Kyprolis
Amgen,USA
$765.00-
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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
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