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Summer 2010 - The British Pain Society

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Breakthrough Cancer <strong>Pain</strong> (BTcP)*<br />

Fast relief<br />

as early as<br />

10 minutes 1<br />

UK PRESCRIBING INFORMATION:<br />

Effentora ® ▼ 100 micrograms, 200 micrograms, 400 micrograms,<br />

600 micrograms, 800 micrograms fentanyl buccal tablet (fentanyl)<br />

Please refer to Summary of Product Characteristics (SmPC) before prescribing.<br />

Presentation: Effentora buccal tablet containing 100 micrograms, 200<br />

micrograms,400micrograms,600microgramsand800microgramsfentanyl.<br />

Indications:Treatmentofbreakthroughpain(BTP)inadultswithcancerwho<br />

are already receiving maintenance opioid therapy for chronic cancer pain.<br />

Patients receiving maintenance opioid therapy are taking at least: 60 mg<br />

oforalmorphinedaily,or25microgramsoftransdermalfentanylperhour,<br />

or 30 mg of oxycodone daily, or 8 mg of oral hydromorphone daily or an<br />

equianalgesic dose of another opioid for a week or longer. Dosage and<br />

Administration:SeeSmPCforfullinformation.Method:Placetheentiretablet<br />

inthebuccalcavity(nearamolarbetweenthecheekandgum).Alternatively,<br />

sublingually(seesection5.2ofSmPC).Retainwithinthebuccalcavitylong<br />

enoughforthetablettodisintegrate.Swallowanyremnantswithwaterafter<br />

30minutes.Adult:Treatmentundertheguidanceofaphysicianexperienced<br />

inthemanagementofopioidtherapyincancerpatients.Beawareofpotential<br />

abuseoffentanyl.Individuallytitratetoan“effective”doseprovidingadequate<br />

analgesia,minimisingundesirableeffects.<strong>The</strong>requireddosemayincrease<br />

over time due to progression of the underlying cancer disease. A second<br />

doseofthesamestrengthmaybetakenifrequired.Afterasecondtablet,<br />

wait4hoursbeforetakinganother.Ifaseconddoseistakenseveraltimes<br />

in a row, consider adjusting maintenance dose. Children and adolescents:<br />

Notrecommendedforuseinpatientsbelow18yearsofage.Elderly:Patients<br />

over65tendtoneedalowerdose.Hepaticandrenalimpairment:Cautionin<br />

patientswithmoderatetoseverehepaticorrenalimpairment.Seesection4.4<br />

ofSmPCformoreinformation.Xerostomia:Drinkwatertomoistenthebuccal<br />

cavitypriortoadministrationofEffentora.Ifstillinadequatedisintegration,<br />

switchtherapy. Contraindications:Hypersensitivitytotheactivesubstance<br />

ortoanyoftheexcipients.Treatmentofacutepainotherthanbreakthrough<br />

pain. Patients not on maintenance opioid therapy (see SmPC section 4.1).<br />

Severe respiratory depression or severe obstructive lung conditions.<br />

Building Confidence in BTcP Treatment<br />

Warnings and Precautions: Keep all Effentora tablets out of the reach and<br />

sight of children. Monitor patients closely during the titration process.<br />

StabiliselongactingmaintenancetreatmentbeforeEffentoratherapybegins.<br />

Continue maintenance treatment whilst taking Effentora. Risk of clinically<br />

significant respiratory depression. Increase dose with caution. Particular<br />

cautionwhentitratingpatientswithchronicobstructivepulmonarydisease<br />

orothermedicalconditionspredisposingtorespiratorydepression.Extreme<br />

cautioninpatientssusceptibletointracranialeffectsofCO2retention,suchas<br />

increasedintracranialpressureorimpairedconsciousness.Cautioninpatients<br />

withpre-existingbradyarrhythmias,withhepaticorrenalimpairment.Care<br />

withpatientswithhypovolaemiaandhypotension.Interactions:Metabolised<br />

mainly via cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore<br />

potential interactions with agents that affect CYP3A4 activity. Inducers of<br />

3A4activitymayreducetheefficacyofEffentora.StrongCYP3A4inhibitors<br />

ormoderateCYP3A4inhibitorsmayincreasefentanylplasmaconcentrations,<br />

potentiallycausingfatalrespiratorydepression.Additivedepressanteffects<br />

withconcomitantuseofothercentralnervoussystemdepressants(referto<br />

theSmPCforfulllist).Notrecommendedforusewithin14daysofreceiving<br />

MonoamineOxidaseInhibitors.Concomitantuseofpartialopioidagonists/<br />

antagonistsnotrecommendedduetopartialantagonismofanalgesiaand<br />

potential withdrawal symptoms. Pregnancy and lactation: Not to be used<br />

in pregnancy unless clearly necessary. Use of Fentanyl may cause opioid<br />

withdrawalinthenew-borninfant.Useduringlabouranddelivery(including<br />

caesareansection)maycausefoetalrespiratorydepression,requiringready<br />

availabilityofanantidoteforthechild.Notbeusedbybreastfeedingwomen<br />

andnobreastfeedinguntilatleast48hoursafterthelastadministrationof<br />

fentanyl.Effects on ability to drive and use machines:Mayimpairmentaland/<br />

or physical ability required for potentially dangerous tasks (e.g., driving a<br />

caroroperatingmachinery).Advisenottodriveoroperatemachinerywhile<br />

taking Effentora until reaction to Effentora is known. Undesirable effects:<br />

Please see the SmPC for complete list of adverse effects. Typical opioid<br />

undesirable effects. Serious adverse reactions: Respiratory depression<br />

(potentiallyleadingtoapnoeaorrespiratoryarrest),Circulatorydepression,<br />

Hypotension and shock. Monitor for these. Very common effects (>10%) –<br />

Nausea, Vomiting, Dizziness and Headaches, Application site reactions.<br />

Common(>1%-10%)–Weightdecreased,Tachycardia,Anaemia,Neutropenia,<br />

Dysgeusia,Somnolence,Lethargy,Tremor,Sedation,Hypoaesthesia,Migraine,<br />

Dyspnoea, Pharyngolaryngeal pain, Constipation, Stomatitis, Dry mouth,<br />

Diarrhoea, Abdominal pain, Gastro-oesophageal reflux disease, Stomach<br />

discomfort, Dyspepsia. Toothache, Pruritis, Hyperhidrosis, Rash, Myalgia,<br />

Back pain, Anorexia, Oral candidiasis, Fall, Hypotension, Hypertension,<br />

Peripheral oedema, Fatigue, Asthenia, Drug withdrawal syndrome, Chills,<br />

Depression, Anxiety, Confusional state, Insomnia. Tolerance, physical and/<br />

orpsychologicaldependence.OpioidwithdrawalsymptomssuchasNausea,<br />

Vomiting, Diarrhoea, Anxiety and Shivering. Loss of consciousness and<br />

Respiratory arrest have been observed in the context of overdose. See<br />

fullSmPCforotherundesirableeffectsclassifiedasUncommon,Rareand<br />

unknown.Overdose:SeeSmPCforfullinformation.Immediatemanagement<br />

ofopioidoverdoseincludesremovalofEffentora,ensuringapatentairway,<br />

physicalandverbalstimulation,assessmentofthelevelofconsciousness,<br />

ventilatoryandcirculatoryassessment,andventilatorysupportifnecessary.<br />

Basic UK NHS Costs: Effentora all strengths x 4 £19.96. Legal Category:<br />

CD (Sch2), POM. Marketing Authorisation Numbers: EU/1/08/441/001-010.<br />

Marketing Authorisation Holder: Cephalon Europe 5 rue Charles Martigny<br />

F-94700Maisons-AlfortFrance.Date of SmPC:December 2009.Information,<br />

including SmPC, is available from Cephalon UK Limited, 1 Albany Place,<br />

HydeWay,WelwynGardenCity,Hertfordshire,AL73BTMedicalInformation<br />

ukmedinfo@cephalon.com).Freephone:UK08007834869<br />

Adverse events should be reported. Reporting forms and<br />

information can be found at www.yellowcard.gov.uk. Adverse<br />

events should also be reported to Cephalon UK Ltd on 0800<br />

783 4869 or ukmedinfo@cephalon.com<br />

DateofPrescribingInformation:21DEC2009CE/FE-09121<br />

©Cephalon UK Ltd. All rights reserved. ®Cephalon and Effentora are registered trademarks CE/FE-10008c/Jan10<br />

* For the treatment of Breakthrough <strong>Pain</strong> (BTcP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.<br />

1. Slatkin NE et al., Fentanyl Buccal Tablet For Relief of Breakthrough <strong>Pain</strong> in Opioid-Tolerant Patients With Cancer-Related Chronic <strong>Pain</strong>. J Support Oncol. 2007; 5(7): 327-334.

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