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The Science of Prescribing Informa3on Kellie Schoolar Reynolds, Pharm.D. Deputy Division Director, Division of Clinical Pharmacology IV Office of Clinical Pharmacology Office of Transla=onal Sciences Center for Drug Evalua=on and Research, FDA
Transcript
Page 1: TheScienceof PrescribingInformaon$ - ACMT...PrescribingInformaon$ Goals • FDA’s’primary’communicaon’tool’ – safe’and’effec=ve’use’of’adrug’ • Inform’health’care’providers

The  Science  of    Prescribing  Informa3on  

Kellie  Schoolar  Reynolds,  Pharm.D.  Deputy  Division  Director,  Division  of  Clinical  Pharmacology  IV    

Office  of  Clinical  Pharmacology  Office  of  Transla=onal  Sciences  

Center  for  Drug  Evalua=on  and  Research,  FDA  

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Disclaimer  

•  The  opinions  expressed  in  this  presenta=on  are  the  presenter’s  and  do  not  necessarily  reflect  the  official  views  of  the  Food  and  Drug  Administra=on  (FDA)  

•  The  presenter  has  no  disclosures  related  to  the  content  of  this  presenta=on  

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Prescribing  Informa3on  Goals  

•  FDA’s  primary  communica=on  tool  –  safe  and  effec=ve  use  of  a  drug  

•  Inform  health  care  providers  –  prescribe  drugs  –  counsel  pa=ents  

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Prescribing  Informa3on  Data  Source  

•  Drug  company  submits  data  –  Chemistry  –  Preclinical  –  Clinical  

•  FDA  reviews  data  •  Process  con=nues  post-­‐marke=ng  (some  changes  are  ini=ated  by  FDA)  

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Prescribing  Informa3on  Format  and  Presenta3on  

Clear  Communica3on  Concise  and  Complete  

ART and    

SCIENCE 5

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The  Basics  •  PLR  =  Physician  Labeling  Rule  (2006)  

–  Designed  to  make  informa=on  easier  for  health  care  providers  to  access,  read,  and  use.  

•  Parts  –  Highlights  –  Table  of  Contents  –  Full  Prescribing  Informa=on  

•  Considera=ons  –  Avoid  redundancy  –  Use  cross  references  –  Use  ac=onable  language  

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Highlights  

•  Concise  (half  page)  summary  

•  Crucial  prescribing  informa=on,  based  on    –  Knowledge  of  clinical  seYng  –  Judgment  

•  Based  on  Full  Prescribing  Informa=on  •  Succinct,  relevant,  complete  

–  Ex:  risk,  consequences,  ac=ons  to  mi=gate  or  prevent  

•  Direc=ve  Language  

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Highlights  Headings  

•  Limita=ons  Statement  

•  Product  Names  and  Date  of  Ini=al  Approval  

•  Boxed  Warning  •  Recent  Major  Changes  •  Indica=ons  and  Usage  •  Dosage  and  Administra=on  

•  Dosage  Forms  and  Strengths  

•  Contraindica=ons  •  Warnings  and  Precau=ons  

•  Adverse  Reac=ons  •  Drug  Interac=ons  •  Use  in  Specific  Popula=ons  

•  Pa=ent  Counseling  Informa=on  (reference)  

•  Revision  Date  8

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Highlights  Headings  A  few  notes  on  specific  content  •  Ini=al  US  Approval  •  Boxed  Warning  (If  any)  •  Recent  Major  Changes  •  Dosage  and  Administra=on  

•  Contraindica=ons  •  Warnings  and  Precau=ons  •  Adverse  Reac=ons  •  Drug  Interac=ons  •  Use  in  Specific  Popula=ons  

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Highlights  Example  of  Drug  interac3on  informa3on  in  Highlights  

Lurasidone  hydrochloride  (LATUDA®)-­‐-­‐  •  DOSAGE  AND  ADMINISTRATION  

–  Concomitant  Use  of  a  Moderate  CYP3A4  inhibitor  (e.g.,  dil=azem):  LATUDA  dose  should  be  reduced  to  half  of  the  original  dose  level.  Recommended  star=ng  dose  is  20  mg  per  day.  Maximum  recommended  dose  is  80  mg  per  day.  

–  Concomitant  Use  of  a  Moderate  CYP3A4  inducer:  It  may  be  necessary  to  increase  the  dose  of  LATUDA.  

•  CONTRAINDICATIONS  –  Concomitant  use  with  a  strong  CYP3A4  inhibitor  (e.g.,  ketoconazole).  

–  Concomitant  use  with  a  strong  CYP3A4  inducer  (e.g.,  rifampin).  

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Highlights  sec3on  Example  of  Warnings  and  Precau3ons  

UNITUXIN™  (dinutuximab)  injec3on,  for  intravenous  use  WARNINGS  AND  PRECAUTIONS  • Capillary  leak  syndrome  and  hypotension:  Administer  required  prehydra=on  and  monitor  pa=ents  closely  during  treatment.  Depending  upon  severity,  manage  by  interrup=on,  infusion  rate  reduc=on,  or  permanent  discon=nua=on.  (5.3,  5.4)    

• Infec=on:  Interrupt  un=l  resolu=on  of  systemic  infec=on.  (5.5)    

• Neurological  Disorders  of  the  Eye:  Interrupt  for  dilated  pupil  with  sluggish  light  reflex  or  other  visual  disturbances  and  permanently  discon=nue  for  recurrent  eye  disorders  or  loss  of  vision.  (5.6)    

• Bone  marrow  suppression:  Monitor  peripheral  blood  counts  during  Unituxin  therapy.  (5.7)    • Electrolyte  abnormali=es:  Monitor  serum  electrolytes  closely.  (5.8)    

• Atypical  hemoly=c  uremic  syndrome:  Permanently  discon=nue  Unituxin  and  ins=tute  suppor=ve  management.  (5.9)    

• Embryo-­‐Fetal  toxicity:  May  cause  fetal  harm.  Advise  females  of  reproduc=ve  poten=al  of  poten=al  risk  to  a  fetus  and  to  use  effec=ve  contracep=on.  (5.10,  8.1,  8.3)    

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Full  Prescribing  Informa3on  

Boxed  Warning  

1. Indica=ons  and  Usage  2. Dosage  and  Administra=on  

3. Dosage  Forms  and  Strengths  4. Contraindica=ons  5. Warnings  and  Precau=ons  

6. Adverse  Reac=ons  7. Drug  Interac=ons  8. Use  in  Specific  Popula=ons  9. Drug  Abuse  and  Dependence  

10.  Overdosage  

11.  Descrip=on  12.  Clinical  Pharmacology  

13.  Nonclinical  Toxicology  14.  Clinical  Studies  

15.  References  

16.  How  Supplied/Storage  and  Handling  

17.  Pa=ent  Counseling  Informa=on  

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Full  Prescribing  Informa3on  

•  Consistent  numbering  for  sec=ons  –  Skip  number  if  sec=on  is  not  included  

•  Limit  redundancy  –  Same  informa=on  may  appear  with  different  level  of  detail  in  different  sec=ons  

–  Cross  reference  •  Clear  Language  

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Labeling  Review  Process  

•  CDER  has  a  defined  process  for  labeling  review  •  Process  includes  

–  Timeline  with  milestones  –  Oversight  by  Project  Manager  

–  Reviewer  and  team  leader  roles  

–  Labeling  mee=ngs  –  Study  Endpoint  and  Labeling  Development  team  input  

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ART and  SCIENCE

Drug  Interac=on  Informa=on  –  Complicated  science  –  Impact  on  many  sec=ons  of  prescribing  informa=on  

–  Poten=al  for  harm  –  Same  informa=on  affects  at  least  two  drugs  

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Physician  Percep3on  of    Drug  Interac3on  Informa3on  

•  Some  informa=on  is  intui=ve,  universally  appreciated,  ingrained    –  Aspirin  and  oral  an=coagulants  –  MAO  inhibitors  and  SSRIs  

•  Clinicians  are  otherwise  overwhelmed  –  Sheer  number  of  drug  interac=ons  –  Complexity  of  mechanisms  and  terminology  

•  Adapted  from  informa=on  presented  by  David  Juurlink  (University  of  Toronto)  at  FDA  Clinical  Pharmacology  Advisory  Comminee  Mee=ng  on  9/25/2013  

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Physician  percep3on-­‐  What  is  wrong  with  drug  interac3on  informa3on  in  Prescribing  Informa3on?  

•  Confusing  structure  •  Too  much  informa=on  •  Wrong  informa=on  •  No  conveyance  of  risk  •  No  real  guidance  

•  Adapted  from  informa=on  presented  by  David  Juurlink  (University  of  Toronto)  at  FDA  Clinical  Pharmacology  Advisory  Comminee  Mee=ng  on  9/25/2013  

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Ideal  drug  interac3on  informa3on  

•  Easy  to  access  and  navigate  •  Minimal  pharmacology  jargon  •  Structured  in  a  clinically  intui=ve  way  •  Imparts  sense  of  severity  or  risk  

•  Provides  risk  management  instruc=ons  •  Does  not  include  unnecessary  informa=on  •  Up  to  date  

•  Adapted  from  informa=on  presented  by  David  Juurlink  (University  of  Toronto)  at  FDA  Clinical  Pharmacology  Advisory  Comminee  Mee=ng  on  9/25/2013  

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Prescribing  Informa3on  Parts  that  include  Drug  Interac3on  Informa3on  (1)  

Labeling  Loca=on   Drug  Interac=on  (DI)  Informa=on  

Highlights  

Highlights  Headings  •  Typical  DI  informa=on:    contraindica=ons,  dose  adjustments,  and  poten=al  for  serious  DI      

• May  be  a  short  statement  regarding  general  poten=al  for  DI    

Full  Prescribing  Informa=on  Sec=ons  (2)  Dosage  and  Administra=on  

Specific  dose  adjustments  for  drug  that  is  subject  of  labeling    

(4)  Contraindica=ons  List  coadministered  drugs  that  are  contraindicated  because  combina=on  is  dangerous  and  risk  clearly  outweighs  benefit    

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Prescribing  Informa3on  Sec3ons  that  include  Drug  Interac3on  Informa3on  (2)  

Labeling  Loca=on   DI  Informa=on  

Full  Prescribing  Informa=on  Sec=ons  

(5)  Warnings  and  Precau=ons  

Known  or  predicted  DI  with  serious  or  clinically  significant  outcomes.    Examples:  

•  Sildenafil  with  ritonavir  (11  fold  increase  in  sildenafil  AUC,  reports  of  decreased  blood  pressure  and  syncope)  

•  Viekira  Pak  and  mul=ple  other  drugs  (loss  of  therapeu=c  effect  and  possible  resistance,  and  possible  clinically  significant  adverse  reac=ons)    

(7)  Drug  Interac=ons  

Drugs  that  interact  or  are  predicted  to  interact  in  a  clinically  significant  way.  Includes  prac=cal  instruc=ons  for  managing  DI.    May  also  include  brief  informa=on  about  mechanisms  of  DI.    

(12)  Clinical  Pharmacology  

Present  summary  of  results  of  in  vitro  drug  metabolism,  in  vitro  DI,  and  in  vivo  DI  studies.    

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Drug  Interac3on  Study  Results  

•  Content  –  Results  from  drug  interac=on  studies  –  Study  design  informa=on  (Level  of  detail  varies)  

•  Ra=onale  –  supports  the  drug  interac=on  management  informa=on  that  is  useful  to  clinicians    

–  may  be  useful  to  clinical  pharmacologists  or  clinical  pharmacists  who  provide  drug  interac=on  management  informa=on  to  the  prescribers    

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Drug  Interac3on  Study  Results  Tables  (Clinical  Pharmacology  Sec3on)  •  Posaconazole  (effect  of  coadministered  drugs  on  posaconazole  in  healthy  volunteers)  –  Coadministered  drug  (postulated  mechanism)  

–  Dose  and  schedule  for  both  drugs  –  Percent  change  in  mean  Cmax  and  AUC  (and  90%  confidence  intervals)  

Note-­‐  The  table  on  the  next  slide  is  one  example  of  the  type  of  table  that  is  used  to  convey  drug  interac:on  informa:on.    It  is  not  a  template  or  required  format.  

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Drug  Interac3on  Study  Results  Forest  Plot  (Clinical  Pharmacology  Sec3on)  •  Apixaban  (effect  of  coadministered  drugs  on  apixaban  pharmacokine=cs)  –  Coadministered  drug  (mechanism;  dose)  

–  Plot  illustrates  “fold-­‐change  and  90%  CI”  for  Cmax  and  AUC  –  Ver=cal  lines  indicate  “no  effect”  boundary  (not  a  characteris=c  of  all  Forest  plots)  

–  Recommenda=on-­‐  cross  reference  to  sec=on  7  (Drug  Interac=ons)  

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Apixaban  Drug  Interac=on  Study  Results:    Forest  Plot  

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Drug  interac3on  predic3ons  •  Tamsulosin  hydrochloride  (Flomax®)-­‐  substrate  for  CYP3A4  and  

CYP2D6.  

•  The  following  informa=on  is  in  the  labeling  (paragraph)  –  Ketoconazole  (strong  CYP3A4  inhibitor)  400  mg  qd  x  5d  ↑  Cmax  2.2  x  and  AUC  

2.8  x.  

–  Effect  of  moderate  CYP3A4  inhibitor  not  evaluated  

–  Paroxe=ne  (strong  CYP2D6  inhibitor)  20  mg  qd  x  9d  ↑  Cmax  1.3  x  and  AUC  1.6x.  

–  Similar  effect  expected  for  CYP2D6  PMs  and  EMs  –  Poten=al  for  significant  ↑  exposure  when  CYP2D6  PMs  receive  strong  CYP3A4  

inhibitor  (Don’t  use  with  strong  CYP3A4  inhibitors)  

–  Effect  of  moderate  CYP2D6  inhibitor  not  evaluated  

–  Effect  of  coadminister  of  both  CYP3A4  and  CYP2D6  inhibitors  not  evaluated.    Poten=al  for  significant  increase.  

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Drug  interac3on  management  

•  Informa=on  for  clinicians  –  Alter  therapy  (dose  adjust;  don’t  coadminister)  –  Specific  monitoring  instruc=ons  

•  Instruc=ons  are  based  on  –  Study  results  or  predic=on  –  Exposure-­‐response  (efficacy  and  safety)  

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Dosage  and  Administra3on  •  Guanfacine  (Intuniv®)  

•  Dose  adjustment  in  pa=ents  taking  concomitant  CYP3A4  inhibitors  or  inducers  

Comedica=ons  Scenarios  

Ini=ate  Intuniv  when  taking  comedica=ons  

Con=nue  Intuniv  when  adding  a  medica=on  

Stop  a  comedica=on  when  con=nuing  Intuniv  

Strong  CYP3A  inhibitors  

Intuniv  dose  should  be  limited  to  2  mg/day  

Intuniv  dose  should  be  decreased  by  half  

Intuniv  dose  should  be  doubled  based  on  pa=ent  tolerability.    The  maximum  dose  should  not  exceed  4  mg/day.  

Strong  CYP3A4  inducers  

Intuniv  dose    may  be  =trated  up  to  8  mg/day.  Consider  faster  =tra=on  (e.g.,  in  increments  of  2  mg/week)  

Consider  increase  in  Intuniv  dose  gradually  in  1-­‐2  weeks  to  2  fold  of  the  original  dose  based  on  pa=ent  tolerability  

Intuniv  dose  should  be  decreased  by  half  in  1-­‐2  weeks  based  on  pa=ent  tolerability.    The  maximum  dose  should  not  exceed  4  mg/day.  

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Contraindica3ons  •  Darunavir  (Prezista)-­‐  Table  in  contraindica=ons  sec=on.  2  of  9  rows  shown.  •  Co-­‐administra=on  of  PREZISTA/ritonavir  is  contraindicated  with  drugs  that  are  highly  dependent  

on  CYP3A  for  clearance  and  for  which  elevated  plasma  concentra=ons  are  associated  with  serious  and/or  life-­‐threatening  events  (narrow  therapeu=c  index).    

Drug  Class   Drugs  within  class  that  are  contraindicated  with  Prezista/ritonavir    

Clinical  Comment  

Ergot  deriva=ves   Dihydroergotamine,  Ergonovine,  Ergotamine,  Methylergonovine    

Poten=al  for  serious  and/or  life  threatening  events  such  as  acute  ergot  toxicity  characterized  by  peripheral  vasospasm  and  ischemia  of  the  extremi=es  and  other  =ssues.  

An=-­‐mycobacterial   Rifampin   Rifampin  is  a  potent  inducer  of  CYP450  metabolism.    PREZISTA/ritonavir  should  not  be  used  in  combina=on  with  rifampin,  as  this  may  cause  significant  decreases  in  darunavir  plasma  concentra=ons.    This  may  result  in  loss  of  therapeu=c  effect  to  PREZISTA.  

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Darunavir  •  Table  (Drug  Interac=on  Sec=on)  

–  Established  and  Other  Poten=ally  Significant  Drug  Interac=ons:  Altera=ons  in  Dose  or  Regimen  May  be  Recommended  Based  on  Drug  Interac=on  Studies  or  Predicted  Interac=on  (cross  reference  to  table  with  study  results)    

•  Columns  –  Concomitant  drug  class:  drug  name  –  Effect  on  concentra=on  of  darunavir  or  concomitant  drug  

–  Clinical  comment  

Note-­‐  The  table  on  the  next  slide  is  one  example  of  the  type  of  table  that  is  used  to  convey  drug  interac:on  informa:on.    It  is  not  a  template  or  required  format.  

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Some  clinical  comments    in  the  darunavir  prescribing  informa3on  

(interac=on  with  lopinavir/ritonavir)  

•  Appropriate  doses  of  the  combina=on  have  not  been  established.  Hence,  it  is  not  recommended  to  co-­‐administer  lopinavir/ritonavir  and  PREZISTA,  with  or  without  ritonavir.    

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33

Some  clinical  comments    in  the  darunavir  prescribing  informa3on  (interac=on  with  rifabu=n)  

•  Dose  reduc=on  of  rifabu=n  by  at  least  75%  of  the  usual  dose  (300  mg  once  daily)  is  recommended  (i.e.,  a  maximum  dose  of  150  mg  every  other  day).  Increased  monitoring  for  adverse  events  is  warranted  in  pa=ents  receiving  this  combina=on  and  further  dose  reduc=on  of  rifabu=n  may  be  necessary.      

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Ideal  drug  interac3on  informa3on  in  labeling  Are  we  there,  yet?  •  Easy  to  access  and  navigate  •  Minimal  pharmacology  jargon  •  Structured  in  a  clinically  intui=ve  way  •  Imparts  sense  of  severity  or  risk  

•  Provides  risk  management  instruc=ons  •  Does  not  include  unnecessary  informa=on  •  Up  to  date  •  Adapted  from  informa=on  presented  by  David  Juurlink  (University  of  Toronto)  at  FDA  Clinical  Pharmacology  Advisory  

Comminee  Mee=ng  on  9/25/2013  

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Labeling  changes  (1)  

•  Safety  Labeling  Changes  under  FDAAA  –  New  safety  informa=on  that  becomes  available  ater  approval  of  product  

–  New  informa=on  is  related  to  serious  risk  

–  May  include  a  class  of  drugs  –  Defined  process  and  =meline  

FDAAA-­‐  Food  and  Drug  Administra:on  Amendments  Act  of  2007  

Guidance:  

hnp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma=on/Guidances/UCM250783.pdf  

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Labeling  changes  (2)  

Ini=ated  by  FDA  or  Drug  Sponsor  Mechanism  of  submission  varies  based  on  type  of  change  

•  Sponsor  submits  change  –  Prior  approval  labeling  supplement  –  Changes  being  effected  labeling  supplement  

–  Annual  report  

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Resources  Link  to  PLR  Requirements  of  Prescribing  Informa=on  and  Labeling  Guidances  hnp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma=on/LawsActsandRules/ucm084159.htm  

Some  guidances  address  specific  sec=ons  of  labeling  Adverse  Reac=ons  

Dosage  and  Administra=on  

Warnings  and  Precau=ons,  Contraindica=ons,  and  Boxed  Warnings  

Clinical  Pharmacology  (drat)  

Pregnancy,  Lacta=on,  Reproduc=ve  Poten=al  (new  drat  guidance;  12/2014)    

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How are we doing?

•  YOU can help OCP achieve its goal of translating its regulatory reviews into understandable and actionable labeling language

•  Provide feedback on the quality, clarity and utility of the professional and consumer drug labeling you are using

EMAIL: [email protected]

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