for the security and safe storage of the medication
`
`Other Education Program materials include the Prescribing Information, Medication
`Guide, and Education Confirmation Form. We strongly recommend that you read the
`Education Program materials before prescribing NUCYNTA® ER.
`
`You can find the Education Program and other helpful information on our website:
`www.NUCYNTAERREMS.com.
`
`Adverse Event Reporting
`
`Prescribers should report all adverse events associated with the use of NUCYNTA® ER to
`Janssen Pharmaceuticals, Inc. at 1-800-526-7736.
`
`If you have any questions about NUCYNTA® ER including any information found in this
`letter, the Full Prescribing Information and Medication Guide for NUCYNTA® ER, and
`the NUCYNTA® ER Education Program, please call our Customer Communications
`Center at 1-800-526-7736.
`
`Sincerely,
`
`Paul Chang, MD
`Vice President Medical Affairs
`Internal Medicine
`
`
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`APPENDIX 3
`
`PRESCRIBING NUCYNTA® ER HEALTHCARE PROFESSIONAL EDUCATION
`PROGRAM: A GUIDE FOR HEALTHCARE PROFESSIONALS WHO INTEND
`TO PRESCRIBE NUCYNTA® ER
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`NUCYNTA® ER Healthcare Professional Education Program: A Guide for
`Healthcare Professionals Who Intend to Prescribe NUCYNTA® ER
`
`
`
`WARNING: POTENTIAL FOR ABUSE, PROPER PATIENT SELECTION AND
`LIMITATIONS OF USE
`
`Potential for Abuse
`
`NUCYNTA® ER contains tapentadol, a mu-opioid agonist and a Schedule II
`controlled substance with an abuse liability similar to other opioid analgesics.
`
`NUCYNTA® ER can be abused in a manner similar to other opioid agonists, legal or
`illicit. These risks should be considered when prescribing, or dispensing
`NUCYNTA® ER in situations where the physician or pharmacist is concerned about
`an increased risk of misuse, abuse, or diversion. Schedule II opioid substances which
`include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone, and
`methadone have the highest potential for abuse and risk of fatal overdose due to
`respiratory depression.
`
`Proper Patient Selection
`
`NUCYNTA® ER is an extended-release formulation of tapentadol indicated for the
`management of moderate to severe chronic pain in adults when a continuous,
`around-the-clock opioid analgesic is needed for an extended period of time.
`
`Limitations of Use
`
`NUCYNTA® ER is not intended for use as an as-needed analgesic.
`
`NUCYNTA® ER is not indicated for the management of acute or postoperative pain.
`
`NUCYNTA® ER tablets are to be swallowed whole and are not to be split, broken,
`chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or crushed
`NUCYNTA® ER tablets could lead to rapid release and absorption of a potentially
`fatal dose of tapentadol.
`
`Patients must not consume alcoholic beverages, prescription or non-prescription
`medications containing alcohol. Co-ingestion of alcohol with NUCYNTA® ER may
`result in a potentially fatal overdose of tapentadol.
`
`
`
`To find this and other information about NUCYNTA® ER, please go to our website:
`www.NUCYNTAERREMS.com.
`
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`Janssen Pharmaceuticals, Inc. is dedicated to providing you with the most up-to-date
`knowledge about our products; if you have any questions about NUCYNTA® ER
`including information found in the Full Prescribing Information and Medication Guide
`for NUCYNTA® ER, and/or this Education Program, please call our Customer
`Communications Center at 1-800-526-7736.
`
`
`
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`Reference ID: 3006589
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