forward to a collegeForward to a Colleague
Home>NUCYNTA®>Healthcare Professional Resources>Healthcare Professional FAQs

Healthcare Professional FAQs

How does NUCYNTA® work to relieve pain?

Tapentadol is a centrally acting synthetic analgesic. Although the exact mechanism is unknown, analgesic efficacy is thought to be due to mu-opioid agonist activity and the inhibition of norepinephrine reuptake.

Return to top

Are there equianalgesic dose conversions of NUCYNTA®  to other mu-opioid agonists?

In Phase II and III clinical studies, active controls were used to validate the sensitivity of a variety of pain models and to assess the true difference in treatment effect between tapentadol and placebo. These studies did not employ a crossover design to ensure patients served as their own control, so equianalgesic conversions could not be made.

Return to top

Can NUCYNTA® be taken on an empty stomach?

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

Return to top

How quickly will NUCYNTA® work to relieve pain?

In a postoperative pain study of 602 patients, NUCYNTA® was shown to demonstrate median time to confirmed perceptible pain relief in as early as 32 to 46 minutes after it was taken. Dosing needs to be individualized and individual results may vary.1

Return to top

How do I successfully titrate NUCYNTA® in my patients with moderate to severe acute pain?

As with many centrally acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs, and the ability to monitor the patient. The dose for NUCYNTA® is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending on pain intensity. If there is inadequate relief with the initial dose on the first day of dosing, the second dose may be administered as soon as 1 hour after the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Higher dosages may be used if adequate relief is not achieved, up to a maximum of 700 mg on Day 1 and 600 mg on subsequent days.

Return to top

Is it safe for patients to consume alcohol while taking NUCYNTA®?

Patients should be advised to avoid alcohol while taking NUCYNTA®, as the combination may lead to additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma, or death may result if alcohol is taken in combination with NUCYNTA®. Additionally, patients should be cautioned that 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.

Return to top

Can I prescribe NUCYNTA® with a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI)?

The development of potentially life-threatening serotonin syndrome may occur when NUCYNTA® is used with serotonergic drugs, including SSRIs, TCAs, MAOIs, and triptans, and with drugs that impair metabolism of serotonin (including MAOIs). Serotonin syndrome may occur within the recommended dose.

Return to top

What are the contraindications associated with NUCYNTA®?

  • Impaired pulmonary function (significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment)
  • Paralytic ileus
  • Concomitant use with monoamine oxidase inhibitors (MAOI) or use within 14 days
Return to top

Can NUCYNTA® be used in opioid-allergic patients?

The risk of an allergic reaction cannot be excluded with NUCYNTA®.

Return to top

Can NUCYNTA® be abused?

NUCYNTA® can be abused in a manner similar to other opioid agonists, legal or illicit, by crushing, chewing, snorting, or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help limit the abuse of drugs with mu-opioid agonist properties.

Return to top

What adverse events can occur while taking NUCYNTA®?

NUCYNTA® was extensively evaluated in multiple pain models. Click here to see a list of selected adverse events that occurred in clinical trials in greater than or equal to 5% of the patients.

The most common adverse events (≥10% in any NUCYNTA® dose group) are nausea, dizziness, vomiting and somnolence. For adverse events reported by ≥1% of NUCYNTA®-treated patients, please see Table 1 in the Adverse Reactions section in the full Prescribing Information.

Return to top

Should I monitor my patients who take NUCYNTA® for cardiovascular side effects?

NUCYNTA® had no relevant effect on ECG parameters (heart rate, PR interval, QRS duration, T-wave, or U-wave morphology). There was no effect of therapeutic and supratherapeutic doses of NUCYNTA® on the QT interval. In a randomized, double-blind, placebo- and positive-controlled crossover study, healthy subjects were administered 5 consecutive doses of NUCYNTA® 100 mg every 6 hours, NUCYNTA® 150 mg every 6 hours, placebo, and a single oral dose of moxifloxacin. As always, treatment needs to be individualized according to the patient’s needs.

Return to top

Is it safe to prescribe NUCYNTA® to patients under the age of 18?

The safety and effectiveness of NUCYNTA® in pediatric patients younger than 18 years of age have not been established. Therefore, NUCYNTA® is not recommended in this population.

Return to top

Is there a way to make NUCYNTA® more affordable for my patients?

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

Return to top

How can I order a formulary dossier for NUCYNTA®?

You can receive the NUCYNTA® dossier by contacting the Medical Information Center at
1-800-JANSSEN (Monday-Friday, 9 AM-5 PM ET).

Return to top

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®, visit www.nucynta.com and use the pharmacy search engine to locate a local participating pharmacy in the United States (and Puerto Rico). 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®.

Return to top

Is NUCYNTA® available on a Patient Assistance Program (PAP)?

Yes, NUCYNTA® is available on a Patient Assistance Program. Patients or providers should call 1-800-652-6227 to request the application. The application is also available on www.access2wellness.com.

Return to top

 

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.
Reference:
  1. 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.
Click here to go to Nucynta Section Click here to go to Nucynta-ER Section