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Carfilzomib Dosage

Applies to the following strengths: 60 mg; 30 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Multiple Myeloma

BEFORE INITIATING DOSING:
-Hydrate patients with both oral fluids (30 mL/kg at least 48 hours before Cycle 1, Day 1) and IV fluids (250 to 500 mL prior to each dose in Cycle 1). If needed, give an additional 250 to 500 mL of IV fluids following drug administration. Continue oral and/or IV hydration, as needed, in subsequent cycles. Monitor for volume overload and adjust hydration to individual need (especially in patients with or at risk for cardiac failure).
-Monitor serum potassium levels regularly.
-Premedicate with dexamethasone at the recommended dose for either monotherapy or combination therapy. Administer dexamethasone orally or IV at least 30 minutes but no more than 4 hours prior to all doses during Cycle 1 to reduce infusion reactions. Reinstate dexamethasone if symptoms occur during subsequent cycles.
-Infuse over 10 or 30 minutes depending on dosing regimen. Do not administer as a bolus. Flush the IV line with normal saline or 5% dextrose immediately before and after drug administration. Do not mix this drug with or administer as an infusion with other products.
-Calculate the dose based on the actual BSA of the patient at baseline. Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2. Dose adjustments do not need to be made for weight changes of less than or equal to 20%.
-Thromboprophylaxis is recommended for patients being treated with the combination of this drug with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient's underlying risks.
-Antiviral prophylaxis should be considered to decrease the risk of herpes zoster reactivation.

IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE:
-Cycle 1: 20 mg/m2 IV over 10 minutes on Days 1 and 2; if tolerated, increase to 27 mg/m2 IV over 10 minutes on Days 8, 9, 15, and 16 of a 28-day cycle
-Cycles 2 through 12: 27 mg/m2 IV over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle
-Cycle 13 and later: Omit the Day 8 and 9 doses
-Discontinue this drug after Cycle 18
-Lenalidomide 25 mg is taken orally on Days 1 through 21 and dexamethasone 40 mg orally or IV on Days 1, 8, 15, and 22 of the 28-day cycles
-Each 28-day period is considered one cycle.
-Continue therapy until disease progression or unacceptable toxicity occurs.
-Refer to the lenalidomide and dexamethasone prescribing information for other concomitant medications.

DOSE IN COMBINATION WITH DEXAMETHASONE:
-Cycle 1: 20 mg/m2 IV over 30 minutes on Days 1 and 2; if tolerated, increase to 56 mg/m2 IV over 30 minutes on Days 8, 9, 15, and 16 of a 28-day cycle
-Cycles 2 and later: 56 mg/m2 IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle
-Dexamethasone 20 mg is taken orally or IV Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle; administer dexamethasone 30 minutes to 4 hours before this drug.
-Administer dexamethasone 30 minutes to 4 hours before this drug.
-Continue therapy until disease progression or unacceptable toxicity.
-Refer to the dexamethasone prescribing information for other concomitant medications.

MONOTHERAPY BY THE 10-MINUTE INFUSION:
-Cycle 1: 20 mg/m2 IV over 10 minutes on Days 1 and 2; if tolerated, increase to 27 mg/m2 IV over 10 minutes on Days 8, 9, 15, and 16 of a 28-day cycle
-Cycles 2 through 12: 27 mg/m2 IV over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle
-Cycle 13 and later: Omit the Day 8 and 9 doses.
-Premedicate with dexamethasone 4 mg orally or IV 30 minutes to 4 hours before each dose of this drug in Cycle 1, then as needed to prevent infusion reactions.
-Continue therapy until disease progression or unacceptable toxicity.

MONOTHERAPY BY THE 30-MINUTE INFUSION:
-Cycle 1: 20 mg/m2 IV over 30 minutes on Days 1 and 2; if tolerated, increase to 56 mg/m2 IV over 30 minutes on Days 8, 9, 15, and 16 of a 28-day cycle
-Cycles 2 through 12: 56 mg/m2 IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day treatment cycle
-Cycle 13 and later: Omit the Day 8 and 9 doses.
-Premedicate with dexamethasone 8 mg orally or IV 30 minutes to 4 hours before each dose of this drug in Cycle 1, then as needed to prevent infusion reactions.
-Continue therapy until disease progression or unacceptable toxicity.

Comments:
-For patients on hemodialysis, administer this drug after the hemodialysis procedure.

Uses:
-In combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy
-As a single agent for the treatment of relapsed or refractory multiple myeloma who have received 1 or more lines of therapy

Renal Dose Adjustments

-Serum creatinine 2 x baseline or greater, OR CrCl less than 15 mL/min, OR CrCl decreased to 50% or less of baseline, OR need for hemodialysis: Withhold dose and monitor renal function (serum creatinine or CrCl).
-If attributable to this drug, resume when renal function has recovered to within 25% of baseline; start at 1 dose level reduction.
-If not attributable to this drug, dosing may be resumed at the discretion of the physician.
-The dose is to be administered after the hemodialysis procedure for patients on hemodialysis.

Liver Dose Adjustments

Mild or moderate hepatic impairment: Reduce dose by 25%.
Severe hepatic impairment: Dosing recommendations cannot be made.

Dose Adjustments

HEMATOLOGIC TOXICITY:
-Absolute neutrophil count (ANC) less than 0.5 X 10(9)/L: Withhold dose; if recovered to 0.5 x 10(9)/L or greater, continue at the same dose level. For subsequent drops to less than 0.5 x 10(9) /L, follow the same recommendations as above and consider 1 dose level reduction when restarting therapy.
-Febrile neutropenia (ANC less than 0.5 x 10(9)/L and an oral temperature of more than 38.5C or 2 consecutive readings of more than 38C for 2 hours): Withhold dose; if ANC returns to baseline grade and fever resolves, resume at the same dose level.
-Platelets less than 10 X 10(9)/L or evidence of bleeding with thrombocytopenia: Withhold dose; if recovered to greater than or equal to 10 x 10(9)/L and/or bleeding is controlled, continue at the same dose level. For subsequent drops to less than 10 x 10(9)/L, follow the same recommendations as above and consider 1 dose level reduction when restarting therapy.

RENAL TOXICITY:
-See RENAL DOSE ADJUSTMENTS.

HEPATIC TOXICITY:
-See LIVER DOSE ADJUSTMENTS.

OTHER NONHEMATOLOGIC TOXICITY:
-All other severe or life-threatening nonhematologic toxicities (Grades 3 and 4): Withhold therapy until resolved or returned to baseline; consider restarting the next scheduled dose at 1 dose level reduction.

DOSE LEVEL REDUCTION GUIDELINES:
If initial dose is 27 mg/m2:
-First dose reduction: 20 mg/m2
-Second dose reduction: 15 mg/m2
-Third dose reduction: Discontinue therapy
If initial dose is 56 mg/m2:
-First dose reduction: 45 mg/m2
-Second dose reduction: 36 mg/m2
-Third dose reduction: 27 mg/m2; if toxicity persists discontinue therapy

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Patients with end stage renal disease on dialysis: Administer the dose after the dialysis procedure.

Other Comments

Administration advice:
-The IV administration line should be flushed with normal saline or 5% dextrose injection immediately before and after drug administration.
-This drug is available for IV use only.
-Do not administer this drug as a bolus.
-Do not mix this drug with or administer as an infusion with other medicinal products.

Storage requirements:
-Consult the manufacturer product information.

Reconstitution/preparation techniques:
-Consult the manufacturer product information.

General:
-The quantity of drug contained in one single-use vial may exceed the required dose; caution should be used in calculating dosage to prevent overdosing.
-Clinical benefit, such as improvement in survival or symptoms, has not been verified.
-Approval of this drug is based on response rate.

Monitoring:
-Cardiovascular: Fluid overload, cardiac complications
-Hematologic: Blood chemistries, platelet counts, Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome
-Hepatic: Liver function (transaminases, bilirubin)
-Nervous: Posterior Reversible Encephalopathy Syndrome
-Oncologic: Tumor Lysis Syndrome
-Other: Infusion reactions (immediately following or up to 24 hours after treatment administration)
-Renal: Renal function (serum creatinine)
-Respiratory: Dyspnea, pulmonary arterial hypertension

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