What is cutaneous T-cell lymphoma (CTCL)? | POTELIGEO® (mogamulizumab-kpkc)

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Cutaneous T-cell lymphoma (CTCL) is a rare form of cancer that starts in a type of white blood cell called a T cell

Healthy T cells are part of the immune system. They help the body fight infection
CTCL develops when your T cells grow uncontrollably and become cancerous

There are several types of CTCL; mycosis fungoides (MF) and Sézary syndrome (SS) are the most common

In MF and SS, cancerous T cells are usually found in the skin first
- T cells in the skin may appear as a flat area called a patch, or a slightly raised area called a plaque

- This can cause sunburn-like redness or rash, and sometimes skin tumors
In addition to the skin, cancerous T cells can spread and grow in the blood, lymph nodes, or other organs in the body
- Lymph nodes are found in many parts of the body, such as the neck, armpit, and groin

Image of MF plaque

Image of MF plaque

Image of erythroderma in SS

Erythroderma in SS

Learn about mycosis fungoides (MF), the most common form of CTCL

Learn more about MF

Discover what is different about Sézary syndrome (SS) and why blood involvement matters

Learn more about SS

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.

Please see full Prescribing Information as well as 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.

Please see full Prescribing Information as well as Patient Information.