Badanemjeong 300 Milligrams (Bada Dose Start)

Adult dose

Treatment with this drug should be initiated by a physician experienced in the diagnosis and treatment of anemia. Before deciding to initiate treatment with this drug or increase the dose, evaluate other causes of anemia. Ensure adequate iron stores when initiating treatment with this drug, and check transferrin saturation (TSAT) and ferritin levels. For patients not previously treated with erythropoiesis-stimulating agents (ESA), the criterion for initiating this drug is a hemoglobin (Hb) level below 10 g/dL. Patients receiving erythropoiesis-stimulating agents (ESA) may be switched to this drug. During treatment with this drug, individualize the dose according to the patient's condition to achieve and maintain a hemoglobin (Hb) level of 11 ± 1 g/dL. Initial dose Administer vadadustat orally at a starting dose of 300 mg once daily. Dose adjustment and maintenance dose After starting treatment, increase or decrease the dose as appropriate according to the patient's condition. The maximum dose is 600 mg once daily. Monitor hemoglobin (Hb) levels every 2 weeks until the target is reached and maintained, and thereafter every 4 weeks or as clinically indicated. If dose adjustment is needed, increase or decrease the dose by one step at a time, referring to Tables 1 and 2. When increasing the dose, the increment is 150 mg, with at least 4 weeks between increases. Do not adjust the dose of this drug more often than every 4 weeks. As an exception, if hemoglobin (Hb) levels rise rapidly (e.g., > 1 g/dL within 2 weeks or > 2 g/dL within 4 weeks) or exceed 12 g/dL, take appropriate measures, such as promptly reducing the dose or temporarily interrupting treatment. When resuming treatment after an interruption, restart at a dose at least one step lower than the dose before the interruption. Table 1. Dose adjustment steps and sequence Step 1: Dose of this drug 150 mg Step 2 (initial dose): Dose of this drug 300 mg Step 3: Dose of this drug 450 mg Step 4 (maximum dose): Dose of this drug 600mg Table 2. Dose adjustment table Recent Hb change: No increase of 2 g/dL or more over 4 weeks Current Hb level < 10 g/dL: Increase by 150 mg if the dose has not been increased in the past 4 weeks Current Hb level 10 - 12 g/dL: Maintain current dose Current Hb level 12 - 12.9 g/dL: Reduce by 150 mg Current Hb level ≥ 13 g/dL: Discontinue this drug until Hb is 12 g/dL or lower, then restart at a dose 150 mg lower than the previous dose. If the patient was taking 150 mg immediately before discontinuation, restart at 150 mg. Recent Hb change: Increase of 2 g/dL or more over 4 weeks Current Hb level < 10 g/dL: Reduce by 150 mg or maintain the current dose* Current Hb level 10 - 12 g/dL: Reduce by 150 mg or maintain the current dose* Current Hb level 12 - 12.9 g/dL: Reduce by 150 mg * A dose reduction may not be necessary for a transient Hb fluctuation. Missed dose If a dose is missed, take it as soon as remembered on the same day. On the day after a missed dose, skip the missed dose and take the scheduled dose at the usual time. Do not take 2 doses at once. Patients with hepatic impairment Use of this drug is not recommended in patients with moderate hepatic impairment at the start of treatment or in patients with elevated aminotransferase levels (ALT or AST at least 2 times the upper limit of normal). Monitoring of liver enzymes is recommended in all patients before starting therapy with this drug and periodically thereafter.

This medication should be administered at the minimum dosage necessary to keep hemoglobin levels from exceeding the recommended target. Blood tests should be conducted regularly during treatment to monitor hemoglobin levels and avoid excessive hematopoiesis. There is an increased risk of severe thromboembolism, such as stroke, myocardial infarction, and thrombosis, with the use of this medication, so it is crucial to assess the patient's medical history or risk factors carefully before administration. During treatment, the patient's condition should be closely monitored, and if symptoms of thromboembolism or stroke occur, the patient should be directed to seek immediate medical attention. Liver dysfunction may occur; therefore, regular liver function tests should be performed to detect any signs early. This medication should not be used in specific patients, such as those with severely impaired liver function, pregnant or potentially pregnant women, nursing mothers, and those with hypersensitivity to this drug or its components. It should be administered cautiously to patients with a history of thromboembolism or with hypertension, malignant tumors, specific retinal diseases, severe infections, polycystic kidney disease, or heart failure, and consultation with a specialist may be necessary. Blood pressure may rise while taking this medication, so it is important to measure and manage blood pressure regularly. In patients undergoing hemodialysis, the flow rate of the shunt or dialysis machine should be carefully monitored. It is advised not to combine this medication with other erythropoiesis stimulants. Iron supplementation may be necessary when taking this medication, so it is advisable to take appropriate iron supplements based on iron levels. When this medication is taken in conjunction with certain oral drugs (such as calcium, iron, magnesium, etc.), the absorption of this medication may be inhibited, so it should be taken with a gap of more than 2 hours. Additionally, when combined with probenecid, the blood concentration of this medication may increase, requiring dosage adjustments and patient status monitoring. This medication may elevate liver enzyme levels and bilirubin levels, so regular blood tests should be conducted to monitor liver function. Patients with a history of seizures or convulsions should be cautious when using this medication, and if any unusual symptoms occur, immediate consultation with healthcare providers is necessary. Overdosage may lead to excessively elevated hemoglobin levels, resulting in life-threatening complications, so it is crucial to adhere strictly to the dosage and seek immediate treatment for any unusual symptoms. Care should be taken not to swallow the packaging sheet of this medication, and it should be stored in a secure place out of the reach of children.

• Thromboembolism
• diarrhea
• hypertension
• hypotension
• hypersensitivity
• cough
• constipation
• nausea
• vomiting
• upper abdominal pain

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C at room temperature. Proper storage helps maintain the medication's effectiveness and safety.

Appearance

Yellow oval film-coated tablet

Package unit

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