ct the ratesobserved in practice. The adverse reaction information from clinical trials does, however, provide a basis foridentifying the adverse events that appear to be related to drug use and for approximating rates.
Rash was the most frequently occurring EXTRANEAL-related adverse reaction (5.5%, EXTRANEAL; 1.7%Control). Seven patients on EXTRANEAL discontinued treatment due to rash, and one patient on EXTRANEALdiscontinued due to exfoliative dermatitis. The rash typically appeared within the first three weeks of treatment and
resolved with treatment discontinuation or, in some patients, with continued treatment.
Table 1 shows the adverse events reported in these clinical studies regardless of causality, occurring in 5% ofpatients and more common on EXTRANEAL than control.
Table 1 – Adverse Experiences in ≥5% of Patients and More Common on EXTRANEAL
EXTRANEAL Control
N = 493 N = 347
Peritonitis 26% 25%
Upper respiratory infection 15% 13%
Hypertension 13% 8%
Rash 10% 5%
Headache 9% 7%
Abdominal Pain 8% 6%
Flu syndrome 7% 6%
Nausea 7% 5%
Cough increase 7% 4%
Edema 6% 5%
Accidental injury 6% 4%
Chest pain 5% 4%
Dyspepsia 5% 4%
Hyperglycemia 5% 4%
Adverse events related to EXTRANEAL use or in conjunction with performing the peritoneal dialysis procedure
include:
Reported with an incidence of > 5% and at least as common on dextrose control included asthenia, exit siteinfection, infection, back pain, hypotension, diarrhea, vomiting, anemia, peripheral edema, hypokalemia,hyperphosphatemia, hypoproteinemia, hypervolemia, arthralgia, dizziness, dyspnea, pruritis.
Reported with an incidence of < 5%: pain on infusion, abdominal enlargement, cloudy effluent, ultrafiltrationdecrease, postural hypotension, heart failure, hyponatremia, hypochloremia, hypercalcemia, hypoglycemia, alkalinephosphatase increase, SGPT increase, SGOT increase, cramping, confusion, lung edema, facial edema, exfoliativedermatitis, eczema, vesicobullous rash, maculopapular rash, erythema multiforme.
EXTRANEAL was additionally studied in a subpopulation of 92 high average/high transporter APD patients in atwo-week controlled clinical trial where patients received a single daily exchange of EXTRANEAL (n=47) ordextrose control (n=45) for the long dwell (14 2 hours). Consistent with the data reported in the original trials of
EXTRANEAL, rash was the most frequently occurring event.
Clinical Laboratory Findings
An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receivingEXTRANEAL. No associated increases in other liver chemistry tests were observed. Serum alkaline phosphataselevels did not show progressive increase over a 12-month study period. Levels returned to normal approximately
two weeks after discontinuation of EXTRANEAL.
Decreases in serum sodium and chloride have been observed in patients using EXTRANEAL. The mean change inserum sodium from baseline to the last study visit was -2.8 mmol/L for patients on EXTRANEAL and -0.3 mmol/Lfor patients on control solution. Four EXTRANEAL patients and two control patients developed serum sodium< 125 mmol/L.The mean change in serum chloride from baseline to last study visit was -2 mmol/L forEXTRANEAL patients and + 0.6 mmol/L for control patients. Similar changes in serum chemistries were observedin an additional clinical study in a subpopulation of hig |
