Volibris Tablets 10 mg (Ambrisentan)

Adult dose

Treatment should be initiated and monitored by a physician experienced in treating patients with pulmonary arterial hypertension. The dose should be appropriately adjusted according to the patient's symptoms, tolerability, etc. The initial dose is 5mg once daily, with or without food. If 5mg is tolerated, an increase to 10mg once daily may be considered. This medication may be taken with or without food. Do not split, crush, or chew this medication. Patients with hepatic impairment Exposure to this medication may increase in patients with hepatic impairment. This medication should not be administered to patients with severe hepatic impairment or to patients whose hepatic aminotransferases (ALT, AST) exceed 3 times the upper limit of normal. Patients with renal impairment No dose adjustment is required in patients with mild or moderate renal impairment. There is no clinical experience with administration of this medication to patients with severe renal impairment. Older patients No dose adjustment is required in patients aged 65 years and older. Discontinuation of treatment There are insufficient clinical data to establish that discontinuation of the medication will not result in adverse reactions or worsening of pulmonary arterial hypertension.

Child dose

Use is not recommended in children and adolescents under 18 years of age because safety and efficacy have not been established.

This medication can cause serious congenital defects in the fetus if taken during pregnancy, so women of childbearing potential must confirm pregnancy before taking this medication. Women of childbearing potential should use reliable contraception while taking this medication and for one month after discontinuation. Monthly pregnancy tests are also important. This medication should not be used in women who are pregnant or may become pregnant, women who are nursing, patients with severe liver dysfunction, patients with very high levels of aminotransferases, patients allergic to this medication or its ingredients, patients with certain genetic metabolic disorders, patients allergic to soybean oil or peanuts, or patients with specific lung diseases. Caution should be exercised when using this medication in patients with impaired liver or kidney function, patients with anemia, and elderly patients, and regular liver function tests and blood tests should be performed during treatment. This medication may lower hemoglobin levels in the blood; therefore, patients with severe anemia should avoid using this medication and should monitor their condition through blood tests during treatment. This medication may cause fluid retention and peripheral edema and may be more severe in the elderly, so immediate consultation with healthcare professionals is necessary if weight gain or edema symptoms occur. Serious pulmonary-related complications such as pulmonary artery occlusion may occur; therefore, immediate treatment is required if symptoms of dyspnea or sudden pulmonary edema appear. This medication is mainly metabolized by the liver and should not be administered in patients with very severe liver impairment. If there are signs of liver dysfunction, medication administration should be stopped. Interactions with other medications may occur; therefore, dosage adjustment is necessary when taken with cyclosporine A, and if other medications are being taken, healthcare professionals must be informed. This medication may affect the ability to drive or operate machinery, thus caution is required during treatment. It is not recommended for children or adolescents, as safety and efficacy have not been established, and there may be a higher risk of side effects in elderly patients. Overdosage may result in serious symptoms such as hypotension, so the prescribed dosage must be strictly followed, and it should be stored out of reach of children.

• peripheral edema
• fluid retention
• headache
• anemia
• hypersensitivity reaction
• dizziness
• blurred vision
• visual impairment
• heart failure
• palpitations

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Dark pink, convex, egg-shaped tablet

Package unit

30 tablets (10 tablets/PTP X 3)