NUCYNTA ER- tapentadol hydrochloride tablet, film coated, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TAPENTADOL HYDROCHLORIDE (UNII: 71204KII53) (TAPENTADOL - UNII:H8A007M585)

थमां उपलब्ध:

Collegium Pharmaceutical, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

NUCYNTA ER (tapentadol) is indicated for the management of: - Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. - Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)] , 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. NUCYNTA ER is contraindicated in patients with: - Significant respiratory depression - Acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment - Known or suspected gastrointestinal obstruction, including paralytic ileus - Hypersensitivity (e.g., anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product [see Adverse Reactions (6.2)] . - Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Drug Interactions (7)]. Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. Available data with NUCYNTA ER are insufficient to inform a drug- associated risk for major birth defects and miscarriage or adverse maternal outcomes. In animal reproduction studies, embryofetal mortality and structural malformations were observed with subcutaneous administration of tapentadol during organogenesis to rabbits and delays in skeletal maturation were observed in rats at exposures equivalent to and less than the maximum recommended human dose (MRHD), respectively. When administered to pregnant rats during organogenesis and through lactation, increased pup mortality was noted following oral tapentadol exposures to doses equivalent to the MRHD [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse reaction. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psychophysiological effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. NUCYNTA ER is not recommended for use in pregnant women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including NUCYNTA ER, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Tapentadol HCl was evaluated for teratogenic effects in pregnant rats and rabbits following intravenous and subcutaneous exposure during the period of embryofetal organogenesis. When tapentadol was administered twice daily by the subcutaneous route in rats at dose levels of 10, 20, or 40 mg/kg/day [producing up to 1.36 times the plasma exposure at the maximum recommended human dose (MRHD) of 500 mg/day for NUCYNTA ER based on an area under the time-curve (AUC) comparison], no teratogenic effects were observed. Evidence of embryofetal toxicity included transient delays in skeletal maturation (i.e., reduced ossification) at the 40 mg/kg/day dose which was associated with significant maternal toxicity. Administration of tapentadol HCl in rabbits at doses of 4, 10, or 24 mg/kg/day by subcutaneous injection [producing 0.3, 0.8, and 2.5 times the plasma exposure at the MRHD based on an AUC comparison, respectively] revealed embryofetal toxicity at doses ≥10 mg/kg/day. Findings included reduced fetal viability, skeletal delays and other variations. In addition, there were multiple malformations including gastroschisis/thoracogastroschisis, amelia/phocomelia, and cleft palate at doses ≥10 mg/kg/day and above, and ablepharia, encephalopathy, and spina bifida at the high dose of 24 mg/kg/day. Embryofetal toxicity, including malformations, may be secondary to the significant maternal toxicity observed in the study. In a study of pre- and postnatal development in rats, oral administration of tapentadol at doses of 20, 50, 150, or 300 mg/kg/day to pregnant and lactating rats during the late gestation and early postnatal period [resulting in up to 2.28 times the plasma exposure at the MRHD on an AUC basis] did not influence physical or reflex development, the outcome of neurobehavioral tests or reproductive parameters. At maternal tapentadol doses ≥150 mg/kg/day, a dose-related increase in pup mortality was observed to postnatal Day 4. Treatment-related developmental delay was observed in the dead pups, including incomplete ossification. In addition, significant reductions in pup body weights and body weight gains at doses associated with maternal toxicity (150 mg/kg/day and above) were seen throughout lactation. Risk Summary There is insufficient/limited information on the excretion of tapentadol in human or animal breast milk. Physicochemical and available pharmacodynamic/toxicological data on tapentadol point to excretion in breast milk and risk to the breastfeeding child cannot be excluded. Because of the potential for serious adverse reactions including excess sedation and respiratory depression in a breastfed infant, advise patients that breast feeding is not recommended during treatment with NUCYNTA ER. Clinical Considerations Monitor infants exposed to NUCYNTA ER through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2), Nonclinical Toxicology (13.1)] . The safety and efficacy of NUCYNTA ER in pediatric patients less than 18 years of age have not been established. Of the total number of patients in Phase 2/3 double-blind, multiple-dose clinical studies of NUCYNTA ER, 28% (1023/3613) were 65 years and over, while 7% (245/3613) were 75 years and over. No overall differences in effectiveness or tolerability were observed between these patients and younger patients. Elderly patients (aged 65 or older) may have increased sensitivity to tapentadol. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)] . Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of NUCYNTA ER slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.8)] . Tapentadol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. 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), dosage reduction of NUCYNTA ER is recommended [see Dosage and Administration (2.5)]. No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see Warnings and Precautions (5.16), Clinical Pharmacology (12.3)] . Use of NUCYNTA ER in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) is not recommended. No dosage adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30-90 mL/minute) [see Warnings and Precautions (5.17), Clinical Pharmacology (12.3)] . NUCYNTA ER contains tapentadol, a Schedule II controlled substance. NUCYNTA ER contains tapentadol, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.1)]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of NUCYNTA ER increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of NUCYNTA ER with alcohol and/or other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of NUCYNTA ER abuse include those with a history of prolonged use of any opioid, including products containing tapentadol, those with a history of drug or alcohol abuse, or those who use NUCYNTA ER in combination with other abused drugs. "Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. NUCYNTA ER, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of NUCYNTA ER Abuse of NUCYNTA ER poses a risk of overdose and death. This risk is increased with the concurrent use of NUCYNTA ER with alcohol and/or other CNS depressants [see Warnings and Precautions (5.1, 5.3), Drug Interactions (7)] . NUCYNTA ER is approved for oral use only. With parenteral abuse, the inactive ingredients in NUCYNTA ER can result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis and valvular heart injury, embolism and death. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Do not abruptly discontinue NUCYNTA ER in a patient physically dependent on opioids. Rapid tapering of NUCYNTA ER in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing NUCYNTA ER, gradually taper the dosage using a patient-specific plan that considers the following: the dose of NUCYNTA ER the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see Dosage and Administration (2.6), Warnings and Precautions (5.3)] . Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)] .

उत्पाद समीक्षा:

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 24510-058-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-058-01). 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 24510-116-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-116-01). 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 24510-174-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-174-01). 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 24510-232-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-232-01). 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 24510-291-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-291-01). Storage and Handling Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15° C - 30°C (59° F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store NUCYNTA ER securely and dispose of properly.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

Collegium Pharmaceutical, Inc.
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MEDICATION GUIDE
NUCYNTA® ER (NEW-SINN-TAH E-R) (TAPENTADOL) EXTENDED-RELEASE ORAL
TABLETS, CII
This Medication Guide has been approved by the U.S. Food
and Drug Administration
NUCX-012-C.4 Revised: 12/2023
NUCYNTA ER is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
severe and persistent pain in adults that requires an extended
treatment period with a daily opioid
pain medicine, when other pain medicines do not treat your pain well
enough or you cannot
tolerate them.
•
Also used in adults to manage severe and persistent pain from damaged
nerves (neuropathic pain)
that happens with diabetes, and that requires an extended treatment
period with a daily opioid
pain medicine, when other pain medicines do not treat your pain well
enough or you cannot
tolerate them.
•
A long-acting (extended-release) opioid pain medicine that can put you
at risk for overdose and
death. Even if you take your dose correctly as prescribed you are at
risk for opioid addiction,
abuse, and misuse that can lead to death.
•
Not to be taken on an "as needed" basis.
Important information about NUCYNTA ER:
•
Get emergency help or call 911 right away if you take too much NUCYNTA
ER (overdose).
When you first start taking NUCYNTA ER, when your dose is changed, or
if you take too much
(overdose), serious or life-threatening breathing problems that can
lead to death may occur. Talk
to your healthcare provider about naloxone, a medicine for the
emergency treatment of an opioid
overdose.
•
Taking NUCYNTA ER with other opioid medicines, benzodiazepines,
alcohol, or other central
nervous system depressants (including street drugs) can cause severe
drowsiness, decreased
awareness, breathing problems, coma, and death.
•
Never give anyone else your NUCYNTA ER. They could die from taking it.
Selling or giving
away NUCYNTA ER is against the law.
•
Store NUCYNTA ER securely, out of sight and reach of children, and in
a location not accessible
by others,

उत्पाद विशेषताएं

NUCYNTA ER- TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
COLLEGIUM PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUCYNTA ER SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NUCYNTA ER
NUCYNTA ER (TAPENTADOL) EXTENDED-RELEASE TABLETS FOR ORAL USE C-II
INITIAL U.S. APPROVAL: 2008
WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF NUCYNTA ER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
NUCYNTA ER EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD
TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK BEFORE PRESCRIBING
AND REASSESS
REGULARLY FOR DEVELOPMENT OF THESE BEHAVIORS OR CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR,
ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF
RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF NUCYNTA ER ARE ESSENTIAL.
INSTRUCT
PATIENTS TO SWALLOW NUCYNTA ER TABLETS WHOLE TO AVOID EXPOSURE TO A
POTENTIALLY
FATAL DOSE OF TAPENTADOL. (2.1, 5.2)
ACCIDENTAL INGESTION OF NUCYNTA ER, ESPECIALLY IN CHILDREN, CAN RESULT
IN FATAL
OVERDOSE OF TAPENTADOL. (5.2)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE
TAKING NUCYNTA ER BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA
TAPENTADOL
LEVELS. (5.3)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE
IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. (5.3, 7)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME,
WHICH MAY
BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT
MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY. (5.4)
HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COM