Zypadhera ® (olanzapin)

För fullständig produktresumé för Zypadhera® se FASS.

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ZypAdhera® (olanzapinpamoat): Effekt av rökning

Dosen behöver inte anpassas till rökare i allmänhet, men rökning har en liten till måttlig effekt på olanzapins plasmakoncentration.

Label information

The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.1

The metabolism of olanzapine may be induced by smoking. Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary.1

When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose. When indicated, dose escalation should be performed with caution in these patients.1

Effect of smoking

The plasma concentration of olanzapine is influenced by individual factors such as smoking.2-4

Smoking increases the clearance of olanzapine, thereby resulting in lower average steady-state plasma concentrations. The distribution of olanzapine plasma concentration in smokers was somewhat greater after oral dosing than after olanzapine LAI dosing.3,4

Pharmacokinetic consideration

Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.1

The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations. Only slight to moderate increase in olanzapine clearance has been oberved. The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary.1

Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/hr) versus males (27.3 l/hr), and in non-smokers (18.6 l/hr) versus smokers (27.7 l/hr). Similar pharmacokinetic differences between males and females and smokers and non-smokers were observed in olanzapine pamoate clinical trials. However, the magnitude of the impact of gender, or smoking on olanzapine clearance is small in comparison to the overall variability between individuals.1

References

1. ZypAdhera [summary of product characteristics] Eli Lilly Netherland B.V., The Netherlands.

2. Callaghan JT, Bergstrom RF, Ptak LR, Beasley CM. Olanzapine. Pharmacokinetic and pharmacodynamic profile. Clin Pharmacokinet. 1999;37(3):177-193. http://dx.doi.org/10.2165/00003088-199937030-00001

3. Heres S, Kraemer S, Bergstrom RF, Detke HC. Pharmacokinetics of olanzapine long-acting injection: the clinical perspective. Int Clin Psychopharmacol. 2014;29(6):299-312. http://dx.doi.org/10.1097/yic.0000000000000040

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

LAI = long-acting injection

Datum fӧr senaste ӧversyn 2018 M04 12

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