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IncyteCARES for ZYNYZ is a program for residents
of the United States and Puerto Rico.

Patient Terms and Conditions: Update effective as of December 1, 2023. Maximum benefits per claim and per calendar year apply, as may other restrictions. You must have minimum out-of-pocket costs of $15.01 to redeem this offer. Patients will be responsible for any out-of-pocket costs above the maximum annual and monthly program benefit. Program benefit applies to medication cost only and does not cover any costs to administer the medication. Program is valid through December 31 of the year of issue. On January 1 of the following year, the program automatically resets and is subject to annual limits if the primary plan benefit remains the same. The IncyteCARES for ZYNYZ Savings Program uses advanced logic to detect plans attempting to remove the benefit provided by this program from applying to a patient's out-of-pocket cost, such as, but not specifically limited to, copayments, coinsurance, and deductibles. These plans often refer to these saving programs as accumulators/maximizers. If such activity is detected, the program will automatically implement a per claim maximum of $25 and reduce the number of allowable uses per year. Offer is not valid if you are uninsured or paying cash for your treatment. Offer is not valid if you are enrolled in a federal or state healthcare program (including Medicare Part B, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program). If you move or switch from commercial benefit coverage to any government benefit coverage, you will no longer be eligible. This program is not insurance. Offer valid only for an FDA-approved or recognized compendia use. You are responsible for reporting receipt of program benefits to any commercial insurer that pays for or reimburses any part of the services filled with this program, to the extent required by law or by the insurer. You agree not to seek reimbursement from your insurer or any other third party for all or any part of the benefit received through this offer. This offer may not be sold, purchased, traded, or transferred and is void if reproduced. Use of this offer does not obligate you to use or continue to use ZYNYZ® (retifanlimab-dlwr). No other purchase and no refills are necessary. This offer is limited to one (1) per person during this offering period and is not transferable. You are responsible for all taxes. No membership fees. Offer is good only in the United States and Puerto Rico, and void where prohibited or otherwise restricted by law. Incyte Corporation reserves the right to rescind, revoke, or amend this program without notice. If you have any questions, please call 1-855-452-5234.

INDICATIONS AND USAGE

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.

ZYNYZ is approved based on tumor response and duration of response. There are ongoing studies to confirm the clinical benefit of ZYNYZ.

IMPORTANT SAFETY INFORMATION

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.

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.

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.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Please see the full Prescribing Information, including the Medication Guide, which includes a more complete discussion of the risks associated with ZYNYZ.

INDICATIONS AND USAGE

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.

ZYNYZ is approved based on tumor response and duration of response. There are ongoing studies to confirm the clinical benefit of ZYNYZ.

IMPORTANT SAFETY INFORMATION

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.

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.

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.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Please see the full Prescribing Information, including the Medication Guide, which includes a more complete discussion of the risks associated with ZYNYZ.