isatuximab: clinical use

Prescribing considerations

• Specialist initiation and administration are required.
• Use premedication and ensure appropriate support is available for administration reactions.
• Assess infection risk and consider antibacterial and antiviral prophylaxis according to clinical circumstances.
• Give the Patient Card and explain interference with blood-bank and myeloma-response testing.
• Data are limited in very elderly people and in moderate or severe hepatic impairment.
• Subcutaneous exposure may be reduced in patients weighing more than 120 kg.

Contraindications and cautions

• Hypersensitivity to isatuximab or any formulation excipient.
• Use caution with active infection, clinically significant cytopenias, tumour lysis risk or previous severe administration reactions.
• When combined with carfilzomib, assess relevant cardiac history and symptoms.

Monitoring

• Full blood count, particularly neutrophils and platelets
• Signs and symptoms of infection
• Vital signs and administration reactions
• Tumour lysis risk and relevant biochemical markers
• Development of second primary malignancies
• Cardiac and respiratory symptoms when used with carfilzomib
• Blood group and antibody screen before starting; notify transfusion services after treatment begins
• Possible interference with serum electrophoresis and immunofixation when assessing response

Clinical pharmacology

IgG1 monoclonal antibody targeting an extracellular CD38 epitope. Activity includes antibody-dependent cellular cytotoxicity and phagocytosis, complement-dependent cytotoxicity, direct apoptosis and inhibition of CD38 enzymatic activity.

Formulation and product differences

• The intravenous product is a concentrate requiring dilution and administration through a filtered infusion line.
• The subcutaneous product is a ready-to-use solution for abdominal injection using the specified delivery system or manual administration equipment.
• The formulations are not interchangeable at preparation: labels and route must be checked carefully.
• Systemic administration reactions occur less often with subcutaneous than intravenous administration; local injection-site reactions can occur with the subcutaneous formulation.

Solution for infusion

Route: Intravenous

Strengths: 20 mg/mL

Injection

Route: Parenteral

Strengths: 1400 mg