INDICATIONS AND USAGE（适应症）

DARZALEX is indicated for the treatment of adult patients with multiple myeloma:

in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.

in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.

in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

DOSAGE（服用剂量）

Administer pre-infusion and post-infusion medications.

Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection, USP.

DARZALEX should be administered by a healthcare provider, with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur.

Type and screen patients prior to starting DARZALEX.

Recommended Dosage

Monotherapy and In Combination with Lenalidomide (D-Rd) or Pomalidomide (D-Pd) and Dexamethasone

The DARZALEX dosing schedule in Table 1 is for combination therapy (4-week cycle regimens) and monotherapy as follows:

combination therapy with lenalidomide and low-dose dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed/refractory multiple myeloma

combination therapy with pomalidomide and low-dose dexamethasone for patients with relapsed/refractory multiple myeloma

monotherapy for patients with relapsed/refractory multiple myeloma.

ADVERSE REACTIONS（不良反应）

Infusion-related reactions

Neutropenia

Thrombocytopenia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a4d0efe9-5e54-467e-9eb4-56fa7d53b60b/spl-doc?hl=darzalex

Darzalexinformation