nd aseptic peritonitis has been associated with EXTRANEAL use. Following EXTRANEAL use, inspect
the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improperclamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominalpain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy.
Encapsulating peritoneal sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and hasbeen reported in patients using EXTRANEAL.
5.4 Hypersensitivity Reactions
Serious hypersensitivity reactions to EXTRANEAL have been reported such as toxic epidermal necrolysis,angioedema, serum sickness, erythema multiforme and vasculitis [see Adverse Reactions (6.1,6.2)].
Anaphylactic oranaphylactoid reactions may occur. Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected hypersensitivity reaction develop. Institute appropriate therapeutic
countermeasures as clinically indicated.
5.5 Lactic Acidosis
Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that
can be associated with acute renal failure, inborn errors of metabolism, treatment with drugs such as
nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] for lactic acidosis before the start of treatment and
during treatment with EXTRANEAL [see Contraindications (4.3)].
5.6 Overinfusion
Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal
distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal
cavity to treat overinfusion.
5.7 Electrolyte, Fluid, and Nutrition Imbalances
Peritoneal dialysis may affect a patient’s protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate,
and magnesium levels and volume status [see Adverse Reactions (6)]. Monitor electrolytes and blood chemistry
periodically and take appropriate clinical action.
Potassium is omitted from EXTRANEAL solutions because dialysis may be performed to correct hyperkalemia. In
situations where there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a
concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.
Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart
failure, volume depletion, and hypovolemic shock.
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience
EXTRANEAL was originally studied in controlled clinical trials of 493 patients with end-stage renal disease whoreceived a single daily exchange of EXTRANEAL for the long dwell (8-to 16- hours). There were 215 patientsexposed for at least 6 months and 155 patients exposed for at least one year. The population was 18-83 years of age,56% male and 44% female, 73% Caucasian, 18% Black, 4% Asian, 3% Hispanic, and it included patients with thefollowing comorbid conditions: 27% diabetes, 49% hypertension and 23% hypertensive nephropathy.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinicaltrials of a drug cannot be compared to rates in the clinical trials of another drug and may not refle |
