Approved Use

KYPROLIS® (carfilzomib) is a prescription medication used to treat adult patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS® is approved for use in combination with daratumumab plus dexamethasone, dexamethasone or with lenalidomide plus dexamethasone, or isatuximab plus dexamethasone, which are other medicines used to treat multiple myeloma.
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KYPROLIS® results

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KYPROLIS® helps people with relapsed or refractory multiple myeloma live longer without their disease getting worse and reach a complete response*

*Complete response is defined as no detectable M-proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

Seeing that my labs were actually changing by using KYPROLIS® put me in a better way that we were going the right direction. In my case, I went into complete remission with KYPROLIS®.

–Yolanda (real KYPROLIS® patient)

KYPROLIS® + Darzalex® + dexamethasone

KYPROLIS® + Sarclisa® + dexamethasone

KYPROLIS® + Revlimid® + dexamethasone

KYPROLIS® + dexamethasone
RESULTS FOR
KYPROLIS® + Darzalex®* + dexamethasone (DKd)
8 out of 10 people 8 out of 10 people

Over 8 out of 10 people responded to KYPROLIS® + Darzalex® + dexamethasone (84% vs 75% with Kd alone)†

2.5x 2.5x

as many people on KYPROLIS® + Darzalex® + dexamethasone achieved a complete response than with Kd alone (28% vs 10%)

KYPROLIS® + Darzalex® + dexamethasone helped people live an average of 29 months longer without their disease getting worse‡

Nearly 29 months median progression-free survival (mPFS) with KRPTOLIS® + Darzalex® + dexamethasone (Dkd) Nearly 29 months median progression-free survival (mPFS) with KRPTOLIS® + Darzalex® + dexamethasone (Dkd)

Median progression-free survival was 28.6 months with KYPROLIS® + Darzalex® + dexamethasone and 15.2 months with Kd alone§

*Darzalex® (daratumumab).

†Response was defined as partial response or better.

‡In a clinical study of 466 people with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy, 312 people received KYPROLIS® in combination with Darzalex® and dexamethasone, and 154 received KYPROLIS® in combination with dexamethasone. The study compared how long people lived without their disease getting worse. The median follow-up was nearly 28 months.

§In an earlier analysis with a median follow-up of ~17 months, the median progression-free survival (the length of time from the start of treatment until half of the people with relapsed or refractory multiple myeloma had experienced disease progression or death) had not been reached with KYPROLIS® + Darzalex® (daratumumab) + dexamethasone vs 15.8 months with Kd alone.

Kd=KYPROLIS® + dexamethasone; mPFS=median progression-free survival; M-proteins=monoclonal proteins.

Complete response is defined as no detectable M-proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

Median is the middle value in a list of values arranged from low to high such that there are the same number of values above and below this middle value.

Darzalex® (daratumumab) is a registered trademark of Johnson & Johnson Corporation, New Jersey.

RESULTS FOR
KYPROLIS® + Sarclisa® + dexamethasone (Isa-Kd)
9 out of 10 people 9 out of 10 people

Almost 9 out of 10 people responded to KYPROLIS® + Sarclisa® + dexamethasone (87% vs 84% with Kd alone)*

1.5x 1.5x

as many people on KYPROLIS® + Sarclisa® + dexamethasone achieved a complete response than with Kd alone (44% vs 29%)

KYPROLIS® + Sarclisa® + dexamethasone helped people live an average of 42 months longer without their disease getting worse†

Nearly 42 months median progression-free survival (mPFS) with KYPROLIS® + Sarclisa® + dexamethasone (Isa-Kd) Nearly 42 months median progression-free survival (mPFS) with KYPROLIS® + Sarclisa® + dexamethasone (Isa-Kd)

Median progression-free survival was 41.7 months with KYPROLIS® + Sarclisa® + dexamethasone and 20.8 months with Kd alone‡

*Response was defined as partial response or better.

†In a clinical study of 302 people with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy, 179 people received KYPROLIS® in combination with Sarclisa® and dexamethasone, and 123 received KYPROLIS® in combination with dexamethasone. The study compared how long people lived without their disease getting worse. The median follow-up was 44 months.

‡In an earlier analysis with a median follow-up of nearly 21 months, the median progression-free survival (the length of time from the start of treatment until half of the people in the clinical study had experienced disease progression or death) had not been reached with KYPROLIS® + Sarclisa® + dexamethasone vs 20.3 months with Kd.

Kd=KYPROLIS® + dexamethasone; mPFS=median progression-free survival; M-proteins=monoclonal proteins.

Complete response is defined as no detectable M-proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

Median is the middle value in a list of values arranged from low to high such that there are the same number of values above and below this middle value.

Sarclisa® (isatuximab-irfc) is a registered trademark of Sanofi Corporation, New Jersey

RESULTS FOR
KYPROLIS® + Revlimid®  + dexamethasone (KRd)
9 out of 10 people 9 out of 10 people

Almost 9 out of 10 people responded to KYPROLIS® + Rd (87% vs 67% with Rd alone)*

3x 3x

as many people on KYPROLIS® + Rd achieved a complete response than with Rd alone (32% vs 9%)

KYPROLIS® + Rd helped people live an average of 26 months longer without their disease getting worse†

26 months median progression-free survival (mPFS) with KYPROLIS® + Rd 26 months median progression-free survival (mPFS) with KYPROLIS® + Rd

Median progression-free survival was 26.3 months with KYPROLIS® + Revlimid® + dexamethasone and 17.6 months with Rd alone

*Response was defined as partial response or better.

†In a clinical study of 792 people with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy, 396 people received KYPROLIS® in combination with Revlimid® and dexamethasone, and 396 received Revlimid® in combination with dexamethasone. The study compared how long people lived without their disease getting worse as well as how long they lived overall.

mPFS=median progression-free survival; M-proteins=monoclonal proteins; Rd=Revlimid® + dexamethasone.

Complete response is defined as no detectable M-proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

Median is the middle value in a list of values arranged from low to high such that there is the same number of values above and below this middle value.

Revlimid® (lenalidomide) is a registered trademark of Celgene.

RESULTS FOR
Once-weekly KYPROLIS® + d (dexamethasone)
6 out of 10 people 6 out of 10 people

Over 6 out of 10 people responded to KYPROLIS® + d once weekly than with twice-weekly KYPROLIS® + d (62.9% vs 40.8%)*

4x 4x

as many people on once-weekly KYPROLIS® + d achieved a complete response (7.1% vs 1.7% with twice-weekly KYPROLIS® + d)

KYPROLIS® + d once weekly helped people live an average of 11 months longer without their disease getting worse†

11 months median progression-free survival (mPFS) with KYRPROLIS® + d once weekly 11 months median progression-free survival (mPFS) with KYRPROLIS® + d once weekly

Median progression-free survival was 11.2 months with KYPROLIS® + d once weekly and 7.6 months with KYPROLIS® + d twice weekly

*Response was defined as partial response or better.

†In a clinical study of 478 people with relapsed or refractory multiple myeloma who had received 2 to 3 prior lines of therapy, 240 people received KYPROLIS® at 70 mg/m2 in combination with dexamethasone once weekly and 238 people received KYPROLIS® at 27 mg/m2 in combination with dexamethasone twice weekly. The study compared how long people lived without their disease getting worse.

d=dexamethasone; mPFS=median progression-free survival; M-proteins=monoclonal proteins.

Complete response is defined as no detectable M-proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

Median is the middle value in a list of values arranged from low to high such that there is the same number of values above and below this middle value.

27 mg/m2 is not an FDA-approved dose for KYPROLIS® in combination with dexamethasone alone.

RESULTS FOR
Twice-weekly KYPROLIS® + d (dexamethasone)
8 out of 10 people 8 out of 10 people

Almost 8 out of 10 people responded to twice-weekly KYPROLIS® + d (77% vs 63% with Velcade® + d [Vd])*

2x 2x

as many people on twice-weekly KYPROLIS® + d achieved a complete response than with Vd (13% vs 6%)

KYPROLIS® + d twice weekly helped people live an average of nearly 19 months longer without their disease getting worse†

Nearly 19 months median progression-free survival (mPFS) KYRPROLIS® + d twice weekly Nearly 19 months median progression-free survival (mPFS) KYRPROLIS® + d twice weekly

Median progression-free survival was 18.7 months with KYPROLIS® + d twice weekly and 9.4 months with Vd alone

*Response was defined as partial response or better.

†In a clinical study of 929 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy, 464 patients received KYPROLIS® in combination with dexamethasone, and 465 received Velcade® in combination with dexamethasone. The study compared how long patients lived without their disease getting worse as well as how long they lived overall.

d=dexamethasone; mPFS=median progression-free survival; M-proteins=monoclonal proteins.

Complete response is defined as no detectable M-proteins in the blood and urine, less than 5% abnormal plasma cells in bone marrow, and no detectable plasma cell tumors.

Median is the middle value in a list of values arranged from low to high such that there is the same number of values above and below this middle value.

Velcade® (bortezomib) is a registered trademark of Millennium Pharmaceuticals.

What to expect with KYPROLIS® treatment

IMPORTANT SAFETY INFORMATION

KYPROLIS® (carfilzomib) can cause serious side effects:

  • Heart problems: KYPROLIS can cause heart problems or worsen pre-existing heart conditions. Death due to cardiac arrest has occurred within one day of KYPROLIS administration. Before starting KYPROLIS, you should have a full medical work-up (including blood pressure and fluid management). You should be closely monitored during treatment.
  • Kidney problems: There have been reports of sudden kidney failure in patients receiving KYPROLIS. Your kidney function should be closely monitored during treatment.
  • Tumor lysis syndrome (TLS): Cases of TLS have been reported in patients receiving KYPROLIS, including fatalities. You should be closely monitored during treatment for any signs of TLS.
  • Lung damage: Cases of lung damage have been reported in patients receiving KYPROLIS, including fatal cases.
  • Pulmonary hypertension (high blood pressure in the lungs): There have been reports of pulmonary hypertension in patients receiving KYPROLIS.
  • Lung complications: Shortness of breath was reported in patients receiving KYPROLIS. Your lung function should be closely monitored during treatment.
  • High blood pressure: Cases of high blood pressure, including fatal cases, have been reported in patients receiving KYPROLIS. Your blood pressure should be closely monitored during treatment.
  • Blood clots: There have been reports of blood clots in patients receiving KYPROLIS. If you are at high risk for blood clots, your doctor can recommend ways to lower the risk.
  • If you are using KYPROLIS in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone, your doctor should assess and may prescribe another medicine to help lower your risk for blood clots.
  • If you are using birth control pills or other medical forms of birth control associated with a risk of blood clots, talk to your doctor and consider a different method of birth control during treatment with KYPROLIS in combination with dexamethasone, with lenalidomide plus dexamethasone, or with daratumumab and dexamethasone.
  • Infusion-related reactions: Signs and symptoms of infusion-related reactions included fever, chills, joint pain, muscle pain, facial flushing and/or swelling, swelling of the larynx (voice box), vomiting, weakness, shortness of breath, low blood pressure, fainting, chest tightness, and chest pain. These symptoms can occur immediately following infusion or up to 24 hours after administration of KYPROLIS. If you experience any of these symptoms, contact your doctor immediately.
  • Severe bleeding problems: Fatal or serious cases of bleeding problems have been reported in patients receiving KYPROLIS. Your doctor should monitor your signs and symptoms of blood loss.
  • Very low platelet count: Low platelet levels can cause unusual bruising and bleeding. You should have regular blood tests to check your platelet count during treatment.
  • Liver problems: Cases of liver failure, including fatal cases, have been reported in patients receiving KYPROLIS. Your liver function should be closely monitored during treatment.
  • Blood problems: Cases of a blood disease called thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal cases, have been reported in patients who received KYPROLIS. Your doctor should monitor your signs and symptoms.
  • Brain problems: A nerve disease called Posterior Reversible Encephalopathy Syndrome (PRES), formerly called Reversible Posterior Leukoencephalopathy Syndrome (RPLS), has been reported in patients receiving KYPROLIS. It can cause seizure, headache, lack of energy, confusion, blindness, altered consciousness, and other visual and nerve disturbances, along with high blood pressure. Your doctor should monitor your signs and symptoms.
  • Cases of a brain infection called Progressive Multifocal Leukoencephalopathy (PML), including fatal cases, have been reported in patients receiving KYPROLIS. Your doctor should monitor your signs and symptoms.
  • KYPROLIS should not be combined with melphalan and prednisone: Newly diagnosed transplant ineligible multiple myeloma patients have shown an increased risk of serious and fatal side effects when using KYPROLIS in combination with melphalan and prednisone.
  • Possible fetal harm: KYPROLIS can cause harm to a fetus (unborn baby) when given to a pregnant woman. Women should use effective contraception during treatment with KYPROLIS and for 6 months following the final dose. Men should use effective contraception during treatment with KYPROLIS and for 3 months following the final dose. KYPROLIS can cause harm to a fetus if used during pregnancy or if you or your partner become pregnant during treatment with KYPROLIS.
You should contact your doctor immediately if you experience any of the following:
  • Shortness of breath
  • Prolonged, unusual or excessive bleeding
  • Yellowing of the skin and/or eyes (jaundice)
  • Headaches, confusion, seizures, or loss of sight
  • Pregnancy (women should not receive KYPROLIS if they are pregnant or breastfeeding)
  • Any other side effect that bothers you or does not go away
What are the possible side effects of KYPROLIS?
  • The most common side effects occurring in at least 20% of patients receiving KYPROLIS in the combination therapy trials are: low red blood cell count, diarrhea, high blood pressure (hypertension), tiredness (fatigue), upper airway (respiratory tract) infection, low platelets, fever, cough, difficulty breathing and sleeplessness (insomnia).

These are not all the possible side effects of KYPROLIS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088

APPROVED USE

  • KYPROLIS® (carfilzomib) is a prescription medication used to treat adult patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS is approved for use in combination with daratumumab plus dexamethasone, dexamethasone or with lenalidomide plus dexamethasone, or isatuximab plus dexamethasone, which are other medicines used to treat multiple myeloma.