Serdolect leave behind

Switch into a new dimension of schizophrenia treatment

Switch on Serdolect

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It is widely accepted that sedation is one of

the most common side effects of antipsychotic

medications and that excessive daytime

sleepiness is associated with significant

impairment in function and well-being.1-4

Sedation has undesirable repercussions on life quality

for patients, leading to inactivity, lethargy and a loss

of vitality, which may be interconnected related with

other common side effects such as lack of sexual

interest, weight gain and inability to concentrate.

Antipsychotic treatment may lead to

sedated patients1-4 experiencing:

Impaired cognition

Inactive life-style,risk of weight gain

Reduced libido

Factors decreasing treatment outcome

74% of schizophrenia patients discontinue treatment5


Switch off sedationSwitch on ef cacy

Serdolect has proven very effective in the

treatment of schizophrenia.8-13 Serdolect delivers

efficacy without sedation, EPS or excessive

weight gain.2-3, 6, 8-13

Serdolect is likely to enhance quality of life

providing improved cognition, maintained sexual

function and no anticholinergic side effects.2-3, 6, 12-13

Improved cognition6-7

Active on negative symptoms, 2-3 kg weight gain8-13

Maintained sexual function6

Factors improvingtreatment outcome

Switch patients onto the benefits of Serdolect


Switch off sedation

Serdolect - the only non-sedative treatment 2, 6, 12-13

Clinical ef cacy is on the same level as other second-

generation 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

Lindstrm & Levander 20063

No sedation

Mild sedation

Moderate sedation

Severe sedation

Serd

olect

Amisu

lpride

Aripi

praz

ole

Rispe

ridon

e

Zipr

asido

ne

Olan

zapin

e

Quet

iapine

Cloz

apine

Lublin et al 20052


Switch on ef cacy

Superior to risperidone on negative symptoms8

Ef cacy, PANSS positive & negative

0

-2

*p

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


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.

Slower titration and lower maintenance doses may be appropriate

Making the switch

In patients where sedation is required, a benzodiazepine may be co-administered

Switching to Serdolect15

titra

tion

dose

mai

nten

ance

dos

e

Day 1-4

Day 5-8

Day 9-12

1 tablet 4 mg

8 mg

12 mg

12 mg

16 mg

20 mg

2 tablets

3 tablets

1 tablet

1 tablet

1 tablet


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 ( 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).

H Lundbeck A/S

Ottiliavej 9, DK-2500 Valby

Copenhagen, Denmark

www.serdolect.com

June 2007

Switch off... Sedation Excessive weight gain EPS

Switch on... Ef cacy Improved cognition Maintained sexual function

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 Lindstrm 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)


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