Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
The most common adverse reactions (incidence ≥ 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Pharmaceuticals LLC at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, controlled clinical trials.
The control group (n = 303) received non-activated autologous peripheral blood mononuclear cells.
Patients received 3 infusions of PROVENGE or control every other week over a period of 4 weeks.
Almost all (98.3%) patients in the PROVENGE group and 96% in the control group reported an adverse event.
In 67.4% of patients in the PROVENGE group, these adverse events were mild or moderate in severity.
Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group.
5 WARNINGS AND PRECAUTIONS Acute infusion reactions may occur.
If reactions occur, decrease the rate or stop the infusion and administer appropriate medical treatment.
( 5.1 ) Syncope and hypotension have also been observed.
Closely monitor patients with cardiac or pulmonary conditions.
( 5.1 ) PROVENGE should be used with caution in patients with risk factors for thromboembolic events.
Like all medications, Provenge can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: