Patient Terms and Conditions: Update effective as of January 1, 2024. Patients must have minimum out-of-pocket costs of $15.01 to redeem this offer. Annual benefit maximum applies, as may other restrictions. Patients will be responsible for any out-of-pocket costs above the maximum annual program benefit. Program benefit applies to medication cost only and does not cover any costs to administer the medication. Offer with program member number is valid through December 31 of the year of issue. On January 1 of the following year, the offer automatically resets and is subject to annual limits if the prescription benefit remains the same. Patients must have commercial prescription benefit coverage. Offer is not valid if a patient is uninsured, is paying cash for the treatment, or is covered by an Alternate Funding Program (AFP). Offer is not valid if a patient is enrolled in a federal or state prescription program (including Medicare Part B, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program). Patient enrollment in a copay adjustment program, such as a maximizer or accumulator program, may impact the value of this offer. If patients move or switch from commercial prescription benefit coverage to any government prescription benefit coverage, they will no longer be eligible. This offer is not insurance. Offer is valid only for an FDA-approved or compendia-recognized use. Patients are responsible for reporting receipt of program benefits to any commercial insurer that pays for or reimburses any part of the prescriptions filled with this program to the extent required by law or by the insurer. Patients agree not to seek reimbursement from their 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 the patient 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. Patient is responsible for all taxes. There are no membership fees associated with this program. Offer is good only in the United States and Puerto Rico and is void where prohibited or otherwise restricted by law. Incyte Corporation reserves the right to rescind, revoke, or amend this program without notice. If questions arise, 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.