Onyx Pharmaceuticals, Inc.
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Onyx Pharmaceuticals, Inc. Drugs
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Quartermate Plus
2.1 Administration Precautions
• Hydration - Adequate hydration is required prior to dosing in Cycle 1, especially in patients at high risk of tumor lysis syndrome or renal toxicity. The recommended hydration includes both oral fluids (30 mL per kg at least 48 hours before Cycle 1, Day 1) and intravenous fluids (250 mL to 500 mL of appropriate intravenous fluid prior to each dose in Cycle 1). If needed, give an additional 250 mL to 500 mL of intravenous fluids following Kyprolis administration. Continue oral and/or intravenous hydration, as needed, in subsequent cycles. Monitor patients for evidence of volume overload and adjust hydration to individual patient needs, especially in patients with or at risk for cardiac failure [see Warnings and Precautions (5)]. • Premedications - Premedicate with dexamethasone 4 mg for monotherapy (or the recommended dexamethasone dose if on combination therapy [see Dosage and Administration (2.2)]) orally or intravenously at least 30 minutes but no more than 4 hours prior to all doses of Kyprolis during Cycle 1 to reduce the incidence and severity of infusion reactions [see Warnings and Precautions (5.5)]. Reinstate dexamethasone premedication if these symptoms occur during subsequent cycles. • Administration - Infuse over 10 minutes. 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. Patients with a body surface area greater than 2.2 m2 should receive a dose based upon a body surface area of 2.2 m2. • Thromboprophylaxis - Thromboprophylaxis is recommended for patients being treated with the combination of Kyprolis, lenalidomide, and 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 in 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, 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 to a target dose of 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 in Combination with Lenalidomide and Dexamethasone a Kyprolis is administered through Cycle 18, lenalidomide and dexamethasone continue thereafter.Cycle 1
Week 1
Week 2
Week 3
Week 4
Day 1
Day 2
Days 3–7
Day 8
Day 9
Days 10–14
Day 15
Day 16
Days 17–21
Day 22
Days 23-28
Kyprolis (mg/m2):
20
20
-
27
27
-
27
27
-
-
-
Dexamethasone
40 mg
-
-
40 mg
-
-
40 mg
-
-
40 mg
-
Lenalidomide
25 mg daily
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-
Cycles 2 to 12
Week 1
Week 2
Week 3
Week 4
Day 1
Day 2
Days3–7
Day 8
Day 9
Days 10–14
Day 15
Day 16
Days 17–21
Day 22
Days 23-28
Kyprolis (mg/m2):
27
27
-
27
27
-
27
27
-
-
-
Dexamethasone
40 mg
-
-
40 mg
-
-
40 mg
-
-
40 mg
-
Lenalidomide
25 mg daily
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-
Cycles 13 ona
Week 1
Week 2
Week 3
Week 4
Day 1
Day 2
Days 3–7
Day 8
Day 9
Days 10–14
Day 15
Day 16
Days 17–21
Day 22
Days 23-28
Kyprolis (mg/m2):
27
27
-
-
-
-
27
27
-
-
-
Dexamethasone
40 mg
-
-
40 mg
-
-
40 mg
-
-
40 mg
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Lenalidomide
25 mg daily
Continue treatment until disease progression or unacceptable toxicity occurs. 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 Monotherapy
For monotherapy, 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 2. 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 to a target dose of 27 mg/m2 on Day 8 of Cycle 1. From Cycle 13, omit the Day 8 and 9 doses of Kyprolis. Continue treatment until disease progression or unacceptable toxicity occurs.
Table 2: Kyprolis MonotherapyCycle 1
Week 1
Week 2
Week 3
Week 4
Day1
Day2
Days3–7
Day8
Day9
Days10–14
Day15
Day16
Days17–21
Days22–28
Kyprolis (mg/m2):
20
20
-
27
27
-
27
27
-
-
Cycles 2 to 12
Week 1
Week 2
Week 3
Week 4
Day1
Day2
Days3–7
Day8
Day9
Days10–14
Day15
Day16
Days17–21
Days22–28
Kyprolis (mg/m2):
27
27
-
27
27
-
27
27
-
-
Cycles 13 on
Week 1
Week 2
Week 3
Week 4
Day1
Day2
Days3–7
Day8
Day9
Days10–14
Day15
Day16
Days17–21
Days22–28
Kyprolis (mg/m2):
27
27
-
-
-
-
27
27
-
-
2.3 Dose Modifications Based on Toxicities
Modify dosing based on toxicity. Recommended actions and dose modifications for Kyprolis are presented in Table 3. See the lenalidomide and dexamethasone Prescribing Information respectively for dosing recommendations.
Table 3: Dose Modifications for Toxicitya during Kyprolis Treatment a From 27 mg/m2 to 20 mg/m2 or from 20 mg/m2 to 15 mg/m2 is considered 1 dose level reduction.b CTCAE Grades 3 and 4Hematologic Toxicity
Recommended Action
• Absolute neutrophil count < 0.5 x10 9/L • Withhold dose • If recovered to ≥ 0.5 x10 9/L, continue at the same dose level • For subsequent drops to < 0.5 x10 9/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolis a • Platelets <10 x10 9/L or evidence of bleeding with thrombocytopenia [ see Warnings and Precautions (5)] • Withhold dose • If recovered to ≥ 10 x10 9/L and/or bleeding is controlled, continue at the same dose level • For subsequent drops to < 10 x10 9/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolis aRenal Toxicity
Recommended Action
• Serum creatinine ≥ 2 × baseline, or • Creatinine clearance < 15 mL/min or creatinine clearance decreases to ≤ 50% of baseline, or need for dialysis [ see Warnings and Precautions, (5)] • Withhold dose and continue monitoring renal function (serum creatinine or creatinine clearance) • If attributable to Kyprolis, resume when renal function has recovered to within 25% of baseline; start at 1 dose level reduction a • If not attributable to Kyprolis, dosing may be resumed at the discretion of the physician • For patients on dialysis receiving Kyprolis, the dose is to be administered after the dialysis procedureOther Non-hematologic Toxicity
Recommended Action
• All other severe or life-threatening b non-hematological toxicities • Withhold until resolved or returned to baseline • Consider restarting the next scheduled treatment at 1 dose level reduction a2.4 Reconstitution and Preparation for Intravenous Administration
Kyprolis vials contain no antimicrobial preservatives and are intended for single use only. Unopened vials of Kyprolis are stable until the date indicated on the package when stored in the original package at 2°C to 8°C (36°F to 46°F). The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL. The quantity of Kyprolis contained in one single-dose vial (60 mg carfilzomib) may exceed the required dose. Caution should be used in calculating the quantity delivered to prevent overdosing. Read the complete preparation instructions prior to reconstitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstitution/Preparation Steps:
1 Remove vial from refrigerator just prior to use. 2 Calculate the dose (mg/m 2) and number of vials of Kyprolis required using the patient’s body surface area (BSA) at baseline. Patients with a BSA greater than 2.2 m 2 should receive a dose based upon a BSA of 2.2 m 2. Dose adjustments do not need to be made for weight changes of less than or equal to 20%. a Aseptically reconstitute each vial by slowly injecting 29 mL Sterile Water for Injection, USP, through the stopper and directing the solution onto the INSIDE WALL OF THE VIAL to minimize foaming. 3 Gently swirl and/or invert the vial slowly for about 1 minute, or until complete dissolution. DO NOT SHAKE to avoid foam generation. If foaming occurs, allow the solution to settle in the vial until foaming subsides (approximately 5 minutes) and the solution is clear. 4 Visually inspect for particulate matter and discoloration prior to administration. The reconstituted product should be a clear, colorless solution and should not be administered if any discoloration or particulate matter is observed. 5 Discard any unused portion left in the vial. 6 Optionally, Kyprolis can be administered in an intravenous bag. 7 When administering in an intravenous bag, withdraw the calculated dose [ see Dosage and Administration (2)] from the vial and dilute into 50 mL intravenous bag containing 5% Dextrose Injection, USP.The stabilities of reconstituted Kyprolis under various temperature and container conditions are shown in Table 4.
Table 4: Stability of Reconstituted Kyprolis a Total time from reconstitution to administration should not exceed 24 hoursb 5% Dextrose Injection, USPStorage Conditions of Reconstituted Kyprolis
Stabilitya per Container
Vial
Syringe
Intravenous Bag (D5Wb)
Refrigerated (2°C to 8°C; 36°F to 46°F)
24 hours
24 hours
24 hours
Room Temperature (15°C to 30°C; 59°F to 86°F)
4 hours
4 hours
4 hours
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Ortho Micronor
To achieve maximum contraceptive effectiveness, ORTHO MICRONOR® must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
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