Prescribing Information & Medication Guide
Medication Guide for WELIREG
What is WELIREG? 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 hemangioblastomas, or a type of pancreatic cancer called pancreatic neuroendocrine tumors, that do not require surgery right away.
It is not known if WELIREG is safe and effective in children.
What is the most important information I should know about WELIREG?
WELIREG may cause serious side effects, including:
See “What are the possible side effects of WELIREG?” for more information about side effects.
Before taking WELIREG, 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. WELIREG and certain other medicines can affect each other and cause serious side effects.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take WELIREG?
What are the possible side effects of WELIREG? WELIREG may cause serious side effects, including:
The most common side effects of WELIREG include:
WELIREG may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of WELIREG. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store WELIREG?
Keep WELIREG and all medicines out of the reach of children.
General information about the safe and effective use of WELIREG. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use WELIREG for a condition for which it was not prescribed. Do not give WELIREG to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about WELIREG that is written for health professionals.
What are the ingredients in WELIREG? Active ingredient: belzutifan Inactive ingredients: croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, mannitol, microcrystalline cellulose, and silicon dioxide. The film-coating contains FD&C Blue #2 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Please read the 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.
For information about obtaining WELIREG, please see The Merck Access Program.