June 30, 2016
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Provenge

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Provenge




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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]

Thromboembolic Events

Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders

Cerebrovascular Disease

In controlled clinical trials, cerebrovascular events (hemorrhagic and ischemic strokes) were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group. In the postmarketing setting, cerebrovascular events, including transient ischemic attacks, have been observed following infusion of Provenge. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Cardiovascular Disorders

In controlled clinical trials, myocardial infarctions were observed in 0.8% of patients in the PROVENGE group compared with 0.3% of patients in the control group. In the postmarketing setting, myocardial infarctions have been observed following infusion of Provenge. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions For Control Of Infectious Disease

PROVENGE is not tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Accordingly, health care professionals should employ universal precautions when handling leukapheresis material or PROVENGE.

Concomitant Chemotherapy Or Immunosuppressive Therapy

Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, evaluate patients carefully to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE.

Product Safety Testing

PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the credit of contamination.

Patient Counseling Information

  • Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
  • Inform the patient or caregiver about the following:
    • The recommended course of therapy for PROVENGE is 3 complete doses. Each infusion of PROVENGE is preceded by a leukapheresis procedure approximately 3 days prior. It is important to maintain all scheduled appointments and arrive at each appointment on time because the leukapheresis and infusions must be appropriately spaced and the PROVENGE expiration time must not be exceeded.
    • If the patient is unable to receive an infusion of PROVENGE, the patient will need to undergo an additional leukapheresis procedure if the treatment is to be continued.
    • Counsel the patient on the importance of adhering to preparation instructions for the leukapheresis procedure, the possible side effects of leukapheresis, and post-procedure care.
    • If the patient does not have adequate peripheral venous access to accommodate the leukapheresis procedure and infusion of PROVENGE, inform the patient about the need for a central venous catheter. Counsel the patient on the importance of catheter care. Instruct the patient to tell their doctor if they are experiencing fevers or any swelling or redness around the catheter site, because these symptoms could be signs of an infected catheter.
    • Report signs and symptoms of acute infusion reactions such as fever, chills, fatigue, breathing problems, dizziness, high blood pressure, low blood pressure, lightheadedness, nausea, vomiting, headache, or muscle aches.
    • Report any symptoms suggestive of a cardiac arrhythmia.
    • Report any symptoms suggestive of cardiac ischemia.
    • Report any symptoms suggestive of cerebral ischemia.
    • Report any symptoms suggestive of deep vein thrombosis.
    • Report any symptoms suggestive of pulmonary embolism.
    • Inform their doctor if they are taking immunosuppressive agents.

For more information, please call the toll-free number: 1-877-336-3736.

Nonclinical Toxicology

Use In Specific Populations

Geriatric

In controlled clinical trials, 72.9% of patients (438 of 601) in the PROVENGE group were ≥ 65 years of age. There were no apparent differences in the safety of PROVENGE between patients ≥ 65 years of age and younger patients.

In a survival analysis of the controlled clinical trials of PROVENGE in metastatic castrate-resistant prostate cancer, 78.3% of randomized patients (382 of 488) were ≥ 65 years of age. The median survival of patients in the PROVENGE group ≥ 65 years of age was 23.4 months (95% confidence interval 22.0, 27.1), compared with 17.3 months in the control group (95% confidence interval: 13.5, 21.5).

Race

In controlled clinical trials, 90.6% of patients were Caucasian, 5.8% were African American, and 3.7% were “Other”. Due to the low numbers of non-Caucasian patients in the trials, no conclusions can be made regarding the safety or efficacy of PROVENGE by race.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/7/2016

Warnings
Precautions

Provenge - User Reviews

Provenge User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Provenge sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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