Effective ammonia control that you can prescribe with confidence1

Review dosing and administration information for your patient starting on or switching to RAVICTI

Find your patient’s dose

This tool is intended to provide dose calculations based on patient body surface area (BSA). For additional information about dosing and administration, please refer to the Full Prescribing Information.

Starting RAVICTI

1. Choose the age of your patient.

2. Enter the height and weight of your patient in desired units to determine body surface area (BSA).a The BSA is then used to calculate the daily dosage range.b

BSA

3. Use the slider below to select the daily dosage from the calculated range.c Be sure to follow the guidelines outlined in Need to Know.

X.X Y.Y mL/day
X.X

4. Select number of doses per day.

  • 3
  • 4
  • 5
  • 6

Calculated dosage for phenylbutyrate-naïve patients.

This is the dose of RAVICTI for your patient, which includes proper rounding.

X.X mL per dose, based on 3 doses a day

Multiply this dose by 90 in order to find your patient’s prescription amount for 3 doses per day for 30 days.

Switching to RAVICTI

1. Choose the form of NaPBA.

2. Choose the age of your patient.

3. Enter the current daily dosage of NaBPA.d,e

4.Select number of RAVICTI doses per day.

  • 3
  • 4
  • 5
  • 6

Calculated dose for patients transitioning from sodium phenylbutyrate (NaPBA).

This is the dose of RAVICTI for your patient, which includes proper rounding.

X.XmL per dose, based on 3 doses a day

Multiply this dose by 90 in order to find your patient’s prescription amount for 3 doses per day for 30 days.

The results may be printed or emailed once calculated. Note the email address provided will not be registered for educational or promotional emails and is used solely for delivering the custom dosing results.

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aBSA can be calculated by multiple equations; the Mosteller equation is used on this website.2,3

bThe recommended dosage range, based on BSA, in patients naïve to phenylbutyrate is 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day). For patients with some residual enzyme activity who are not adequately controlled with protein restriction, the recommended starting dosage is 4.5 mL/m2/day. These values are multiplied by your patient’s BSA to calculate the daily dosage range indicated in the slider.1

cThe maximum total daily dosage of RAVICTI is 17.5 mL (19 g); any dose value calculated on this website cannot exceed this value.1

The results may be printed or emailed once calculated. Note the email address provided will not be registered for educational or promotional emails and is used solely for delivering the custom dosing results.

Email results

Print results

dThe total daily dosage of RAVICTI (mL) equals the total daily dosage of NaPBA tablets (g) x 0.86.1

eThe total daily dosage of RAVICTI (mL) equals the total daily dosage of NaPBA powder (g) x 0.81.1

RAVICTI Dosing

A representative can answer your questions and provide information about appropriate dosing and administration

Learn More About Dosing

Optimize RAVICTI

Evaluate whether dosage needs to be modified for your patient managing their UCD with RAVICTI

Learn More

Recommended dosage range

The recommended dosage range, based on body surface area, in patients naïve to phenylbutyrate is 4.5 to 11.2 mL/m²/day (5 to 12.4 g/m²/day).1

Maximum RAVICTI dosage

Residual urea synthetic capacity

For patients with some residual enzyme activity who are not adequately controlled with protein restriction, the recommended starting dosage is 4.5 mL/m²/day.1

Hepatic status

For patients with moderate to severe hepatic impairment, the recommended starting dosage is at the lower end of the recommended range (4.5 mL/m²/day) and should be kept at the lowest dosage necessary to control the patient’s plasma ammonia.1

Dietary protein requirements

An initial estimated RAVICTI dose for a 24-hour period is 0.6 mL RAVICTI per gram of dietary protein ingested.1

Diet adherence

Poor adherence with prescribed diets will increase your patient’s protein intake, which may necessitate increasing dosage.1

Proper rounding of doses

Patients 2 years of age and older: Give RAVICTI in 3 equally divided doses, each rounded up to the nearest 0.5 mL.1

Patients less than 2 years of age: Give RAVICTI in 3 or more equally divided doses, each rounded up to the nearest 0.1 mL.1

Please note: the RAVICTI dose is automatically rounded up when using the calculator.

Maximum dosage

The maximum total daily dosage is 17.5 mL (19 g).1 Please note: the dosage calculator will not exceed the maximum.

Use with dietary protein restriction and supplements

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).1

Help control ammonia with an easy-to-administer oral liquid1,f

Nearly tasteless and odorless liquid icon.

Nearly odorless and nearly tasteless liquid1,4

No pill or powder preparation and minimal dosing steps required icon.

No pill or powder preparation and minimal dosing steps required1

Taken with meals or feedings via oral dosing syringe icon.

Taken with meals or feedings via oral dosing syringe1,g

fOf the 51 adult patients in the 12-month study of RAVICTI, 7 patients (14%) reported a total of 10 hyperammonemic crises. Of the 26 pediatric patients 6 to 17 years of age in both 12-month studies of RAVICTI, 5 patients (19%) reported a total of 5 hyperammonemic crises. Of the 17 pediatric patients 2 months to less than 2 years of age in 3 open-label studies, 7 patients (41%) reported a total of 11 hyperammonemic crises. Of the 16 pediatric patients less than 2 months of age in an uncontrolled, open-label study, 5 patients (31%) reported a total of 7 hyperammonemic crises.1

gFor 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.1

How to administer RAVICTI

If you’re ready to prescribe RAVICTI to your patients, it’s important that you and your patients understand how to administer RAVICTI properly. Watch the videos below to review the complete directions for taking RAVICTI.

Directions for taking RAVICTI by mouth
Image of video showing how to take RAVICTI oral liquid by mouth

Download the video transcript

Directions for taking RAVICTI via nasogastric or gastronomy feeding tube
Image of video showing how to take RAVICTI by nasogastric or gastronomy feeding tube

Download the video transcript

Dosing Guide

Download the Dosing Brochure to learn about dosing and administration of RAVICTI

View the Dosing Brochure

Patient Assessment

This assessment tool can help evaluate treatment of your patient and ensure management of their UCD

Download the Assessment

Stay informed about RAVICTI

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References: 1. RAVICTI (glycerol phenylbutyrate) Oral Liquid [prescribing information] Horizon. 2. Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987;317(17):1098. doi:10.1056/nejm198710223171717 3. Verbraecken J, Van de Heyning P, De Backer W, Van Gaal L. Body surface area in normal-weight, overweight, and obese adults: a comparison study. Metab Clin Exp. 2006;55(4):515-524. doi:10.1016/j.metabol.2005.11.004 4. Diaz GA, Krivitzky LS, Mokhtarani M, et al. Ammonia control and neurocognitive outcome among urea cycle disorder patients treated with glycerol phenylbutyrate. Hepatology. 2013;57(6):2171-2179. doi:10.1002/hep.26058

INDICATION and IMPORTANT SAFETY INFORMATION

true

INDICATION

RAVICTI (glycerol phenylbutyrate) Oral Liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or supplementation alone. 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).

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
  • Patients with known hypersensitivity to phenylbutyrate: Reactions include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash.
WARNINGS AND PRECAUTIONS
  • Neurotoxicity: Phenylacetate (PAA), the major metabolite of RAVICTI, may be toxic at levels of 500 micrograms/mL or greater. If symptoms of vomiting, nausea, headache, somnolence, or confusion, are present in the absence of high ammonia or other intercurrent illness which explains these symptoms, consider the potential for PAA neurotoxicity which may need reduction in the RAVICTI dosage.
  • Pancreatic Insufficiency or Intestinal Malabsorption: Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely.
ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials (at least 10% of patients) were:

  • Adult patients: diarrhea, flatulence, and headache occurred during 4-week treatment (n=45) with RAVICTI; nausea, vomiting, diarrhea, decreased appetite, dizziness, headache, and fatigue occurred during 12-month treatment (n=51) with RAVICTI.
  • Pediatric patients ages 2 to 17 years: upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, and headache occurred during 12-month treatment (n=26) with RAVICTI.
  • Pediatric patients ages 2 months to less than 2 years: neutropenia, vomiting, constipation, diarrhea, pyrexia, hypophagia, cough, nasal congestion, rhinorrhea, rash, and papule occurred during 12-month treatment (n=17) with RAVICTI.
  • Pediatric patients less than 2 months of age: vomiting, rash, gastroesophageal reflux, increased hepatic enzymes, feeding disorder (decreased appetite, hypophagia), anemia, cough, dehydration, metabolic acidosis, thrombocytosis, thrombocytopenia, neutropenia, lymphocytosis, diarrhea, flatulence, constipation, pyrexia, lethargy, and irritability/agitation occurred during 24-month treatment (n=16) with RAVICTI.
DRUG INTERACTIONS
  • Corticosteroids, valproic acid, or haloperidol may increase plasma ammonia level. Monitor ammonia levels closely.
  • Probenecid may affect renal excretion of metabolites of RAVICTI, including phenylacetylglutamine (PAGN) and PAA.
  • CYP3A4 substrates with narrow therapeutic index (eg, alfentanil, quinidine, cyclosporine): RAVICTI may decrease exposure to the concomitant drug.
  • Midazolam: Use of RAVICTI decreased exposure of midazolam with concomitant use.
USE IN SPECIFIC POPULATIONS
  • Pregnancy: RAVICTI should be used with caution in patients who are pregnant or planning to become pregnant. Based on animal data, RAVICTI may cause fetal harm. Report pregnancies to Horizon at 1‐866‐479‐6742.
  • Lactation: breastfeeding is not recommended during treatment with RAVICTI. There are no data on the presence of RAVICTI in human milk, the effects on the breastfed infant, nor the effects on milk production.

Please see Full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION

true

INDICATION

RAVICTI (glycerol phenylbutyrate) Oral Liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or supplementation alone. 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).

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
  • Patients with known hypersensitivity to phenylbutyrate: Reactions include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash.
WARNINGS AND PRECAUTIONS
  • Neurotoxicity: Phenylacetate (PAA), the major metabolite of RAVICTI, may be toxic at levels of 500 micrograms/mL or greater. If symptoms of vomiting, nausea, headache, somnolence, or confusion, are present in the absence of high ammonia or other intercurrent illness which explains these symptoms, consider the potential for PAA neurotoxicity which may need reduction in the RAVICTI dosage.
  • Pancreatic Insufficiency or Intestinal Malabsorption: Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely.
ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials (at least 10% of patients) were:

  • Adult patients: diarrhea, flatulence, and headache occurred during 4-week treatment (n=45) with RAVICTI; nausea, vomiting, diarrhea, decreased appetite, dizziness, headache, and fatigue occurred during 12-month treatment (n=51) with RAVICTI.
  • Pediatric patients ages 2 to 17 years: upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, and headache occurred during 12-month treatment (n=26) with RAVICTI.
  • Pediatric patients ages 2 months to less than 2 years: neutropenia, vomiting, constipation, diarrhea, pyrexia, hypophagia, cough, nasal congestion, rhinorrhea, rash, and papule occurred during 12-month treatment (n=17) with RAVICTI.
  • Pediatric patients less than 2 months of age: vomiting, rash, gastroesophageal reflux, increased hepatic enzymes, feeding disorder (decreased appetite, hypophagia), anemia, cough, dehydration, metabolic acidosis, thrombocytosis, thrombocytopenia, neutropenia, lymphocytosis, diarrhea, flatulence, constipation, pyrexia, lethargy, and irritability/agitation occurred during 24-month treatment (n=16) with RAVICTI.
DRUG INTERACTIONS
  • Corticosteroids, valproic acid, or haloperidol may increase plasma ammonia level. Monitor ammonia levels closely.
  • Probenecid may affect renal excretion of metabolites of RAVICTI, including phenylacetylglutamine (PAGN) and PAA.
  • CYP3A4 substrates with narrow therapeutic index (eg, alfentanil, quinidine, cyclosporine): RAVICTI may decrease exposure to the concomitant drug.
  • Midazolam: Use of RAVICTI decreased exposure of midazolam with concomitant use.
USE IN SPECIFIC POPULATIONS
  • Pregnancy: RAVICTI should be used with caution in patients who are pregnant or planning to become pregnant. Based on animal data, RAVICTI may cause fetal harm. Report pregnancies to Horizon at 1‐866‐479‐6742.
  • Lactation: breastfeeding is not recommended during treatment with RAVICTI. There are no data on the presence of RAVICTI in human milk, the effects on the breastfed infant, nor the effects on milk production.

Please see Full Prescribing Information.