Indications
  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • 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.
  • ... Read More 

DKd Dosing

A once-weekly dosing option for your patients1-3,*

Once-weekly dosing schedule

  • Administer a priming dose of KYPROLIS® (20 mg/m2) on Day 1 of Cycle 1 to evaluate tolerability
  • Administer the 70 mg/m2 dose of KYPROLIS® starting on Day 8 of Cycle 1 if the priming dose is tolerated on Day 1 of Cycle 1
  • Administer KYPROLIS® (70 mg/m2) as a 30-minute IV infusion on 1 day each week for 3 weeks
  • Follow with a 13-day rest period, as part of a 28-day treatment cycle


kdd_dosing_once_weekly_v2 kdd_dosing_once_weekly_m

Refer to Darzalex® (daratumumab) and dexamethasone Prescribing Information for additional dosage information on that product.

Modify dosing based on toxicity. Refer to the full Prescribing Information and Dosing Quickstart Guide for more information1

*Once-weekly dosing was demonstrated in the EQUULEUS study, a phase 1b, open-label, multi-cohort study (N = 85) which evaluated the combination of once-weekly KYPROLIS® with IV daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma who received 1 to 3 prior lines of therapy. KYPROLIS® was administered weekly on Days 1, 8, and 15 of each 28-day cycle at a dose of 70 mg/m2 with a priming dose of 20 mg/m2 on Day 1 of Cycle 1. Safety and tolerability of DKd were evaluated as primary endpoints. Results from the EQUULEUS study set a precedent of DKd regimen safety and efficacy for the phase 3 CANDOR study and provided the rationale for the once-weekly dosing of DKd.1,4

IV = intravenous; DKd = KYPROLIS®+Darzalex® (daratumumab) and dexamethasone; PI = proteasome inhibitor; mAb = monoclonal antibody; dex = dexamethasone.

Cycle 1

In Cycle 1, the 20 mg/m2 dose is used for Day 1 to evaluate tolerability1

dosing_kdd_cycle_1_once_weekly dosing_kdd_once_weekly_cycle_m_1

Cycle 2

In Cycle 2, the targeted label dose of KYPROLIS® is 70 mg/m2, as tolerated1

dosing_kdd_cycle_2_once_weekly dosing_kdd_once_weekly_cycle_m_2

Cycles 3-6

dosing_kdd_cycle_3through6_once_weekly dosing_kdd_once_weekly_cycle_3-6_m

Cycles 7+

dosing_kdd_cycle_7plus_once_weekly dosing_kdd_once_weekly_cycle_7+_m

*For patients > 75 years of age, 20 mg of dexamethasone was administered weekly after the first week, and the entire 20-mg dose was given as a daratumumab pre-infusion medication on days when daratumumab was administered. Dosing of dexamethasone was otherwise split across days when KYPROLIS® was administered in both study arms.1

Also available with a twice-weekly dosing option for your patients1-3,*

Twice-weekly dosing schedule

  • Administer a priming dose of KYPROLIS® (20 mg/m2) on Days 1 and 2 of Cycle 1 to evaluate tolerability
  • Administer the 56 mg/m2 dose of KYPROLIS® starting on Day 8 of Cycle 1 if the priming dose is tolerated on Days 1 and 2 of Cycle 1
  • Administer KYPROLIS® (56 mg/m2) as a 30-minute IV infusion on 2 days each week for 3 weeks
  • Follow with a 12-day rest period, as part of a 28-day treatment cycle


kdd_dosing_twice_weekly Kdd_dosing_twice_weekly_m

*Demonstrated in CANDOR.1
Refer to Darzalex® (daratumumab) and dexamethasone Prescribing Information for additional dosage information on that product.

Cycle 1

In Cycle 1, the 20 mg/m2 dose is used for Days 1 and 2 to evaluate tolerability1

dosing_kdd_cycle_1_twice_weekly dosing_kdd_twice_weekly_cycle_m_1

Cycle 2

In Cycle 2, the targeted label dose of KYPROLIS® is 56 mg/m2, as tolerated1

dosing_kdd_cycle_2_twice_weekly dosing_kdd_twice_weekly_cycle_m_2

Cycles 3-6

dosing_kdd_cycle_3through6_twice_weekly dosing_kdd_twice_weekly_cycle_3-6_m

Cycles 7+

dosing_kdd_cycle_7plus_twice_weekly dosing_kdd_twice_weekly_cycle_7+_m

*For patients > 75 years of age, 20 mg of dexamethasone was administered weekly after the first week, and the entire 20-mg dose was given as a daratumumab pre-infusion medication on days when daratumumab was administered. Dosing of dexamethasone was otherwise split across days when KYPROLIS® was administered in both study arms.1

Select precautions: Adequate hydration is required1

Administration Precautions: Adequate hydration is required

Adequate hydration is required prior to dosing in Cycle 1, especially in patients at high risk of tumor lysis syndrome or renal toxicity.

  • Consider hydration with both oral fluids (30 mL per kg at least 48 hours before Cycle 1, Day 1) and IV fluids (250 mL to 500 mL of appropriate IV fluid prior to each dose in Cycle 1)
  • If needed, give an additional 250 mL to 500 mL of IV fluids following KYPROLIS® administration
  • Continue oral and/or IV 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

Please see the full Prescribing Information for KYPROLIS® for dosing and administration.

REFERENCES

1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Orlowski RZ, Kuhn DJ. Proteasome inhibitors in cancer therapy: lessons from the first decade. Clin Cancer Res. 2008;14:1649-1657. 3. Darzalex® (daratumumab) prescribing information, Janssen Biotech Inc. 4. Chari A, Martinez-Lopez J, Mateos MV, et al. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019;134:421-431.

IMPORTANT SAFETY INFORMATION FOR KYPROLIS

Cardiac Toxicities

  • New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
  • Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse reactions until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
  • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate.
  • For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.

Acute Renal Failure

  • Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

Tumor Lysis Syndrome

  • Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.

Pulmonary Toxicity

  • Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue KYPROLIS.

Pulmonary Hypertension

  • Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.

Dyspnea

  • Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.

Hypertension

  • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.

Venous Thrombosis

  • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Provide thromboprophylaxis for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.
  • For patients using hormonal contraception associated with a risk of thrombosis, consider an alternative method of effective contraception during treatment.

Infusion-Related Reactions

  • Infusion-related reactions, including life-threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion-related reactions.

Hemorrhage

  • Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.

Thrombocytopenia

  • KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.

Hepatic Toxicity and Hepatic Failure

  • Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.

Thrombotic Microangiopathy

  • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)

  • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.

Progressive Multifocal Leukoencephalopathy (PML)

  • Cases of PML, including fatal cases, have occurred. In addition to KYPROLIS, other contributary factors may include prior or concurrent use of immunosuppressive therapy. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. If PML is suspected, discontinue and initiate evaluation for PML including neurology consultation.

Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

  • In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse reactions was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.

Embryo-fetal Toxicity

  • KYPROLIS can cause fetal harm when administered to a pregnant woman.
  • Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should use effective contraception during treatment with KYPROLIS and for 3 months following the final dose.

Adverse Reactions

  • The most common adverse reactions in the combination therapy trials: anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection, thrombocytopenia, cough, dyspnea, and insomnia.
  • The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

Please see accompanying full Prescribing Information.

INDICATIONS

  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • 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.

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