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Counseling FAQs

Patients with moderate to severe acute pain who are receiving opioids may have questions regarding their treatment. Below is a sampling of potential questions and answers you may want to use when counseling your patients who are prescribed NUCYNTA®. This series of questions and answers may not provide the specific information you are looking for. If this is the case, please see the full Prescribing Information and Medication Guide for more information.You may also contact the Medical Information Center at 1-800-JANSSEN (Monday-Friday, 9 am-5 pm ET).

What is NUCYNTA®?

NUCYNTA® is a prescription medicine that is used in adults 18 years of age or older to treat moderate to severe acute pain.

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What are opioids?

Opioids are medications prescribed to relieve moderate to severe pain associated with surgery or trauma. Opioids affect the way we feel pain and enable us to better tolerate it by interfering with, and blocking, pain messages in the body. The human body produces its own natural opioids, called endorphins, as part of its survival response to danger and/or injury. Since opioids are designed to work in the same manner as endorphins, they tend to work well in blocking pain. NUCYNTA® is one type of opioid.1

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Is there a way to make NUCYNTA® more affordable?

Yes, there is a savings card program available for NUCYNTA®. With this savings card, available at www.nucynta.com, you will pay no more than $25 for your NUCYNTA® prescription, with a maximum benefit amount of $100. Your savings card is valid for up to 3 prescriptions per calendar year. Some restrictions apply. See Eligibility Criteria on the savings card. Additional patient assistance programs can be found on www.access2wellness.com.

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Where can I find NUCYNTA®?

NUCYNTA® should be available at most pharmacies. However, if you are experiencing difficulty locating a pharmacy that can fill a prescription for NUCYNTA®, you can visit www.nucynta.com and use the pharmacy search engine to locate a local participating pharmacy in the United States (and Puerto Rico). Not all pharmacies may be identified. Contact your local pharmacy for availability. Please be advised that not all retail pharmacies participate in this locator service. Please call ahead to your pharmacy to confirm the availability of NUCYNTA®.

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How do I take NUCYNTA®?

Do not take NUCYNTA® unless it has been prescribed for you by your healthcare professional. NUCYNTA® can be taken with or without food. Take NUCYNTA® exactly as prescribed by your healthcare professional. Do not change the dose of NUCYNTA® unless your healthcare professional tells you to. Your healthcare professional may change your dose after seeing how the medicine affects you. Do not use NUCYNTA® more often than prescribed. Call your healthcare professional if your pain is not well controlled while taking NUCYNTA®. Follow your healthcare professional’s instructions about how to slowly stop taking NUCYNTA® to help lessen withdrawal symptoms.

Remember to tell your healthcare professional about any other medications, prescribed or over-the-counter, that you may be taking. If you have taken opioids in the past and had side effects, be sure to discuss this with your healthcare professional.

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How quickly will NUCYNTA® work to relieve my pain?

In a clinical trial, most people reported pain relief from NUCYNTA® in as early as 32 to 46 minutes after they had taken their first tablet. Dosing needs to be individualized and individual results may vary.2

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Does NUCYNTA® have an effect on my EKG?

In a clinical trial, NUCYNTA® had no relevant effect on EKG parameters (heart rate, PR interval, QRS duration, and T-wave or U-wave morphology). If you have a history of cardiovascular disease, please discuss it with your healthcare professional.

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What are the possible side effects of NUCYNTA®?

NUCYNTA® can cause serious side effects, including

  • Life-threatening breathing problems. Call your doctor right away or get emergency medical help if you:
    • have trouble breathing, or have slow or shallow breathing
    • have a slow heartbeat
    • have severe sleepiness
    • have cold, clammy skin
    • feel faint, dizzy, confused, or can not think, walk or talk normally
    • have a seizure
    • have hallucinations
  • Physical Dependence. NUCYNTA® can cause physical dependence. Talk to your doctor about slowly stopping NUCYNTA® to avoid getting sick with withdrawal symptoms. You could become sick with uncomfortable symptoms because your body has become used to the medicine. Tell your doctor if you have any of these symptoms of withdrawal: feeling anxious, sweating, sleep problems, shivering, pain, nausea, tremors, diarrhea, upper respiratory symptoms, hallucinations, hair “standing on end.” Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction.
  • Serotonin syndrome. Serotonin syndrome is a rare, life-threatening problem that could happen if you take NUCYNTA® with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans or certain other medicines. Call your doctor or get medical help right away if you have any one or more of these symptoms: you feel agitated, have hallucinations, coma, rapid heart beat, feel overheated, loss of coordination, overactive reflexes, nausea, vomiting, or diarrhea.
  • Seizures. NUCYNTA® can cause seizures in people who are at risk for seizures or who have epilepsy. Tell your doctor right away if you have a seizure and stop taking NUCYNTA®.
  • Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.
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What are the most common side effects of NUCYNTA®?

The most common side effects with NUCYNTA® are nausea, dizziness, vomiting, sleepiness, and itching. Constipation is a common side effect of opioid medicines. Talk to your healthcare professional about the use of laxatives and stool softeners to prevent or treat constipation while taking NUCYNTA®. Tell your healthcare professional about any side effect that bothers you or that does not go away. These are not all the possible side effects of NUCYNTA®. For a complete list, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects. You may report side effects to the US Food and Drug Administration (FDA) at 1-800-FDA-1088.

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Can I take NUCYNTA® on an empty stomach?

Yes, NUCYNTA® may be taken with or without food.

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Is it safe for me to drink alcohol while taking NUCYNTA®?

You should not drink alcohol while using NUCYNTA®. Alcohol increases your chance of having dangerous side effects.

Additionally, NUCYNTA® combined with alcohol may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery.

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If I am taking other medications, such as antidepressants, and received a prescription for NUCYNTA®, should I be concerned?

Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using NUCYNTA® with other medicines can cause serious side effects. The doses of some other medicines may need to be changed. Your healthcare professional can tell you what medicines can be safely taken with NUCYNTA®. Especially tell your healthcare professional if you take:

  • Monoamine oxidase inhibitors (MAOIs)
  • Any medicine that makes you sleepy. NUCYNTA® can make you sleepy and affect your breathing. Taking these medicines together can be dangerous.
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Should I be worried about becoming addicted to, or dependent on, NUCYNTA®?

All opioids carry some risk of addiction/dependence. However, concerns about abuse and addiction should not prevent the proper management of pain. NUCYNTA® can cause physical dependence. Talk with your healthcare professional about slowly stopping NUCYNTA® to avoid getting sick with withdrawal symptoms (eg, feeling anxious, sweating, sleep problems, nausea, diarrhea). Physical dependence is not the same as drug addiction. Your healthcare professional can tell you more about the differences between physical dependence and drug addiction.

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Can I drive while taking NUCYNTA®?

Do not drive, operate machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. Remember, NUCYNTA® can make you sleepy.

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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 IMPORTANT SAFETY INFORMATION

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 intended 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, or prescription or nonprescription medications containing alcohol. Co-ingestion of alcohol with NUCYNTA® ER may result in a potentially fatal overdose of tapentadol.


CONTRAINDICATIONS

  • NUCYNTA® ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment.
  • NUCYNTA® ER is contraindicated in any patient who has or is suspected of having a paralytic ileus.
  • NUCYNTA® ER is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have taken them within the last 14 days due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.
  • NUCYNTA® ER is contraindicated in patients with a known hypersensitivity to the active substance, tapentadol, or any component of the product. Angioedema has been reported in association with use of tapentadol.

WARNINGS and PRECAUTIONS

  • NUCYNTA® ER tablets are to be swallowed whole and are not to be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, crushed, or dissolved NUCYNTA® ER tablets leads to the rapid release and absorption of a potentially fatal dose of tapentadol.
  • NUCYNTA® ER tablets must be kept in a secure place out of the reach of children. Accidental consumption of NUCYNTA® ER, especially in children, can result in a fatal overdose of tapentadol.
  • Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
  • Use NUCYNTA® ER with caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve, such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA® ER may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non–mu-opioid agonist analgesics should be considered, and NUCYNTA® ER should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.
  • Patients receiving other opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, centrally acting muscle relaxants, or other CNS depressants (including alcohol) concomitantly with NUCYNTA® ER may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma, or death may result if these drugs are taken in combination with NUCYNTA® ER. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.
  • Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA® ER should not be used in patients who may be susceptible to the effects of raised cerebrospinal fluid pressure, such as those with evidence of head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA® ER should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.
  • Tapentadol is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty.
  • Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
  • NUCYNTA® ER can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addiction, since use of mu-opioid agonist analgesic products carries the risk of addiction even under appropriate medical use.
  • Drug abusers may attempt to abuse NUCYNTA® ER by crushing, chewing, snorting, or injecting the product. These practices may result in the uncontrolled delivery of NUCYNTA® ER and pose a significant risk to the abuser that could result in overdose and death.
  • NUCYNTA® ER may cause severe hypotension. Patients at higher risk of hypotension include those with hypovolemia or those taking concurrent products that compromise vasomotor tone (eg, phenothiazines, general anesthetics).
  • Patients should be cautioned that NUCYNTA® ER may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected, especially at the beginning of treatment, at any change of dosage, as well as in combination with alcohol or tranquilizers.
  • NUCYNTA® ER may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause CNS depression, because respiratory depression, hypotension, hypertension, and profound sedation, coma, or death may result.
  • NUCYNTA® ER has not been evaluated in patients with a predisposition to a seizure disorder, and such patients were excluded from clinical studies. As with other opioids, NUCYNTA® ER should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.
  • Cases of life-threatening serotonin syndrome have been reported with the concurrent use of tapentadol and serotonergic drugs. Serotonergic drugs comprise selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, drugs that affect the serotonergic neurotransmitter system (eg, mirtazapine, trazodone, and tramadol), and drugs that impair metabolism of serotonin (including MAOIs). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination) and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea), and can be fatal.
  • Withdrawal symptoms may occur if NUCYNTA® ER is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA® ER.
  • A study with the immediate-release formulation of tapentadol in subjects with hepatic impairment showed higher serum concentrations of tapentadol than in those with normal hepatic function. Tapentadol should be used with caution in patients with moderate hepatic impairment.
  • NUCYNTA® ER has not been studied in patients with severe hepatic impairment, and use in this population is not recommended.
  • Like other drugs with mu-opioid agonist activity, NUCYNTA® ER may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
  • NUCYNTA® ER should be used with caution in the following conditions: adrenocortical insufficiency (eg, Addison's disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis.
  • Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA® ER in pregnant women. NUCYNTA® ER should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus.

ADVERSE REACTIONS

  • The most common (≥10%) adverse reactions were nausea, constipation, headache, dizziness, and somnolence.

For the relief of moderate to severe acute pain in patients 18 years of age
or older

NUCYNTA® IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Like other drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment. NUCYNTA® is contraindicated in patients who have or are suspected to have paralytic ileus. NUCYNTA® is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOIs) due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

WARNINGS & PRECAUTIONS

  • Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. NUCYNTA® should be administered with caution to the elderly, debilitated patients, and patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA® may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-mu-opioid agonist analgesics should be considered and NUCYNTA® should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.
  • Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with NUCYNTA® may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma or death may result if these drugs are taken in combination with NUCYNTA®. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.
  • Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA® should not be used in patients susceptible to the effects of raised cerebrospinal fluid pressure such as those with head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA® should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.
  • NUCYNTA® is a mu-opioid agonist and is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty. NUCYNTA® can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing NUCYNTA® in situations where the physician or pharmacist is concerned about an increased risk of misuse and abuse. All patients treated with mu-opioid agonists require careful monitoring for signs of abuse and addiction. NUCYNTA® may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death.
  • Experience with NUCYNTA® overdose is very limited. Management of overdose should be focused on treating symptoms of mu-opioid agonism. Primary attention should be given to reestablishment of a patent airway and institution of assisted or controlled ventilation when overdose of NUCYNTA® is suspected. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
  • Patients should be cautioned that NUCYNTA® may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This is to be expected especially at the beginning of treatment, at any change of dosage as well as in combination with alcohol or tranquilizers.
  • NUCYNTA® has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. NUCYNTA® should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.
  • The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including NUCYNTA® , particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination) and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).
  • Withdrawal symptoms may occur if NUCYNTA® is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA®.
  • Pregnancy Category C. There are no adequate and well-controlled studies of NUCYNTA® in pregnant women. NUCYNTA® should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the fetus. NUCYNTA® is not recommended for use in women during and immediately prior to labor and delivery. Neonates whose mothers have been taking NUCYNTA® should be monitored for respiratory depression. NUCYNTA® should not be used during breastfeeding.
  • NUCYNTA® is not recommended in patients with severe renal or hepatic impairment. NUCYNTA® should be used with caution in patients with moderate hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA® may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.

ADVERSE REACTIONS

  • The most common adverse events are nausea, dizziness, vomiting, somnolence and headache.
References:
  1. American Pain Foundation. Treatment options: a guide for people living with pain. http://www.painfoundation.org/learn/publications/files/TreatmentOptions2006.pdf. Accessed July 7, 2010.
  2. Daniels SE, Upmalis D, Okamoto A, Lange C, Häeussler J. A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin. 2009;25(3):765-776.
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