Loargys (pegzilarginase-nbln)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Most common adverse reactions (>10%) are vomiting, pyrexia, infusion associated reactions, and constipation.

Less Frequent

• Accidental fall

Rare or Very Rare

• Anaphylaxis

More Frequent

• Abnormal hepatic function tests
• Constipation
• Fever
• Hypersensitivity drug reaction
• Injection site sequelae
• Vomiting

Less Frequent

• Dizziness
• Increased alanine transaminase
• Increased aspartate transaminase
• Pharyngitis
• Rhinorrhea

No enhanced messaging available.

The safety and effectiveness of pegzilarginase-nbln have been established under accelerated approval for the treatment of hyperargininemia in pediatric patients 2 years of age and older with ARG1-D, in conjunction with dietary protein restriction. Use of pegzilarginase-nbln for this indication is supported by evidence from an adequate and well-controlled trial in adult and pediatric patients that included 29 pediatric patients 2 to 17 years of age with ARG1-D (Trial 1) and additional safety information from an open-label extension trial in adult and pediatric patients that included 9 pediatric patients (Trial 3).

The safety and effectiveness of pegzilarginase-nbln have not been established for the treatment of hyperargininemia in pediatric patients less than 2 years of age with ARG1-D.

Juvenile rats with normal circulating arginine levels were administered once weekly IV pegzilarginase-nbln doses of 0.1, 0.3 and 1 mg/kg/dose from postnatal day 21 (the equivalent of a 2-year-old human) up to 13 weeks of age. At 1 mg/kg (15-fold the human exposure based on AUC at the MRHD), male and female rats showed increased incidence of tremors, salivation, and piloerection, along with reduced body weight and body weight gain. Reproductive organ effects were observed in male rats administered 1 mg/kg, including decreased sperm motility and total sperm count, increased percentage of abnormal sperm, and decreased epididymis, testes and prostate gland weights.

There are no available data on pegzilarginase-nbln use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In animal reproduction studies, IV administration of pegzilarginase-nbln to pregnant rats and rabbits during organogenesis resulted in maternal toxicity with associated increased incidence of fetal growth deficiencies.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no data on the presence of pegzilarginase-nbln in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pegzilarginase-nbln and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Clinical studies of pegzilarginase-nbln did not include patients 65 years of age and older to determine whether they respond differently from younger adult patients.