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Table 1 Reports of pruritus and sipuleucel-T submitted to the U.S. FDA Adverse Event Reporting Systema

From: Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System

 

Time to onset of symptoms from leukapheresis or infusion

 

Case No.

Age (years)

Serious report? b

Preferred Termc

Rash

Clinical description

Day No.

Leukapheresis No.

Infusion No.

Medical historyd

Concomitant medications

Reports describing events in temporal association with sipuleucel-T

 1e

70

Yes

Pruritus generalized

No

Itching on palms, head, torso, and soles of feet

10

~

2

Hypertension, diabetes

Cetirizine, cyproheptadine, doxepin, dutasteride, famotidine, flecainide, magnesium oxide, metformin, mometasone (inhaled), montelukast, olmesartan, prednisone

 2

69

No

Pruritus

Yes

Broke out in a rash, itching

2

~

2

NOS

Enzalutamide, metformin, tocopherol-fish oil

 3

61

No

Pruritus

Yes

Tingling and discomfort in hands, then forearm rash (looked like red rings) with facial swelling; severe itching; eyelid swelling. Ten days after infusion was well except for itching

7

~

3

NOS

Aspirin, calcium, famotidine, lisinopril, vitamin D

 4

81

Yes

Pruritus

Yes

Rash, itching, rigors, nausea, chest tightness, hypotension, vomited and hypoxic (85%) after 75–80% of infusion administered. Infusion discontinued. Admitted to hospital due to lack of response to medical therapy

0

~

1

Hypertension, hypercholesterolemia

Atenolol, calcium/cholecalciferol, citalopram, enalapril, simvastatin, vitamins

 5

73

Yes

Pruritus

Yes

Swelling right upper arm (superficial thrombophlebitis), rash (IV catheter right hand), itching, tingling, cough, dyspnea

0

~

2

Deep vein thrombosis

NOS

Reports describing events in temporal association with leukapheresis (preceding sipuleucel-T)

 6

82

No

Injection site pruritus

No

Right arm injection site itching

1

1

~

Cardiac disorder, diabetes

Atenolol, furosemide, levothyroxine

 7

63

No

Eye pruritus

No

Two separate events of allergic reaction with watery and itchy eyes associated with leukapheresis (tolerated three infusions without problem)

0

1 and 3

~

NOS

NOS

Report with insufficient information to assess temporal relationship with sipuleucel-T

 8

87

No

Catheter site pruritus

No

Catheter site pruritus; device related infection

NOS

NOS

NOS

NOS

Aspirin, calcium carbonate, denosumab, fiber, finasteride, hydrochlorothiazide/lisinopril, probiotic

  1. Abbreviations: IV intravenous, MedDRA Medical Dictionary for Regulatory Activities, NOS not otherwise specified; ~ not applicable
  2. aThe FAERS database was searched for all U.S. reports of sipuleucel-T submitted between April 29, 2010 (FDA approval date) and December 31, 2018 (data-lock point, February 9, 2019). Among the 11 reports identified, three were excluded from this study (two duplicate reports and one report associated with enzalutamide therapy). All cases were reported among males. Two reports (Case no. 2 and 7) were premedicated prior to receiving sipuleucel-T (acetaminophen, diphenhydramine)
  3. bA report is considered serious if the patient outcome results in death, life-threatening illness, hospitalization or prolongation of existing hospitalization, permanent disability, or birth defect (21 CFR Part 600.80. Post-marketing reporting of adverse experiences: https://www.ecfr.gov/cgi-bin/text-idx?SID=41533ceac3cc630045810ffe75304c63&mc=true&node=se21.7.600_180&rgn=div8)
  4. cPruritus-related MedDRA Preferred Terms: administration site pruritus, anal pruritus, application site pruritus, aquagenic pruritus, brachioradial pruritus, catheter site pruritus, cholestatic pruritus, ear pruritus, eye pruritus, eyelids pruritus, gingival pruritus, implant site pruritus, incision site pruritus, infusion site pruritus, injection site pruritus, instillation site pruritus, lip pruritus, medical device site pruritus, nasal pruritus, oral pruritus, pruritus, pruritus allergic, pruritus generalized, pruritus genital, senile pruritus, stoma site pruritus, tongue pruritus, tumor pruritus, uremic pruritus, vaccination site pruritus, vessel puncture site pruritus, vulvovaginal pruritus
  5. dOther than prostate cancer
  6. eIndex case