Doctors conducted a clinical study with 61 adults taking three 40-mg pills of WELIREG once a day in order to measure the percentage of patients whose tumors shrank. A closer look at this study is provided below.
49% of patients (30 out of 61) saw tumors in their kidneys partially shrink.
56% of these patients (17 out of 30) were still responding to treatment after 12 months or more.
63% of patients (15 out of 24) saw tumors in their brain and spinal cord partially or completely shrink. 14 out of these 24 patients saw their tumors partially shrink and 1 saw their tumors completely shrink.
73% of these patients (11 out of 15) were still responding to treatment after 12 months or more.
83% of patients (10 out of 12) saw tumors in their pancreas partially or completely shrink. 8 out of these 12 patients saw their tumors partially shrink and 2 saw their tumors completely shrink.
50% of these patients (5 out of 10) were still responding to treatment after 12 months or more.
WELIREG is a prescription medicine used to treat adults with von Hippel-Lindau (VHL) disease who need treatment for a type of kidney cancer called renal cell carcinoma (RCC), tumors in the brain and spinal cord called central nervous system (CNS) hemangioblastomas, or a type of pancreatic cancer called pancreatic neuroendocrine tumors (pNET), that do not need surgery right away.
It is not known if WELIREG is safe and effective in children.
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.
