Indications
  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of 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.
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PLEASE SEE THE IMPORTANT SAFETY INFORMATION IN THE SECTION BELOW.

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IMPORTANT SAFETY INFORMATION

Warning: Skin rash

In clinical studies, nearly all patients (90%) taking Vectibix® experienced skin rash or other skin reactions. Severe or life-threatening skin reactions have been reported.

Skin reactions included (but were not limited to):

  • Acne-like rash
  • Skin rash
  • Nail infections
  • Dry skin
  • Redness
  • Skin peeling
  • Openings in the skin
  • Itching

percent of these patients had severe skin reactions, which involved pain, disfigurement, ulceration, or loss of outer layers of skin. Some patients who developed severe skin reactions also developed infections in the blood, skin, fat, or tissue that sometimes resulted in death.

doctor may decrease your dose, delay your next dose, or stop Vectibix® treatment altogether to manage your side effects. It is important that you tell your doctor right away if you have any skin reactions or any signs of infection (such as chills, fever, or increased redness or swelling of an existing skin reaction).

RAS-Mutant mCRC

with RAS-mutant mCRC should not take Vectibix®. Investigations of the clinical studies that used Vectibix® showed that Vectibix® exposed patients with RAS-mutant mCRC to serious side effects without working to treat cancer.

Low Electrolytes

patients who were taking Vectibix® developed low levels of certain electrolytes, including:

  • Magnesium
  • Calcium
  • Potassium

doctor may check the levels of these electrolytes in your blood while you are on treatment and for 2 months after you finish treatment. Your doctor may add other oral or intravenous medications to your Vectibix® treatment.

Infusion Reactions

Vectibix® is given by infusion into a vein. Some patients may develop an infusion reaction, which can be severe and in rare cases has resulted in death. Infusion reactions developed in 4% of patients in one clinical trial, and 1% of patients experienced serious infusion reactions. Infusion reactions included:

  • Fever
  • Shortness of breath
  • Low blood pressure
  • Chills
  • Throat spasms

on how severe the reaction is, your doctor may decide to slow the rate of the infusion, stop the infusion, or stop your Vectibix® treatment completely.

Kidney problems

Tell your doctor right away if you experience severe diarrhea or dehydration. Some patients treated with Vectibix® and chemotherapy developed kidney failure or other complications because of severe diarrhea and dehydration.

Lung problems

Lung disease, including fatal lung disease, occurred in 1% or less of patients who had taken Vectibix®. Tell your doctor if you have problems breathing, wheezing, or a cough that doesn’t go away or keeps coming back. If you have been told that you have had lung problems in the past, be sure to tell your doctor. Your doctor may decide to stop Vectibix® treatment.

Avoid sunlight

Being in the sun may make skin reactions worse. Wear sunscreen and protective clothing (like a hat), and avoid direct sunlight while you are on treatment with Vectibix®. Tell your doctor if you have new or worsening skin reactions.

Eye problems

Inflammation of the eye and injury to the cornea have been reported. Tell your doctor if you have any vision changes or eye problems.

Do not take with Avastin®

Patients treated with Avastin® (bevacizumab) and Vectibix® together did not live as long and had more serious side effects, such as acne-like rash, diarrhea, dehydration, painful ulcers and mouth sores, and low levels of potassium and magnesium in the blood. Some patients developed blood clots that can travel to the lungs, which can be very serious or even fatal. Do not take Avastin® with Vectibix®.

Avoid pregnancy

Use effective birth control to avoid pregnancy while taking Vectibix® and for 6 months after the last dose. It is possible for a pregnant patient to transfer Vectibix® to an unborn child, which could be harmful to the unborn child.

Avoid breastfeeding

Vectibix® could also be transferred to a child through breast milk. Your doctor may tell you that you should not nurse your baby during Vectibix® therapy and for 2 months after your last dose of Vectibix®.

Pregnancy Surveillance Program

Women who become pregnant during Vectibix® treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Women who are nursing during Vectibix® treatment are encouraged to enroll in Amgen’s Lactation Surveillance Program. Call 1 (800) 772-6436 to enroll.

Most common side effects

In clinical studies using Vectibix® alone, the most common side effects were severe skin reactions, nail infections, lack of energy, nausea, and diarrhea. The most common serious side effects were general declining health and blockage of the bowel.

In clinical studies using Vectibix® with FOLFOX, the most commonly reported side effects for wild-type KRAS patients were diarrhea, painful mouth swelling, swelling/redness of the inner lining of the mouth, lack of energy, nail infection, lack of hunger, unusual magnesium and potassium levels in the blood, rash, acne-like rash, severe itching, and dry skin. The most serious side effects reported in Vectibix®-treated wild-type KRAS patients were diarrhea and dehydration.

Talk to your doctor

Tell your doctor right away if you have any side effects such as worsening skin problems, eye problems, fever, chills, breathing problems (such as a cough that doesn’t go away or keeps coming back, wheezing, or shortness of breath), if you develop diarrhea or become dehydrated, or if you become pregnant.

Other medications

Do not change or stop any medications you may be taking (including over-the-counter drugs or supplements you can buy without a prescription) without first speaking with your doctor.

Please read the full Prescribing Information and discuss it with your doctor.

Kd vs Vd study results

Median PFSPFS at 12 monthsPFS at 24 monthsPFS by 1 previous linePFS by 2 or 3 previous linesPFS by prior bortezomib exposurePFS by bortezomib naive

Superior median progression-free survival: 18.7 months for Kd vs 9.4 for Vd1

KYPROLIS® and dexamethasone significantly increased median progression-free survival by 9.3 months vs VELCADE® and dexamethasone1

Primary endpoint: progression-free survival1
9.3-month increase in median progression-free survival demonstrated with KYPROLIS® regimen vs VELCADE® regimen (Kd vs Vd)9.3-month increase in median progression-free survival demonstrated with KYPROLIS® regimen vs VELCADE® regimen (Kd vs Vd)
Median PFS

Kd = 18.7 months
Rd = 9.4 months
HR (Kd/Vd) = 0.53 (95% CI: 0.44-0.65);
one-sided P < 0.0001

NCCN Guidelines®: Carfilzomib (KYPROLIS®) in combination with dexamethasone (Kd) is the only preferred doublet regimen for relapsed multiple myeloma1,2

Carfilzomib (KYPROLIS®) in combination with dexamethasone (Kd) has a category 1 designation in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma (Version 4.2018) for previously treated multiple myeloma.1,2

CI = confidence interval; HR = hazard ratio; Kd = KYPROLIS® (carfilzomib) and dexamethasone; NCCN = National Comprehensive Cancer Network; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Post hoc analysis: progression-free survival at 12 months: 62.7% with Kd vs 41.5% with Vd3

Progression-free survival at 12 months1,3
Post hoc analysis: progression-free survival at 12 monthsPost hoc analysis: progression-free survival at 12 months

Post hoc analysis: demonstration of progression-free survival at 12 months was not a study objective.

Kd = KYPROLIS® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Post hoc analysis: progression-free survival at 24 months: 43.9% with Kd vs 22.2% with Vd3

Progression-free survival at 24 months1,3
Post hoc analysis: progression-free survival at 24 monthsPost hoc analysis: progression-free survival at 24 months

At 2 years, nearly twice as many patients were alive without disease progression in the Kd arm vs the Vd arm3

Post hoc analysis: demonstration of progression-free survival at 24 months was not a study objective.

Kd = KYPROLIS® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Exploratory analysis: At first relapse, Kd demonstrated a 12-month improvement in median progression-free survival over Vd4

1 previous line of therapy4
Exploratory analysis: At first relapse, Kd demonstrated a 12-month improvement in median progression-free survival over VdExploratory analysis: At first relapse, Kd demonstrated a 12-month improvement in median progression-free survival over Vd

HR (Kd/Vd) = 0.45 (95% CI: 0.33-0.61)

Although this subgroup analysis was preplanned, demonstration of progression-free survival within these subgroups was not a study objective. The study was not powered to evaluate progression-free survival within each of these subgroups.

CI = confidence interval; HR = hazard ratio; Kd = KYPROLIS® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Exploratory analysis: Kd demonstrated a 6.5-month improvement in median progression-free survival over Vd in patients who had received 2 or 3 previous lines of therapy4

2 or 3 previous lines of therapy4
Exploratory analysis: Kd demonstrated a 6.5-month improvement in median progression-free survival over Vd in patients who had received 2 or 3 previous lines of therapyExploratory analysis: Kd demonstrated a 6.5-month improvement in median progression-free survival over Vd in patients who had received 2 or 3 previous lines of therapy

HR (Kd/Vd) = 0.60 (95% CI: 0.47-0.78)

Although this subgroup analysis was preplanned, demonstration of progression-free survival within these subgroups was not a study objective. The study was not powered to evaluate progression-free survival within each of these subgroups.

CI = confidence interval; HR = hazard ratio; Kd = KYPROLIS® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Kd progression-free survival results were consistent, independent of prior proteasome inhibitor exposure5

In an exploratory subgroup analysis of patients with prior exposure to bortezomib, results were consistent with overall PFS results5,*

Prior bortezomib exposure5
Kd progression-free survival results were consistent, independent of prior proteasome inhibitor exposureKd progression-free survival results were consistent, independent of prior proteasome inhibitor exposure

HR (Kd/Vd) = 0.56 (95% CI: 0.44-0.73)

*Study was not powered for PFS efficacy in these subgroups and estimation of PFS efficacy was not a study objective.

CI = confidence interval; HR = hazard ratio; Kd = KYPROLIS® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Kd progression-free survival results were consistent, independent of prior proteasome inhibitor exposure5,*

Bortezomib naive5
Kd progression-free survival results were consistent, independent of prior proteasome inhibitor exposureKd progression-free survival results were consistent, independent of prior proteasome inhibitor exposure

HR (Kd/Vd) = 0.48 (95% CI: 0.36-0.66)

*Study was not powered for PFS efficacy in these subgroups and estimation of PFS was not a study objective.

CI = confidence interval; HR = hazard ratio; Kd = KYPROLIS® (carfilzomib) and dexamethasone; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Kd significantly increased median overall survival by 7.6 months vs Vd (Kd 47.6 months vs Vd 40.0 months)1

KYPROLIS® and dexamethasone reduced the risk of death by 21% compared to VELCADE® and dexamethasone1

Secondary endpoint: overall survival1
Kd significantly increased median overall survival by 7.6 months vs VdKd significantly increased median overall survival by 7.6 months vs Vd
Median OS

Kd = 47.6 months
Rd = 40.0 months
HR (Kd/Rd) = 0.79 (95% CI: 0.65-0.96); one-sided P = 0.01

CI = confidence interval; HR = hazard ratio; Kd = KYPROLIS® (carfilzomib) and dexamethasone; OS = overall survival; Vd = VELCADE® (bortezomib) and dexamethasone.

Kd doubled the patient’s chance of achieving a complete response or better (Kd vs Vd)1

Secondary endpoint: responses by category1
Kd doubled the patient’s chance of achieving a complete response or better (Kd vs Vd)Kd doubled the patient’s chance of achieving a complete response or better (Kd vs Vd)
  • Post hoc analysis: rates of CR or better in the Kd vs Vd study were consistent regardless of number of prior lines of therapy (1 prior line: 12% Kd vs 8% Vd compared with 2 or 3 prior lines: 13% Kd vs 5% Vd)4
  • Demonstration of CR by line of therapy was not a study objective
IMWG uniform response criteria6
Response Multiple myeloma response criteria
Stringent complete response (sCR) CR as defined below plus normal free light chain (FLC) ratio* and absence of clonal cells in bone marrow biopsy by immunohistochemistry†
Complete response (CR) Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates
Very good partial response (VGPR) Serum and urine M‑protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M‑protein plus urine M‑protein level < 100 mg/24 hours
Partial response (PR)

≥ 50% reduction of serum M‑protein and reduction in 24‑hour urinary M‑protein by ≥ 90% or to < 200 mg/24 hours

If the serum and urine M‑protein are unmeasurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M‑protein criteria

If serum and urine M‑protein are unmeasurable, and serum free light assay is also unmeasurable, ≥ 50% reduction in plasma cells is required in place of M‑protein, provided baseline bone marrow plasma cell percentage was ≥ 30%. In addition to these criteria, if present at baseline, a ≥ 50% reduction in the size (SPD)‡ of soft tissue plasmacytomas is also required

Adapted by permission from Elsevier Limited: Lancet Oncol. 2016;17:e328-e346. © 2016.

*All recommendations regarding clinical uses relating to serum FLC levels or FLC ratio are based on results obtained with the validated Freelite test (Binding Site, Birmingham, UK).

†Presence/absence of clonal cells on immunohistochemistry is based upon the kappa/lambda ratio. An abnormal kappa/lambda ratio by immunohistochemistry requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting presence of an abnormal clone is kappa/lambda of > 4:1 or < 1:2.

‡Plasmacytoma measurements should be taken from the CT portion of the PET/CT, or MRI scans, or dedicated CT scans where applicable. For patients with only skin involvement, skin lesions should be measured with a ruler. Measurement of tumor size will be determined by the SPD.

≥ CR = complete response or better; CT = computed tomography; IMWG = International Myeloma Working Group; Kd = KYPROLIS® (carfilzomib) and dexamethasone; MRI = magnetic resonance imaging; ORR = overall response rate (CR or better + VGPR + PR); PET = positron-emission tomography; PR = partial response; SPD = sum of the products of the maximal perpendicular diameters of measured lesions; Vd = VELCADE® (bortezomib) and dexamethasone; ≥ VGPR = very good partial response or better.

Dr. Richter expert video

See why multiple myeloma specialist Dr. Joshua Richter chooses Kd for his patients with relapsed multiple myeloma

Multiple myeloma specialist Dr. Joshua Richter expert video

Kd = KYPROLIS® (carfilzomib) and dexamethasone.

See Kd DosingSee Kd dosing
Next KRd vs Rd study design

Kd vs Vd study: A phase 3, randomized, open-label, multicenter superiority study compared KYPROLIS® plus dexamethasone (Kd) to VELCADE® plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy. 929 patients were randomized to a 1:1 ratio to receive Kd (n = 464) for 28-day cycles or Vd (n = 465) for 21-day cycles until disease progression or unacceptable toxicity occurred. Patient stratification included prior proteasome inhibitor therapy (either VELCADE® or KYPROLIS®, or no prior therapy), prior lines of therapy (1 vs 2 or 3), International Staging System stage (1 vs 2 or 3), and planned route of VELCADE® administration, if randomized to the VELCADE® group (intravenous vs subcutaneous). The primary endpoint was progression-free survival (PFS). Select secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety.1,7

REFERENCES

1. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed February 27, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN GUIDELINES, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 3. Data on file, Amgen; 2015. 4. Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017;31:115-122. 5. Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17:27-38. 6. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17:e328-e346. 7. Dimopoulos MA, Goldschmidt H, Niesvizky R, et al. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18:1327-1337.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their applications or use in any way.

VELCADE® (bortezomib) is a product of Millennium Pharmaceuticals.

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IMPORTANT SAFETY INFORMATION

Cardiac Toxicities

  • New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive 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 KYPROLIS administration.
  • Monitor patients for clinical signs or symptoms of cardiac failure or cardiac ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart KYPROLIS 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 in patients with baseline cardiac failure or who are at risk for cardiac failure.
  • 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 (including blood pressure control and fluid management) prior to starting treatment with KYPROLIS and remain under close follow-up.

Acute Renal Failure

  • Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred in patients receiving KYPROLIS. 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 in patients receiving KYPROLIS. Patients with multiple myeloma and 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. Withhold KYPROLIS until TLS is 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 in patients receiving KYPROLIS. Some events have been fatal. In the event of drug‐induced pulmonary toxicity, discontinue KYPROLIS.

Pulmonary Hypertension

  • Pulmonary arterial hypertension (PAH) was reported in patients treated with KYPROLIS. 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 KYPROLIS 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 KYPROLIS based on a benefit/risk assessment.

Hypertension

  • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with KYPROLIS. Some of these events have been fatal. It is recommended to 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 KYPROLIS based on a benefit/risk assessment.

Venous Thrombosis

  • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with KYPROLIS. 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.
  • Patients using oral contraceptives or a hormonal method of contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment with KYPROLIS in combination with dexamethasone or lenalidomide plus dexamethasone.

Infusion Reactions

  • Infusion reactions, including life-threatening reactions, have occurred in patients receiving KYPROLIS. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial 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 of KYPROLIS. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms of an infusion reaction and to contact a physician immediately if they occur.

Hemorrhage

  • Fatal or serious cases of hemorrhage have been reported in patients receiving KYPROLIS. 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. Thrombocytopenia was reported in patients receiving KYPROLIS. Monitor platelet counts frequently during treatment with KYPROLIS. Reduce or withhold dose as appropriate.

Hepatic Toxicity and Hepatic Failure

  • Cases of hepatic failure, including fatal cases, have been reported during treatment with KYPROLIS. 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 in patients receiving KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS therapy in patients previously experiencing TTP/HUS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)

  • Cases of PRES have occurred in patients receiving KYPROLIS. PRES was formerly known as Reversible Posterior Leukoencephalopathy Syndrome. Consider a neuro-radiological imaging (MRI) for onset of visual or neurological symptoms. Discontinue KYPROLIS if PRES is suspected and evaluate. The safety of reinitiating KYPROLIS therapy in patients previously experiencing PRES is not known.

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 events was observed in patients in the KMP arm. KYPROLIS in combination with melphalan and prednisone 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 based on its mechanism of action and findings in animals.
  • Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

ADVERSE REACTIONS

  • The most common adverse reactions occurring in at least 20% of patients treated with KYPROLIS in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia.
  • The most common adverse reactions occurring in at least 20% of patients treated with KYPROLIS in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

Please see full Prescribing Information.

INDICATIONS

  • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of 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.