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NUCYNTA® ER NUCYNTA®
NUCYNTA® Savings Card

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Patients pay no more than $25 for their prescription co-pay*

NUCYNTA® ER NUCYNTA®

*Some restrictions apply. See eligibility criteria on Savings Card.

NUCYNTA® ER is an opioid agonist indicated for the management of:

  • • Moderate to severe chronic pain in adults.

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults.

When a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

NUCYNTA® ER is not intended for: • Use as an as-needed (prn) analgesic. • For pain that is mild or not expected to persist for an extended period of time. • For acute pain. • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery, or it the postoperative pain is expected to be severe and persist for an extended period of time.

NUCYNTA® ER IMPORTANT SAFETY INFORMATION

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL

Abuse Potential

NUCYNTA® ER contains tapentadol, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing NUCYNTA® ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving NUCYNTA® ER for signs of misuse, abuse, and addiction during treatment.

Life-threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of NUCYNTA® ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential, and NUCYNTA® ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole. Crushing, dissolving, or chewing NUCYNTA® ER can cause rapid release and absorption of a potentially fatal dose of tapentadol.

Accidental Exposure

Accidental ingestion of NUCYNTA® ER, especially in children, can result in a fatal overdose of tapentadol.

Interaction With Alcohol

The co-ingestion of alcohol with NUCYNTA® ER may result in an increase of plasma levels and potentially fatal overdose of tapentadol. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while on NUCYNTA® ER.

  • 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 agonists/antagonists (e.g., butorphanol, nalbuphine, pentazocine) and partial agonists (e.g., buprenorphine) are used in patients who have received or are receiving NUCYNTA® ER. Avoid the use of mixed agonists/antagonists and partial agonists with NUCYNTA® ER.
  • 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® ER 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® ER in patients with severe hepatic impairment (Child-Pugh Score 10-15); reduce the dose in patients with moderate impairment (Child-Pugh Score 7-9); and monitor for respiratory and CNS depression when initiating and titrating NUCYNTA® ER.

 

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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