Isatuximab subcutaneous injection is a CD38-targeting cytolytic antibody used in combination therapy for multiple myeloma.
I. Indications
1. Relapsed or Refractory Multiple Myeloma
(1) Isatuximab subcutaneous injection in combination with pomalidomide and dexamethasone is indicated for adult patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
(2) Isatuximab subcutaneous injection in combination with carfilzomib and dexamethasone is indicated for adult patients with relapsed or refractory disease who have received 1 to 3 prior lines of therapy.
2. Newly Diagnosed Multiple Myeloma
This product in combination with bortezomib, lenalidomide, and dexamethasone is indicated for adult patients with newly diagnosed disease who are not eligible for autologous stem cell transplantation.
II. Dosage and Administration
1. Route of Administration and Dose
(1) This product is for subcutaneous injection in the abdomen only. The recommended fixed dose is 1,400 mg (i.e., 10 mL solution). Do not administer intravenously.
(2) Each injection must be administered by a healthcare professional, using either the CirCLIQ® on-body delivery system or a manual syringe (with an infusion set).
2. Dosing Frequency in Combination Regimens
(1) In combination with pomalidomide/dexamethasone or carfilzomib/dexamethasone: Cycle 1 (28 days) – once weekly on Days 1, 8, 15, and 22; from Cycle 2 onward – once every 2 weeks on Days 1 and 15.
(2) In combination with bortezomib/lenalidomide/dexamethasone: Cycle 1 – once weekly; Cycles 2 to 12 – once every 2 weeks; from Cycle 13 onward – once every 4 weeks on Day 1.
(3) Treatment continues until disease progression or unacceptable toxicity.
3. Management of Missed Doses
If a planned dose is missed, administer it as soon as possible and adjust the subsequent dosing interval accordingly, while maintaining the original cycle duration.
III. Pre‑administration Preparations and Administration Procedures
1. Premedication Requirements
(1) Before each injection, 15 to 60 minutes prior, administer dexamethasone (dose adjusted according to the combination regimen and patient age), a leukotriene receptor antagonist (for Cycle 1 only), acetaminophen, and an antihistamine (e.g., diphenhydramine) to reduce the risk of systemic reactions.
(2) If no reaction occurs during Cycle 1, premedication may be omitted in subsequent cycles at the physician's discretion.
2. Preparation and Storage of the Solution
(1) After removing the vial from refrigeration, allow it to stand at room temperature (18‑28°C) for approximately 20 minutes. Do not heat or shake.
(2) After puncture, the injection must be completed within 4 hours; any unused solution should be discarded.
(3) The solution should be clear to slightly opalescent, colorless to slightly yellow, and may contain a small amount of translucent particles, which is normal. Do not use if turbid or discolored.
3. Injection Site and Technique
(1) Abdomen only. Change the injection site each time (at least 2.5 cm from the previous site), avoiding the 2‑inch area around the navel and skin with lesions, redness, scarring, or excessive hair.
(2) For manual injection, insert the needle quickly at a 45° angle and complete the push over approximately 6 minutes. If pain occurs, pause or slow down the rate; if needed, switch to the opposite side of the abdomen to complete the remaining dose.
