Approved Uses

KYPROLIS® (carfilzomib) is a prescription medication used to treat 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 dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.

KYPROLIS® is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one or more previous treatments for multiple myeloma. KYPROLIS is approved for use alone to treat relapsed or refractory multiple myeloma.

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Multiple myeloma is a
complicated disease.
You need
all the support you can get.

FUEL YOUR DETERMINATION
TO LIVE LONGER WITH KYPROLIS®

When your multiple myeloma comes back, let your doctor know that you will do what it takes to live longer.

In clinical studies with patients with relapsed or refractory multiple myeloma, 2 treatment regimens that included KYPROLIS® kept multiple myeloma from getting worse and helped patients live longer.

KYPROLIS® given with dexamethasone kept the disease from getting worse longer than Velcade® and dexamethasone (median of 18.7 months compared with 9.4 months) and helped patients live longer (median of 47.6 months compared with 40 months).*

KYPROLIS® given with Revlimid® and dexamethasone kept the disease from getting worse longer than Revlimid and dexamethasone (median of 26.3 months compared with 17.6 months) and helped patients live longer (median of 48.3 months compared with 40.4 months).

Keep reading for the details on these studies.


A separate study compared results for patients taking KYPROLIS® and dexamethasone once a week at a higher dose to results for patients taking the same combination twice a week at a lower dose.

When patients received KYPROLIS® and dexamethasone once a week at a higher dose, instead of twice a week at a lower dose, they were able to:

In a clinical study of 478 patients with relapsed and refractory multiple myeloma who had received 2-3 prior therapies, 240 patients received KYPROLIS® in combination with dexamethasone once weekly at 70 mg/m2, and 238 patients received KYPROLIS® in combination with dexamethasone twice weekly at 27 mg/m2. 27 mg/m2 is not a FDA approved dose for KYPROLIS®. The study compared how long patients lived without their disease getting worse.


When patients received KYPROLIS® with Revlimid and dexamethasone, instead of Revlimid and dexamethasone only, they were able to:

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


When patients received KYPROLIS® and dexamethasone twice a week,* instead of Velcade® and dexamethasone, they were able to:

*In a clinical study of 929 patients with relapsed or refractory multiple myeloma who had received 1-3 prior therapies, 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 overall survival.

§The median is the middle number in a group of numbers arranged from lowest to highest.

**For patients on treatment, a complete response means 3 things: no detectable M-proteins in the blood and urine, fewer than 5% abnormal plasma cells in bone marrow, and no detectable soft tissue tumors.

Revlimid is a registered trademark of Celgene Corporation.

Velcade is a registered trademark of Millennium Pharmaceuticals, Inc.

We're Here to Help

Connect with an Amgen Nurse Ambassador*

If your doctor has prescribed KYPROLIS® for you, your Amgen Nurse Ambassador* is a single point of contact who takes the time to help you or your care partner identify which types of assistance are most important to you. They can answer questions you might have about Amgen products and will assist you in finding resources, so that you and your care partner can focus on your KYPROLIS® treatment.

*Nurse Ambassadors are there to support, not replace, a patient treatment plan and do not provide medical advice or case management services. Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.
Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

How Amgen Assist 360 Can Help

CO-PAY AND REIMBURSEMENT ASSISTANCE

Whatever insurance you have—even if you have none—your Amgen Nurse Ambassador* can put you in touch with programs that may be able to help you afford KYPROLIS® (carfilzomib) such as KYPROLIS FIRST STEP for commercially insured patients or independent charitable patient assistance programs.

HELP FINDING TRANSPORTATION AND LODGING ASSISTANCE

If you need assistance with travel that's connected to your KYPROLIS® treatment, your Amgen Nurse Ambassador* can put you in touch with independent, charitable patient assistance programs that provide travel cost assistance for gas, tolls, parking, airfare, and lodging.

REFERRALS TO RESOURCES FOR DAY-TO-DAY LIVING

Sometimes you can use a little support from someone who knows what you're going through. Your Amgen Nurse Ambassador* can refer you and/or your care partner to independent, charitable patient organizations that connect you to one-on-one counseling services and local support groups.

* Nurse Ambassadors are there to support, not replace, a patient treatment plan and do not provide medical advice or case management services. Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.

Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

Discover how Amgen Assist 360 can help refer you to resources most important to you. To connect with an Amgen Nurse Ambassador, call
888‑4ASSIST (888‑427‑7478), Monday through Friday, 9 AM to 8 PM Eastern Time.

Find Additional Resources

Access tools to help you manage your multiple myeloma and take an active role in your treatment.

KYPROLIS® Patient Starter Kit

If your doctor has prescribed KYPROLIS® for you, ask about the KYPROLIS® Starter Kit. It includes the KYPROLIS® Brochure, Treatment Organizer, a tote bag, and other useful tools to help you with your care.

Other materials for download

KYPROLIS® Patient and Care Partner Brochure

Find useful information about multiple myeloma and KYPROLIS® in this Brochure.

Lab Results Tracker

Keep track of M-protein and other lab numbers with this Lab Results Tracker.

Weekly Treatment Tracker

Keep track of treatment and appointments with this Weekly Treatment Tracker.

Inspire others by telling your story

Through Amgen's Voices of Experience network, you can inspire others like you by sharing your experience with relapsed or refractory multiple myeloma and KYPROLIS®. Call 1-855-894-4352 to learn more or visit voicesofexperience.net.

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, 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 or with lenalidomide plus dexamethasone.
  • Infusion reactions: Symptoms of infusion reactions included fever, chills, joint pain, muscle pain, facial flushing and/or swelling, 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.
  • 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 avoid becoming pregnant during treatment with KYPROLIS and for 6 months following the final dose. Men should avoid fathering a child 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 becomes 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, low white blood cell count, diarrhea, difficulty breathing, tiredness (fatigue), low platelets, fever, sleeplessness (insomnia), muscle spasm, cough, upper airway (respiratory tract) infection, and decreased potassium levels.
  • The most common side effects occurring in at least 20% of patients receiving KYPROLIS when used alone (monotherapy) in trials are: low red blood cell count, tiredness (fatigue), low platelets, nausea, fever, difficulty breathing, diarrhea, headache, cough, swelling of the lower legs or hands.

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 USES

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

Please see full Product Information.

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