HIF-2α = hypoxia-inducible factor 2 alpha.
Cells in the body contain a protein called VHL. When the VHL protein is working normally, and when the cell is getting enough oxygen, VHL helps to break down another protein called
HIF-2α, and contributes to maintaining normal cell growth.
When the VHL protein is not working, or when a cell is not getting enough oxygen, too much
HIF-2α can build up. HIF-2α then moves to the nucleus, the cell's control center, and joins another protein called HIF-1β. This turns on genes that can contribute to uncontrolled cell growth in certain types of RCC.HIF-1β = hypoxia-induced factor 1 beta.
WELIREG attaches to HIF-2α. When the VHL protein is not working, or when the cell is not getting enough oxygen, WELIREG prevents HIF-2α from joining HIF-1β in the nucleus.
For certain adults whose kidney cancer has spread (advanced RCC), WELIREG works differently by targeting HIF-2α, a key driver of tumor growth.
WELIREG is a prescription medicine used to treat adults with kidney cancer that has spread (advanced RCC) following treatment with a PD-1 or PD-L1 and VEGF cancer medicines.
It is not known if WELIREG is safe and effective in children.
PD-1 = programmed death receptor-1;
PD-L1 = programmed death-ligand 1;
VEGF = vascular endothelial growth factor.
WELIREG may cause serious side effects. WELIREG may cause harm to your unborn baby.
WELIREG may cause serious side effects, including:
Low red blood cell counts (anemia). Low red blood cell counts are common with WELIREG and can be severe. You may need a blood transfusion if your red blood cell counts drop too low. Your health care provider will do blood tests to check your red blood cell counts before you start and during treatment with WELIREG. Tell your health care provider if you get any symptoms of low red blood cell counts, including tiredness, feeling cold, shortness of breath, chest pain, or fast heartbeat.
Low oxygen levels in your body. WELIREG can cause low oxygen levels in your body that can be severe and may require you to stop treatment with WELIREG, receive oxygen therapy, or be hospitalized. Your health care provider will monitor your oxygen levels before you start and during treatment with WELIREG. Tell your health care provider or get medical help right away if you get symptoms of low oxygen in your body, including shortness of breath or increased heart rate.
Harm to your unborn baby. Treatment with WELIREG during pregnancy can cause harm to your unborn baby.
Females who are able to become pregnant:
Males with female partners who are able to become pregnant:
Before taking WELIREG, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. WELIREG and certain other medicines can affect each other and cause serious side effects.
The most common side effects of WELIREG in adults with VHL disease include:
The most common side effects of WELIREG in adults with advanced RCC include:
WELIREG may cause fertility problems in males and females, which may affect your ability to have children. Talk to your health care provider if this is a concern for you.
These are not all of the possible side effects of WELIREG. Call your health care provider for medical advice about side effects.
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.
Please read the accompanying Medication Guide for WELIREG, including an important warning about harm to an unborn baby, and discuss it with your doctor. The physician Prescribing Information also is available.