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INTRODUCTION

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sipuleucel (si-pyoo-loo-sel)

Provenge

Classification

Therapeutic: antineoplastics

Pharmacologic: autologous cellular immunotherapies

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Indications
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Asymptomatic/minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.

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Action
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Autologous immunotherapy produced by collecting peripheral mononuclear cells during leukapheresis. Cells include antigen-presenting cells (APCs), which are activated during a culture period with prostatic acid phosphatase (PAP, an antigen found in prostatic cancer tissue) linked to granulocyte/macrophage colony-stimulating factor (GM-CSF, which activates immune cells). Induces an immune response against prostatic acid phosphatase. Therapeutic Effects: ↓ spread of prostate cancer.

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Adverse Reactions/Side Effects
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CNS: fatigue, headache, dizziness, insomnia. Resp: dyspnea. CV: hypertension, peripheral edema. GI: constipation, diarrhea, nausea, vomiting. GU: hematuria. Derm: flushing, rash, sweating. Hemat: anemia. MS: back pain, joint pain, extremity pain, muscle spasms, musculoskeletal pain. Neuro: paresthesia, tremor. Misc: chills, fever, acute infusion reactions, citrate toxicity.

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PHYSICAL THERAPY IMPLICATIONS

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Examination and Evaluation
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  • Report allergy-like responses such as wheezing, laryngeal edema, urticaria, and other skin reactions that occur during and after administration (infusion-related events).

  • Assess blood pressure (BP) and compare to normal values (See Appendix F). Report a sustained increase in BP (hypertension).

  • Assess peripheral edema using girth measurements, volume displacement, and measurement of pitting edema (See Appendix N). Report increased swelling in feet and ankles or a sudden increase in body weight due to fluid retention.

  • Monitor signs of anemia, including unusual fatigue, shortness of breath with exertion, bruising, and pale skin. Notify physician immediately if these signs occur.

  • Assess any breathing problems, and report signs of difficult or labored breathing (dyspnea).

  • Watch for signs of citrate toxicity and related low calcium levels (hypocalcemia). Signs include headache, lethargy, weakness, cramping, and muscle hyperexcitability and tetany. Notify physician immediately if these signs occur.

  • Assess signs of paresthesia (numbness, tingling) or tremor. Perform objective tests, including electroneuromyography and sensory testing to document any drug-related neuropathic changes.

  • Assess any back, joint, or extremity pain or muscle spasms to rule out musculoskeletal pathology; that is, try to determine if pain is drug-induced rather than caused by anatomic or biomechanical problems.

  • Assess dizziness that might affect gait, balance, and other functional activities (See Appendix C). Report balance problems and functional limitations to the physician and nursing staff, and caution the patient and family/caregivers to guard against falls and trauma.

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Interventions
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  • For patients who are medically able to begin exercise, implement appropriate resistive exercises and aerobic training to maintain muscle strength and aerobic capacity during cancer chemotherapy or to help restore function after chemotherapy.

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Patient/Client-Related Instruction
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  • Instruct patient or family/caregivers to report other side effects such as severe or prolonged headache, fatigue, sleep loss, chills, fever, bloody urine, skin reactions (rash, flushing, excessive sweating), or GI problems (nausea, ...

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