because of this [1%),:<1%), pain (12%) Gastrointestinal: Nausea (22%; grades 3:> <1%), vomiting (13% grades 3:> <1%), constipation (12%; grades 3:> <1%) Hematologic: Anemia (13%) Hypersensitivity: Severe infusion related reaction (71%; grade 3: 4%) Neuromuscular & skeletal: Back pain (30%; grades 3: 3%), myalgia (12%; grades 3:> <1%), weakness (11%; grades 3: 1%) Miscellaneous: Fever (31%; grades 3: 1%), citrate toxicity (15%) 1% to 10%: Cardiovascular: Hypertension (8% grades 3:> <1%), hemorrhagic stroke (4%) Dermatologic: Diaphoresis (5%; grades 3:> <1%), skin rash (5%) Gastrointestinal: Anorexia (7%), acute ischemic stroke (4%) Genitourinary: Hematuria (8%) Neuromuscular & skeletal: Musculoskeletal pain (9%; grades 3:> <1%), muscle spasm (8%; grades 3:> <1%), neck pain (6%), tremor (5%) Renal: Hematuria (8%) Respiratory: Flu-like symptoms (10%), dyspnea (9%; grades 3: 2%)> <1% (Limited to important or life-threatening): Cerebrovascular accident, eosinophilia, hypotension, myasthenia gravis, myocardial infarction, myositis, paresthesia (grades 3), pulmonary embolism, rhabdomyolysis, sepsis, syncope, transient ischemic attacks, tumor flare, venous thrombosis Warnings/Precautions Concerns related to adverse effects: Infusion reaction: Acute infusion reactions may occur within 1 day of infusion and are usually mild or moderate for most patients; the incidence of severe reaction may be higher with the second infusion, while the third infusion is associated with a decrease in the incidence of severe reactions. Premedication with oral acetaminophen and diphenhydramine is recommended. Depending on the severity of the infusion reaction, interrupt or slow infusion rate; in clinical trials, acetaminophen, intravenous (IV) H 1 and/or H 2 antagonists, and low-dose meperidine were used to manage acute symptoms. Symptoms of acute infusion reaction may include chills, rigor, fever, bronchospasm, dyspnea, hypoxia, hypertension, tachycardia, syncope, hypotension, joint or muscle aches, nausea, vomiting, dizziness, fatigue, headache, and weakness; fever and chills usually resolved within 2 days. Observe patient for at least 30 minutes after infusion. Thromboembolic events: Deep venous thrombosis (DVT) and pulmonary embolism occurred following sipuleucel-T infusion (postmarketing reports), usually in patients with multiple risk factors for thromboembolism. Use with caution in patients at risk for thromboembolic events. Vascular disorders: Cerebrovascular (hemorrhagic and ischemic stroke) and cardiovascular events (myocardial infarction [MI]) have occurred; transient ischemic attacks have been reported following infusion (postmarketing reports). Such events usually occurred in patients with multiple risk factors for cerebrovascular or cardiovascular incidents. Disease-related concerns: Cardiovascular disease: Closely monitor during infusion in patients with cardiac conditions. Pulmonary disease: Closely monitor during infusion in patients with pulmonary conditions. Concurrent drug therapy issues: Androgen deprivation therapy: In clinical trials, patients who had androgen deprivation therapy without prior bilateral orchiectomy were continued on gonadal suppression with a luteinizing hormone-releasing hormone (LHRH) agonist (Higano, 2009). Chemotherapy: Concurrent use with chemotherapy has not been studied. Immunosuppressive therapy: Concurrent use with immunosuppressives (eg, corticosteroids) has not been studied; may alter the efficacy and/or safety of sipuleucel-T. Carefully evaluate patients for appropriateness of reducing or discontinuing immunosuppressive agents prior to treatment. Other warnings/precautions: Appropriate use: For autologous use only. Patient identity must be matched to the patient identifiers on the infusion bag and on the Final Product Disposition Notification (provided by manufacturer) prior to infusion. Confirmation of product release must be received from the manufacturer prior to infusion. Handling precautions: Apply universal precautions for product handling. Sipuleucel-T is not routinely tested for transmissible infectious diseases; patient-specific leukapheresis collection and activated product may have a risk for infectious disease transmission. Sterility testing: Preliminary sterility testing is done based on a 2-day incubation period. Final (7-day incubation) testing is not available until after administration; physicians will be notified if 7-day sterility tests are positive for microbial contamination. Treatment delays: If unable to receive a scheduled reinfusion, an additional leukapheresis procedure may be required; advise patients of this possibility before treatment initiation. Monitoring Parameters Monitor for infusion reaction during and for at least 30 minutes after infusion; monitor closely during infusion for patients with cardiovascular and pulmonary disease; monitor for thromboembolic and vascular events. Pregnancy Considerations Animal reproduction studies have not been conducted. Not indicated for use in women. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience constipation, diarrhea, joint pain, or back pain. Have patient report immediately to prescriber signs of infection, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), burning or numbness feeling, confusion, shortness of breath, wheezing, passing out, dizziness, tachycardia, angina, arrhythmia, coughing up blood, severe loss of strength and energy, severe nausea, severe vomiting, headache, muscle cramps, muscle pain, muscle weakness, or injection site pain, edema, or irritation (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. 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