Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability

In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Infections

Administration of satralizumab should be delayed in patients with an active infection until the infection is controlled (see section 4.2).

Vigilance for the timely detection and diagnosis of infection is recommended for patients receiving treatment with satralizumab. Treatment should be delayed in case the patient develops any serious or opportunistic infection and appropriate therapy should be initiated under further monitoring. Patients should be instructed on seeking early medical attention in case of signs and symptoms of infections to facilitate timely diagnosis of infections. Patients should be provided with a patient alert card.

Vaccinations

Live and live-attenuated vaccines should not be given concurrently with satralizumab as clinical safety has not been established. The interval between live vaccinations and initiation of satralizumab treatment should be in accordance with current vaccination guidelines regarding immunomodulatory or immunosuppressive agents.

No data are available on the effects of vaccination in patients receiving satralizumab. It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating satralizumab treatment.

Liver enzymes

Mild and moderate elevations of liver transaminases have been observed with satralizumab treatment, most elevations were below 5 x ULN (see section 4.8).

ALT and AST levels should be monitored every four weeks for the first three months of treatment, followed by every three months for one year, thereafter as clinically indicated.

Treatment with satralizumab should be discontinued in patients with ALT or AST >5 x ULN (see section 4.2).

Neutrophil count

Decreases in neutrophil counts have occurred following treatment with satralizumab (see section 4.8).
Neutrophil counts should be monitored 4 to 8 weeks after start of treatment and thereafter as clinically indicated. For recommended dose interruption see section 4.2.

Effects on Driving

4.7    Effects on ability to drive and use machines

Enspryng has no or negligible influence on the ability to drive and use machines.