Looking for more information on POTELIGEO? Review the frequently asked questions below or reach out to your doctor
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1. Who is POTELIGEO for?

POTELIGEO is a chemo-free treatment for people who have been diagnosed with Mycosis Fungoides (MF) or Sézary Syndrome (SS) who have already taken at least 1 prior medicine (taken by mouth or injection) that did not work because it:
  • caused new or worsening symptoms
  • did not prevent the disease from coming back or spreading to new parts of the body
  • did not prevent symptoms that are impacting their life

2. How does POTELIGEO work?

POTELIGEO is a targeted immunotherapy (not a chemotherapy) that is specifically designed to help your immune system target and attack cancerous T cells. Slowing the spread of cancerous T cells in the body can help control Mycosis Fungoides (MF) or Sézary Syndrome (SS) on the skin and in the body.

3. How is POTELIGEO given?

POTELIGEO is injected by needle into your arm through an intravenous (IV) line by a trained healthcare professional at an infusion center.

4. How long does treatment with POTELIGEO take?

Each infusion of POTELIGEO takes at least an hour. This does not include the time it takes for travel, preparation of the infusion, and post-infusion monitoring. If you’d like to better understand how long these steps may take, contact your infusion center for more information.

5. How often will I be treated with POTELIGEO?

You will be given 1 infusion of POTELIGEO every week for the first 5 weeks. After the first 5 weeks, you will be given 1 infusion of POTELIGEO every 2 weeks. Your infusion schedule can vary by up to 2 days. If a dose is missed, an infusion of POTELIGEO should be given as soon as possible to continue with the dosing schedule.

6. How long until I can stop treatment with POTELIGEO?

There is no limit on how long you can be given POTELIGEO. At any point during treatment, you can discuss with your doctor about discontinuing POTELIGEO. Your doctor will tell you if POTELIGEO has stopped working, or if you need to pause or stop infusions of POTELIGEO due to moderate, severe, or life-threatening side effects.

7. How will I know if POTELIGEO is working?

Most people who responded to POTELIGEO did so in their blood first. This may cause you to feel better overall. You may see an improvement in your skin symptoms after a few months of infusions with POTELIGEO. You should work closely with your doctor to determine if and how POTELIGEO is working; there are a number of tests they can do to determine your response to treatment.

8. How might POTELIGEO improve my skin?

Each person’s experience with POTELIGEO may be different. In the clinical trial, 42% of people treated with POTELIGEO experienced response to treatment on their skin vs 16% of people treated with vorinostat. It is also important to know that drug rashes can occur with POTELIGEO. Rash is considered a possible side effect of treatment and it may make it appear as if your skin is getting worse when it is not. This can occur at any time while you’re receiving POTELIGEO. Let your doctor know right away if you experience skin rash or any other side effects. Your doctor will evaluate if it’s necessary to pause or stop treatment with POTELIGEO.

9. What kind of response might I expect with POTELIGEO?

Each person’s experience with POTELIGEO may be different. In the clinical trial, people who were treated with POTELIGEO stopped their disease from worsening for more than twice as long as those treated with vorinostat (median of 7.6 months vs 3.1 months, respectively). More than 5 times as many people (28%) responded to POTELIGEO compared to people treated with vorinostat (5%).a Furthermore, in people who responded to treatment, those who were treated with POTELIGEO experienced a longer response than those treated with vorinostat (median of 13.9 months vs 9.0 months, respectively).
aResponse was measured if skin cleared up by 50% or more; if a person had more than a 50% reduction in the number of cancerous cells in their blood; if a person had at least a 50% improvement in lymph nodes or other organs; If there was no worsening in skin, blood, lymph nodes, or other organs.

10. 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.

11. What should I do if I experience any side effects while receiving POTELIGEO?

POTELIGEO may cause serious side effects including skin problems, infusion reactions, infections, autoimmune problems, and complications of stem cell transplants. Call your doctor if you develop symptoms or if symptoms get worse. Let your doctor 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.

12. How much does POTELIGEO cost?

A dedicated Kyowa Kirin Cares specialist may help you figure out coverage with your insurance and/or if you qualify for any financial assistance programs through the patient support program for POTELIGEO, Kyowa Kirin Cares.
To get help while on treatment, POTELIGEO has a robust patient support program, Kyowa Kirin Cares
Learn about the patient support program

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.