INDICATIONS
Indications
  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone, or with lenalidomide plus dexamethasone, or with daratumumab plus dexamethasone, or with daratumumab plus hyaluronidase-fihj plus dexamethasone, or with isatuximab plus dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.Read More
  • KYPROLIS® is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.Close
    • ... Read More  Read Less
HCP Site | Patient Site
Important Safety Information Indications Prescribing Information Connect with a rep
KYPROLIS® (carfilzomibz) for injection logo
mob_search_icon
hamburger _icon_open
DKd Dosing

Flexible dosing options to meet the needs of your patients, including subcutaneous daratumumab1

In the CANDOR study, KYPROLIS® was administered atDKd 56 mg/m² dosed twice weekly or DKd 70 mg/m² dosed once weekly
In the EQUULEUS study, KYPROLIS® was administered atDKd 56 mg/m² dosed twice weekly or DKd 70 mg/m² dosed once weekly

KYPROLIS® is approved in combination with both daratumumab for intravenous infusion and daratumumab and hyaluronidase-fihj for subcutaneous injection.1

Study Design for KYPROLIS® 70 mg/m2 dose

DKd (EQUULEUS)

Phase 1b, open-label, multicohort study that evaluated the combination of once weekly KYPROLIS® 70 mg/m2 with intravenous daratumumab plus dexamethasone (DKd) in a cohort of 85 patients with RRMM who had 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. Overall response rate and overall survival were evaluated as secondary 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.2

DKd (PLEIADES)

Phase 2, open-label, multicenter trial that evaluated the combination of KYPROLIS® 70 mg/m2 once weekly with subcutaneous daratumumab and hyaluronidase-fihj plus dexamethasone (DKd) in a cohort of 66 patients with RRMM who had received at least one prior line of therapy.1,3

DKd = carfilzomib + daratumumab + dexamethasone; mg/m2 = milligrams per meter squared body surface area.

A once weekly dosing option for your patients1

2nd generation PI + mAb + dex

DKd_70_TEXT
30 minute IV infusion

Infusion time

30 minutes

KYPROLIS® (carfilzomib) DKd priming dose 20mg² on days 1 and 2 of cycle 1

KYPROLIS® priming dose

20 mg/m2 on Day 1 of Cycle 1 to evaluate tolerability

KYPROLIS® (carfilzomib) DKd 70mg/m² for once weekly therapeutic dose day 8 on cycle 1

Target KYPROLIS® therapeutic dose

70 mg/m2 starting Day 8 of Cycle 1

Treatment schedule

  • Administer KYPROLIS® 70 mg/m2 1 day each week for 3 weeks
  • Followed by a 13-day rest period, as part of a 28-day treatment cycle
  • Continue until disease progression or unacceptable toxicity occurs

Modify dosing based on toxicity. Refer to the full Prescribing Information.

PI = proteasome inhibitor; mAb = monoclonal antibody; dex = dexamethasone; DKd = carfilzomib + daratumumab + dexamethasone; mg/m2 = milligrams per meter squared body surface area.

  • CYCLE 1
  • CYCLE 2
  • CYCLES 3–6
  • CYCLE 7+

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

DKd priming dose 20mg/m² on days 1 and 2 of cycle 1 schedule

*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.

In Cycle 2, the targeted label dose of KYPROLIS® is 70 mg/m2, as tolerated.1

dosing_kdd_cycle_2_once_weekly

*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.

dosing_kdd_cycle_3through6_once_weekly

*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.

dosing_kdd_cycle_7plus_once_weekly

*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.

  • CYCLE 1

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

    DKd priming dose 20mg/m² on days 1 and 2 of cycle 1 schedule

    *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.

  • CYCLE 2

    In Cycle 2, the targeted label dose of KYPROLIS® is 70 mg/m2, as tolerated.1

    dosing_kdd_cycle_2_once_weekly

    *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.

  • CYCLES 3-6
    dosing_kdd_cycle_3through6_once_weekly

    *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.

  • CYCLE 7+
    dosing_kdd_cycle_7plus_once_weekly

    *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.

Also available with a twice weekly dosing option1

2nd generation PI + mAb + dex

DKd_56_TEXT
30 minute IV infusion

Infusion time

30 minutes

KYPROLIS® (carfilzomib) DKd priming dose 20mg² on days 1 and 2 of cycle 1

KYPROLIS® priming dose

20 mg/m2 on Days 1 and 2 of Cycle 1 to evaluate tolerability

KYPROLIS® (carfilzomib) DKd 56mg/m² for twice weekly therapeutic dose day 8 on cycle 1

Target KYPROLIS® therapeutic dose

56 mg/m2 starting Day 8 of Cycle 1

Treatment schedule

  • Administer KYPROLIS® 56 mg/m2 on 2 consecutive days each week for 3 weeks
  • Followed by a 12-day rest period, as part of a 28-day treatment cycle
  • Continue until disease progression or unacceptable toxicity occurs

dex = dexamethasone; DKd = carfilzomib + daratumumab + dexamethasone; mAb = monoclonal antibody; PI = proteasome inhibitor.

  • CYCLE 1
  • CYCLE 2
  • CYCLES 3-6
  • CYCLE 7+

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

DKd priming dose 20mg/m² on days 1 and 2 of cycle 1 schedule

*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.

In Cycle 2, the targeted label dose of KYPROLIS® is 56 mg/m2, as tolerated.1

dosing_kdd_cycle_2_once_weekly

*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.

dosing_kdd_cycle_3through6_once_weekly

*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.

dosing_kdd_cycle_7plus_once_weekly

*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.

  • CYCLE 1

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

    DKd priming dose 20mg/m² on days 1 and 2 of cycle 1 schedule

    *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.

  • CYCLE 2

    In Cycle 2, the targeted label dose of KYPROLIS® is 56 mg/m2, as tolerated.1

    dosing_kdd_cycle_2_once_weekly

    *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.

  • CYCLES 3-6
    dosing_kdd_cycle_3through6_once_weekly

    *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.

  • CYCLE 7+
    dosing_kdd_cycle_7plus_once_weekly

    *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.

EXPAND

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 occurring in at least 20% of patients taking KYPROLIS® in the combination therapy trials: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia.
  • The most common adverse reactions occurring in at least 20% of patients taking KYPROLIS® 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 plus dexamethasone, or with daratumumab plus hyaluronidase-fihj plus dexamethasone, or with isatuximab plus 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 patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

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 occurring in at least 20% of patients taking KYPROLIS® in the combination therapy trials: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia.
  • The most common adverse reactions occurring in at least 20% of patients taking KYPROLIS® 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 plus dexamethasone, or with daratumumab plus hyaluronidase-fihj plus dexamethasone, or with isatuximab plus 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 patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Back To Top

References: 1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. 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. 3. Chari A, Goldschmidt H, Yang S, et al. Subcutaneous daratumumab plus carfilzomib and dexamethasone (D-Kd) in relapsed/refractory multiple myeloma: an open-label, multicenter, phase 2 study (PLEIADES). 17th International Myeloma Workshop. 2019;e144.