The difficulties of supplying the Zypadhera (Olanzapine) have worsened to the point that the date of delivery is now “Indeterminated”The National Medicines Safety Agency (ANSM) announced on Wednesday 13 on Wednesday 13. This atypical antipsychotic, known as second generation, has experienced supplies of supplies in Europe since May 2024.
The zypadhera (injectable olanzapine prolonged liberation) is indicated in the treatment of maintaining schizophrenic adult patients sufficiently stabilized by oral olanzapine. He is administered in the hospital.
The ANSM written in a press release having been “Informed by the CHEPLAPHARM Laboratory of supplies of supplies in ZYPADHERA, linked to additional manufacturing and supply chain difficulties on its production site”. Moreover, “Two lots could not be marketed due to a quality defect, which accentuates tensions” supply, adds the health agency. Tensions mainly concern 300 mg and 405 mg dosages.
The laboratory, which was planned in July to make the drug available from September 2025, said that the date of resumption of supplies remained for the time being “Indeterminated”.
Do not initiate new treatments
The agency asks doctors to no longer start new treatments with Zypadhera, so that patients already under treatment can continue to benefit from it.
She also asks them to consider switching to the oral form of Olanzapine for patients in whom this is possible, or to consider another antipsychotic if an injectable form with prolonged action is necessary.
For the Zypadhera (Injectable Olanzapine) relay to oral olanzapine, the ANSM specifies that Zypadhera “Ensures a slow and continuous release of Olanzapine which extends about six to eight months after the last injection.” So, “A very low dose of oral olanzapine can be initiated on the date initially planned for the next injection, with attentive clinical monitoring, in particular during the first two months following the passage of the zypadhera to oral olanzapine”. The titration is then gradually adapted according to the evolution of the patient (clinical response and tolerance) after stopping Zypadhera.
Favor the relay by oral olanzapine
When the use of an injectable antipsychotic to prolonged release is essential and that a zypadhera (injectable olanzapine) relay to another antipsychotic is envisaged, it is recommended to perform “First a relay to the oral form of the new antipsychotic to assess the tolerance of the patient and the effectiveness of the drug before prescribing the injectable form of this antipsychotic”, underlines the agency. The recommendations are the same as for the relay to oral olanzapine: a very low dose of the new antipsychotic by oral route can be initiated on the initially planned date of the following injection of Zypadhera, with attentive monitoring, in particular during the first two months following the passage of the zypadhera to the new antipsychotic.
ANSM adds that, given the prolonged duration of action of the Zypadhera, it is “Generally preferable to favor a relay by oral olanzapine rather than a change of molecule, especially if a return under Zypadhera is considered later”.
ZYPADHERA 300 mg imported drugs have been made available since June 2025 in a transitory and exceptional manner to meet the needs of patients in France, according to the ANSM.
The difficulties of supplying psychotropic drugs persist in France, especially for Quetiapine, a neuroleptic often prescribed to treat schizophrenia, bipolarity and certain depressions.
