Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Summary of the safety profile

The most common adverse reaction in heavily treatment experienced adult patients with HIV was nausea (4%).

Tabulated list of adverse reactions
A tabulated list of adverse reactions is presented in Table 3. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).

Table 3: Tabulated list of adverse reactions

Frequencya                          Adverse reaction
Immune system disorders
Not known                          immune reconstitution inflammatory syndrome Gastrointestinal disorders
Common                              nausea a     Frequency based on all patients (Cohorts 1 and 2) in CAPELLA (see section 5.1).

Description of selected adverse reactions

Immune Reconstitution Inflammatory Syndrome
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).



Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

You can report any side effects to the Ministry of Health by clicking on the link "Report side effects due to medical treatment" that is located on the Ministry of Health homepage (www.health.gov.il) which redirects to the online form for reporting side effects or by clicking on the link: https://sideeffects.health.gov.il.