Adverse Reactions
The most common adverse reactions reported with VAPRISOL administration were infusion site reactions. In studies in patients and healthy volunteers, infusion site reactions occurred in 52.5% of subjects treated with VAPRISOL 40 mg/day compared to 3.3% in the placebo group. The majority of the reactions were mild and did not lead to discontinuation of drug. However, some serious infusion site reactions did occur, and infusion site reactions were the most common type of adverse event leading to discontinuation of VAPRISOL. (See DOSAGE AND ADMINISTRATION)
The adverse reactions presented in Table 5 are derived from 72 healthy volunteers and 111 patients with euvolemic hyponatremia who received VAPRISOL 20 mg IV as a loading dose followed by 40 mg/day IV for 2 to 4 days and from 40 healthy volunteers and 21 patients with euvolemic hyponatremia who received placebo. The adverse reactions occurred in at least 2% of patients treated with VAPRISOL and at a higher incidence for VAPRISOL-treated patients than for placebo-treated patients.
Table 5. IV VAPRISOL: Adverse Reactions Occurring in ≥2% of Patients or Healthy Volunteers and VAPRISOL Incidence >Placebo Incidence Hyponatremia and Healthy Volunteer Studies |
| Term Adapted from MedDRA version 6.0 |
Placebo
N=61
n (%) |
40 mg
N=183
n (%) |
|
| Blood and Lymphatic System Disorders |
| Anemia NOS | 2 (3.3%) | 7 (3.8%) |
| | |
| Cardiac Disorders | | |
| Atrial Fibrillation | 0 | 5 (2.7%) |
|
| Gastrointestinal Disorders |
| Constipation | 2 (3.3%) | 9 (4.9%) |
| Diarrhea NOS | 0 | 10 (5.5%) |
| Dry mouth | 2 (3.3%) | 8 (4.4%) |
| Nausea | 2 (3.3%) | 7 (3.8%) |
| Vomiting NOS | 0 | 12 (6.6%) |
|
| General Disorders and Administration Site Conditions |
| Cannula site reaction | 0 | 10 (5.5%) |
| Edema peripheral | 1 (1.6%) | 10 (5.5%) |
| Infusion site erythema | 0 | 9 (4.9%) |
| Infusion site pain | 1 (1.6%) | 14 (7.7%) |
| Infusion site phlebitis | 0 | 29 (15.8%) |
| Infusion site reaction | 0 | 37 (20.2%) |
| Infusion site swelling | 1 (1.6%) | 5 (2.7%) |
| Pain NOS | 0 | 4 (2.2%) |
| Pyrexia | 0 | 7 (3.8%) |
| Thirst | 1 (1.6%) | 18 (9.8%) |
|
| Infections and Infestations |
| Oral candidiasis | 0 | 4 (2.2%) |
| Pneumonia NOS | 0 | 5 (2.7%) |
| Urinary tract infection NOS | 1 (1.6%) | 6 (3.3%) |
|
| Metabolism and Nutritional Disorders |
| Dehydration | 0 | 4 (2.2%) |
| Hyperglycemia NOS | 0 | 5 (2.7%) |
| Hypoglycemia NOS | 0 | 6 (3.3%) |
| Hypokalemia | 1 (1.6%) | 18 (9.8%) |
| Hypomagnesemia | 0 | 4 (2.2%) |
| Hyponatremia | 0 | 6 (3.3%) |
|
| Nervous system disorders |
| Headache | 2 (3.3%) | 22 (12.0%) |
|
| Psychiatric Disorders |
| Confusional state | 1 (1.6%) | 7 (3.8%) |
| Insomnia | 0 | 6 (3.3%) |
|
| Renal and urinary disorders |
| Hematuria | 1 (1.6%) | 4 (2.2%) |
| Pollakiuria | 0 | 11 (6.0%) |
| Polyuria | 0 | 9 (4.9%) |
| | |
| Skin and subcutaneous disorders | | |
| Erythema | 0 | 5 (2.7%) |
|
| Vascular Disorders |
| Hypertension NOS | 0 | 10 (5.5%) |
| Hypotension NOS | 1 (1.6%) | 5 (2.7%) |
| Orthostatic hypotension | 0 | 10 (5.5%) |
| Phlebitis NOS | 1 (1.6%) | 9 (4.9%) |
The safety of VAPRISOL in hyponatremic patients with underlying congestive heart failure has not been established.
|
