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REISAMIC: Expertise Focused on the Side Effects of Immunotherapy
Immunotherapies have revolutionized the treatment of many cancers. Like any treatment, they can cause specific adverse effects. To better identify and manage these effects, Gustave Roussy has developed REISAMIC (Registry of Severe Adverse Effects of Immunomodulatory Monoclonal Antibodies in Oncology), a reference system dedicated to monitoring and managing immunotherapy-related toxicities.
Why a specific mechanism?
Immunotherapies work by stimulating the immune system. In some cases, this stimulation can lead to inflammatory reactions affecting various organs in the body. These side effects require special management, different from that used for chemotherapy or targeted therapies.
Expertise in the Side Effects of Immunotherapy
At Gustave Roussy, care is based on:
- a network of referring specialists;
- specific guidelines;
- a national pharmacovigilance registry (REISAMIC);
- a dedicated multidisciplinary consultation meeting (RCP) (ImmunoTox).
Key Takeaways
Most side effects associated with immunotherapy are reversible when detected and treated promptly. Any new symptoms should be reported to your healthcare team.
What side effects might occur?
The most common side effects
- fatigue;
- skin reactions;
- diarrhea or digestive problems;
- hormonal disorders;
- joint or muscle pain.
Rarer complications may also occur
Certain inflammatory reactions may affect the lungs, liver, kidneys, or other organs and require specific treatment.
When should you contact your healthcare team?
Any new or unusual symptoms that occur during immunotherapy treatment should be reported promptly to your healthcare team.
How does REISAMIC support patients?
REISAMIC relies on a network of experts and specialists dedicated to improving the detection, assessment, and management of adverse effects associated with immunotherapies.
Coordinated Care
To ensure the best possible follow-up, Gustave Roussy has established a system that brings together various specialists based on the symptoms observed. This expertise relies in particular on a network of referring physicians and on consultation meetings dedicated to immunotherapy-related toxicities.
How are complex cases discussed?
Specific cases may be reviewed during specialized multidisciplinary consultation meetings that bring together experts in immunological toxicities and the healthcare professionals involved in the patient’s care.
A unique research and monitoring program
REISAMIC is also a national registry that collects and analyzes data on adverse effects associated with immunomodulatory monoclonal antibodies used in oncology. This information helps improve our understanding of these toxicities and optimize their management.
Definition
Pharmacovigilance
Pharmacovigilance involves monitoring, evaluating, and preventing adverse drug reactions in order to improve patient safety.
Frequently Asked Questions
Side effects do occur, but their nature and frequency vary depending on the treatment and the patient. Most are reversible when treated promptly.
Any new or unusual symptoms that develop during treatment should be reported immediately to your healthcare team.
Data collection helps us better understand the side effects associated with immunotherapies and improve their management for current and future patients.
How does REISAMIC work?
The data are entered by healthcare professionals participating in the REISAMIC network. They are then analyzed by teams of experts in immunotherapy-related toxicities.
They help improve treatment safety, provide a better understanding of observed side effects, and advance knowledge for the benefit of current and future patients.
To access the registry’s web portal, you must have a username and password, which are provided by the Pharmacovigilance Unit at Gustave Roussy.
Once you have received your login credentials, type “reisamic.fr” into your browser’s address bar to access the registry’s web portal.
This access allows you to enter information about your patients and to view all data recorded by your colleagues regarding adverse events that have occurred in patients treated at your facility.
A user manual is available on the web platform’s home page to guide you through the data entry process.
You can also report adverse effects to us by email.
Is the causal relationship uncertain? Is there limited documentation on the case? Is the event unusual? Please don’t hesitate to report the case.
Contact us!
For any additional information about the registry, to obtain login credentials, or to report cases, please feel free to contact the Pharmacovigilance Unit at Gustave Roussy by email.