Download HEART FAILURE PATIENT WITH HYPERVOLEMIC

CASE STUDY
HEART FAILURE PATIENT WITH HYPERVOLEMIC HYPONATREMIA
Why Vaprisol was chosen for treatment
DIAGNOSIS
Hypervolemic hyponatremia in an elderly patient with acute
decompensated heart failure*
*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. Vaprisol should be used to raise serum sodium in
patients with hypervolemic hyponatremia associated with heart
failure only after consideration of other treatment options.
Initial Presentation
A 75-year-old woman was admitted to the hospital with
hyponatremia secondary to acute decompensated congestive
heart failure (CHF) of several days’ onset, primarily attributed to
medication noncompliance. Her ejection fraction (EF) was 20%.
Medical History: • Chronic ischemic cardiomyopathy
Medications:
• Lisinopril
• Carvedilol
• Furosemide
• Aspirin
• Pravastatin
• For this patient with hyper volemic hyponatremia resulting from
CHF, IV furosemide failed to raise serum sodium to normal range.
• Treatment with Vaprisol was initiated to provide aquaresis and a
demonstrated increase in serum sodium.
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.
Safety Considerations
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 know allergy to corn or corn products.
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 to discharge
LAB VALUES
Serum K+
(mEq/L)
Serum Na+
(mEq/L)
Admission
4.0
124
IV furosemide was started.
Day 3
4.0
126
A 20-mg loading dose of Vaprisol was started followed by a continuous
infusion of 20 mg/day because serum sodium remained below normal.
Day 4
–
130
A second 24-hour continuous infusion of Vaprisol 20 mg/day was initiated.
Day 5
4.2
136
Serum sodium increased and infusion of Vaprisol was discontinued.
Patient was discharged to home on previous drug therapy and diuretics.
NOTES
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 arginine vasopressin (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 placebo1,3†
— 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, respectively1,4‡
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 efficacy endpoint of which was
change from baseline in serum sodium during the course of treatment, measured by the baseline-adjusted area under the sodium-time curve (AUC) from the beginning through the end of treatment. 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 or 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. 3. Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N. Assessment of the efficacy and safety of
intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27:447-457. 4. Data on file. Astellas.
PLEASE SEE FULL PRESCRIBING INFORMATION AT WWW.VAPRISOL.COM
©2012 Astellas Pharma US, Inc.
All rights reserved.
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