Table 2 Suggested monitoring pattern and AEs management strategiesa
Time | What to do | Results | Possible strategies |
|---|---|---|---|
I Step | General and neurological examination (weight, waist circumference, blood pressure…) | Normal | Plan a careful and tailored monitoring program/psychoeducation on drug side effects/healthy lifestyle, including diet and, when possible, exercise |
Baseline | |||
Abnormal | |||
Careful anamnestic interview about personal and familiar history of: Dyslipidemia, DM2, Obesity, Thyroid dysfunction, Arrythmogenic risk (sudden death, syncope, Prolonged QTc, Brugada syndrome) | Negative History | Regular monitoring | |
Positive History | Plan a careful and close monitoring program/psychoeducation on drug side effects/healthy lifestyle/ECG (see below) | ||
Blood examination for haemachrome, liver function, glucose, insulin and lipid profile, (thyroid function and PRL if possible) | Normal | Regular monitoring/healthy lifestyle | |
Glucose, transaminases, insulin and/or lipids significantly increased | Careful and close monitoring/psychoeducation/chose a SGA with lower metabolic impact | ||
ECG (in case of Ziprasidone or positive personal or familiar history) | Normal ECG and QTc<450 msec | Monitoring | |
QTc>450 msec or other arrythmogenic signs | Discuss with paediatric cardiologist about the cardiac safety and the risk- benefit ratio in starting a SGA/if possible chose another drug class or a SGA with lower impact on QTc | ||
II Step | Weight and waist circumference monitoring | Weight gain <7 % of baseline weight | Regular monitoring/healthy lifestyle |
1 month control | |||
Weight gain >7 % of baseline weight | Careful and close monitoring/Healthy lifestyle/Psychoeducation/if possible switch to another SGA | ||
Blood examination for haemachrome, liver function, glucose, insulin and lipid profile | Normal | Regular monitoring/healthy lifestyle | |
Glucose, transaminases, insulin and/or lipids significantly increased | Careful and close monitoring/Healthy lifestyle interventions/Psychoeducation/if possible switch to another SGA | ||
PRL related symptoms (galactorrhea, increased breasts volume, sexual dysfunction…) monitoring | - symptoms | Regular monitoring | |
+ symptoms | Blood prolactin determination/if possible lower the SGA dose/if possible switch to another SGA/if possible add Aripiprazole/discuss with paediatric endocrinologist the possible add on of a prolactin-lowering drug (cabergoline or bromocriptine) | ||
EPS and other neurological symptoms monitoring | - EPS | Regular monitoring | |
+ EPS | If possible lower dose/if possible add on anticholinergics or benzodiazepines | ||
NMS symptoms | Hospitalization | ||
ECG (in case of Ziprasidone or positive personal of family history) | Normal ECG and QTc<450 msec | Regular monitoring | |
QTc>450 msec or increase from 60 msec from baseline or other arrythmogenic signs | Discuss with paediatric cardiologist about the cardiac safety and the risk- benefit ratio in continuing a SGA/possible SGA discontinuation | ||
III Step | Weight and waist circumference monitoring | Weight gain <7 % of baseline weight | Regular monitoring/healthy lifestyle |
3-, 6- month and periodic (every 6 months) | |||
Weight gain still increasing | Careful and close monitoring/Healthy lifestyle/Psychoeducation/if possible switch to another SGA | ||
Blood examination for haemachrome, liver function, glucose, insulin and lipid profile | Normal | Regular monitoring/healthy lifestyle | |
Glucose, transaminases, insulin and/or lipids significant increased | Careful and close monitoring/Healthy lifestyle interventions/Psychoeducation/if possible switch to another SGA | ||
PRL blood determination | Normal PRL | Regular monitoring | |
PRL↑- associated symptoms | Careful and close monitoring/if possible lower SGA dose/if possible switch to another SGA/if possible add Aripiprazole/discuss with pediatric endocrinolgist to add on cabergoline or bromocriptine | ||
PRL↑ + associated symptoms | |||
EPS and other neurological symptoms monitoring | - EPS | Regular monitoring | |
+ EPS | If possible lower dose/if possible add on anticholinergic or benzodiazepines | ||
NMS symptoms | Hospitalization | ||
ECG (if possible and feasible; mandatory in case of Ziprasidone or positive personal of family history) | Normal ECG and QTc<450 msec | Regular monitoring | |
QTc>450 msec or increase from 60 msec from baseline or other arrythmogenic signs | Discuss with paediatric cardiologist about the cardiac safety and the risk benefit ratio of SGA continuation/possible SGA discontinuation |