The usage age for JW Pharmaceutical's high-dose iron injection 'Ferinject (ingredient name: ferric carboxymaltose)' has been expanded from ages 14 and older to ages 1 and older.
The company recently noted that it received approval from the Ministry of Food and Drug Safety to add usage and dosage for pediatric patients aged 1 and older for Ferinject.
Launched in March 2011, Ferinject is a high-dose iron injection that can replenish up to 1000 mg of iron in a minimum of 15 minutes. Previously, Ferinject was not recommended for pediatric patients under 14 years old. With this approval, Ferinject can now be used by all ages except those under 1 year old.
According to the revised approval conditions, the maximum single administration dosage for children aged 1 to 13 years is limited to 15 mL (750 mg of iron) or 0.3 mL (15 mg of iron) per 1 kg of body weight. Doses of 15 mL (750 mg of iron) can be administered up to once a week. If the total iron requirement exceeds this amount, additional doses can be given at least 7 days apart after the first administration.
This treatment is mainly used for women at high risk of iron deficiency or iron deficiency anemia, chronic bleeding patients, and for treating iron deficiency anemia caused by various surgeries and chemotherapy. Iron is an essential mineral that activates various functions including oxygen transport within the body, enhances immune function, supports cognitive function and fetal development, and generates energy. Symptoms of iron deficiency may include dizziness, fatigue, shortness of breath, palpitations, and headaches.
Ferinject became eligible for national health insurance coverage in May of last year. JW Pharmaceutical plans to enhance the accessibility and utilization of Ferinject in medical settings and strengthen its market competitiveness. A company representative remarked, 'We expect that this revised approval will provide substantial help in treating iron deficiency in pediatric patients.'