ZYNYZ- retifanlimab-dlwr injection
Incyte Corporation
----------
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. | ||||||
|
|
|
||||
Intestinal problems. | ||||||
|
||||||
Liver problems. | ||||||
|
|
|||||
Hormone gland problems. | ||||||
|
|
|||||
Kidney problems. | ||||||
|
|
|||||
Skin problems. | ||||||
|
|
|||||
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:
|
||||||
|
||||||
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include:
|
||||||
|
|
|||||
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:
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?
|
||||||
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: |
||||||
|
|
|||||
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?
|
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 11/2023