Akinji Injection

Adult dosage

Adults Administer this product by intravenous infusion over at least 30 minutes, once, approximately 30 minutes before the start of chemotherapy. When this product is administered concomitantly with dexamethasone, reduce the dose of oral dexamethasone by approximately 50 % (see Precautions for Use, section 5. Drug Interactions, and section 10. Information for Healthcare Professionals). Patients with renal impairment No dosage adjustment is necessary in patients with mild to moderate renal impairment. Avoid use of this product in patients with severe renal impairment or end-stage renal disease requiring hemodialysis, as no clinical data are available for these patients. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh score 5~8). Clinical data in patients with severe hepatic impairment (Child-Pugh score ≥9) are limited; therefore, caution should be exercised when administering this product to these patients. <Preparation of this product> 1. Aseptically prepare a vial or bag containing 30mL of 5% dextrose injection or 0.9% sodium chloride injection. 2. Transfer the entire contents (20mL) from the vial of this product into the vial or bag to make a total volume of 50mL. Gently shake until completely dissolved. 3. Before administration, visually inspect the injection solution for particulate matter and discoloration.

This medication should not be used by patients who are allergic to this medication or its ingredients. It should not be administered to pregnant women, and women who may become pregnant should avoid pregnancy while using this medication. Patients who have had allergic reactions to similar medications in the past should use this medication with caution. Patients with constipation or bowel obstruction symptoms should be closely monitored after administering this medication. Patients taking other serotonergic drugs should be cautious as there is a risk of serious side effects known as serotonin syndrome. Patients with a risk of prolonged QT interval or those taking medications that prolong the QT interval should use this medication carefully. Patients with very poor liver function, severely impaired kidney function, and elderly patients over 75 years of age should use this medication with special caution. This medication can cause common side effects such as headache, constipation, and fatigue, and various side effects such as blood disorders, cardiac anomalies, and skin rashes may rarely occur. Patients with severe constipation should carefully monitor their bowel condition after taking this medication, and should immediately consult medical personnel if symptoms of serotonin syndrome appear. This medication can cause dizziness or drowsiness when driving or operating machinery, so caution is necessary if these symptoms occur. Additionally, as this medication is metabolized by a specific enzyme (CYP3A4) in the liver, it should be used with caution when used with other medications that inhibit or induce this enzyme, as the drug concentration may change. Women who are pregnant or breastfeeding should not take this medication, and breastfeeding should be discontinued for one month after administering this medication. Safety and efficacy in children under 18 years of age have not been established, so this medication should not be used in this age group. In case of overdose, symptoms may include headache, dizziness, constipation, and anxiety; in such cases, discontinue use immediately and seek treatment from medical personnel.

• Headache
• constipation
• fatigue
• cystitis
• neutropenia
• leukocytosis
• leukopenia
• lymphocytosis
• decreased appetite
• hypokalemia

This medication should be stored at room temperature between 1°C to 30°C and must be kept in a tightly sealed container to avoid contact with air. This will help maintain the medication's effectiveness for a longer period.

Appearance

A transparent solution that is colorless to slightly yellow, contained in a colorless transparent glass vial as an injection.

Package unit

1 vial/box [20 mL/vial]