PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
IMPORTANT SAFETY INFORMATION
Before getting PROVENGE, tell your doctor if you:
- Have heart problems
- Have lung problems
- Have a history of stroke
- Take any other medicines including prescription and nonprescription drugs, vitamins, and dietary supplements.
What are the possible side effects of PROVENGE
PROVENGE infusion can cause serious reactions.
Tell your doctor right away if you:
- Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems.
- Develop numbness or weakness on one side of the body, decreased vision in one eye or difficulty speaking. Any of these may be signs of a stroke.
- Develop symptoms of thrombosis which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath or chest pain that worsens on deep breathing.
- Get a fever over 100°F, or redness or pain at the infusion or collection sites. Any of these may be signs of infection.
The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache.
These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information on PROVENGE, please see the Full Prescribing Information or call 1-800-667-5924.