Benef Tablet (Cinacalcet Hydrochloride)

Adult dose

Adults: Administer 25 mg of cinacalcet orally once daily. Thereafter, while monitoring the patient's parathyroid hormone (iPTH) and serum calcium levels, adjust the dose to 25, 50, or 75 mg once daily based on the serum calcium level or parathyroid hormone (iPTH) level, and administer orally. If improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum single dose of 100 mg. When increasing the dose, increase it in 25 mg increments at intervals of at least 3 weeks. Do not divide the dose when taking this medicine orally.

This medication should be used with caution in patients with a history of seizures, as seizures may recur. In patients with heart failure, blood pressure may drop or heart failure symptoms may worsen, requiring close monitoring. Patients who have allergies to any of the ingredients in this medication or have genetic issues such as lactose intolerance should not take it. Patients with hypocalcemia should be particularly careful as this medication may further lower calcium levels. Patients with impaired liver function may require dose adjustments and monitoring due to slowed drug metabolism. Those with a history of gastrointestinal bleeding or ulcers should be administered with caution due to the potential for exacerbation of symptoms. During treatment, gastrointestinal symptoms such as nausea, vomiting, and loss of appetite may occur, alongside symptoms of hypocalcemia, making regular serum calcium tests and monitoring for abnormal symptoms important. Due to the risk of QT interval prolongation, arrhythmia, and hypotension, close monitoring of heart status is necessary. There are significant drug interactions; concomitant use with certain antifungals, antibiotics, and antidepressants can increase blood levels, heightening the risk of side effects. Elderly patients over 65 years old are at a higher risk for adverse effects and may require dose adjustments upon symptom onset. Pregnant or breastfeeding women are advised to avoid this medication and should consult with a specialist for careful consideration if necessary. Safety for children and adolescents under 19 years has not been established, so use is not recommended. In cases of overdose, symptoms of hypocalcemia may occur, necessitating appropriate treatment according to the symptoms, as blood dialysis is ineffective. When taking this medication, it should be swallowed whole without crushing to prevent esophageal damage or perforation. This medication can lower calcium levels in chronic renal failure patients, so careful management before and after administration is crucial. Additionally, there is a risk of hypocalcemia and osteodystrophy due to a rapid decrease in parathyroid hormone, requiring caution.

• Convulsions
• hypotension
• worsening of heart failure
• nausea
• vomiting
• abdominal discomfort
• loss of appetite
• abdominal bloating
• hypocalcemia
• decreased serum calcium

This medication should be stored in a tightly closed container protected from air and moisture, keeping the storage temperature between 1°C and 30°C. Therefore, it is important to avoid direct sunlight and not store it in excessively hot or cold places.

Appearance

Round film-coated tablet, light green or light yellow-green

Package unit

100 tablets (10 tablets/PTP packaging x 10)