American Regent launches trace element injections for underweight newborns

06 Sep 2021 --- American Regent is introducing Multrys, a Food and Drug Administration (FDA)-approved trace element injection for neonatal and pediatric patients weighing less than 10 kg. 

As 1 mL single-dose vials, Multrys contains 1 mg of zinc, 60 mcg of copper, 3 mcg of manganese and 6 mcg of selenium, supplementing parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated. 

“The launch of Multrys demonstrates American Regent’s continued commitment to addressing the needs of patients who require trace element supplementation,” says Joann Gioia, vice president and chief commercial officer at American Regent.

“This new formulation is part of our overall initiative to retire our line of marketed unapproved trace element products.”

According to UNICEF data published in May 2019, approximately 321,100 US newborns weighed less than 2.5 kg in 2015, up from 279,000 in 2000.

Overall in 2015, 20.5 million newborns, an estimated 14.6 percent of all babies born globally that year, suffered from low birthweight. 

Multrys is recommended only for pediatric patients who require supplementation with all four of the individual trace elements.Weight-specific supplementation
Multrys is recommended only for pediatric patients who require supplementation with all four of the individual trace elements.

Moreover, babies in different weight groups require specific supplementation. In the 0.4 to 0.59 kg category, the total recommended dosage of Multrys is 0.2 mL every second day. In specific cases, daily supplementation of zinc, copper and selenium is needed to meet daily requirements.

Pediatric patients weighing between 0.6 and 10 kg are advised to supplement with 0.3 mL per kg per day, rounded to the nearest 0.1 mL for a maximum of 1 mL per day. The recommended volume of Multrys to be added to parenteral nutrition ranges from 0.2 mL per day to 1 mL per day based on body weight.

Nutrition research for low birthweight infants
Babies classified as low birthweight (under 2.5 kg) are at risk of several nutrient deficiencies. Iron deficiency is one of them, linked to impaired neurological development. A study from 2017 found that iron supplements for low birthweight infants prevented behavioral problems, lowered aggression levels and rule-breaking behavior at school age.

Meanwhile, human-based milk fortifiers may have better health outcomes for severely underweight premature babies compared to traditional, cow’s milk-derived fortifiers.

This was the latest suggestion from a US-UK study last year that found that babies who were fed cow milk fortifiers were more than three times as likely to develop necrotizing enterocolitis and more than twice as likely to develop retinopathy of prematurity, an eye disorder that can lead to blindness.

Edited by Anni Schleicher