Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record batch number as well.

IRRs
IRRs have been reported in patients receiving elotuzumab (see section 4.8).

Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and paracetamol must be administered prior to Empliciti infusion (see section 4.2 Premedication). The rate of IRRs was much higher in patients who were not premedicated.

If any of the symptoms of IRR reach Grade ≥ 2, Empliciti infusion must be interrupted and appropriate medical and supportive measures instituted. Vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion. Once the reaction has resolved (symptoms ≤ Grade 1),
Empliciti can be restarted at the initial infusion rate of 0.5 mL/min. If symptoms do not recur, the infusion rate may be gradually escalated every 30 minutes to a maximum of 5 mL/min (see section 4.2 Method of administration).

Very severe IRRs may require permanent discontinuation of Empliciti therapy and emergency treatment. Patients with mild or moderate IRRs may receive Empliciti with a reduced infusion rate and close monitoring (see section 4.2 Method of administration).

Conditions for use of medicinal products used with Empliciti
Empliciti is used in combination with other medicinal products; therefore, the conditions for use applicable to those medicinal products also apply to the combination therapy. The prescribing information leaflets for all medicinal products used in combination with Empliciti must be consulted before starting therapy.

Infections
In clinical trials of patients with multiple myeloma, the incidence of all infections, including pneumonia, were higher in patients treated with Empliciti (see section 4.8). Patients should be monitored and infections should be managed with standard treatment.

Second primary malignancies (SPMs)
In a clinical trial of patients with multiple myeloma that compared Empliciti combined with lenalidomide and dexamethasone treatment to lenalidomide and dexamethasone treatment (CA204004), the incidence of SPMs, and specifically of solid tumours and non-melanoma skin cancer, was higher in patient treated with Empliciti (see section 4.8). SPMs are known to be associated with lenalidomide exposure, which was extended in patients treated with Empliciti combined with lenalidomide and dexamethasone vs. lenalidomide and dexamethasone. The rate of haematologic malignancies was the same between the two treatment arms. Patients should be monitored for the development of SPMs.

Excipients
This medicinal product contains 3.92 mg sodium per 300 mg vial or 5.23 mg sodium per 400 mg vial, which is equivalent to 0.2% or 0.3% respectively, of the WHO recommended maximum daily intake of 2 g sodium for an adult.

 

Effects on Driving

4.7    Effects on ability to drive and use machines

On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines. Patients experiencing IRRs should be advised not to drive and use machines until symptoms abate.