EMPLICITI

What it is

Empliciti contains elotuzumab. Elotuzumab is a humanised recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Empliciti is available as 300 mg and 400 mg powder for concentrate for solution for intravenous infusion.

Approved indications

— Multiple myeloma in patients who have received at least one prior therapy, in combination with lenalidomide and dexamethasone.

Dosing overview

The recommended dose of Empliciti is 10 mg/kg administered intravenously every week (28-day cycle), on days 1, 8, 15, and 22 for the first two cycles and every 2 weeks thereafter on days 1 and 15 when administered with lenalidomide and dexamethasone. Patients must receive premedication before each dose of Empliciti. Premedication should include 8 mg intravenous dexamethasone, diphenhydramine (25–50 mg orally) or equivalent H1 blocker, ranitidine (50 mg intravenous or 150 mg oral) or equivalent H2 blocker, and paracetamol (650–1000 mg orally) administered 45–90 minutes prior to Empliciti infusion.

Key safety warnings

Empliciti can cause infusion reactions. The frequency of infusion reactions was much higher in patients who were not premedicated. The incidence of infections, including pneumonia, was higher with Empliciti treatment than with control; infections were reported in 81.4% of patients in the Empliciti combined with lenalidomide and dexamethasone arm and 74.4% in lenalidomide and dexamethasone. Grade 3–4 infections were noted in 28% and 24.3% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively. Monitor patients for development of infections and treat promptly. The need for anti-viral, or pneumocystis jiroveci pneumonia prophylaxis should be assessed on a case by case basis by the treating physician in accordance with local treatment policies. In a clinical trial, invasive second primary malignancies have been observed in 6.9% of patients treated with Empliciti combined with lenalidomide and dexamethasone and 4.1% of patients treated with lenalidomide and dexamethasone. Solid tumours were reported in 2.5% and 1.9% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively. Non-melanoma skin cancer was reported in 3.1% and 1.6% of patients treated with Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone, respectively. Monitor patients for the development of second primary malignancies. Elevations in liver enzymes consistent with hepatotoxicity were reported in 2.5% of Empliciti combined with lenalidomide and dexamethasone treated patients and 0.6% of lenalidomide and dexamethasone treated patients in a clinical trial. Monitor liver enzymes periodically. Stop Empliciti upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.

Contraindications

Empliciti should not be administered to patients with known hypersensitivity to the active substance elotuzumab or to any of the excipients. Empliciti is used in combination with other medicinal products; therefore, the contraindications applicable to those medicinal products also apply to Empliciti combination therapy.

PBS listing

Empliciti 300 mg powder for injection is listed on the PBS with 2 items. Authority required restriction applies. The ex-manufacturer price is A$1237.51.

Regulatory history

Empliciti was approved by the TGA on 12 September 2016. The 300 mg and 400 mg lyophilised powder formulations were first listed on the ARTG on 22 September 2016. The PBAC recommended Empliciti in July 2021 for the treatment of relapsed and/or refractory multiple myeloma.