NUCYNTA ER (tapentadol extended-release tablets) Fact Sheet

Transcription

1 NUCYNTA ER (tapentadl extended-release tablets) Fact Sheet What is NUCYNTA ER (prnunced 'new-sinn-tah')? NUCYNTA ER (tapentadl extended-release tablets), an ral analgesic taken twice daily, is nw apprved by the U.S. Fd and Drug Administratin (FDA) fr the management f mderate t severe chrnic pain in adults when a cntinuus, arund-the-clck piid analgesic is needed fr an extended perid f time. NUCYNTA ER is available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg dses by prescriptin nly. NUCYNTA ER has demnstrated prven efficacy in mderate t severe chrnic pain mdels. The New Drug Applicatin (NDA) fr NUCYNTA ER is based n data frm duble-blind, randmized, active- and/r placeb-cntrlled Phase 3 studies that evaluated the efficacy and safety f NUCYNTA ER fr the treatment f mderate t severe chrnic lw back pain and painful diabetic peripheral neurpathy (DPN). In additin t the Phase 3 studies n chrnic lw back pain and painful diabetic peripheral neurpathy, safety was als evaluated in mre than 1,100 patients with mderate t severe chrnic pain ver a 1-year perid. NUCYNTA ER demnstrated: A favrable tlerability prfile. Favrable discntinuatin rates. That its mst cmmn ( 10%) adverse events were nausea, cnstipatin, headache, dizziness, and smnlence. Additinal Infrmatin abut NUCYNTA ER T help ensure the risks f NUCYNTA ER are cmmunicated accurately, Janssen Pharmaceuticals has develped a Risk Evaluatin and Mitigatin Strategy (REMS) fr the medicatin, in cllabratin with the FDA. This REMS, which is in line with similar prgrams fr ther medicines in this categry, educates prescribers abut the ptentials fr abuse, misuse, verdse and addictin frm expsure t NUCYNTA ER. T supplement the REMS, Janssen Pharmaceuticals als utilizes surveillance methdlgies t mnitr fr inapprpriate use f its prducts. The U.S. Drug Enfrcement Agency has placed NUCYNTA ER int Schedule II f the Cntrlled Substances Act. 1

2 Janssen Pharmaceuticals, Inc. markets NUCYNTA ER in the United States. IMPORTANT SAFETY INFORMATION WARNING: POTENTIAL FOR ABUSE, PROPER PATIENT SELECTION, AND LIMITATIONS OF USE Ptential fr Abuse NUCYNTA ER cntains tapentadl, a mu-piid agnist and a Schedule II cntrlled substance with an abuse liability similar t ther piid analgesics. NUCYNTA ER can be abused in a manner similar t ther piid agnists, legal r illicit. These risks shuld be cnsidered when prescribing r dispensing NUCYNTA ER in situatins where the physician r pharmacist is cncerned abut an increased risk f misuse, abuse, r diversin. Schedule II piid substances, which include hydrmrphne, mrphine, xycdne, fentanyl, xymrphne, and methadne, have the highest ptential fr abuse and risk f fatal verdse due t respiratry depressin. Prper Patient Selectin NUCYNTA ER is an extended-release frmulatin f tapentadl indicated fr the management f mderate t severe chrnic pain in adults when a cntinuus, arund-theclck piid analgesic is needed fr an extended perid f time. Limitatins f Use NUCYNTA ER is nt intended fr use as an as-needed analgesic. NUCYNTA ER is nt intended fr the management f acute r pstperative pain. NUCYNTA ER tablets are t be swallwed whle and are nt t be split, brken, chewed, disslved, r crushed. Taking split, brken, chewed, disslved, r crushed NUCYNTA ER tablets culd lead t rapid release and absrptin f a ptentially fatal dse f tapentadl. Patients must nt cnsume alchlic beverages, r prescriptin r nnprescriptin medicatins cntaining alchl. C-ingestin f alchl with NUCYNTA ER may result in a ptentially fatal verdse f tapentadl. CONTRAINDICATIONS NUCYNTA ER is cntraindicated in patients with significant respiratry depressin, acute r severe brnchial asthma r hypercapnia in unmnitred settings r in the absence f resuscitative equipment. NUCYNTA ER is cntraindicated in any patient wh has r is suspected f having a paralytic ileus. NUCYNTA ER is cntraindicated in patients wh are receiving mnamine xidase inhibitrs (MAOIs) r wh have taken them within the last 14 days due t ptential additive effects n nrepinephrine levels, which may result in adverse cardivascular events. 2

3 NUCYNTA ER is cntraindicated in patients with a knwn hypersensitivity t the active substance, tapentadl, r any cmpnent f the prduct. Angiedema has been reprted in assciatin with use f tapentadl. WARNINGS and PRECAUTIONS NUCYNTA ER tablets are t be swallwed whle and are nt t be split, brken, chewed, disslved, r crushed. Taking split, brken, chewed, crushed, r disslved NUCYNTA ER tablets leads t the rapid release and absrptin f a ptentially fatal dse f tapentadl. NUCYNTA ER tablets must be kept in a secure place ut f the reach f children. Accidental cnsumptin f NUCYNTA ER, especially in children, can result in a fatal verdse f tapentadl. Respiratry depressin is the primary risk f mu-piid agnists. Respiratry depressin ccurs mre frequently in elderly r debilitated patients and in thse suffering frm cnditins accmpanied by hypxia, hypercapnia, r upper airway bstructin, in whm even mderate therapeutic dses may significantly decrease pulmnary ventilatin. Use NUCYNTA ER with cautin in patients with cnditins accmpanied by hypxia, hypercapnia, r decreased respiratry reserve, such as: asthma, chrnic bstructive pulmnary disease r cr pulmnale, severe besity, sleep apnea syndrme, myxedema, kyphsclisis, central nervus system (CNS) depressin, r cma. In such patients, even usual therapeutic dses f NUCYNTA ER may increase airway resistance and decrease respiratry drive t the pint f apnea. Alternative nn mu-piid agnist analgesics shuld be cnsidered, and NUCYNTA ER shuld be emplyed nly under careful medical supervisin at the lwest effective dse in such patients. If respiratry depressin ccurs, it shuld be treated as any mu-piid agnist-induced respiratry depressin. Patients receiving ther piid agnist analgesics, general anesthetics, phenthiazines, ther tranquilizers, sedatives, hypntics, centrally acting muscle relaxants, r ther CNS depressants (including alchl) cncmitantly with NUCYNTA ER may exhibit additive CNS depressin. Interactive effects resulting in respiratry depressin, hyptensin, prfund sedatin, cma, r death may result if these drugs are taken in cmbinatin with NUCYNTA ER. When such cmbined therapy is cntemplated, a dse reductin f ne r bth agents shuld be cnsidered. Opiid analgesics can raise cerebrspinal fluid pressure as a result f respiratry depressin with carbn dixide retentin. Therefre, NUCYNTA ER shuld nt be used in patients wh may be susceptible t the effects f raised cerebrspinal fluid pressure, such as thse with evidence f head injury and increased intracranial pressure. Opiid analgesics may bscure the clinical curse f patients with head injury due t effects n pupillary respnse and cnsciusness. NUCYNTA ER shuld be used with cautin in patients with head injury, intracranial lesins, r ther surces f preexisting increased intracranial pressure. 3

4 Tapentadl is a mu-piid agnist and is a Schedule II cntrlled substance. Such drugs are sught by drug abusers and peple with addictin disrders. Diversin f Schedule II prducts is an act subject t criminal penalty. Patients shuld be assessed fr their clinical risks fr piid abuse r addictin prir t being prescribed piids. NUCYNTA ER can be abused in a manner similar t ther piid agnists, legal r illicit. This shuld be cnsidered when prescribing r dispensing NUCYNTA ER in situatins where the physician r pharmacist is cncerned abut an increased risk f misuse and abuse. Cncerns abut abuse and addictin shuld nt prevent the prper management f pain. Hwever, all patients treated with mu-piid agnists require careful mnitring fr signs f abuse and addictin, since use f mu-piid agnist analgesic prducts carries the risk f addictin even under apprpriate medical use. Drug abusers may attempt t abuse NUCYNTA ER by crushing, chewing, snrting, r injecting the prduct. These practices may result in the uncntrlled delivery f NUCYNTA ER and pse a significant risk t the abuser that culd result in verdse and death. NUCYNTA ER may cause severe hyptensin. Patients at higher risk f hyptensin include thse with hypvlemia r thse taking cncurrent prducts that cmprmise vasmtr tne (eg, phenthiazines, general anesthetics). Patients shuld be cautined that NUCYNTA ER may impair the mental and/r physical abilities required fr the perfrmance f ptentially hazardus tasks such as driving a car r perating machinery. This is t be expected, especially at the beginning f treatment, at any change f dsage, as well as in cmbinatin with alchl r tranquilizers. NUCYNTA ER may be expected t have additive effects when used in cnjunctin with alchl, ther piids, r illicit drugs that cause CNS depressin, because respiratry depressin, hyptensin, hypertensin, and prfund sedatin, cma, r death may result. NUCYNTA ER has nt been evaluated in patients with a predispsitin t a seizure disrder, and such patients were excluded frm clinical studies. As with ther piids, NUCYNTA ER shuld be prescribed with care in patients with a histry f a seizure disrder r any cnditin that wuld put the patient at risk f seizures. Cases f life-threatening sertnin syndrme have been reprted with the cncurrent use f tapentadl and sertnergic drugs. Sertnergic drugs cmprise selective sertnin reuptake inhibitrs (SSRIs), sertnin and nrepinephrine reuptake inhibitrs (SNRIs), tricyclic antidepressants (TCAs), triptans, drugs that affect the sertnergic neurtransmitter system (eg, mirtazapine, trazdne, and tramadl), and drugs that impair metablism f sertnin (including MAOIs). This may ccur within the recmmended dse. Sertnin syndrme may include mental-status changes (eg, agitatin, hallucinatins, cma), autnmic instability (eg, tachycardia, labile bld pressure, hyperthermia), neurmuscular aberratins (eg, hyperreflexia, 4

5 incrdinatin) and/r gastrintestinal symptms (eg, nausea, vmiting, diarrhea), and can be fatal. Withdrawal symptms may ccur if NUCYNTA ER is discntinued abruptly. These symptms may include: anxiety, sweating, insmnia, rigrs, pain, nausea, tremrs, diarrhea, upper respiratry symptms, pilerectin, and rarely, hallucinatins. Withdrawal symptms may be reduced by tapering NUCYNTA ER. A study with the immediate-release frmulatin f tapentadl in subjects with hepatic impairment shwed higher serum cncentratins f tapentadl than in thse with nrmal hepatic functin. Tapentadl shuld be used with cautin in patients with mderate hepatic impairment. NUCYNTA ER has nt been studied in patients with severe hepatic impairment, and use in this ppulatin is nt recmmended. Like ther drugs with mu-piid agnist activity, NUCYNTA ER may cause spasm f the sphincter f Oddi and shuld be used with cautin in patients with biliary tract disease, including acute pancreatitis. NUCYNTA ER shuld be used with cautin in the fllwing cnditins: adrencrtical insufficiency (eg, Addisn's disease); delirium tremens; myxedema r hypthyridism; prstatic hypertrphy r urethral stricture; and txic psychsis. Pregnancy Categry C. There are n adequate and well-cntrlled studies f NUCYNTA ER in pregnant wmen. NUCYNTA ER shuld be used during pregnancy ONLY if the ptential benefit justifies the ptential risk t the fetus. ADVERSE REACTIONS The mst cmmn ( 10%) adverse reactins were nausea, cnstipatin, headache, dizziness, and smnlence. ### 5