Prescribing Information

Ongentys® Opicapone Please refer to the SPC before prescribing. Presentation:  Capsules  containing  50  mg  of  opicapone. Indication:  Adjunctive  therapy  to  preparations  of  levodopa/DOPA  decarboxylase  inhibitors  (DDCI)  in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised  on those  combinations.  Dosage  and  administration:  The  recommended  dose  of  opicapone  is  50  mg.  It should be taken  once-daily at bedtime at least  one hour before  or after levodopa combinations. Opicapone enhances the effects of levodopa. Hence, it is often necessary to adjust  levodopa dosage within  the  first  days  to  first  weeks  after  initiating  the  treatment  with  opicapone.  Elderly  patients:  No dose adjustment is needed for elderly patients. Caution must be exercised in patients ≥ 85  years of  age as there  is  limited  experience  in  this  age  group.  Patients  with  renal  impairment:  No  dose  adjustment  is necessary  in  patients with  renal  impairment,  as opicapone  is not excreted  by  the  kidney.  Patients  with hepatic impairment: No dose adjustment is necessary in patients  with mild  hepatic impairment  (Child-Pugh  Class  A). There is  limited  clinical  experience  in  patients  with moderate hepatic  impairment (Child-Pugh Class B). Caution must be exercised in these patients and dose adjustment may be  necessary. There  is  no  clinical  experience  in  patients  with  severe  hepatic  impairment  (Child-Pugh  Class  C), therefore, Ongentys  is not recommended in these  patients.  Contraindications:  Hypersensitivity  to  the active  substance  or  to  any  of  the  excipients.  Phaeochromocytoma,  paraganglioma,  or  other catecholamine  secreting  neoplasms.  History  of neuroleptic malignant syndrome  and/or  non-traumatic rhabdomyolysis.  Concomitant  use  with  monoamine  oxidase  (MAO-A  and  MAO-B)  inhibitors  (e.g. phenelzine,  tranylcypromine  and  moclobemide)  other  than  those  for  the  treatment  of  Parkinson’s disease.  Pregnancy: Ongentys  is not recommended during pregnancy and in women of  childbearing potential  not using  contraception.  Lactation:  Breast-feeding  should  be  discontinued  during  treatment with Ongentys.  Warnings  and  precautions:  Opicapone  enhances  the  effects  of  levodopa.  To  reduce levodopa-related dopaminergic adverse reactions (e.g. dyskinesia, hallucinations, nausea,  vomiting and orthostatic hypotension), it is often necessary to adjust the daily dose of levodopa by  extending the dosing intervals and/or reducing the amount  of levodopa per dose within the first days to  first weeks after initiating treatment  with Ongentys, according to the clinical condition of the patient. Ongentys  contains  lactose.  Patients with  rare  hereditary  problems  of  galactose intolerance,  the  Lapp lactase  deficiency  or  glucose-galactose  malabsorption  should  not  take  Ongentys.  Patients  and caregivers should be made aware  that  impulse  control disorders  including  pathological  gambling,  increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating  can occur  in patients  treated  with  dopamine  agonists  and/or  other  dopaminergic  treatments.  Patients  should  be monitored  regularly  for  the  development  of  impulse  control  disorders  and review  of  treatment  is recommended  if  such  symptoms  develop.  Increases  in  liver     enzymes     were     reported    in    studies   with    nitrocatechol    inhibitors of

catechol-O-methyltransferase  (COMT). For  patients  who  experience progressive anorexia, asthenia and weight decrease  within a relatively short period of time, a  general medical evaluation including liver function should be considered. Drug interactions: Concomitant  use of opicapone  with  MAO inhibitors (e.g. phenelzine,  tranylcypromine  and  moclobemide)  other than  those for  the  treatment  of  Parkinson’s  disease  is  contraindicated.  Concomitant  use  of  opicapone  and  MAO inhibitors for the treatment of Parkinson’s disease, e.g. rasagiline (up to 1 mg/day) and selegiline  (up to 10  mg/day  in  oral  formulation  or  1.25  mg/day  in  buccal  absorption  formulation),  is  permissible. Opicapone  may  interfere  with  the  metabolism  of  medicinal  products  containing  a  catechol  group  that are metabolised  by  COMT, e.g.  rimiterole,  isoprenaline,  adrenaline,  noradrenaline,  dopamine, dopexamine or  dobutamine,  leading  to potentiated  effects  of  these  medicinal  products.  Careful monitoring of patients being treated with these medicinal products is advised when opicapone  is used. Concomitant  use with tricyclic  antidepressants  and  noradrenaline  re-uptake  inhibitors  (e.g.  venlafaxine,  maprotiline  and desipramine)  should  be  considered  with  appropriate  caution.  Particular  consideration should  be given  to medicinal  products  metabolised  by  CYP2C8  and  their  co-administration  must  be  avoided.  Particular consideration should be given to  medicinal  products transported  by  OATP1B1 and their concomitant use should be considered  with appropriate caution. Adverse events: Refer to the SPC for  all  side  effects.  Very  common  side effects  ≥1/10):  Dyskinesia.  Common  side  effects  (≥  1/100  to  <1/10):  Abnormal  dreams,  Hallucination,  Hallucination  visual,  Insomnia,  Dizziness,  Headache, Somnolence,  Orthostatic  hypotension,  Constipation,  Dry  mouth,  Vomiting,  Muscle  spasms,  Blood creatine phosphokinase increased. Uncommon side effects  (≥ 1/1,000 to < 1/100): Decreased  appetite, Hypertriglyceridaemia,  Anxiety,  Depression,  Hallucination  auditory,  Nightmares,  Sleep  disorder, Dysgeusia,  Hyperkinesia,  Syncope,  Dry  eye,  Ear  congestion,  Palpitations,  Hypertension,  Hypotension, Dyspnoea,  Abdominal  distention,  Abdominal  pain, Abdominal pain upper,  Dyspepsia, Muscle  twitching, Musculoskeletal stiffness, Myalgia, Pain in  extremity, Chromaturia, Nocturia, Weight decreased.  Legal Category: POM.  Basic UK  NHS  cost: Ongentys pack of 30: £93.90.  Marketing authorisation numbers: EU/1/15/1066/003.  Marketing  authorisation  holder:  Bial-Portela  &  Ca.,  S.A.,  A  Avenida  da  Siderurgia nacional  4745-457  Coronado  (S.  Romao  e  S.  Mamede)  –  Portugal.  Further  Information  from:  Bial  Pharma UK Ltd., Admiral  House, St.  Leonards Road, Windsor, SL4 3BL, UK. Job code: UK/ON/2020/006. Date of preparation: January 2020

Adverse events should be reported. For UK healthcare professionals: reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bial   on +44 (0)1628 531171 or  bial@pharmalex.com

 

UK/ON/2020/035
date of preparation April 2020