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Nucynta ER

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Nucynta ER

Indications
Dosage
How Supplied

INDICATIONS

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., non-opioid 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.

DOSAGE AND ADMINISTRATION

Initial Dosing

NUCYNTA® ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with NUCYNTA® ER [see WARNINGS AND PRECAUTIONS].

NUCYNTA® ER tablets must be taken whole. Crushing, chewing, or dissolving NUCYNTA® ER tablets will result in uncontrolled delivery of tapentadol and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].

NUCYNTA® ER is administered at a frequency of twice daily (every 12 hours).

Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA® ER [see WARNINGS AND PRECAUTIONS]. Although the maximum approved total daily dose of NUCYNTAR® immediate-release formulation is 600 mg per day, the maximum total daily dose of NUCYNTA® ER is 500 mg. Do not exceed a total daily dose of NUCYNTA® ER of 500 mg.

Use of NUCYNTA® ER as the First Opioid Analgesic

Initiate treatment with NUCYNTA® ER with the 50 mg tablet orally twice daily (approximately every 12 hours).

Use of NUCYNTA® ER in Patients who are not Opioid Tolerant

The starting dose for patients who are not opioid tolerant is NUCYNTA® ER 50 mg orally twice daily (approximately every 12 hours). Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day or an equianalgesic dose of another opioid.

Conversion from NUCYNTAR® to NUCYNTA® ER

Patients can be converted from NUCYNTAR® to NUCYNTA® ER using the equivalent total daily dose of NUCYNTAR® and dividing it into two equal doses of NUCYNTA® ER separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg of NUCYNTAR® four times per day (200 mg/day) may be converted to 100 mg NUCYNTA® ER twice a day.

Conversion from Other Opioids to NUCYNTA® ER

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

While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient's 24-hour oral tapentadol requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral tapentadol requirements which could result in adverse reactions.

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.

Conversion from Methadone to NUCYNTA® ER

Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long halflife and can accumulate in the plasma.

Titration And Maintenance Of Therapy

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 monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.

Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every three 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 [see Clinical Studies].

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. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the NUCYNTA® ER dose.

If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation Of NUCYNTA® ER

When the patient no longer requires therapy with NUCYNTAR® ER tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.

Patients With Hepatic Impairment

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

In patients with moderate hepatic impairment (Child-Pugh Score 7 to 9), initiate treatment using 50 mg NUCYNTA® ER and administer no more frequently than once every 24 hours. The maximum recommended dose for patients with moderate hepatic impairment is 100 mg of NUCYNTA® ER per day [see CLINICAL PHARMACOLOGY].

No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Patients With Renal Impairment

No dosage adjustment is recommended in patients with mild or moderate renal impairment. Use of NUCYNTA® ER in patients with severe renal impairment is not recommended [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Elderly Patients

In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses [see CLINICAL PHARMACOLOGY].

Administration Of NUCYNTA® ER

Instruct patients to swallow NUCYNTA® ER tablets whole. The tablets are not to be cut, crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of tapentadol [see WARNINGS AND PRECAUTIONS].

Instruct patients to take NUCYNTA® ER one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms And Strengths

NUCYNTA® ER 50 mg, 100 mg, 150 mg, 200 mg and 250 mg extended-release tablets are available in the following colors and prints:

  • 50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side
  • 100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side
  • 150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side
  • 200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and a black print “OMJ 200” on one side
  • 250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and a white print “OMJ 250” on one side.

NUCYNTA® ER tablets are available in the following strengths and packages:

50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-860-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-860-02).

100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-861-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-861-02).

150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-862-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-862-02).

200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print “OMJ 200” on one side, and are available in bottles of 60 with child-resistant closure (NDC 50458- 863-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-863-02).

250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print “OMJ 250” on one side, and are available in bottles of 60 with child-resistant closure (NDC 50458- 864-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-864-02).

Storage And Handling

Store up to 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Protect from moisture.

Keep NUCYNTA® ER in a secure place out of reach of children.

NUCYNTA® ER tablets that are no longer needed should be destroyed by flushing down the toilet.

Manufactured by: Janssen Ortho, LLC, Gurabo, PR 00778. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Revised: April 2014

Last reviewed on RxList: 12/2/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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