Sipeleucel-T (Provenge, Dendreon) is an autologous cellular cancer vaccine that is approved for the treatment of metastatic, castration-resistant prostate cancer. The medication is given in three injected doses with 2 weeks in between each dose. This section details the common adverse reactions, warnings and precautions, drug interactions and other contraindications associated with sipuleucel-T therapy.
Common adverse reactions
Warnings and precautions
Drug interactions and other contraindications
Sipeleucel-T common adverse reactions
Adverse reactions occurring in at least 15% of patients in sipuleucel-T clinical trials included chills, fever, fatigue, back pain, nausea, arthralgia and headache.
Sipeleucel-T warnings and precautions
Almost two-thirds of patients receiving sipuleucel-T in clinical trials experienced an infusion reaction; reactions included fever, chills, respiratory events, nausea, vomiting, fatigue, headache, hypertension and dizziness. Most of these reactions occurred within 24 hours of the first infusion. Reactions were most severe after the second infusion and were less severe after the third infusion; however, most infusion reactions were not severe. If a patient experiences a severe infusion reaction, then the infusion should be interrupted or discontinued, depending on the severity of the symptoms.
Patients with cardiopulmonary conditions should be closely monitored.
Because of the risk for infusion reaction, patients should be premedicated with an antihistamine and acetaminophen.
Sipeleucel-T drug interactions and other contraindications
As sipuleucel-T is an autologous therapy (meaning it is derived from the patient’s own cells or tissues), it is not routinely tested for infectious diseases. Medical professionals should use standard precautions when handling sipuleucel-T. The drug is intended for autologous use only. It has not been tested or approved for use with systemic chemotherapy or other immunosuppressive drugs.