Side Effects
Important PROVENGE safety and side effect information
Your health care team will talk to you about what to expect and how to work with them to help manage side effects of therapy.
The most common side effects reported with PROVENGE treatment are:
- Chills
- Fatigue
- Fever
- Back pain
- Nausea
- Joint ache
- Headache
PROVENGE can cause serious reactions, including reactions resulting from the infusionThe act of putting fluid (usually a medication) into a vein. itself (These are called infusion reactions and generally occur within 1 day of infusionThe act of putting fluid (usually a medication) into a vein.), and strokes.
Severe infusionThe act of putting fluid (usually a medication) into a vein. reactions included chills, fever, fatigue, weakness, breathing problems (shortness of breath, decreased oxygen level and wheezing), dizziness, headache, high blood pressure, muscle ache, nausea, and vomiting.
These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor.
Each dose of PROVENGE is checked several times for quality (which includes a sterility test) before infusion. However, the results from the final sterilityBeing free from living germs and other microscopic organisms. test are not typically available before your infusion. This means it is possible that you may receive an infusion that did not pass the final test. If this occurs, your doctor will be contacted immediately to determine how best to treat you.
Before Starting PROVENGE Treatment
Tell your doctor about any medical problems you have, including heart problems, lung problems, or if you have had a stroke.
Tell your doctor about all of the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements.
After Treatment with PROVENGE, tell your doctor if you:
- Have breathing problems
- Have chest pains
- Feel your heart racing or have an irregular heartbeat
- Feel dizzy
- Feel nauseous or vomit
- Have a fever (a temperature over 100°F)
- Have redness or pain at the infusionThe act of putting fluid (usually a medication) into a vein. or cell-collection sites
These may be signs of heart or lung problems, or of infection.
Tell your doctor about any side effect that concerns you or does not go away. For more information about side effects, talk with your doctor.
NEXT: Is PROVENGE Right for Me?
PROVENGE is made from your own immune cells. Your cells will be collected at a cell collection center approximately 3 days before
each scheduled infusion of PROVENGE. There can be risks associated with the cell collection process, which you should discuss with
your doctor before deciding to begin treatment with PROVENGE.
PROVENGE can cause serious reactions. In controlled clinical trials for the treatment of prostate cancer, serious reactions
reported in patients in the PROVENGE group include reactions resulting from the infusion of the drug, which occurred within 1
day of infusion, and strokes. Severe infusion reactions included chills, fever, fatigue, weakness, breathing problems (shortness
of breath, decreased oxygen level, and wheezing), dizziness, headache, high blood pressure, muscle ache, nausea, and vomiting.
Tell your doctor right away if you have breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea,
or vomiting after getting PROVENGE because any of these may be signs of heart or lung problems.
The most common side effects reported with PROVENGE are 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.
Tell your doctor about all your medical problems including heart problems, lung problems or a history of stroke.
Tell your doctor right away if you get a fever over 100°F, or redness at the cell collection or infusion sites,
because any of these may be signs of infection.
Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements.
Tell your doctor about any side effect that concerns you or does not go away.
For more information on PROVENGE, please see the Full Prescribing Information or
call Dendreon ON Call at 1-877-336-3736.