Summer 2010 - The British Pain Society
Summer 2010 - The British Pain Society
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.