Download geriatric patient with euvolemic hyponatremia_01

CASE STUDY GERIATRIC PATIENT WITH EUVOLEMIC HYPONATREMIA
Why Vaprisol was chosen for treatment
DIAGNOSIS
Euvolemic hyponatremia secondary to pneumonia
in an elderly patient
In this patient with euvolemic hyponatremia and a history of
hypertension, Vaprisol was selected as treatment to raise serum sodium
and to try to avoid excess sodium and fluid overload. Fluid restriction
alone might suffice to treat the hyponatremia but it can take up to a
week to manage the patient’s water/sodium balance
Initial Presentation
The patient is an 82-year-old white male admitted to the hospital from
a nursing home with 2 to 3 days of increasing confusion and a cough
Medical History
• Hypertension
• Gout
Medications
• Hydrochlorothiazide
• Allopurinol
• Propanolol
Indication
Vaprisol is indicated to raise serum sodium in hospitalized patients with
euvolemic and hypervolemic hyponatremia.
Exam Findings
Vital Signs:
Important Limitations: Vaprisol has not been shown to be effective
for the treatment of the signs and symptoms of heart failure and is not
approved for this indication. It has not been established that raising
serum sodium with Vaprisol provides a symptomatic benefit to patients.
BP: 126/62 mm Hg, HR: 90 bpm without orthostatic
changes, temperature: 100.2° F, RR: 14
Mental Status: Patient was oriented to person, place, and time but
appeared confused about the timelines of recent events
Lungs:
Rhonchi and slight wheezing noted on auscultation
of left lower lobe
EKG:
NSR with evidence of left ventricular hypertrophy
Chest X-ray:
Infiltrate noted in left lower lobe. No evidence of pleural
effusion or increased pulmonary vasculature
Other:
No pedal edema
Safety Considerations
Overly rapid correction of serum sodium: Monitor serum sodium,
volume and neurological status. Serious neurologic sequelae, including
osmotic demyelination syndrome, can result from over rapid correction
of serum sodium. In susceptible patients, including those with severe
malnutrition, alcoholism or advanced liver disease, slower rates of
correction should be used.
In clinical studies of Vaprisol, the adverse event profile in elderly
patients was similar to that seen in the general population1
Patient’s progression from admission through follow-up at day 10
VITAL SIGNS
LAB VALUES
BP
(mm Hg)
HR
(bpm)
Weight
(lb)
Urine
Output
(cc)
Urine
Osmolality
(mOsm/kg-H20)
Urine
Na+
(mEq/L)
Serum
Na+
(mEq/L)
NOTES
Upon
Admission
126/62
90
180
—
655
57
124
Broad spectrum antibiotics started. A loading dose of Vaprisol
20-mg IV administered over 30 minutes was followed by a
20-mg continuous infusion administered over 24 hours
Day 1
130/66
76
179
2400
—
—
128
20-mg Vaprisol IV infusion administered over 24 hours
Day 2
132/64
70
178
1700
164
9
132
20-mg Vaprisol IV infusion administered over 24 hours.
Patient switched to oral antibiotics based on sputum
culture results
Day 3
136/68
66
178
1200
103
10
136
Fluid restriction 1 L /day; discharged to nursing home
Follow-up
Day 10
136/70
64
178
—
—
—
138
Patient no longer restricting fluids
Please see additional Important Safety Information on the back.
PLEASE SEE FULL PRESCRIBING INFORMATION AT WWW.VAPRISOL.COM
Reliable, defined control in hospitalized patients
with euvolemic and hypervolemic hyponatremia
Targets AVP and excess water to raise serum sodium concentration1,2
Vaprisol pivotal trials showed increases in serum sodium concentrations¹*
— 69% of patients receiving Vaprisol 40 mg/day IV achieved a ≥6 mEq/L increase in serum sodium concentration or normal serum
sodium concentration by the end of treatment (day 4) compared with 21% of patients receiving placebo¹†
— Mean changes in serum sodium concentration from baseline to end of treatment (day 4) in patients receiving Vaprisol 20 mg/day
or 40 mg/day IV were 9.4 mEq/L and 8.8 mEq/L, respectively¹‡
Premixed IV formulation with convenient administration
An established safety profile1
* The effect of Vaprisol on maintenance of serum sodium concentration is not known.
†
Results from a double-blind, placebo-controlled, randomized, multicenter study in patients with euvolemic or hypervolemic hyponatremia (serum sodium 115-130 mEq/L), the primary endpoint of which was cumulative
effective water clearance at day 4. Fluid restricted to ≤2.0 L/day in all patients. The mean baseline serum sodium concentrations in patients treated with Vaprisol or placebo were 123.3 mEq/L and 124.3 mEq/L, respectively.
‡
Results of an open-label study of 251 patients with euvolemic or hypervolemic hyponatremia, the primary endpoint of which was baseline adjusted serum Na+ AUC over duration of treatment (mEq·hr/L). Patients were
treated for 4 days with Vaprisol 20 mg/day IV or 40 mg/day IV (n=37, n=214, respectively) following a 20-mg loading dose via 30-minute IV infusion. The mean baseline serum sodium concentrations in patients
treated with Vaprisol 20 mg/day IV or 40 mg/day IV were 122.5 mEq/L and 123.8 mEq/L, respectively.
Indication
Vaprisol is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.
Important Limitations: Vaprisol has not been shown to be effective for the treatment of the signs and symptoms of heart
failure and is not approved for this indication. It has not been established that raising serum sodium with Vaprisol provides
a symptomatic benefit to patients.
Important Safety Information
CONTRAINDICATIONS
Vaprisol is contraindicated in patients with hypovolemic hyponatremia. Coadministration of Vaprisol with potent CYP3A4
inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. In addition, in
patients unable to make urine, no benefit can be expected. Solutions containing dextrose are contraindicated in patients
with known allergy to corn or corn products.
WARNINGS & PRECAUTIONS
Hypervolemic hyponatremia associated with heart failure: Safety data on use of Vaprisol in these patients are limited.
Consider other treatment options.
Overly rapid correction of serum sodium: Monitor serum sodium, volume and neurologic status. Serious neurologic sequelae,
including osmotic demyelination syndrome, can result from over rapid correction of serum sodium. In susceptible patients,
including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction should be used
Infusion site reactions: Serious reactions have occurred. Administer through large veins and change infusion site every
24 hours.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥10%) reported in clinical trials were infusion site reactions
(including phlebitis), pyrexia, hypokalemia, headache and orthostatic hypotension.
DRUG INTERACTIONS
Potent CYP3A inhibitors may increase the exposure of conivaptan and are contraindicated. Generally avoid CYP3A
substrates. Exposure to coadministered digoxin may be increased and digoxin levels should be monitored.
SPECIAL POPULATIONS
Pregnancy: Based on animal data, Vaprisol may cause fetal harm.
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother.
Pediatric Use: Safety and effectiveness in pediatric patients has not been studied.
Severe renal impairment: Vaprisol is not recommended.
References: 1. Vaprisol Prescribing Information. Astellas Pharma US, Inc. 2. Verbalis JG, Goldsmith SR, Greenberg A, Schrier RW, Sterns RH. Hyponatremia treatment guidelines 2007:
expert panel recommendations. Am J Med. 2007;120(11 suppl 1):S1-S21.
PLEASE SEE FULL PRESCRIBING INFORMATION AT WWW.VAPRISOL.COM
©2012 Astellas Pharma US, Inc.
All rights reserved.
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