PI - UCB PD Expert Series Meeting

PRESCRIBING INFORMATION
(Please consult the Summary of Product Characteristics (SPC) before prescribing).
Neupro®
Rotigotine
aggressive behaviour and agitation. Ophthalmologic monitoring is
recommended at regular intervals or if vision abnormalities occur.
Consideration should be taken when prescribing Neupro in combination
with levodopa in PD patients as a generally higher incidence of some
2
Active Ingredient: 1 mg/24 h transdermal patch is 5 cm and
dopaminergic adverse events have been observed. Neupro contains
contains 2.25 mg rotigotine, releasing 1 mg rotigotine over 24 hours.
sodium metabisulphite, which may cause allergic-type reactions
2
2 mg/24 h transdermal patch is 10 cm and contains 4.5 mg
including anaphylactic symptoms and life threatening or less severe
rotigotine, releasing 2 mg rotigotine over 24 hours. 3 mg/24 h
asthmatic episodes in certain susceptible individuals. Syncope has been
2
transdermal patch is 15 cm and contains 6.75 mg rotigotine,
observed in clinical trials but at a rate that was similar to patients treated
releasing 3 mg rotigotine over 24 hours. 4 mg/24 h transdermal
with placebo. Peripheral oedema has been observed in clinical trials.
2
patch is 20 cm and contains 9.0 mg rotigotine, releasing 4 mg
PD: Switching to another dopamine agonist may be beneficial for those
2
rotigotine over 24 hours. 6 mg/24 h transdermal patch is 30 cm and
patients who are insufficiently controlled by rotigotine.
contains 13.5 mg rotigotine, releasing 6 mg rotigotine over 24 hours.
RLS: Augmentation may occur. Interactions: Do not administer
2
8 mg/24 h transdermal patch is 40 cm and contains 18.0 mg
neuroleptics or dopamine antagonists to patients taking dopamine
rotigotine, releasing 8 mg rotigotine over 24 hours.
agonists. Caution is advised when treating patients taking sedating
Indications: Neupro is indicated for the (i) treatment of the signs
medicines or other depressants in combination with rotigotine. Neupro
and symptoms of idiopathic Parkinson’s disease (PD), either as
may potentiate the dopaminergic adverse reaction of levodopa.
monotherapy for early-stage PD or in combination with levodopa
Pregnancy and lactation: Neupro should not be used during pregnancy.
over the course of the disease, through to late stages (ii)
Breast-feeding should be discontinued. Driving etc: Neupro may have
symptomatic treatment of moderate to severe idiopathic Restless
major influence on the ability to drive and use machines.
Legs Syndrome (RLS) in adults.
Adverse Effects: PD: Very common (≥ 1/10): Somnolence,
Dosage and Administration: Neupro is applied to clean, healthy,
dizziness, headache, nausea, vomiting, application and instillation
intact skin once a day. The patch remains on the skin for 24 hours
site reactions. Common (≥ 1/100 - < 1/10): Perception disturbances,
and will then be replaced by a new one at a different application site.
insomnia, sleep disorder, nightmare, abnormal dreams,
PD Monotherapy: treatment initiated with a single daily dose of
impulse control disorders(ICD), disturbances in consciousness,
2 mg/24 h and increased weekly by 2 mg/24 h until an effective
dyskinesia, dizziness postural, lethargy, vertigo, palpitations,
dose is reached. Maximal dose is 8 mg/24 h. PD Adjunctive therapy
orthostatic hypotension, hypertension, hiccups, constipation, dry
(with levodopa): treatment initiated with a single daily dose of 4
mouth, dyspepsia, erythema, hyperhidrosis, pruritus, oedema
mg/24 h and increased weekly in 2 mg/24 h increments, up to a
peripheral, asthenic conditions, weight decreased, fall. RLS: Very
maximal dose of 16 mg/24 h. RLS: treatment initiated at 1 mg/24 h
common (≥ 1/10): Headache, nausea, application and instillation site
and may be increased in weekly increments of 1 mg/24 h to a
reactions, asthenic conditions. Common(≥ 1/100 - < 1/10):
maximal dose of 3 mg/24 h. The need for treatment continuation
Hypersensitivity which may include angioedema, tongue oedema
should be reconsidered every 6 months. Hepatic and renal
and lip oedema, sleep attacks/sudden onset of sleep, sexual desire
impairment: Adjustment of the dose is not necessary in patients with
(including hypersexuality, libido increased), insomnia, sleep
mild to moderate hepatic impairment or in patients with mild to
disorder, abnormal dreams, somnolence, hypertension, vomiting,
severe renal impairment, including those requiring dialysis. Caution
dyspepsia, pruritus, irritability, peripheral oedema, impulse control
is advised and dose adjustment may be needed when treating
disorder(ICD). Consult SPC in relation to other side effects.
patients with severe hepatic impairment. Children and adolescents:
Pharmaceutical Precautions: Store in the original package. Cold
The safety and efficacy of rotigotine have not yet been established.
chain
storage patch should be stored in a refrigerator (2°C - 8°C).
No data are available. Treatment discontinuation: If treatment is to
Room
temperature stable patch should not be stored above 25°C.
be withdrawn, it should be gradually reduced, in steps of 1 mg/24 h
Legal Category: POM.
for RLS or 2 mg/24 h for PD, both with a dose reduction preferably
Marketing Authorisation Numbers: 1 mg x 28 patches:
every other day, to avoid the possibility of developing neuroleptic
EU/1/05/331/040;
2 mg x 28 patches: EU/1/05/331/002; 3 mg x 28
malignant syndrome.
patches: EU/1/05/331/049; 4 mg x 28 patches: EU/1/05/331/005;
Contraindications, Warnings, etc: Contraindications:
6 mg x 28 patches: EU/1/05/331/008; 8 mg x 28 patches:
Hypersensitivity to rotigotine or to any of the excipients. Neupro
EU/1/05/331/011; PD Treatment Initiation Pack: EU/1/05/331/013.
should be removed prior to Magnetic Resonance Imaging (MRI) or
cardioversion to avoid burns. Precautions: External heat should not be NHS Cost: 1 mg x 28 patches: £77.24; 2 mg x 28 patches: £81.10;
3 mg x 28 patches: £102.35; 4 mg x 28 patches: £123.60; 6 mg x 28
applied to the patch. Dopamine agonists are known to cause
patches:
£149.93; 8 mg x 28 patches: £149.93; PD Treatment
hypotension, and monitoring of blood pressure is recommended
Initiation
Pack: £142.79.
especially at the beginning of treatment. Where somnolence or sudden
sleep onset occurs, or where there is persistent, spreading or serious
Marketing Authorisation Holder:UCB Manufacturing Ireland Ltd,
skin rash at the application site, consider dose reduction or termination Shannon, Industrial Estate, Co. Clare, Ireland.
of therapy. Rotate the site of patch application to minimise the risk of Further information is available from:
skin reactions. In case of generalised skin reaction associated with use UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE.
of Neupro, discontinue treatment. Avoid exposure to direct sunlight
Tel: +44 (0)1753 534655. Fax: +44 (0)1753 536632
until the skin is healed. Patients and carers should be made aware that
behavioural symptoms of impulse control disorders can occur. Patients UCB (Pharma) Ireland Ltd ,United Drug House, Magna Drive,
should be regularly monitored for the development of impulse control Magna Business Park, City West Road, Dublin 24, Ireland
disorders, including pathologic gambling, increased libido,
Tel: +353 1 4637395. Fax: + 353 1 4637396.
hypersexuality, compulsive spending or buying, binge eating and
Email: [email protected]
compulsive eating. Dose reduction/tapered discontinuation should be Date of Revision: 02/2014 UK/14NE0011.
considered. Abnormal thinking and behaviour have been reported and Neupro is a registered trademark.
can consist of a variety of manifestations including paranoid ideation,
hallucinations, confusion, psychotic-like behaviour, disorientation,
UK Specific Information
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to UCB Pharma Ltd