e Kyprolis dose regimen [see Dosage and Administration (2.2)]. Do not administer as a bolus. Flush the intravenous administration line with normal saline or 5% dextrose injection, USP immediately before and after Kyprolis administration. Do not mix Kyprolis with or administer as an infusion with other medicinal products.
Dose Calculation - Calculate the Kyprolis dose [see Dosage and Administration (2.2)] using the patient's actual body surface area at baseline. In patients with a body surface area greater than 2.2 m2, calculate the dose based upon a body surface area of 2.2 m2.
Thromboprophylaxis - Thromboprophylaxis is recommended for patients being treated with the combination of Kyprolis with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient's underlying risks [see Warnings and Precautions (5.8)].
Infection Prophylaxis - Consider antiviral prophylaxis for patients being treated with Kyprolis to decrease the risk of herpes zoster reactivation.
2.2 Recommended Dosing
Kyprolis in Combination with Lenalidomide and Dexamethasone
For the combination regimen with lenalidomide and dexamethasone, administer Kyprolis intravenously as a 10-minute infusion on two consecutive days, each week for three weeks followed by a 12-day rest period as shown in Table 1. Each 28-day period is considered one treatment cycle. 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. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis. Discontinue Kyprolis after Cycle 18. Lenalidomide 25 mg is taken orally on Days 1–21 and dexamethasone 40 mg by mouth or intravenously on Days 1, 8, 15, and 22 of the 28-day cycles.
Table 1: Kyprolis (10-Minute Infusion) in Combination with Lenalidomide
Kyprolis is administered through Cycle 18; lenalidomide and dexamethasone continue thereafter
Continue treatment until disease progression or unacceptable toxicity occurs [see Dosage and Administration (2.3)]. Refer to the lenalidomide and dexamethasone Prescribing Information for other concomitant medications, such as the use of anticoagulant and antacid prophylaxis, that may be required with those agents.
Kyprolis in Combination with Dexamethasone
For the combination regimen with dexamethasone, administer Kyprolis intravenously as a 30-minute infusion on two consecutive days, each week for three weeks followed by a 12-day rest period as shown in Table 2. Each 28-day period is considered one treatment cycle. Administer Kyprolis by 30-minute infusion at a starting dose of 20 mg/m2 in Cycle 1 on Days 1 and 2. If tolerated, escalate the dose to 56 mg/m2 on Day 8 of Cycle 1. Dexamethasone 20 mg is taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. Administer dexamethasone 30 minutes to 4 hours before Kyprolis.
Table 2: Kyprolis (30-Minute Infusion) in Combination
Treatment may be continued until disease progression or unacceptable toxicity occurs [see Dosage and Administration (2.3)]. Refer to the dexamethasone Prescribing Information for other concomitant medications.
Kyprolis Monotherapy
For monotherapy, administer Kyprolis intravenously as a 10-minute or 30-minute infusion depending on the regimen as described below.
20/27 mg/m2 regimen by 10-minute infusion
For monotherapy using the 20/27 mg/m2 regimen, administer Kyprolis intravenously as a 10- |
