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) and 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.
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 symptoms?
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 symptoms are getting worse when they are 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 symptoms 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 their symptoms in the skin, blood, lymph nodes, or other organs did not get worse.
10. What are the most common side effects of POTELIGEO?
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.