Switch on Serdolect
®
– Switch into a
new dimension of schizophrenia treatment
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Antipsychotic treatment may lead to 1-4 experiencing:
sedated patients
Impaired cognition Inactive life-style, risk of weight gain
Reduced libido
Factors decreasing treatment outcome
74% of schizophrenia patients discontinue treatment5
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It is widely accepted that sedation is one of
Sedation has undesirable repercussions on life quality
the most common side effects of antipsychotic
for patients, leading to inactivity, lethargy and a loss
medications and that excessive daytime
of vitality, which may be interconnected related with
sleepiness is associated with significant
other common side effects such as lack of sexual
impairment in function and well-being.1-4
interest, weight gain and inability to concentrate.
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Switch off sedation Switch on efďŹ cacy Improved cognition 6-7 Active on negative symptoms, 2-3 kg weight gain8-13
Maintained sexual function6
Factors improving treatment outcome
Switch patients onto the benefits of Serdolect Serdolect has proven very effective in the
Serdolect is likely to enhance quality of life
treatment of schizophrenia.8-13 Serdolect delivers
providing improved cognition, maintained sexual
efficacy without sedation, EPS or excessive
function and no anticholinergic side effects.2-3, 6, 12-13
weight gain.2-3, 6, 8-13
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Switch off sedation
Se
rd o
lec
Am t ® isu lp rid Ar e ip ip ra zo Ri le sp er id on Zi e pr as id on O e l an za pi ne Q ue tia pi ne Cl oz ap in e
Serdolect - the only non-sedative treatment 2, 6, 12-13
No sedation Mild sedation Moderate sedation Severe sedation
Lublin et al 20052
“Clinical efficacy is on the same level as other secondgeneration compounds, but with potential superiority
for effects on cognition because of the freedom of sedative effects and no need for anticholinergic control of side effects” Lindström & Levander 20063
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Switch on efficacy Superior to risperidone on negative symptoms8 Efficacy, PANSS positive & negative Positive subscale
Mean change from baseline to final (ITT)
0
LOCF
OC
Negative subscale LOCF
OC
-2 -4 -6 -8 -10
* ** Serdolect, 12-24 mg/day (n=98)
-12 Risperidone, 4-10 mg/day (n=89) *p<0.05 vs. risperidone **p<0.001 vs. risperidone Azorin et al 20068
“Serdolect® demonstrated clinically relevant efficacy advantages over risperidone” Azorin et al 20068
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Switch life back on Switch to non-sedative treatment – switch to active patients Frank was 20 when he was diagnosed with paranoid-type schizophrenia. He has previously been treated with several conventional antipsychotic agents, suffering from common side effects: EPS, cognitive impairment and sedation. In addition, he has been taking antidepressant medication and he had to give up work due to severe social and occupational dysfunction.
Today Frank is 27 and after switching to Serdolect, he has noticed improvements in memory and concentration. He does no longer take antidepressant medication. Frank describes himself as feeling more relaxed, in a better mood, more realistic and more ‘like other people’. He has even started a new job, which he is enjoying a lot. Schuck et al 200414
Cathrine, 24, was treated with olanzapine for 5 months in 2003. In this period she was feeling apahtic, had no motivation, and was treated concomitantly with an antidepressant. Cathrine was overweight before she began therapy and she continued to gain weight during treatment.
After witching to Serdolect there was a rapid reduction in depressive symptoms and antidepressant medication was discontinued. She also experienced improvements in attention, concentration and vocational functioning. She was even able to address her pre-existing weight problem by seeking dietary advise. Schuck et al 200414
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Making the switch Switching to Serdolect速15 Once daily, with or without meals Adults: All patients should be started on Serdolect 4 mg/day The dose should be increased by increments of 4 mg after 4-5 days on each dose until the optimal daily maintenance dose of 12-20 mg is reached Elderly (over 65 years): Treatment should only be initiated after a thorough cardiovascular examination.
maintenance dose
titration dose
Slower titration and lower maintenance doses may be appropriate
Day 1-4
1 tablet
4 mg
Day 5-8
2 tablets
8 mg
Day 9-12
3 tablets
12 mg
1 tablet
12 mg
1 tablet
16 mg
1 tablet
20 mg
In patients where sedation is required, a benzodiazepine may be co-administered
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Switch on... Efficacy Improved cognition Maintained sexual function
Switch off... Sedation Excessive weight gain EPS
Presentation: Tablets of 4, 12, 16 or 20 mg. Indication: Treatment of schizophrenia. Due to cardiovascular safety concerns, sertindole should only be used for patients intolerant to at least one other antipsychotic agent. Not for urgent relief of symptoms in acutely disturbed patients. Switching from other antipsychotics: Treatment can be initiated according to the recommended titration schedule concomitantly with cessation of other oral antipsychotics, or in place of the next depot injection. ECG monitoring: Mandatory prior to and during treatment with Serdolect®. ECG monitoring should be conducted at baseline, upon reaching steady state after approximately 3 weeks or when reaching 16 mg and again after 3 months of treatment. During maintenance therapy an ECG is required every 3 months. Dosage and administration: Once daily with or without meals. In patients where sedation is required, a benzodiazepine may be co-administered. Adults: All patients should be started on sertindole 4 mg/day. The dose should be increased by increments of 4 mg after 4-5 days on each dose until the optimal daily maintenance dose within the range of 12-20 mg is reached. Only in exceptional cases should the maximum dose of 24mg be considered. Elderly (> 65 years): Treatment should only be initiated after a thorough cardiovascular examination. Slower titration and lower maintenance doses may be appropriate. Children and adolescents (< 18 years): Not recommended. Re-titration: Not required if patients have been without Serdolect® for less than a week. Otherwise the recommended titration schedule should be followed. Contraindications: Prescribing physicians should comply fully with the required safety measures. Hypersensitivity to sertindole or any of the excipients. Known uncorrected hypokalaemia or hypomagnesaemia. History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia, or bradycardia (<50 beats per minute). Congenital long QT syndrome (or family history of this disease), or known acquired QT interval prolongation. Pregnancy. Severe hepatic impairment. Drugs known to significantly prolong the QT interval: e.g. class I a and III antiarrhythmics, antipsychotics, macrolides, antihistamines, quinolone antibiotics, cisapride, and lithium. Drugs known to potently inhibit hepatic cytochrome P450 3A enzymes: e.g. ‘azole’ antifungal agents (systemic treatment), macrolide antibiotics, HIV protease inhibitors, calcium channel blockers, and cimetidine. Special precautions: Mild/moderate hepatic dysfunction. Risk of significant electrolyte disturbances: e.g. experiencing vomiting or diarrhoea, potassium depleting diuretic use. Parkinson’s disease. Elderly > 65 years. Known poor metabolisers of CYP2D6. History of seizures. Breast-feeding. Dopamine agonists. Some SSRIs: e.g. fluoxetine, paroxetine (potent CYP2D6 inhibitors). Agents known to induce CYP isozymes: e.g. rifampicin, carbamazepine, phenytoin, phenobarbital. Adverse events: >10%: Rhinitis/nasal congestion. 1-10%: Decreased ejaculatory volume, dizziness, dry mouth, postural hypotension, weight gain, peripheral oedema, dyspnoea, paraesthesia, and prolonged QT interval. Overdose: Symptoms have included somnolence, slurred speech, tachycardia, hypotension, and transient prolongation of the QTc interval. Cases of Torsade de Pointes have been observed, often in combination with other drugs known to induce TdP. Treatment: There is no specific antidote to sertindole, and it is not dialysable, therefore appropriate supportive measures should be instituted. Adrenaline and dopamine should be used with caution (may worsen hypotension).
References: 1 Hawley CJ. Int J Psych Clin Pract 2006, 10 (2): 117-123 2 Lublin et al. Int Clin Psychopharmacol 2005, 20: 183-198 3 Lindström E & S Levander. Expert Opin Pharmacother 2006, 7 (13): 1825-1834 4 APA Practice Guidelines: Treatment of Patients with Schizophrenia 2004, 2nd Edition: 1-114 5 Lieberman et al. N Engl J Med 2005, 353: 1209-1223 6 Perquin L & T Steinert. CNS Drugs 2004, 18 (Suppl 2): 19-30 7 Lis et al. Eur Neuropsychopharmacol 2003, 13 (Suppl 4): S323-S324 8 Azorin et al. Int Clin Psychopharmacol 2006, 21: 49-56 9 Hale et al. Int J Psych Pract 2000, 4: 55-62 10 Zimbroff et al. Am J Psychiatry 1997, 154: 782-791 11 Tamminga et al. Int Clin Psychopharmacol 1997, 12 (Suppl 1): S29-S35 12 Murdoch D & GM Keating. CNS Drugs 2006, 20 (3): 233-255 13 Tamminga CA. Pocket Pharma. Sertindole and Schizophrenia. CMG: 1-65 14 Schuck et al. CNS Drugs 2004, 18 (2): 31-40 15 Summary of Product Characteristics (SPC)
H Lundbeck A/S Ottiliavej 9, DK-2500 Valby Copenhagen, Denmark www.serdolect.com June 2007
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