Horizon By Your Side

Horizon By Your Side (HBYS) is a support program for patients prescribed RAVICTI. Our dedicated team partners with your patient to provide nonclinical personalized support so they can start and continue treatment as you prescribe.

Our mission is to connect, coordinate, and champion your patient
at the most important steps along the way:

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CONNECT: Your patient will be connected to one person dedicated to partnering with them throughout their treatment experience

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COORDINATE: Your patient will receive educational support on insurance, financial assistance options, important appointment-related information, and more

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CHAMPION: Your patient’s dedicated partner will empower them to be confident self-advocates for maintaining treatment goals

Horizon By Your Side

Enroll Your Patient

Call 1-855-UCD-SUPT Monday–Friday 9 AM–8 PM (EST)

Email us at
UCDSupportHBYS@horizontherapeutics.com

Amgen offers support throughout the payor access journey. Our team will help you navigate the unique approval experience for each of your patients.

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The authorization journey may be different for each of your patients, but the Horizon By Your Side team will help you navigate the unique experience. The team at Horizon By Your Side can help identify coverage policies early in the access process to help ensure maximum efficiency.

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Patient Access Liaison (PAL)

A PAL provides dedicated, one-on-one support for your patient. The PAL works directly with your patient to provide nonmedical support upon enrollment and educate your patient about the insurance process and accessing treatment so they can focus less on RAVICTI cost and more on their treatment.

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Amgen Case Manager

A Amgen Case Manager can help healthcare providers to understand their patients’ benefits and unique access solutions. A Case Manager assigned to your patients may also be in touch with your office to make sure important insurance information is properly shared.

Here are tools that may be shared with your patients to help them learn more about RAVICTI

HIPAA Form

Use this form for authorization to use or provide patient-protected health information.

View Resource Email a Copy

HIPAA Form (Spanish)

A Spanish-language form for authorization to use or provide patient-protected information.

View Resource Email a Copy

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

Administering RAVICTI by Mouth

Directions for taking RAVICTI by mouth.

Watch the Video

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

Administering RAVICTI by MouthDirections for taking RAVICTI by mouth.

Directions for taking RAVICTI by mouth.

View video transcript

Welcome to the RAVICTI® (glycerol phenylbutyrate) Oral Liquid instructional dosing video.

In this video you will see step-by- step instructions for the oral administration of RAVICTI for you or your child.

Use for RAVICTI® (glycerol phenylbutyrate) Oral Liquid

RAVICTI is a prescription medicine used for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD). RAVICTI should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone. RAVICTI must be used along with a low-protein diet and in some cases, dietary supplements.

RAVICTI is not used to treat extremely high levels of ammonia in the blood (hyperammonemic crisis) in people with UCDs.

It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

Please listen to the RAVICTI Important Safety Information at the end of this video. For additional important safety information, see the Medication Guide at RAVICTI.com and discuss with your doctor.

This video is intended to complement the instructions you have already received from your doctor. Always take RAVICTI exactly as directed by your doctor.

Do not mix RAVICTI with formula or any other liquids.

Now, let’s get started.

Your RAVICTI shipment includes a 25-mL bottle of RAVICTI, a blue AdaptaCap® Bottle Adapter, and an oral dosing syringe.

When dosing RAVICTI, be sure to use the oral dosing syringe provided with the product.

First, remove the childproof cap on the RAVICTI bottle. To do that, push down on the cap while twisting it to the left.

Then, attach the blue AdaptaCap® Bottle Adapter onto the bottle. Put it on top of the bottle and twist it to the right.

Make sure it is secured tightly on the bottle.

While holding the RAVICTI bottle securely, place the tip of the oral dosing syringe into the AdaptaCap®Bottle Adapter.

Turn the bottle upside down with the oral dosing syringe still inserted.

Now you’re ready to fill the oral dosing syringe with RAVICTI.

Get the medicine into the oral dosing syringe by pulling the plunger back slowly. Pulling slowly will help avoid large air bubbles from forming in the medicine.

Pull the plunger back until the first line of the black rubber stopper is even with the dosing mark. The dosing marks are on the barrel of the oral dosing syringe. Match the dosing mark with the amount of medicine prescribed by your doctor.

Then, turn the bottle upright again.

If there are large air bubbles, push the medicine back into the bottle. Do this slowly.

Then draw up the medicine again.

Once you have your oral dosing syringe ready, place it into the mouth. Push the plunger to squirt the medicine directly into the mouth.

Make sure all of the medicine is pushed out of the oral dosing syringe and swallowed.

Put the cap on the oral dosing syringe.

Drink liquid or eat some food right after taking RAVICTI.

This helps ensure that all of the medicine is swallowed.

Close the tab on the AdaptaCap® Bottle Adapter.

Make sure it’s closed tightly.

You can use 1 oral dosing syringe and 1 blue AdaptaCap® Bottle Adapter for all doses each day. You can also choose to use a new oral dosing syringe with each dose. Do not rinse the AdaptaCap® Bottle Adapter or oral dosing syringe between doses.

After the last dose of the day, dispose of the oral dosing syringe.

If you take too much RAVICTI, call your doctor or go to the nearest hospital emergency room right away.

You should consult your physician if you have missed a dose of RAVICTI.

Do not mix RAVICTI with formula or any other liquids.

Image of video showing how to take RAVICTI by nasogastric or gastronomy feeding tube

Administering RAVICTI by Nasogastric or G-Tube

Directions for taking RAVICTI by nasogastric or G-tube.

Watch the Video

Image of video showing how to take RAVICTI by nasogastric or gastronomy feeding tube

Administering RAVICTI by Nasogastric or G-TubeDirections for taking RAVICTI via nasogastric or gastronomy feeding tube

Directions for taking RAVICTI by nasogastric or G-tube.

View video transcript

Welcome to the RAVICTI® (glycerol phenylbutyrate) Oral Liquid instructional dosing video.

In this video, you will see step-by-step instructions for administration of RAVICTI if you or your child have a nasogastric or gastrostomy feeding tube.

If you can swallow liquids, it is recommended you take RAVICTI by mouth.

Use for RAVICTI® (glycerol phenylbutyrate) Oral Liquid

RAVICTI is a prescription medicine used for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD). RAVICTI should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone. RAVICTI must be used along with a low-protein diet and in some cases, dietary supplements.

RAVICTI is not used to treat extremely high levels of ammonia in the blood (hyperammonemic crisis) in people with UCDs.

.

It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

Please listen to the RAVICTI Important Safety Information at the end of this video. For additional important safety information, see the Medication Guide at RAVICTI.com and discuss with your doctor.

This video is intended to complement the instructions you have already received from your doctor. Always take RAVICTI exactly as directed by your doctor.

Do not mix RAVICTI with formula or any other liquids.

Now, let’s get started.

Your RAVICTI shipment includes: a 25-mL bottle of RAVICTI, a blue AdaptaCap® Bottle Adapter, and an oral dosing syringe.

When dosing RAVICTI, be sure to use the oral dosing syringe provided with the product.

First, remove the childproof cap on the RAVICTI bottle. To do that, push down on the cap while twisting it to the left.

Then, attach the blue AdaptaCap® Bottle Adapter onto the bottle. Put it on top of the bottle and twist it to the right.

Make sure it is secured tightly on the bottle.

While holding the RAVICTI bottle securely, place the tip of the oral dosing syringe into the AdaptaCap® Bottle Adapter.

Turn the bottle upside down with the oral dosing syringe still inserted.

Now you’re ready to fill the oral dosing syringe with RAVICTI.

Get the medicine into the oral dosing syringe by pulling the plunger back slowly. Pulling slowly will help avoid large air bubbles from forming in the medicine.

Pull the plunger back until the first line of the black rubber stopper is even with the dosing mark. The dosing marks are on the barrel of the oral dosing syringe. Match the dosing mark with the amount of medicine prescribed by your doctor.

Then, turn the bottle upright again.

If there are large air bubbles, push the medicine back into the bottle. Do this slowly.

Then draw up the medicine again.

Next, place the tip of the oral dosing syringe into the smaller port of the feeding tube. The smaller port of the nasogastric or gastrostomy feeding tube is used for medicine. Ask your doctor if you are not sure which port to use.

Using the plunger of the oral dosing syringe, slowly and carefully push RAVICTI into the feeding tube. Make sure all of the medicine is pushed out of the oral dosing syringe.

After you have pushed all of the RAVICTI into the feeding tube, remove the oral dosing syringe, put the cap on, and set it aside.

Close the tab on the AdaptaCap® Bottle Adapter. Make sure it’s closed tightly.

Use a separate large syringe to flush water into the feeding tube. A large syringe can be found in the box containing your feeding tube.

Make sure all of the water or formula drains through the feeding tube.

You can use 1 oral dosing syringe and 1 blue AdaptaCap® Bottle Adapter for all doses each day. You can also choose to use a new oral dosing syringe with each dose. Do not rinse the AdaptaCap® Bottle Adapter or oral dosing syringe between doses.

After the last dose of the day, dispose of the oral dosing syringe.

If you take too much RAVICTI, call your doctor or go to the nearest hospital emergency room right away.

You should consult your physician if you have missed a dose of RAVICTI.

For patients who require a volume of less than 1 mL per dose via nasogastric or gastrostomy tube, the delivered dosage may be less than anticipated due to adherence of RAVICTI to the plastic tubing. Therefore, these patients should be closely monitored using ammonia levels following initiation of RAVICTI dosing or dosage adjustments.

UCD Mentors at RAVICTI.com

UCD Mentors are real patients and caregivers who understand what it means to live with a UCD. UCD Mentors are ready to connect with patients, share their experiences, and answer questions.

Patients Can Sign Up for Support

Explore other organizations that may provide support for patients with UCDs

Your patients may be interested in learning more about independent organizations that are dedicated to improving the lives of patients with UCDs through support, education, advocacy, and research.

Find a Metabolic
Specialist

Locate a specialist experienced in
treating patients with UCD near
you or your patient.

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Order a Metabolite
Testing Kit

Determine your patient’s
plasma PAGN ratio and urinary
PAGN level.

Order a No-Cost Test Kit

View Practice
Resources

Access resources for your practice
to help in the management
of UCDs.

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INDICATION and IMPORTANT SAFETY INFORMATION

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

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.