EXTRANEAL

Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 2 *Frequency has been evaluated using the following criteria: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. †This table represents an integration of safety data from the following clinical trials of 493 patients: RD-97-CA- 130, RD-97-CA-131, ML/IB/001, PRO-Renal-Reg-035, ML/IB/020 (DELIA), ML/IB/011 (DIANA), ML/IB/004 (Midas-2), RD-99-CA-060, and ML/IB/014.

The table also includes adverse events from clinical study BLR-PG21. Additionally, safety data from studies BLR-PG22, RD-00-CA-050 and RD-00-CA-022 were reviewed and did not require additions to the clinical trial data presented. **Reported in 1 of 18 patients who were exposed to EXTRANEAL in clinical trial BLR-PG21.

Therefore, estimation of frequency not presented due to limited patient population in clinical trial BLR-PG21. EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) Page 11 of 28 Post-Market Adverse Drug Reactions In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post marketing experience.

These reactions are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity.

INFECTIONS AND INFESTATIONS:

Fungal peritonitis, Peritonitis bacterial, Catheter site infection, Catheter related infection BLOOD AND LYMPHATIC SYSTEM DISORDERS: Thrombocytopenia, Leukopenia IMMUNE SYSTEM DISORDERS: Vasculitis, Serum sickness, Hypersensitivity METABOLISM AND NUTRITION DISORDERS: Shock hypoglycemia, Fluid overload, Fluid imbalance NERVOUS SYSTEM DISORDERS: Hypoglycemic coma, Burning sensation EYE DISORDERS: Vision blurred RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Bronchospasm, Stridor GASTROINTESTINAL DISORDERS: Encapsulating peritoneal sclerosis, Aseptic peritonitis*, Peritoneal cloudy effluent, Ileus, Ascites, Inguinal hernia, Abdominal discomfort SKIN AND SUBCUTANEOUS DISORDERS: Toxic epidermal necrolysis, Erythema multiforme, Angioedema, Urticaria generalized, Toxic skin eruption, Swelling face, Periorbital edema, Exfoliative rash, Skin exfoliation, Prurigo, Rash (including macular, papular, erythematous), Dermatitis (including allergic and contact), Drug eruption, Erythema, Onychomadesis, Skin […]