120mcg and 240mcg oral lyophilisate
desmopressin (as acetate)
MELT AWAY THE MISERY OF BEDWETTING
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
Children who wet the bed frequently (twice a week or more)
are more likely to continue through childhood.1
The ALSPAC questionnaire-based observational longitudinal study
(large UK population study) showed that:
– at age 7.5 years, while 15.5% of children wet the bed,
only 2.6% wet twice per week or more*3
– children (aged 5 years and older) wetting at least twice per week
were more likely to continue than those wetting infrequently 1
*It is estimated that, at any time, there could be around 140 -150,000 5-19 year olds who wet the bed at least twice per week
(based on a 15% spontaneous remission rate).3-6 This equates to about 3-4 children per GP in the UK.
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
A questionnaire-based observational study by Yeung et al showed 2:
– The proportion of enuretic children with severe bedwetting
increases with age
– 82% of adolescents (over 10 years) with PNE wet the bed
3 or more times per week
Severity of PNE versus age 2
<3 wet nights/week
3-6 wet nights/week
7 wet nights/week
14.3%
10.3%
30% 55.7%
48.3% 41.4%
n=70 n=29
Age 5 Age 19
Adapted from Yeung et al, 20062
The findings suggest that enuretic children with more severe
symptoms (≥3 episodes per week) probably have a significantly
greater chance of persistent PNE in adult life 2
It is important that
children suffering with
PNE are identified early,
and are offered an
appropriate treatment
intervention 1,2,7
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
8-12
PNE – A DISTRESSING CONDITION
PNE can be distressing for children8-12
Children may suffer low self esteem, anxiety, sadness or
depression, avoid socialisation and become withdrawn 8 -10
If low self esteem persists over years, psychological and/or
psychiatric dysfunction is more likely to occur 8
Research has suggested that bedwetting children experience
more light sleep associated with frequent cortical arousal but
an inability to awake completely 12
Children may not be able to, or choose not to, express how
they feel 10
PNE can be distressing for parents9,13,14
Parents endure extra workload and expense13,14
Parents may become irritable and intolerant,13,14 and may
respond inappropriately to their child 9,14
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
DESMOPRESSIN IN PNE
It is important to acknowledge that PNE is multi-factorial 15
Treating early may help to minimise the negative psychological
impact of unresolved PNE 1,8
Better treatment outcomes are achieved when both the child
and the parents have been involved in the decision about
treatment choice 16
PNE can occur when the night time increase in plasma
vasopressin levels is insufficient 17
Plasma vasopressin levels Urinary excretion rates
3.5 Non-enuretic 80 Non-enuretic
* Enuretic Enuretic
Plasma vasopressin levels (pg/ml)
3.0 70
*p<0.025
Urinary excretion rate (ml/hr)
*p<0.001
2.5 non-enuretic vs enuretic 60
enuretic vs non-enuretic
subjects at night
subjects at night
2.0
50 *
40
1.5
30
1.0
20
0.5
10
0.0 0
DAY NIGHT DAY NIGHT
Rittig S. et al. 1989 17
Desmopressin mimics the natural nocturnal anti-diuretic
effect of vasopressin – helping to normalise urinary output
at night 5,18
Long term treatment does not affect the
child’s own vasopressin secretion 19
Desmopressin
is suitable for use
in children of
5 years and over
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Date of preparation: June 2011. DN/379/2011/UK
DESMOMELT – SPECIFICALLY
DESIGNED WITH CHILDREN IN MIND
Children may find tablets difficult to swallow 11
A randomised crossover study in 221 children and
adolescents with PNE compared the Melt with the tablet
formulation of oral desmopressin, and concluded that: 11
Significantly more children aged 5-11 years preferred the
Melt formulation to the tablet (p=0.0089)
Encourages compliance11
Compliance was numerically greater in patients receiving
DesmoMelt than those receiving the tablet formulation
Non-compliance with therapy (<80%, safety population)11
10 9.5
8
% of subjects
6
4.6
4
2 p=NS
Melt
0 Tablet
Melt (n=219) Tablet (n=220)
Persson B-E et al. 200611 All randomised patients (n=221) with available data.
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
DESMOMELT 120MCG – EQUIVALENT ®
EFFICACY TO DESMOTABS 0.2MG 11,20
WITH LOWER DOSES
Clinically equivalent
A recent study involving over 200 patients compared
DesmoMelt with Desmotabs, and showed efficacy was similar
for the two formulations 11
During a 6 month study, 70 -76% of children taking
Desmopressin improved 21
Desmopressin efficacy continued or improved throughout
the treatment period 22
DesmoMelt is
preferred to tablets,
particularly by younger
children, and is the
11
most widely prescribed
form of desmopressin
23
in new patients
120mcg and 240mcg oral lyophilisate
desmopressin (as acetate)
MELT AWAY THE MISERY OF BEDWETTING
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
DESMOMELT – SAFETY IS 5
MAINTAINED LONG-TERM
Greater bioavailabilty means DesmoMelt provides equivalent
efficacy and safety to Desmotabs at a lower dose 20
In a review of 9 trials, patients did not develop a tolerance
to desmopressin5
Long term treatment with desmopressin did not cause any
clinically significant changes in haematology, biochemistry,
blood pressure or endogenous ADH secretion5
Incidence of adverse events considered to be treatment-
related in 1,083 patients treated for six months or more
with oral or nasal desmopressin5
Headache 2% Other 3%
None 95% n=1,083
Van Kerrebroeck PEV. 2002 5
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Date of preparation: June 2011. DN/379/2011/UK
DESMOMELT – MAY BE USED
LONG-TERM
DesmoMelt may be used for as long as symptoms persist
The need for continued treatment should be assessed at
three monthly intervals, with at least one week off treatment
to see if symptoms return. Recommence if necessary
DesmoMelt dosing 24
INCREASING
ONLY IF OR
NECESSARY TO
1 x 120mcg 1 x 240mcg
at bedtime
2 x 120mcg
at bedtime
No unpleasant taste
Dissolves under the tongue
Rapidly dissolving formulation makes it difficult to spit out
DesmoMelt avoids the need for additional water
intake just before bedtime
DesmoMelt can be
used for as long as
symptoms persist –
reassess every
3 months (minimum
one week off treatment
to see if symptoms
24
return)
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
IMPORTANT SAFETY INFORMATION
Desmopressin Nasal Spray: Removal of the Primary Nocturnal Enuresis Indication
The indication for the treatment of primary nocturnal enuresis (PNE) was removed in 2006
from all spray products. Desmospray remains available for the treatment of patients with
cranial diabetes insipidus or nocturia associated with multiple sclerosis. In comparison
with oral formulations of desmopressin, nasal forms were associated with the majority of
serious adverse drug reactions (ADRs) reported in patients with PNE. Rare, serious ADRs
included hyponatraemia, water intoxication and convulsions. As the risk benefit profile of
the oral formulations is more favourable than the nasal spray, the nasal form should no
longer be used for the treatment of PNE in adults and children.
Prescribing Advice
Patients may complete their current course of treatment with desmopressin nasal spray.
At their next routine review, patients needing continued treatment should only be prescribed
an oral form of desmopressin. Regardless of the dose of spray they have been taking, all
patients starting treatment with oral desmopressin should start at the lower recommended
dose, which should only be increased if necessary to achieve control of symptoms.
Further Information
Desmopressin is a synthetic analogue of vasopressin with increased antidiuretic activity
and a prolonged duration of action in comparison with the natural peptide. The nasal spray
has greater bioavailability than the oral formulations. Both forms produce a sustained
decrease in urine output and a decrease in plasma osmolality which can result in
hyponatraemia and water intoxication in the presence of an inappropriate fluid intake.
Hyponatraemia is a rare but serious ADR. Symptoms have been reported at a rate of
approximately 15 cases per 100,000 patient years of exposure for nasal formulations
and 6 cases per 100,000 patient years for oral formulations, and has been predominantly
associated with overdose, excessive fluid intake or inappropriate use. It is not known
whether these adverse effects are dose-related but there is strong evidence of a
relationship to the formulation. Since the majority of cases of hyponatraemia occurred
with the nasal formulation in the PNE indication, only oral formulations should be used
in PNE. The risk of hyponatraemia occurring with oral desmopressin can be further reduced
by closely following the advice in the Summary of Product Characteristics (SPC) and the
Patient Information Leaflet (PIL).
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK
Summary
It is important that children suffering with PNE are identified early, and are
offered treatment intervention1,2,7
Children who wet the bed at least twice a week or more at age 5 are more
likely to continue through childhood 1
Bedwetting children may suffer low self esteem, anxiety, sadness or
depression, avoid socialisation and become withdrawn8 -10
DesmoMelt is preferred to tablets, particularly by younger children11
DesmoMelt is suitable for use in patients of 5 years and over and can be
used for as long as symptoms persist – reassess every 3 months (minimum
one week off treatment to see if symptoms return). Recommence if necessary
Prescribing Information: DesmoMelt® 120 and 240 micrograms oral lyophilisate; Desmotabs® References: 1. Butler RJ & Heron J. Scan J Urol Neph 2008; 42: 257-64.
0.2mg. Please consult the full Summaries of Product Characteristics before prescribing. 2. Yeung CK et al. BJU Int 2006; 97: 1069-1073. 3. Butler RJ et al. BJU Int 2005;
Name of Product: DesmoMelt 120 micrograms oral lyophilisate; DesmoMelt 240 micrograms 96: 404-410. 4. Government Actuary’s Department, Population Projections 2006,
oral lyophilisate; Desmotabs 0.2mg; Composition: DesmoMelt: 120 or 240 micrograms of http://www.gad.gov.uk/Demography_Data/Population/2006/uk/wuk06singyear.xls (Accessed
desmopressin (as acetate). Desmotabs: 0.2mg desmopressin acetate. Indications: Treatment 2nd February 2009). 5. van Kerrerbroeck PEV. BJU Int 2002; 89: 420-425. 6. Forsythe WI,
of primary nocturnal enuresis (5 to 65 years of age). Dosage: Children and adults (5–65 years Redmond A. Arch Dis Child 1974; 49: 259-63. 7. Hjälmås K. Acta Paediatr 1997; 86: 919-22.
of age) with normal urine concentrating ability: DesmoMelt: Initial dose of 120 micrograms 8. Hägglöf B et al. Scand J Urol Nephrol 1997; 183: 79-82. 9. Warzak WJ. Clinical Pediatrics
sublingually at bedtime and only if needed should the dose be increased to 240 micrograms 1993; 38-40. 10. Joinson C et al. J Paed Psychol 2007; 32(5): 605-616. 11. Persson B-E et al.
sublingually. Desmotabs: Initial dose of one tablet (0.2mg) at bedtime and only if needed should 15th European Urology Winter Forum, Davos, Switzerland, February 11-15, 2006. Poster 13.
the dose be increased to two tablets (a total of 0.4mg). Fluid restriction should be observed. The 12. Yeung CK et al. NEJM 2008: 358; 2414-5. 13. Läckgren G et al. Acta Pediatr 1999; 88:
need for continued treatment should be reassessed after 3 months by means of a period of at 679-90. 14. Dobson P Nocturnal enuresis. Family Medicine; 2000; December: 15-17.
least 1 week without desmopressin. Contraindications: Cardiac insufficiency and other conditions .
15. Butler RJ & Holland P Scan J Urol Nephrol 2000; 34: 270-7. 16. Monda JM et al. J Urol
requiring treatment with diuretics, moderate and severe renal insufficiency. DesmoMelt and 1995; 154: 745-78. 17. Rittig S et al. Am J Physiol 1989; 256 (Renal fluid Electrolyte Physiol 25):
Desmotabs should only be used in patients with normal blood pressure and they should not F664-F671. 18. Lawless MR. Pediatrics in Review 2001; 22(12): 399-406. 19. Rew D, Rundle JSH.
be used in patients over the age of 65. Exclude diagnosis of psychogenic polydipsia or alcohol Br J Urol 1989; 63:352-353. 20. DOF. Source: Pharmacokinetic study. Ferring Pharmaceuticals.
abuse. Special Warnings and Precautions: Take care in patients with reduced renal function 21. Stenberg A, Läckgren G. Pediatrics 1994; 94(6): 841-846. 22. Lottmann H et al. Int J Clin
and/or cardiovascular disease or cystic fibrosis. Fluid intake must be limited to a minimum from Prac 2009: 63; 1, 35–45. 23. CSD Patient Data. Cegedim Strategic Data UK Ltd, 06/2007.
1 hour before until 8 hours after administration. Care should be taken to avoid ingesting water 24. DesmoMelt SmPC, January 2006. Ferring Pharmaceuticals Ltd. Further information
while swimming. Treatment with desmopressin should be interrupted during an episode of is available from: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS.
vomiting and/or diarrhoea until their fluid balance is once again normal. Precautions to prevent Main switchboard: 0844 931 0050. Main fax: 0844 931 0051. *DesmoMelt and Desmotabs are
fluid overload must be taken in: illnesses characterized by fluid and/or electrolyte imbalance; trademarks of Ferring BV.
patients at risk for increased intracranial pressure. Side Effects: Headache, stomach pain and
nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions.
Very rare cases of emotional disturbances in children. Treatment with desmopressin without
concomitant reduction of fluid intake may lead to water retention/hyponatraemia with or without Adverse events should be reported. Reporting forms and information can be
accompanying warning symptoms of headache, nausea/vomiting, decreased serum sodium, found at www.yellowcard.gov.uk. Adverse events should also be reported to:
weight gain and in serious cases convulsions. Please consult the full Summaries of Product Medical Information, Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road,
Characteristics for further information about side effects. Basic NHS Prices: DesmoMelt: West Drayton, UB7 7PS. Tel: 0844 931 0050. Email: medical@ferring.com
Carton containing 30 oral lyophilisates in blister strips. 30 x 120 micrograms £30.34.
30 x 240 micrograms £60.68. Desmotabs: Polyethylene bottle containing 30 tablets.
£29.43. Marketing Authorisation Number: DesmoMelt: 120 micrograms 03194/0094. 240
micrograms 03194/0095. Desmotabs: 03194/0046. Marketing Authorisation Holder: Ferring
Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS. Legal Category: POM
Date of Preparation of Prescribing Information: May 2011. All trademarks registered to Ferring. www.urinecontrol.co.uk
120mcg and 240mcg oral lyophilisate
desmopressin (as acetate)
MELT AWAY THE MISERY OF BEDWETTING
Prescribing information is available on the last page. This item is intended for Healthcare Professionals only.
Date of preparation: June 2011. DN/379/2011/UK