ZYNYZ- retifanlimab-dlwr injection 
Incyte Corporation

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 MEDICATION GUIDE
ZYNYZ® (ZYE-niz)
(retifanlimab-dlwr)
injection 

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

ZYNYZ is a medicine that may treat a certain type of skin cancer by working with your immune system. ZYNYZ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

 Lung problems.
  •  cough       
  • shortness of breath
  •  chest pain
 Intestinal problems.
  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness
 Liver problems.
  • yellowing of your skin or the whites of your eyes
  • severe nausea or vomiting
  • pain on the right side of your stomach area (abdomen)
  • dark urine (tea colored)
  • bleeding or bruising more easily than normal
Hormone gland problems.
  • headaches that will not go away or unusual headaches
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • urinating more often than usual
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems.
  • decrease in your amount of urine
  • blood in your urine
  • swelling of your ankles
  • loss of appetite
Skin problems.
  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in your mouth or nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
  • chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include:
  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • feel like passing out
  • fever
  • back or neck pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with ZYNYZ. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious.Your healthcare provider will check you for these problems during your treatment with ZYNYZ. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with ZYNYZ if you have severe side effects.

What is ZYNYZ?

ZYNYZ is a prescription medicine used to treat a type of skin cancer called Merkel cell carcinoma in adults. ZYNYZ may be used to treat your skin cancer when it has spread or returned.

It is not known if ZYNYZ is safe and effective in children.

Before you receive ZYNYZ, tell your healthcare provider about all of your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. ZYNYZ can harm your unborn baby.
    Females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start treatment with ZYNYZ.
    • You should use an effective method of birth control during your treatment and for 4 months after your last dose of ZYNYZ. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZYNYZ.
  • are breastfeeding or plan to breastfeed. It is not known if ZYNYZ passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ZYNYZ.

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

How will I receive ZYNYZ?

  • Your healthcare provider will give you ZYNYZ into your vein through an intravenous (IV) line over 30 minutes.
  • ZYNYZ is usually given every 4 weeks.
  • Your healthcare provider will decide how many treatments you will need.
  • Your healthcare provider will do blood tests to check you for side effects.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of ZYNYZ?

ZYNYZ can cause serious side effects. See "What is the most important information I should know about ZYNYZ?"

The most common side effects of ZYNYZ include:

  • tiredness
  • muscle and bone pain
  • itching
  • diarrhea
  • rash
  • fever
  • nausea
These are not all the possible side effects of ZYNYZ.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ZYNYZ.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ZYNYZ, talk with your healthcare provider. You can ask your healthcare provider for information about ZYNYZ that is written for health professionals.

What are the ingredients in ZYNYZ?
Active ingredient: retifanlimab-dlwr
Inactive ingredients: glacial acetic acid, polysorbate 80, sodium acetate, sucrose, and Water for Injection.

Manufactured by: Incyte Corporation, Wilmington, DE 19803
U.S. License No.2228
ZYNYZ and the ZYNYZ logo are registered trademarks of Incyte.
© 2023 Incyte Corporation. All rights reserved.
Patent Information: www.incyte.com/patents
For more information, call 1-855-463-3463.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                        Issued: 11/2023


Revised: 4/2024
Document Id: 584c49ff-644e-49e0-a1bd-3573d00656c2
Set id: 109648d0-d30a-42fc-8273-39cb1540a751
Version: 7
Effective Time: 20240417
Incyte Corporation