SARCLISA

What it is

Sarclisa (isatuximab) is a 20 mg/mL concentrated injection for infusion. Isatuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that binds to a specific extracellular epitope of cluster of differentiation 38 (CD38) receptor and triggers several mechanisms leading to the death of CD38 expressing tumour cells.

Approved indications

— Treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone. — Treatment of patients with multiple myeloma who have received at least one prior therapy, in combination with carfilzomib and dexamethasone.

Dosing overview

The recommended dose of Sarclisa is 10 mg/kg body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone, or in combination with carfilzomib and dexamethasone, according to the following schedule: Cycle 1, Days 1, 8, 15 and 22 (weekly); Cycle 2 and beyond, Days 1 and 15 (every 2 weeks). Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.

Key safety warnings

Infusion reactions, mostly mild or moderate, have been observed in 38.2% of patients treated with Sarclisa in ICARIA-MM, and in 45.8% of patients treated with Isa-Kd in IKEMA. All infusion reactions started during the first Sarclisa infusion and resolved on the same day in most patients. The most common symptoms included dyspnoea, cough, chills and nausea, with the most common severe signs and symptoms including hypertension, dyspnoea and bronchospasm. Sarclisa may cause serious infusion reactions including anaphylactic reactions, and anaphylactic reactions with a fatal outcome have been reported. In patients treated with Isa-Pd, neutropenia occurred as a laboratory abnormality in 96.1% of patients and as an adverse reaction in 46.7% of patients, with Grade 3–4 neutropenia reported in 84.9% of patients as a laboratory abnormality and in 45.4% as an adverse reaction. Neutropenic complications have been observed in 30.3% of patients, including 11.8% febrile neutropenia and 25.0% neutropenic infections. A higher incidence of infections including grade ≥3 infections, mainly pneumonia, upper respiratory tract infection and bronchitis, occurred with the Sarclisa regimen. Patients receiving Sarclisa regimen should be closely monitored for signs of infection and appropriate standard therapy instituted.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

Sarclisa isatuximab 100 mg/5 mL concentrated injection vial was first listed on the ARTG on 6 May 2020, and Sarclisa isatuximab 500 mg/25 mL concentrated injection vial was first listed on 6 May 2020. This medicinal product is subject to additional monitoring in Australia.