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WHAT TO EXPECT

POTELIGEO® (mogamulizumab-kpkc) injection is given as an IV infusion

POTELIGEO is an intravenous (IV) infusion and will be given at an infusion center by a trained healthcare provider. Each infusion will last for at least 1 hour. You will receive POTELIGEO once per week for the first 5 weeks and then once every 2 weeks as shown below:

INFUSION SCHEDULE EXAMPLE

STARTING SCHEDULE

You will receive 1 infusion of POTELIGEO every week for the first 5 weeks.

ONGOING SCHEDULE

After the first 5 weeks, you will receive 1 infusion of POTELIGEO every other week.

Your infusion schedule can vary by up to 2 days, but be sure not to receive POTELIGEO infusions less than 5 days apart.

LOOK OUT FOR INFUSION-RELATED SIDE EFFECTS

As with any IV infusion, there is potential for infusion-related side effects. This risk may be greater when you first begin treatment but should lessen as you continue and your body has time to adjust.

To reduce the occurrence of these side effects, your healthcare provider may prescribe medications to take on the day you start treatment with POTELIGEO.

Let your healthcare provider know right away if you experience any symptoms such as chills or shaking, nausea, fever, rapid heartbeat, headache, and vomiting.

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.

MAKE THE MOST OF YOUR POTELIGEO INFUSION TIME

As mentioned above, each POTELIGEO infusion will last at least 1 hour, so be sure to plan ahead about how you’d like to spend your time. We’ve included some suggestions below:

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Watch a TV show

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Call a family member or friend to catch up

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Read a book

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Play a game

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Pick up a new hobby (eg, knitting)

Remember, a trained healthcare provider will be available to assist you and answer any questions you may have during your treatments.

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.

WHAT TO TELL YOUR HEALTHCARE PROVIDER BEFORE STARTING POTELIGEO

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 (HPV) 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.

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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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