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WHY POTELIGEO®

(mogamulizumab-kpkc) injection?

Could POTELIGEO be your next treatment?

People living with mycosis fungoides (MF) and Sézary syndrome (SS) can experience unique journeys, and each person’s treatment goals may vary. But you may have decided it’s time for something different because of one or more of the reasons described below.

Your current treatment(s) may not be working as well as it did before, has stopped working altogether, and/or has caused bothersome side effects

You have noticed new or worsening skin symptoms and/or test results have shown that your disease has spread beyond the skin to other areas of your body

Your disease is affecting your life, and you are ready to try a different treatment

If this sounds like you, don’t lose hope. POTELIGEO may offer you something different. Keep reading to learn what POTELIGEO is, how it may help, and how it works in the body.

POTELIGEO IS A TARGETED SYSTEMIC THERAPY

POTELIGEO is a targeted therapy for adults with MF or SS who have tried at least one prior systemic treatment (taken by mouth or injection) that did not work or in whom the disease has come back.

POTELIGEO is a

  • checkSystemic treatment
  • checkTreatment given by an intravenous (IV) infusion
  • checkTreatment that specifically targets cancer cells

POTELIGEO is not a

Because POTELIGEO is an IV infusion, it will be given at an infusion center by a trained healthcare provider.

link iconLearn more about the infusion experience

The effectiveness of POTELIGEO was studied in a large clinical trial

POTELIGEO was studied in the largest clinical trial to date for a systemic treatment for people with the most common cutaneous T-cell lymphoma (CTCL) subtypes MF and SS. The phase 3 clinical trial evaluated the safety and effectiveness of treatment with POTELIGEO compared with the safety and effectiveness of a comparator treatment (vorinostat), which is a drug used in the United States to treat CTCL.

The clinical trial looked at the 4 areas of the body where disease could be found: skin, blood, lymph nodes, and internal organs. (Your healthcare provider may also refer to these areas of the body as "compartments.")

POTELIGEO MAY HELP IN THE FOLLOWING WAYS:

POTELIGEO MAY HELP CONTROL MF AND SS ON THE SKIN AND INSIDE THE BODY

The clinical trial evaluated how well treatment prevented MF and SS from spreading further. Your healthcare provider may also refer to this as "progression-free survival."

In the clinical trial, people taking POTELIGEO experienced control over their disease for more than twice as long as those taking the comparator treatment.

Median number of months that MF or SS was controlled before showing any sign of spreading further

POTELIGEO group

0

months

Comparator group

0

months

MORE PEOPLE TAKING POTELIGEO RESPONDED TO TREATMENT COMPARED WITH THOSE TAKING VORINOSTAT

The clinical trial evaluated how well treatment reduced MF and SS in areas of the body where disease was found when entering the trial. Your healthcare provider may also refer to this as "response to treatment" or "overall response rate."

In the clinical trial, response to treatment was divided into 2 categories: partial response and complete response. Partial response is defined as a reduction in the amount of cancer in the body; complete response is defined as no evidence of disease in the body.

Percentage of people who experienced partial response in 1 or more areas of the body (skin, blood, lymph nodes, and internal organs) or complete response

0 % POTELIGEO group

2% of people who used POTELIGEO experienced complete response vs zero taking the comparator treatment

0 % Comparator group

IN THOSE WHO RESPONDED TO TREATMENT, RESPONSE LASTED LONGER IN PEOPLE TAKING POTELIGEO

The clinical trial evaluated how long people responded to treatment. Your healthcare provider may also refer to this as "duration of response."

Response to treatment lasted 54% longer in people taking POTELIGEO vs those taking the comparator treatment.

Median number of months of partial or complete response (once response was first detected)

POTELIGEO group

0

months

Comparator group

0

months

Find out if POTELIGEO is right for you

If you're considering POTELIGEO, use this guide to start the conversation with your healthcare provider.

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POTELIGEO is different from other treatments you have tried

POTELIGEO is a monoclonal antibody that binds to certain cancerous T-cells, triggering your body’s immune cells to specifically target them. No other treatment for MF and SS works exactly the same way; let's take a closer look.

POTELIGEO works by specifically latching on to certain cancerous T-cells, while aiming to leave your healthy cells alone.

Once POTELIGEO latches on, it attracts certain types of immune cells in your body to come attack the cancer cells.

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TAKING POTELIGEO?

By clicking “Sign up” and providing your name, email address, or other personal information, you agree that Kyowa Kirin and others working on behalf of Kyowa Kirin may send you POTELIGEO.com content updates and educational materials about MF/SS and POTELIGEO, use the information that you have submitted to develop or improve products and services, and contact you in the future about educational programs, health-related topics, and advancements in the treatment of MF/SS. Kyowa Kirin respects the privacy of visitors to its websites, and we recognize your need for protection and management of personally identifiable information you share with us (any information by which you can be identified, including, but not limited to, name, address, email address, and telephone number). Click here to read the Kyowa Kirin Privacy Policy.

INDICATION AND IMPORTANT SAFETY INFORMATION

What is POTELIGEO® (mogamulizumab-kpkc)?

POTELIGEO is a prescription medicine used to treat mycosis fungoides (MF) or Sézary syndrome (SS) in adults who have tried at least one prior medicine (taken by mouth or injection) that did not work or in whom the disease has come back.

Important Safety Information

What is the most important information I should know about POTELIGEO?

POTELIGEO may cause serious side effects that can be severe or life-threatening including skin problems, infusion reactions, infections, autoimmune problems, and complications from stem cell transplant.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

  • Skin problems: Signs and symptoms of skin reactions may include skin pain, itching, skin blistering or peeling, rash, painful sores or ulcers in your mouth, nose, throat or genital area.
  • Infusion reactions: Signs and symptoms of infusion reactions may include chills or shaking, redness on your face (flushing), itching or rash, shortness of breath, coughing or wheezing, dizziness, feeling like passing out, tiredness, fever.
  • Infections: Signs and symptoms of infection may include fever, sweats or chills, nausea, flu-like symptoms, sore throat or difficulty swallowing, shortness of breath, diarrhea or stomach pain, cough.
  • Autoimmune problems: Some people receiving POTELIGEO may develop autoimmune problems, and some people who already have an autoimmune disease may get worse during treatment with POTELIGEO.
  • Complications of stem cell transplant: Patients who receive a stem cell transplant using donor stem cells (allogeneic) after treatment with POTELIGEO may experience complications that can be severe and lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

What are the most common side effects of POTELIGEO?

The most common side effects of POTELIGEO include rash, tiredness, diarrhea, muscle and bone pain, and upper respiratory tract infection.

Before starting POTELIGEO treatment, tell your doctor about all your medical conditions, including whether you:

  • have had a severe skin reaction after receiving POTELIGEO
  • have had an infusion reaction during or after receiving POTELIGEO
  • have or have had liver problems including hepatitis B (HBV) infection
  • have a history of autoimmune problems
  • have undergone or plan to have a stem cell transplant, using cells from a donor
  • have lung or breathing problems
  • are pregnant or plan to become pregnant
    • It is not known if POTELIGEO will harm your unborn baby
  • are breastfeeding or plan to breastfeed
    • Talk to your healthcare provider about the best way to feed your baby during treatment with POTELIGEO

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

pdf iconPLEASE SEE PATIENT INFORMATION.

What is POTELIGEO® (mogamulizumab-kpkc)?

POTELIGEO is a prescription medicine used to treat mycosis fungoides (MF) or Sézary syndrome (SS) in adults who have tried at least one prior medicine (taken by mouth or injection) that did not work or in whom the disease has come back.

Important Safety Information

What is the most important information I should know about POTELIGEO?

POTELIGEO may cause serious side effects that can be severe or life-threatening including skin problems, infusion reactions, infections, autoimmune problems, and complications from stem cell transplant.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

  • Skin problems: Signs and symptoms of skin reactions may include skin pain, itching, skin blistering or peeling, rash, painful sores or ulcers in your mouth, nose, throat or genital area.
  • Infusion reactions: Signs and symptoms of infusion reactions may include chills or shaking, redness on your face (flushing), itching or rash, shortness of breath, coughing or wheezing, dizziness, feeling like passing out, tiredness, fever.
  • Infections: Signs and symptoms of infection may include fever, sweats or chills, nausea, flu-like symptoms, sore throat or difficulty swallowing, shortness of breath, diarrhea or stomach pain, cough.
  • Autoimmune problems: Some people receiving POTELIGEO may develop autoimmune problems, and some people who already have an autoimmune disease may get worse during treatment with POTELIGEO.
  • Complications of stem cell transplant: Patients who receive a stem cell transplant using donor stem cells (allogeneic) after treatment with POTELIGEO may experience complications that can be severe and lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

What are the most common side effects of POTELIGEO?

The most common side effects of POTELIGEO include rash, tiredness, diarrhea, muscle and bone pain, and upper respiratory tract infection.

Before starting POTELIGEO treatment, tell your doctor about all your medical conditions, including whether you:

  • have had a severe skin reaction after receiving POTELIGEO
  • have had an infusion reaction during or after receiving POTELIGEO
  • have or have had liver problems including hepatitis B (HBV) infection
  • have a history of autoimmune problems
  • have undergone or plan to have a stem cell transplant, using cells from a donor
  • have lung or breathing problems
  • are pregnant or plan to become pregnant
    • It is not known if POTELIGEO will harm your unborn baby
  • are breastfeeding or plan to breastfeed
    • Talk to your healthcare provider about the best way to feed your baby during treatment with POTELIGEO

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

pdf iconPLEASE SEE PATIENT INFORMATION.
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