INDICATIONS AND USAGE

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. (1)

DOSAGE AND ADMINISTRATION

• For Autologous Use Only.
• Administer 3 doses at approximately 2-week intervals. (2.1)
• Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. (2.2)
• Before infusion, confirm that the patient's identity matches the patient identifiers on the infusion bag. (2.6)
• Do not initiate infusion of expired PROVENGE. (2.7)
• Infuse PROVENGE intravenously over a period of approximately 60minutes. Do Not Use a Cell Filter. (2.7)
• Interrupt or slow infusion for acute infusion reactions, depending on the severity of the reaction. (2.8)

DOSAGE FORMS AND STRENGTHS

Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, USP in a sealed, patient-specific infusion bag. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

• PROVENGE is intended solely for autologous use. (5)
• Acute infusion reactions have been observed in patients treated with PROVENGE. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed. Closely monitor patients with cardiac or pulmonary conditions. (2.8, 5.1)
• PROVENGE is not routinely tested for transmissible infectious diseases and may transmit diseases to health care professionals handling the product. Universal precautions should be followed. (2.3, 5.2)
• Concomitant use of chemotherapy and immunosuppressive medications with PROVENGE has not been studied. (5.3)

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.