Evaluation of the safety profile of Zolafren®, a generic olanzapine formulation, in patients with bipolar disorder: a post-authorization safety study.

Abstract

INTRODUCTION:

Prior to registration, no clinical trial evaluating safety and tolerability of Zolafren® (Adamed Sp. z o.o., Czosnów, Poland), a generic olanzapine formulation, had been performed. Therefore, the aim of this post-authorization safety study (PASS) was to evaluate the safety and tolerability of Zolafren in patients with bipolar disorder (BD).

METHODS:

Adverse events (AEs) associated with the use of Zolafren were recorded in a PASS, in an open-label, non-randomized, multicenter observational study involving 20,698 outpatients with BD.

RESULTS:

Zolafren was used in both monotherapy (82.8%) and polytherapy (17.2%) at a mean dose of 12.1±4.2 mg. The most commonly used formulation was coated tablets (70.9%). Orally dissolving tablets (19.7%) and hard capsules (9.4%) were less commonly used. During a period of 171±47 days of exposure to Zolafren, 5883 AEs were reported in 2138 patients (10.3% of the study population). None of the reported AEs were severe. Zolafren-associated AEs were the reason for discontinuation in 43 patients and the reason for dose reduction in a further 762 patients. The most common AE was weight gain (by 1.6±3.3 kg) which was considered unrelated to the dose of Zolafren. During follow-up, the percentage of patients with very good tolerance with Zolafren increased from 44.4% to 59.8%. The percentage of patients who had confidence in Zolafren also increased.

CONCLUSION:

The results of this PASS support the safety of Zolafren use and indicate a high tolerance in patients treated for BD.

FUNDING:

Adamed Sp. z o.o., Czosnów, Poland.

• Authors: Jerzy Chudek, Magdalena Olszanecka-Glinianowicz, Agnieszka Almgren-Rachtan, Tomasz Gabryelewicz
• Journal: Advances in therapy (Adv Ther) Vol. 32 Issue 5 Pg. 418-28 (May 2015) ISSN: 1865-8652 [Electronic] United States
• PMID: 25975817 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Drugs, Generic
• Tablets
• Benzodiazepines
• Olanzapine

Topics

• Adult
• Antipsychotic Agents (administration & dosage, adverse effects)
• Benzodiazepines (administration & dosage, adverse effects)
• Bipolar Disorder (drug therapy, prevention & control)
• Drugs, Generic
• Female
• Humans
• Male
• Middle Aged
• Olanzapine
• Tablets