Isatuximab

SARCLISA is indicated: - in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

1). - in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. - in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

and 7 WARNINGS and PRECAUTIONS, General). 3 Pharmacokinetics, Geriatrics). No dose adjustment is recommended in patients with mild hepatic impairment. 3 Pharmacokinetics, Hepatic Insufficiency). 3 Pharmacokinetics, Renal Insufficiency).

SARCLISA (isatuximab for injection) Page 8 of 54 Internal Temporary interruption or definitive discontinuation of Sarclisa treatment may be required for infusion-related reactions (IRRs) or neutropenia; no dose reduction of Sarclisa is recommended (Table 3).

03 criteria definition Administration adjustment Infusion-related reactions (IRRs) Mild (Grade 1): Infusion interruption or intervention not indicated • Continue Sarclisa infusion per the judgment of the physician with close direct monitoring of the patient’s clinical status.

• Sarclisa infusion may be stopped at any time if deemed necessary. , antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 hours • Stop Sarclisa infusion. • Give additional medication with diphenhydramine 25 mg IV (or equivalent) and/or IV methylprednisolone 100 mg (or equivalent) as needed.

SARCLISA is indicated: - in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

1). - in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. - in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.