HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PROVENGE - ® (sipuleucel-T) safely and effectively. See full prescribing information for PROVENGE. PROVENGE - ...
These highlights do not include all the information needed to use PROVENGE ® (sipuleucel-T) safely and effectively. See full prescribing information for PROVENGE.
PROVENGE ® (sipuleucel-T)
Suspension for Intravenous Infusion
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
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Dosage and Administration |
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Administration (2.2) |
9/2014 |
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Warnings and Precautions |
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Acute Infusion Reactions (5.1) |
10/2014 |
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Thromboembolic Events (5.2) |
10/2014 |
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Vascular Disorders (5.3) |
10/2014 |
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.
For intravenous use only.
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Administer 3 doses at approximately 2-week intervals. (2.1)
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Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. (2.2)
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Before infusion, confirm that the patient's identity matches the patient identifiers on the infusion bag. (2.2)
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Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. (2.2)
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Interrupt or slow infusion for acute infusion reactions, depending on the severity of the reaction. (2.2)
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. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Acute infusion reactions may occur. If reactions occur, decrease the rate or stop the infusion and administer appropriate medical treatment. (5.1)
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Syncope and hypotension have also been observed. Closely monitor patients with cardiac or pulmonary conditions. (5.1)
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PROVENGE should be used with caution in patients with risk factors for thromboembolic events. (5.2)
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PROVENGE is not tested for transmissible infectious diseases and may transmit diseases to health care professionals handling the product. Universal precautions should be followed. (5.4)
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Concomitant use of chemotherapy and immunosuppressive medications with PROVENGE has not been studied. (5.5)
ADVERSE REACTIONS
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 Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
1 INDICATIONS AND USAGE
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory ...
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
2 DOSAGE AND ADMINISTRATION
For autologous use only. For intravenous use only. 2.1 Dose Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with ...
For autologous use only.
For intravenous use only.
2.1 Dose
Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF [see Description (11)].
The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. In controlled clinical trials, the median dosing interval between infusions was 2 weeks (range 1 to 15 weeks); the maximum dosing interval has not been established.
If, for any reason, the patient is unable to receive a scheduled infusion of PROVENGE, the patient will need to undergo an additional leukapheresis procedure prior to continuing a course of treatment. Advise patients of this possibility prior to initiating treatment.
2.2 Administration
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Do not use PROVENGE until confirmation of product release is received from Dendreon.
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Dendreon will send the Final Product Disposition Notification form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), to the infusion site. Infusion must begin prior to the expiration date and time indicated on the Final Product Disposition Notification form and Product Label. Do not use expired PROVENGE. Keep the sealed, patient-specific PROVENGE infusion bag within the insulated polyurethane container inside the outer cardboard shipping box until the time of administration.
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To minimize potential acute infusion reactions, premedicate the patients orally with acetaminophen and an antihistamine, such as diphenhydramine, approximately 30 minutes prior to administration of PROVENGE.
Administration steps:
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Remove the infusion bag from the insulated polyurethane container and inspect the bag for signs of leakage or external damage. Contents of the bag will be clear to opaque, with a white to red color, including shades of off-white, cream, light yellow and orange.
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Gently mix and resuspend the contents of the bag, inspecting for clumps and clots. Small clumps of cellular material should disperse with gentle manual mixing. Do not administer if the bag leaks during handling, is damaged, or if clumps remain in the bag.
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Match the patient's identity with the patient identifiers on the Final Product Disposition Notification form and the PROVENGE infusion bag.
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Infuse the entire volume of the PROVENGE infusion bag intravenously over approximately 60 minutes. Do not use a cell filter.
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Observe the patient for acute infusion reactions for at least 30 minutes following each infusion.
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If acute infusion reactions occur, such as chills, fatigue, fever, nausea, and joint ache, interrupt or slow the infusion and administer appropriate medical treatment as needed. In controlled clinical trials, symptoms of acute infusion reactions were treated with acetaminophen, intravenous H1 and/or H2 blockers, and low-dose intravenous meperidine.
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If the infusion is interrupted, keep the PROVENGE infusion bag at room temperature.
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Do not resume infusion if the PROVENGE infusion bag has been at room temperature for more than 3 hours.
3 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.
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.
4 CONTRAINDICATIONS
None.
None.
5 WARNINGS AND PRECAUTIONS
5.1 Acute Infusion Reactions Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills ...
5.1 Acute Infusion Reactions
Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.
In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction. The most common events (≥ 20%) were chills, fever, and fatigue. In 95.1% of patients reporting acute infusion reactions, the reactions were mild or moderate. Fevers and chills generally resolved within 2 days (71.9% and 89%, respectively).
In controlled clinical trials, 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. The incidence of severe events was greater following the second infusion (2.1% vs. 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, decrease the infusion rate or stop the infusion, depending on the severity of the reaction. Administer appropriate medical treatment as needed. [See Dosage and Administration (2.2
