NUCYNTA® ER: Healthcare Professional FAQs

Dosing/Administration

Are there conversion ratios for switching from other mu-opioid agonists to NUCYNTA® ER?

There are no established conversion ratios for conversion from other opioids to NUCYNTA® ER defined by clinical trials. Discontinue all other around-the-clock opioids drugs when NUCYNTA® ER therapy is initiated.

In general, as with other opioid analgesics, begin with half of the estimated daily tapentadol requirement as the initial dose, managing inadequate analgesia by supplementation with immediate‐release rescue medication, with the exception of tramadol and tapentadol products. The maximum total daily dose of NUCYNTA® ER is 500 mg. Do not exceed this limit.

As always, treatment should be individualized for the patient, and you should use your best clinical judgment in dosing and titration decisions. Dosing considerations for a patient should include prior analgesic treatment experience and risk factors for addiction, abuse, and misuse. Titrate as needed to provide adequate analgesia and minimize adverse reactions.

Although the pivotal chronic low back pain trial was not designed to establish equianalgesic doses, it was designed with a dose ratio of 5:1 for NUCYNTA® ER to oxycodone CR, meaning that NUCYNTA® ER 100 mg to 250 mg and oxycodone CR 20 mg to 50 mg were studied.1

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Can NUCYNTA® ER be taken on an empty stomach?

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

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

No, patients must not consume alcoholic beverages or prescription or nonprescription products containing alcohol while on NUCYNTA® ER therapy. The co-ingestion of alcohol with NUCYNTA® ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol. NUCYNTA® ER may be expected to have additive effects when used in conjunction with alcohol that causes central nervous system (CNS) depression, because respiratory depression, hypotension, hypertension, and profound sedation, coma, or death may result. Assess each patient's risk for opioid abuse or addiction prior to prescribing NUCYNTA® ER and monitor regularly for development of these behaviors or conditions.

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How do I titrate a patient’s NUCYNTA® ER dosage?

Individually titrate NUCYNTA® ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving NUCYNTA® ER to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitor for the development of addiction, abuse, or misuse. Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every 3 days. In clinical studies, efficacy with NUCYNTA® ER was demonstrated relative to placebo in the dosage range of 100 mg to 250 mg twice daily. If the level of pain increases, attempt to identify the source of increased pain while adjusting the NUCYNTA® ER dose to decrease the level of pain. Patients who experience breakthrough pain may require a dose increase of NUCYNTA® ER or may need rescue medication with an appropriate dose of an immediate-release analgesic, with the exception of all other tapentadol and tramadol products.

Click here to view and/or download the NUCYNTA® ER Dosing and Titration Guide. Dosing should be individualized according to the severity of pain being treated.

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Can I use NUCYNTA® and NUCYNTA® ER together?

The full Prescribing Information states that all other tapentadol and tramadol products be discontinued in patients who are starting or currently receiving NUCYNTA® ER. Patients should not take NUCYNTA® and NUCYNTA® ER simultaneously.

Should you wish to convert a patient from NUCYNTA® to NUCYNTA® ER, please refer to the question below: "How do I convert patients from NUCYNTA® to NUCYNTA® ER?"

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How do I convert patients from NUCYNTA® to NUCYNTA® ER?

Patients can be converted from NUCYNTA® to NUCYNTA® ER using the equivalent total daily dose of NUCYNTA® and dividing it into 2 equal doses of NUCYNTA® ER, separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg NUCYNTA® 4 times per day (200 mg/day) may be converted to 100 mg NUCYNTA® ER twice a day. This was demonstrated in a clinical study in which patients with moderate to severe low back pain receiving NUCYNTA® immediate-release tablets every 4 to 6 hours were switched to an approximately equivalent total daily dose of NUCYNTA® ER tablets, and vice versa during the crossover period. The results of the study showed equivalent efficacy and similar tolerability.2

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Is there a therapeutic dose range for NUCYNTA® ER?

The therapeutic dose range for NUCYNTA® ER is 100 mg to 250 mg twice daily (approximately every 12 hours).

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Why is 500 mg of NUCYNTA® ER the highest daily dose?

Total daily doses greater than 500 mg of NUCYNTA® ER have not been studied, and therefore, a dose of 500 mg should not be exceeded. The NUCYNTA® ER maintenance dose is 100 mg to 250 mg twice daily (approximately every 12 hours). See below for the dosing recommendations for patients with moderate to severe hepatic impairment.

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What are the dosing recommendations in moderate and severe hepatic impairment?

In clinical studies with NUCYNTA® ER, patients were excluded if they had moderate to severe hepatic impairment, or AST or ALT greater than 3 times the upper limit of normal.1,3,4

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; therefore, tapentadol should be used with caution in patients with moderate hepatic impairment. According to the Hepatic Impairment section of the NUCYNTA® ER full Prescribing Information, patients with moderate hepatic impairment (Child-Pugh Score 7 to 9) should be initiated using 50 mg of NUCYNTA® ER administered no more than once every 24 hours. The maximum recommended dose for patients with moderate hepatic impairment is 100 mg of NUCYNTA® ER per day.

Use of NUCYNTA® ER in patients with severe hepatic impairment (Child-Pugh Score 10 to 15) is not recommended.

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Does NUCYNTA® ER last 12 hours? Is it true twice-daily (bid) dosing?

According to the full Prescribing Information, NUCYNTA® ER should be dosed twice daily approximately every 12 hours. NUCYNTA® ER was approved by the FDA based on clinical trials that demonstrated efficacy using 100 mg to 250 mg twice daily.

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Contraindications

What are the contraindications associated with NUCYNTA® ER?

  • Patients with significant respiratory depression.
  • Patients with acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment.
  • Patients with known or suspected paralytic ileus.
  • Patients with hypersensitivity (eg, anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product.
  • 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.
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Can NUCYNTA® ER and acetaminophen be given concomitantly?

Studies were not conducted to specifically evaluate the safety of the concomitant use of NUCYNTA® ER and acetaminophen. Acetaminophen was permitted at certain points during clinical studies with NUCYNTA® ER.1,3,4 According to the full Prescribing Information for NUCYNTA® ER, acetaminophen was included in a set of interaction studies and there were no clinically significant findings. NUCYNTA® ER does not contain any acetaminophen in its formulation.

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Is it safe for a patient to take a selective serotonin reuptake inhibitor (SSRI), serotonin norepinephrine reuptake inhibitor (SNRI), or anti-epileptic drug (AED) concomitantly with NUCYNTA® ER?

There have been post-marketing reports of serotonin syndrome with the concomitant 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, and drugs that impair metabolism of serotonin. This may occur within the recommended dose. If concomitant treatment with these drugs is clinically warranted, careful observation of the patient is advised particularly during treatment initiation and dose increases.

According to the NUCYNTA® ER prescribing information, concomitant use of SSRIs, SNRIs, AEDs, and triptans with NUCYNTA® ER are not contraindicated (see Contraindications section of the NUCYNTA® ER full Prescribing Information).

Concomitant use of AEDs, SSRIs, and/or SNRIs was allowed in NUCYNTA® ER Phase 3 trials: for example, during the Chronic Low Back Pain and DPN Pain Studies, subjects taking SSRIs were eligible to participate if they were receiving a stable dose of medication for a certain length of time.1,3,4 However, use of SNRIs and AEDs was prohibited in efficacy trials to avoid interference with the efficacy outcome.1,3,4 Subjects taking SSRIs, SNRIs, and AEDs were able to participate in a long-term safety study of up to 52 weeks if they were also receiving a stable dose of medication at least 30 days prior to screening.5

NOTE: Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) and can be fatal.

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Adverse Events

What adverse events were reported during clinical trials with NUCYNTA® ER?

NUCYNTA® ER 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 subjects.

In pooled safety data from clinical studies in chronic low back pain or osteoarthritis, the most common adverse reactions (reported by ≥10% of NUCYNTA® ER-treated subjects) were nausea, constipation, dizziness, headache, and somnolence. In pooled safety data from clinical studies in neuropathic pain associated with diabetic peripheral neuropathy, the most commonly reported adverse reactions (≥10% in NUCYNTA® ER-treated subjects) were nausea, constipation, vomiting, dizziness, somnolence, and headache. For adverse reactions reported by ≥1% of NUCYNTA® ER-treated subjects and greater than placebo-treated subjects, please see Tables 1 and 2 in the Adverse Reactions section in the full Prescribing Information. For complete information on adverse events, please see full Prescribing Information.

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Treatment With NUCYNTA® ER

What are the indications for NUCYNTA® ER?

NUCYNTA® ER (tapentadol) is indicated for the management of:

  • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Usage

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve NUCYNTA® ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • NUCYNTA® ER is not indicated as an as-needed (prn) analgesic.
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How does NUCYNTA® ER work to relieve pain?

Tapentadol is a centrally acting synthetic analgesic; the exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical animal studies have shown that tapentadol is a mu-opioid receptor agonist, as well as a norepinephrine reuptake inhibitor.

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Can stopping treatment with NUCYNTA® ER result in withdrawal symptoms?

Yes, as with other opioid analgesics, withdrawal symptoms may occur.

NUCYNTA® ER should be discontinued with gradual downward titration to prevent signs and symptoms of withdrawal in the physically-dependent patient.

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In the withdrawal analysis for NUCYNTA® ER, how long were patients on therapy before they discontinued?

The opioid withdrawal data are from 9 pooled Phase 2 and Phase 3 studies. There was no analysis performed on the pooled Phase 2 and Phase 3 studies to look at how long patients were on therapy before they discontinued. The longest trial was a safety study that lasted up to 1 year.5

In these studies, patients taking NUCYNTA® ER who stopped abruptly without initiating alternative opioid therapy were assessed for withdrawal symptoms between 2 to 4 days after discontinuation using the Clinical Opiate Withdrawal Scale (COWS).4

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Patient Resources

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

Yes. With the NUCYNTA® ER/NUCYNTA® Pay No More Than $25 Savings Card, patients with commercial insurance may be eligible to pay no more than $25* for their monthly prescription co-pay of NUCYNTA® ER. The Savings Card is easy for patients to use and makes the monthly cost of NUCYNTA® ER affordable, putting it on par with medications that have Tier 2 health plan status.

*The Savings Card is valid for up to 14 prescriptions (not to exceed 12 uses at the same dose) with a maximum annual benefit of $1,400 per year. Not valid for individuals enrolled in Medicare, such as Medicare Part D, or Medicaid. See full eligibility criteria and restrictions on the Savings Card.

NUCYNTA® ER/NUCYNTA® Pay No More Than $25 Savings Cards are available here.

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

Yes, NUCYNTA® ER is available via the Patient Assistance Program. Patients and/or providers should call 1-800-652-6227 to request an application, or visit www.jjpaf.org for more information.

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Physician Tools

How can I order a formulary dossier for NUCYNTA® ER?

You can receive the NUCYNTA® ER dossier by contacting the Medical Information Center at 1-800-JANSSEN (1-800-526-7736) (Monday - Friday, 9 AM - 5 PM ET).

You can also access the NUCYNTA® ER dossier on www.janssenmd.com

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NUCYNTA® ER (tapentadol) is indicated for the management of:

  • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Usage

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve NUCYNTA® ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

  • NUCYNTA® ER is not indicated as an as-needed (prn) analgesic.

NUCYNTA® ER IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL

Addiction, Abuse, and Misuse: NUCYNTA® ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing NUCYNTA® ER, and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTA® ER. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole; crushing, chewing, or dissolving NUCYNTA® ER tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol.

Accidental Ingestion: Accidental ingestion of even one dose of NUCYNTA® ER, especially by children, can result in a fatal overdose of tapentadol.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of NUCYNTA® ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Interaction With Alcohol: Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking NUCYNTA® ER. The co-ingestion of alcohol with NUCYNTA® ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol.

  • After abrupt discontinuation or a significant dose reduction of NUCYNTA® ER in physically dependent patients. When discontinuing NUCYNTA® ER, gradually taper the dose.
  • If mixed agonist/antagonist (e.g., butorphanol, nalbuphine, pentazocine) and partial agonist (e.g., buprenorphine) analgesics are used in patients who have received or are receiving NUCYNTA® ER. Avoid use with mixed agonists/antagonists and partial agonists.
  • If opioid antagonists (e.g., naloxone, nalmefene) are administered in physically dependent patients. Administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

 

NUCYNTA® (tapentadol) is indicated for the management of moderate to severe acute pain in adults.

NUCYNTA® IMPORTANT SAFETY INFORMATION

Contraindications: Significant respiratory depression; acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity to tapentadol or to any other ingredients of the product; concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.

  • After abrupt discontinuation or a significant dose reduction of NUCYNTA® in physically dependent patients. When discontinuing NUCYNTA®, gradually taper the dose.
  • If mixed agonists/antagonists (e.g., butorphanol, nalbuphine, pentazocine) and partial agonists (e.g., buprenorphine) are used in patients who have received or are receiving NUCYNTA®. Avoid the use of mixed agonists/antagonists and partial agonists with NUCYNTA®.
  • If opioid antagonists (e.g., naloxone, nalmefene) are administered in physically dependent patients. Administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
  • Renal: Use of NUCYNTA® in patients with severe renal impairment (CLCR <30 mL/min) is not recommended due to accumulation of a metabolite formed by glucuronidation of tapentadol. The clinical relevance of the elevated metabolite is not known.
  • Hepatic: Avoid use of NUCYNTA® in patients with severe hepatic impairment (Child-Pugh Score 10-15); reduce the dose in patients with moderate impairment (Child-Pugh Score 7-9).

Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients in the lower range of recommended doses.

 

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Please see full Prescribing Information for NUCYNTA®.

References:
  1. Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study. Expert Opin Pharmacother. 2010;11(11):1787-1804.
  2. Etropolski MS, Okamoto A, Shapiro DY, Rauschkolb C. Dose conversion between tapentadol immediate and extended release for low back pain. Pain Physician. 2010;13:61-70.
  3. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011;27(1):151-162.
  4. Data on file. Johnson & Johnson Pharmaceutical Research & Development, LLC.
  5. Wild JE, Grond S, Kuperwasser B, et al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010;10(5):416-427.