INDICATIONS AND USAGE（适应症）

Relapsed or Refractory Multiple Myeloma

Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with:

Lenalidomide and dexamethasone or dexamethasone or daratumumab and dexamethasone.

Kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

DOSAGE（服用剂量）

Kyprolis in Combination with Lenalidomide and Dexamethasone

Administer Kyprolis intravenously as a 10-minute infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle in combination with lenalidomide and dexamethasone until Cycle 12. The recommended starting dose of Kyprolis is 20 mg/m2 on Cycle 1, Days 1 and 2. If tolerated, escalate the dose to 27 mg/m2 on Cycle 1, Day 8. From Cycle 13, administer Kyprolis on Days 1, 2, 15, 16 until Cycle 18. Discontinue Kyprolis after Cycle 18. Continue lenalidomide and dexamethasone until disease progression or unacceptable toxicity occurs.

Kyprolis in Combination with Dexamethasone

Twice weekly 20/56 mg/m2 regimen by 30-minute infusion

Administer Kyprolis intravenously as a 30-minute infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle in combination with dexamethasone until disease progression or unacceptable toxicity. The recommended starting dose of Kyprolis is 20 mg/m2 on Cycle 1, Days 1 and 2. If tolerated, escalate the dose to 56 mg/m2 on Cycle 1, Day 8. Administer dexamethasone 30 minutes to 4 hours before Kyprolis. Refer to the Prescribing Information for dexamethasone for additional dosage information.

Kyprolis in Combination with Intravenous Daratumumab and Dexamethasone

Twice weekly 20/56 mg/m2 regimen by 30-minute infusion

Administer Kyprolis intravenously as a 30-minute infusion on Days 1, 2, 8, 9, 15 and 16 of each 28-day cycle in combination the intravenous daratumumab and dexamethasone until disease progression or unacceptable toxicity. The recommended starting dose of Kyprolis is 20 mg/m2 on Cycle 1, Days 1 and 2. If tolerated, escalate the dose to 56 mg/m2 on Cycle 1, Day 8 and thereafter. Administer dexamethasone 30 minutes to 4 hours before Kyprolis and 1 to 3 hours before intravenous daratumumab.

Kyprolis Monotherapy

20/27 mg/m2 twice weekly regimen by 10-minute infusion

Administer Kyprolis intravenously as a 10-minute infusion. In Cycles 1 through 12, administer Kyprolis on Days 1, 2, 8, 9, 15 and 16 of each 28-day cycle as shown in Table 6. From Cycle 13, administer Kyprolis on Days 1, 2, 15 and 16 of each 28-day cycle. Premedicate with dexamethasone 4 mg orally or intravenously 30 minutes to 4 hours before each Kyprolis dose in Cycle 1, then as needed to minimize infusion-related reactions. The recommended starting dose of Kyprolis is 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 27 mg/m2 on Day 8 of Cycle 1 and thereafter. Continue Kyprolis until disease progression or unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Cardiac Toxicities

Acute Renal Failure

Tumor Lysis Syndrome

Pulmonary Toxicity

Pulmonary Hypertension

Dyspnea

Hypertension

Venous Thrombosis

Infusion-Related Reactions

Hemorrhage

Thrombocytopenia

Hepatic Toxicity and Hepatic Failure

Thrombotic Microangiopathy

Posterior Reversible Encephalopathy Syndrome

Progressive Multifocal Leukoencephalopathy

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/ea66eb30-e665-4693-99a1-a9d3b4bbe2d6/spl-doc?hl=Kyprolis

Kyprolisinformation