Limitations Of Use

• RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels.
• The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.
  

  DOSAGE AND ADMINISTRATION

  Important Administration Instructions

  RAVICTI should be prescribed by a physician experienced in the management of UCDs.

  • Instruct patients to take RAVICTI with food or formula and to administer directly into the mouth via oral syringe or dosing cup.Where to buy Ravicti (1.1 g/mL)
  • For patients who cannot swallow, see the instructions on administration of RAVICTI by nasogastric tube or gastrostomy tube [see Preparation For Nasogastric Tube Or Gastrostomy Tube Administration].
  • For patients who require a volume of less than 1 mL per dose via nasogastric or gastrostomy tube, the delivered dose may be less than anticipated. Closely monitor these patients using ammonia levels [seePreparation For Nasogastric Tube Or Gastrostomy Tube Administration].
  • The recommended dosages for patients switching from sodium phenylbutyrate to RAVICTI and patients naïve to phenylbutyric acid are different  [see Switching From Sodium Phenylbutyrate To RAVICTI, Initial Dosage In Phenylbutyrate-Naïve Patients]. For both subpopulations:
    • Patients 2 years of age and older: Give RAVICTI in 3 equally divided dosages, each rounded up to the nearest 0.5 mL
    • Patients 2 months of age to less than 2 years: Give RAVICTI in 3 or more equally divided dosages, each rounded up to the nearest 0.1 mL.
    • The maximum total daily dosage is 17.5 mL (19 g).
    • RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).