PROVENGE Safety Information
PROVENGE Provides a Side Effect Profile You Can Manage
Only 1.5% of patients in the pivotal Phase 3 IMPACT Trial discontinued treatment with PROVENGE due to adverse events.
Common Adverse Events
- The most common adverse events (incidence ≥15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache
- Most adverse events reported with PROVENGE (67.4%) were mild to moderate and consistent with a response to immunotherapy
Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting.
Serious Adverse Events
In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
Acute Infusion Reactions
The most common acute infusion reactions (≥20%) occurring within one day of infusion were chills, fever, and fatigue—the majority of which were mild to moderate in severity and transient.
Complete Course of Therapy
92% of patients in the PROVENGE group in the pivotal trial received all 3 infusions.
Liver and Kidney Considerations
PROVENGE is not cleared by the liver or the kidneys and does not require dose adjustments or monitoring of liver/kidney functions.
Next: Administration
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
The most common adverse events (incidence ≥ 15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
Please see the Full Prescribing Information.