CRITERIA

Ateneo de Davao University

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Drug Name Mechanism of Action Pharmacokinetics Side Effects/ Nursing Responsibilities/

Adverse Effects Patient and Family Health Teachings
tolvaptan antagonizes the effect Adverse effects:
Generic Name of vasopressin by blocking the Absorption - Nausea (21%) 1. Monitor serum electrolyte levels, volume status, and
tolvaptan binding of arginine vasopressin - Rapidly absorbed - Thirst (16%) neurologic status when therapy is begun, during
dosage titration, and regularly during therapy.
(AVP) at the V2 receptor. This from the GI tract - Dry mouth (13%)
*Drug titration is the process of adjusting the dose of a
Brand Name(s) leads to increased urine output, - Pollakiuria (4-11%) medication for the maximum benefit without adverse effects.
Jinarc which increases free water Distribution - Urinary frequency/output Rationale: To check for any deviations from normal values,
Jynarque clearance, decreases urine - 99% bound to protein increased (11%) which may be symptoms of something serious.
Samsca osmolality, and increases - Fatigue (13.6%) 2. Monitor potassium level in patients with potassium
serum sodium levels to restore Metabolism - Diarrhea (13.3%) level greater than 5 mEq/L and in those who are taking
normal concentrations. - Half-life (t ½): 12 - Dizziness (11.3%) drugs known to increase potassium level.
hours Significant: Hyperuricaemia, gout, Rationale: Treatment with tolvaptan is associated with reducing
the extracellular fluid volume, which could result in increased
Blocking: When this happens, polydipsia, polyuria, hypovolaemia,
serum potassium.
your kidney doesn't absorb as Excretion dehydration, hyperkalaemia, nocturia, 3. Monitor patients for weight loss, tachycardia, and
much water back into your body - Nonrenal routes pollakiuria, hyperglycaemia, increased hypotension.
and you end up urinating the ALT/AST, bilirubin. Rarely, anaphylaxis. Rationale: These may signal dehydration.
water out. This causes your Gastrointestinal disorders: Nausea, dry 4. Educate and instruct patients not to drink grapefruit
blood sodium level to go up. mouth, constipation, diarrhoea. juice.
General disorders and administration site Rationale: It may increase the drug’s concentration.
conditions: Malaise, fever, weakness. 5. For patients with hyponatremia, avoid restricting fluids
during the first 24 hours of therapy.
Investigations: Increased creatinine.
Rationale: Fluid restriction during the first 24 hours of therapy
Classification Indication Metabolism and nutrition disorders: may increase the possibility of overly rapid correction of serum
Hypoglycaemia, decreased appetite, sodium, which may cause serious neurologic sequelae.
Therapeutic class (Samsca) For patients with hypernatraemia. *Neurological sequelae are those complications involving the
Vasopressin antagonists hypervolemic and euvolemic Nervous system disorders: Headache, brain that include cognitive, sensory, and motor deficits that may
Pharmacologic class hyponatremia (serum sodium dizziness. encompass emotional instability and seizure activity in the most
Selective vasopressin receptor <125 mEq/L) in patients with Skin and subcutaneous tissue disorders: severe cases.
antagonists HF or SIADH. Pruritus, ecchymosis. 6. Tell patient not to stop or restart taking tolvaptan
(Jynarque) To slow kidney without consulting the prescriber first.
Vascular disorders: Syncope, orthostatic
Rationale: Samsca should only be restarted in the hospital where
function decline in patients at hypotension. sodium levels can be monitored closely.
risk for rapidly progressing Potentially Fatal: Osmotic demyelination, 7. Advise patient to continue ingestion of fluid in
autosomal dominant polycystic hepatotoxicity. response to thirst during therapy.
kidney disease (ADPKD). Rationale: Fluid restriction during therapy with tolvaptan may
Adverse effects: increase the risk of dehydration and hypovolemia.
Hyponatremia: electrolyte CNS: asthenia, fatigue, dizziness, fever, 8. Perform blood testing for ALT, AST, and bilirubin
imbalance stroke. before initiation of Jynarque, at 2 and 4 weeks after
*hypervolemic hyponatremia: initiation, monthly for 18 months and every 3 months
CV: intracardiac thrombus, PE, ventricular
thereafter.
increase in total body sodium fibrillation, DVT, palpitations. Gl: anorexia, Rationale: To mitigate the risk of significant or irreversible liver
with greater increase in total constipation, nausea, Gl bleeding,
 body water abdominal distention, ischemic colitis, injury
*euvolemic hyponatremia: diarrhea, dyspepsia, dry mouth, thirst. GU: 9. Caution patient of childbearing potential to report if she
Normal body sodium with polyuria, urinary frequency or urgency, is or plans to become pregnant
Rationale: Pregnant women must only use tolvaptan only when
increase in total body water urethral hemorrhage, vaginal hemorrhage,
clearly needed and after weighing the risks and benefits with
nocturia. physician.
Hematologic: DIC. 10. Advise patient to promptly report all adverse reactions.
Metabolic: fluid imbalance, hyperglycemia, Especially difficulty speaking, swallowing or controlling
hyperuricemia, diabetic keloacidosis. body movements, drowsiness, mood changes,
Musculoskeletal: rhabdomyolysis. seizures, muscle weakness in the arms or legs.
Respiratory: respiratory Moreover, right upper abdominal discomfort, dark
failure. urine, anorexia, or jaundice.
Rationale: The first set of symptoms may be of a serious
Skin: dry skin, rash.
condition called osmotic demyelination syndrome (ODS); the
latter may be symptoms of a serious liver problem.
Picture Contraindication Pharmacodynamics Interactions
- Patients who are
hypersensitive to drug Route: PO Drug-Drug.
or its components Onset: 2-4 hours Ace inhibitors, ARBs, potassium-
- With hypovolemic Peak: 2-4 hours sparing diuretics: may increase
hyponatremia & those Duration: Unknown hyperkalemic effect of these drugs
requiring urgent rise in
serum sodium level, CYP3A inducers (rifampin,
are anuric, or are carbamazepine, etc.): may decrease
unable to sense or tolvaptan level
respond to thirst
- Patients receiving Hypertonic sodium chloride solution:
strong CYP3A may increase risk of a too-rapid increase
inhibitors in serum sodium concentrations
- Jynarque: with history
or s/sx of significant Moderate CYP3A inhibitors
liver impairment/injury, (erythromycin, verapamil, etc.): may
uncorrected abnormal increase tolvaptan level.
blood sodium
concentrations, or OATP1B1/B3 & OAT3 substrates
uncorrected urinary (statins, etc.): may increase plasma
outflow obstruction concentrations of some substrates
- Avoid use in those
receiving hypertonic P-gp substrates (digoxin): may increase
saline solution digoxin level
- Avoid use in patients
with underlying liver Strong CYP3A inhibitors
disease (cirrhosis) (ketoconazole): may increase tolvaptan
level; use together is contraindicated

V2-agonists (desmopressin): may

decrease therapeutic effect of
desmopressin

Drug-herb.
St. John’s wort: may decrease drug
level.
 Drug-food.
Grapefruit juice: may increase drug level

Reference:
Mayo Clinic. (2023, October 6). Tolvaptan. https://www.mayoclinic.org/drugs-supplements/tolvaptan-oral-route/side-effects/drg-20073109?p
Medscape. (2023, April 13). Samsca, Jynarque (tolvaptan). https://reference.medscape.com/drug/samsca-jynarque-tolvaptan-999103#4
MIMS Philippines. (n.d.). Tolvaptan. https://www.mims.com/philippines/drug/info/tolvaptan?mtype=generic
Nursing 2023 Drug Handbook (Philippine Edition). (2023). Wolters Kluwer.

 Euvolemic hyponatremia: If the amount of sodium in your body stays the same, but your total body water increases, you have euvolemic hyponatremia.
 Hypervolemic hyponatremia: If the total body water increase is larger than the increase in total body sodium, you have hypervolemic hyponatremia.