Samsca

What is Samsca?

• Samsca (tolvaptan) a selective vasopressin V2-receptor antagonist used to treat hyponatremia (low blood sodium levels) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH).

Tolvaptan

Tolvaptan ball-and-stick model

What are the uses of this medicine?

• SAMSCA is a prescription medicine used to help increase low sodium levels in the blood, in adults with conditions such as heart failure, and certain hormone imbalances. SAMSCA helps raise salt levels in your blood by removing extra body water as urine.

How does this medicine work?

• Tolvaptan (tol vap' tan) is a vasopressin 2 receptor antagonist (vaptan) that is used for treatment of hyponatremia caused by elevated levels of arginine vasopressin (also known as antidiuretic hormone: ADH), commonly found in patients with inappropriate ADH syndrome (SIADH) or with fluid overload from heart failure or cirrhosis.
• Vasopressin acts on type 2 receptors in the distal renal tubules causing reabsorption of free water, without electrolytes.
• Inappropriate secretion of vasopressin (as occurs in some paraneoplastic syndromes) is associated with retention of water and dilutional hyponatremia that can be symptomatic and even fatal.
• In controlled clinical trials, tolvaptan given for 28 days resulted in an increase in serum sodium and diuresis in patients with hypervolemic hyponatremia, in patients with cirrhosis and heart failure, and euvolemic hyponatremia in patients with SIADH.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• you are allergic to tolvaptan or any of the ingredients in SAMSCA.
• the sodium level in your blood must be increased right away.
• you cannot replace fluids by drinking or you cannot feel if you are thirsty.
• you are dizzy, faint, or your kidneys are not working normally because you have lost too much body fluid.

you take certain medicines. These medicines could cause you to have too much SAMSCA in your blood:

• the antibiotic medicines, clarithromycin (Biaxin, Biaxin XL) or telithromycin (Ketek)
• the antifungal medicines, ketoconazole (Nizoral) or itraconazole (Sporanox)
• the anti-HIV medicines, ritonavir (Kaletra, Norvir), indinavir (Crixivan), nelfinavir (Viracept), and saquinavir (Invirase)
• the antidepressant medicine, nefazodone hydrochloride

• your body is not able to make urine.

What drug interactions can this medicine cause?

SAMSCA may affect the way other medicines work and other medicines may affect how SAMSCA works. These medicines could cause you to have too much SAMSCA in your blood:

• the antibiotic medicines, clarithromycin (Biaxin, Biaxin XL) or telithromycin (Ketek)
• the antifungal medicines, ketoconazole (Nizoral) or itraconazole (Sporanox)
• the anti-HIV medicines, ritonavir (Kaletra, Norvir), indinavir (Crixivan), nelfinavir (Viracept), and saquinavir (Invirase)
• the antidepressant medicine, nefazodone hydrochloride

Avoid concomitant use with:

• Moderate CYP3A inhibitors
• Strong CYP3A inducers
• V2-receptor antagonists

Monitor serum potassium during concomitant therapy with:

• Angiotensin receptor blockers
• Angiotensin converting enzyme inhibitors
• Potassium sparing diuretics

Is this medicine FDA approved?

• Tolvaptan was approved for use in the United States in 2009 and current indications are for short term therapy of patients with hypervolemic or euvolemic hyponatremia due to SIADH, congestive heart failure or cirrhosis.
• Tolvaptan has also been used experimentally to prevent progression of disease in patients with autosomal dominant polycystic kidney disease (ADPKD), but has not been approved for this use in the United States.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose is 15 mg once daily.
• Dosage may be increased at intervals ≥24 hr to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium.

Administration:

• Take SAMSCA exactly as prescribed by your healthcare provider.
• Take SAMSCA one time each day.
• You can take SAMSCA with or without food.
• Do not drink grapefruit juice during treatment with SAMSCA. This could cause you to have too much SAMSCA in your blood.
• Certain medicines or illnesses may keep you from drinking fluids or may cause you to lose too much body fluid, such as vomiting or diarrhea. If you have these problems, call your healthcare provider right away.
• Do not miss or skip doses of SAMSCA. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much SAMSCA, call your healthcare provider right away. If you take an overdose of SAMSCA, you may need to go to a hospital.
• If your healthcare provider tells you to stop taking SAMSCA, follow their instructions about limiting the amount of fluid you should drink.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 15 mg and 30 mg

This medicine is available in fallowing brand namesː

• SAMSCA

What side effects can this medication cause?

The most common side effects of this medicine include:

• thirst
• dry mouth
• weakness
• constipation
• making large amounts of urine and urinating often
• increased blood sugar levels

This medicine may cause serious side effects, including:

• make the salt (sodium) level in your blood rise too fast
• liver problems, including life-threatening liver failure

What special precautions should I follow?

• Tolvaptan can cause serious and potentially fatal liver injury. Limit treatment duration to 30 days. If hepatic injury is suspected, discontinue SAMSCA. Avoid use in patients with underlying liver disease.
• SAMSCA therapy induces copious aquaresis, which is normally partially offset by fluid intake. Dehydration and hypovolemia can occur, especially in potentially volume-depleted patients receiving diuretics or those who are fluid restricted. Dehydration and hypovolemia may require intervention.
• Concomitant use with hypertonic saline is not recommended.
• Moderate to strong CYP3A inhibitors can lead to a marked increase in tolvaptan concentrations. Avoid use with moderate to strong CYP3A inhibitors.
• Treatment with tolvaptan is associated with an acute reduction of the extracellular fluid volume which could result in increased serum potassium. Monitor serum potassium in patients with potassium >5 mEq/L or on drugs known to increase potassium.
• Patients with partial obstruction of urinary outflow, for example, patients with prostatic hypertrophy or impairment of micturition, have an increased risk of developing acute retention. Urinary output must be secured.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• rise in serum sodium concentration
• polyuria
• thirst
• dehydration/hypovolemia

Management of overdosage:

• There is no specific antidote for tolvaptan intoxication.
• In patients with suspected SAMSCA overdosage, assessment of vital signs, electrolyte concentrations, ECG and fluid status are recommended.
• Continue replacement of water and electrolytes until aquaresis abates.
• Dialysis may not be effective in removing tolvaptan because of its high binding affinity for human plasma protein.

Can this medicine be used in pregnancy?

• Available data with SAMSCA use in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness of SAMSCA in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tolvaptan.
• Inactive ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colorant.

Who manufactures and distributes this medicine?

• Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
• Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD
• SAMSCA is a registered trademark of Otsuka Pharmaceutical Co., Ltd., Tokyo,Japan

What should I know about storage and disposal of this medication?

• Store SAMSCA between 59°F to 86°F (15°C to 30°C).

• Dailymed label info on Samsca
• FDA Samsca

Samsca Resources
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