Sipuleucel-t
Generic Name: sipuleucel-t
Brand Names:
Provenge
11 DESCRIPTION PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy available as a suspension for intravenous infusion. PROVENGE consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), that have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor...
Overview
11 DESCRIPTION PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy available as a suspension for intravenous infusion. PROVENGE consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), that have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor...
Uses
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) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. For autologous use only. For intravenous 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. ( 2.2 ) Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. ( 2.2 ) Interrupt or slow infusion for acute infusion reactions, depending on the severity of the reaction. ( 2.2 ) 2.1 Dose Each dose of PROVENGE contains a minimum of 50 million autologous CD54 + cells activated with PAP-GM-CSF [ see Description ( 11 ) ].
Side Effects
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.
Interactions
7 DRUG INTERACTIONS
Warnings
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. ( 5.2 ) 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 ) Concomitant use of chemotherapy and immunosuppressive medications with PROVENGE has not been studied. 4 CONTRAINDICATIONS None. None. ( 4 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING PROVENGE is a 250 mL suspension containing a minimum of 50 million autologous CD54 + cells activated with PAP-GM-CSF in Lactated Ringer's Injection, USP. It is supplied in a sealed infusion bag, labeled for the specific recipient. NDC 30237-8900-6: One bag individually packed in a carton.
Frequently Asked Questions
What is Sipuleucel-t used for?▼
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) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )
What are the side effects of Sipuleucel-t?▼
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.
What are the important warnings for Sipuleucel-t?▼
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. ( 5.2 ) 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 ) Concomitant use of chemotherapy and immunosuppressive medications with PROVENGE has not been studied. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.