Legpara Tablet 75 mg (Cinacalcet Hydrochloride)

Adult dose

When taking this medicine orally, do not divide the dose. For the initial dose, adults should take 25 mg of cinacalcet orally once daily. Thereafter, while monitoring the patient's parathyroid hormone (iPTH) and serum calcium levels, adjust the dose based on the serum calcium level or parathyroid hormone (iPTH) to 25, 50, or 75 mg once daily and administer orally. However, if improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum of 100mg per dose. When increasing the dose, increase it by 25mg at intervals of 3 weeks or longer. 1. This medicine lowers blood calcium levels. Begin treatment only after confirming that the serum calcium level is not low (as a guideline, 9.0 mg/dL or higher). 2. Measure serum calcium once weekly when starting this medicine and when adjusting the dose, and at least once every 2 weeks during maintenance therapy. If the serum calcium level falls below 8.4 mg/dL, respond as shown below. Below 8.4mg/dL: As a rule, do not increase the dose of this medicine (reduce the dose of this medicine if necessary). Measure serum calcium at least once weekly. An electrocardiogram is preferably performed. If increasing the dose, do so only after confirming that the level has recovered to 8.4mg/dL or higher. Consider administering calcium or vitamin D preparations. Below 7.5mg/dL: Temporarily discontinue immediately. When resuming treatment, do so only after confirming that the level has recovered to 8.4mg/dL or higher, and resume at the dose used before discontinuation or a lower dose. It is preferable to measure serum calcium before taking this medicine in order to appropriately assess its efficacy and safety. In cases of hypoalbuminemia (serum albumin below 4.0 g/dL), it is preferable to use the corrected value as an indicator. Method for calculating corrected calcium: Corrected calcium (mg/dL)=serum calcium (mg/dL)－serum albumin (g/dL)＋4.0 3. Measure parathyroid hormone (iPTH) regularly to maintain it within the target range. It is preferable to measure parathyroid hormone (iPTH) twice monthly when starting this medicine and when adjusting the dose (approximately 3 months from the start of treatment as a guideline), and once monthly after confirming that parathyroid hormone (iPTH) has become relatively stable. In addition, it is preferable to measure parathyroid hormone (iPTH) before taking this medicine in order to appropriately assess its efficacy and safety. 4. Patients with hepatic impairment: In patients with moderate and severe hepatic impairment (according to the Child-Pugh method), exposure to this medicine (based on AUC) was 2.4-fold and 4.2-fold higher, respectively, than in individuals with normal hepatic function. PTH and serum calcium levels should be closely monitored when this medicine is administered to patients with moderate or severe hepatic impairment.

This medication should be used with caution in patients with a history of seizures, as seizures may recur. In patients with heart failure, there is a possibility of worsening hypotension or heart failure, so their condition should be carefully monitored. This medication should not be used in patients with hypersensitivity to this drug or certain genetic lactose metabolism disorders. In patients with hypocalcemia, this drug may further lower calcium levels, so it must be administered cautiously. Caution is necessary in patients with poor liver function, as the concentration of the drug may increase in the body. Patients with a history of gastrointestinal bleeding or ulcers should be careful as their symptoms may worsen. While taking this medication, serum calcium levels should be regularly monitored to prevent the occurrence of hypocalcemia. Gastrointestinal symptoms such as nausea, vomiting, loss of appetite, and abdominal bloating may occur as side effects. In severe cases, QT interval prolongation, paralysis or muscle spasms due to hypocalcemia, decreased consciousness, and sudden death have been reported. If any abnormal symptoms occur, immediate consultation with healthcare providers is necessary. Changes in blood concentration may occur when used in conjunction with other medications, so it is important to inform about any medications being taken together. Special caution is required for elderly patients over 65 years of age, as the risk of side effects is higher. The use of this medication is not recommended for pregnant or nursing women, and if necessary, consultation with a specialist is required. Safety in children and adolescents under 19 years of age has not been established, and use is not recommended. Symptoms of hypocalcemia may occur in case of overdose, and immediate emergency treatment should be sought; blood dialysis is not effective. When taking this medication, it should be taken out of the packaging and swallowed to prevent esophageal damage. In chronic kidney disease patients, special caution is needed as there is a risk of low blood calcium levels. This medication can rapidly lower parathyroid hormone levels, and if hormone levels become too low, dosage adjustment or discontinuation may be necessary.

Convulsions, hypotension, exacerbation of heart failure, nausea, vomiting, gastric discomfort, loss of appetite, abdominal bloating, hypocalcemia, decreased serum calcium, QT prolongation, paralysis, muscle cramps, malaise, arrhythmia, blood pressure drop, gastrointestinal bleeding, gastrointestinal ulcer, reduced consciousness level, transient loss of consciousness, sudden death, upper abdominal pain, abdominal pain, abdominal discomfort, diarrhea, constipation, gastric ulcer, gastro-duodenitis, gastroesophageal reflux disease, dyspepsia, gastrointestinal disorders, stomatitis, gastroenteritis, fecal occult blood, hemorrhoids, epigastric discomfort, hiatal hernia, hypertension, arrhythmia, myocardial infarction, myocardial ischemia, ventricular extrasystole, loss of excitatory extrasystole, atrial fibrillation, palpitations, tachycardia, dizziness, headache, insomnia, limb pain, arthralgia, myalgia, numbness, elevated CPK, elevated LDH, elevated blood glucose, hyperlipidemia, increased total cholesterol, taste disturbances, elevated ALP, liver function abnormalities (AST and ALT elevation), elevated bilirubin, elevated γ-GTP, conjunctival hemorrhage, dry eyes, pruritus, rash, hair loss, subcutaneous hemorrhage, goiter, anemia, thrombocytopenia, fatigue, chest discomfort, chest pain, exhaustion, edema, arteriovenous fistula occlusion, thirst, fever, erectile dysfunction, myalgia, hypertension, lethargy, infection, peritonitis, dyspnea, systemic weakness, nausea, colonic polyps, enteritis, hematemesis, chest discomfort, fracture, Achilles tendon rupture, nosebleed, pneumonia, pyelonephritis, bronchitis, seizure, exacerbation of heart failure, failure to control blood pressure, diabetic ulcers, infection at the procedure site, cerebral infarction, reaction at the surgical site, laceration, upper respiratory infection, cold, neck/shoulder pain, fatigue, chilliness, cough, bronchitis, reaction at the procedure site, shingles, flank pain, tremors, falling, influenza-like symptoms, arthritis, bone pain, low back pain, bursitis, plantar fasciitis, increased sputum, orthopnea, sore throat, runny nose, exacerbation of pneumonia, abscess, lower respiratory tract infection, leg tremors, peripheral neuropathy, carpal tunnel syndrome, restless legs syndrome, anxiety, sleep disorders, hypoglycemia, eye inflammation, eye congestion, cataract, venous constriction, epididymal cyst, contusion

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid storing it in places that are too hot or too cold, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablets

Package unit

100 tablets/Box - 10 tablets/PTP [100 tablets/Box (10 tablets/PTP x 10)]