For Healthcare Professionals For Patients and Caregivers Important Safety Information Medication Guide RAVICTIhcp.com
FORMS AND DOWNLOADS

Downloadable Forms and Clinical Resources to Help Your Patients and Their Families

The following helpful resources can be shared with your office, patient, or other caregivers. These digital resources can help them get started or learn more about the support available while on RAVICTI® (glycerol phenylbutyrate) Oral Liquid.

Once you decide RAVICTI is right for your patient, it’s easy to start their enrollment in Amgen By Your Side with the Patient Enrollment Form (PEF) and submit it using the following method below. Patient consent will be required.

Offline-Submission-IconOffline-Submission-Icon

Begin Enrollment

Fill out the form, then download, sign and fax the form to 1-877-695-8304 OR email it to UCDABYS@amgen.com

Need help? Download our Patient Enrollment Form Guide (PDF)

Once your patient is enrolled, you will receive a comprehensive summary of your patient’s benefits from the Amgen By Your Side team. We will be there to provide support when your patient needs it throughout their treatment journey.

Reimbursement

Annotated Enrollment Form

This guide walks you through how to complete the Patient Enrollment Form and begin enrollment into Amgen By Your Side.

Letter of Medical Necessity Template

A customizable letter template for HCPs who are submitting a Prior Authorization for specific patient cases seeking payor access.

Prior Authorization Checklist

This resource contains the common criteria, such as documentation or physician attestation, that may be requested for RAVICTI.

Access Roadmap

This resource helps define each stage of the access process and lists resources available to help you and your office understand coverage and reimbursement for RAVICTI.

Template Appeal Letter

Refer to this sample letter if you need to appeal an insurance claim for RAVICTI.

Payor Appeal Letter Checklist and Tips

Refer to this sample letter for times when a prior authorization request is denied by your patient’s health plan.

Patient Resources

Taking RAVICTI by Mouth

RAVICTI can be taken by mouth, even in patients with a feeding tube or G-tube.

Taking RAVICTI by Feeding Tube

Directions for taking RAVICTI by nasogastric or G-tube.

Treatment

Patient Assessment Follow-Up

Use this guide to assess management of urea cycle disorders (UCDs) for patients who have transitioned to RAVICTI.
Read 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.

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-milliliter bottle of RAVICTI, a reclosable bottle cap adapter, and an oral syringe.

When dosing RAVICTI, be sure to use the oral 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 reclosable bottle cap 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 syringe into the reclosable bottle cap adapter. 

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

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

Withdraw the prescribed dose of RAVICTI with the dry oral syringe by pulling the plunger back.

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 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 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 syringe and swallowed. 

Put the cap on the oral 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 reclosable bottle cap adapter. 

Make sure it’s closed tightly. 

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

Take the exact amount of RAVICTI Oral Liquid as instructed by your doctor.

Your doctor may change your dose if needed.

Take RAVICTI with food or formula.

In an infant who is breastfeeding, give RAVICTI just prior to breastfeeding.

Use a new reclosable bottle cap adapter with each new bottle of RAVICTI that is opened.

Use a new dry oral syringe to withdraw each prescribed dose of RAVICTI.

If you take too much RAVICTI, call your doctor or the Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Do not stop taking RAVICTI unless your doctor tells you to stop. 

If you miss a dose of RAVICTI, take it as soon as possible.

Do not take 2 doses of RAVICTI at the same time.

If you miss more than 1 dose and are not feeling well, call your doctor or nurse right away.  

If you still have questions about how to take RAVICTI with an oral syringe, please contact your doctor for more information.

If RAVICTI is in contact with water, it will become cloudy in appearance. If the contents are in contact with water or cloudy, then do not use the remaining RAVICTI and contact your prescribing doctor or pharmacy. 

Discard bottle and any remaining contents 28 days after opening. 

Ask your pharmacist for oral syringes and a reclosable bottle cap adapter for each bottle you receive if you do not have them.

USE and IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RAVICTI?

RAVICTI may cause serious side effects, including: Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of RAVICTI, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking RAVICTI: 

  • sleepiness 
  • lightheadedness 
  • change in taste 
  • problems with hearing 
  • confusion 
  • problems with memory 
  • worsening of numbness, tingling, or burning in your hands or feet  
  • headache 
  • feeling very tired (fatigue) 
  • nausea 
  • vomiting 

Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.

What is RAVICTI? 

  • RAVICTI (glycerol phenylbutyrate) Oral Liquid 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 for the acute treatment of hyperammonemia in people with UCD.
  • It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.

Before taking RAVICTI, tell your doctor about all of your medical conditions, including if you:

  • have liver or kidney problems.
  • have pancreas or bowel (intestine) problems.
  • are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby. If you become pregnant during treatment with RAVICTI, call Horizon at 1‐866‐479‐6742 to report the pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. Breastfeeding is not recommended during treatment with RAVICTI. Talk to your doctor about the best way to feed your baby if you take RAVICTI.

What are possible side effects of RAVICTI?

RAVICTI may cause serious side effects, including:

  • See “What is the most important information I should know about RAVICTI?”

The most common side effects of RAVICTI in adults include:

  • diarrhea
  • gas
  • headache
  • abdomen (stomach) pain
  • vomiting 
  • tiredness
  • decreased appetite
  • indigestion or heartburn

The most common side effects of RAVICTI in children 2 years to 17 years of age include:

  • upper abdomen (stomach) pain
  • rash
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache

The most common side effects of RAVICTI in children 2 months to less than 2 years of age include:

  • low white blood cell count (neutropenia)
  • vomiting
  • constipation
  • diarrhea
  • fever
  • reduced food intake
  • cough
  • stuffy nose 
  • runny nose
  • skin rash
  • small round bumps on the skin

The most common side effects of RAVICTI in children less than 2 months of age include:

  • vomiting
  • rash
  • gastroesophageal reflux
  • increased levels of liver enzymes in the blood
  • decreased appetite and reduced food intake
  • low red blood cell count (anemia)
  • cough
  • loss of too much body fluid (dehydration)
  • too much acid in the blood (acidosis)
  • high blood platelet count (thrombocytosis)
  • low blood platelet count (thrombocytopenia) 
  • low blood neutrophil count (type of white blood cell) (neutropenia)
  • high white blood cell count (lymphocytosis)
  • diarrhea
  • gas
  • constipation
  • fever
  • drowsiness (lethargy)
  • irritability 
  • agitation

These are not all of the possible   side effects of RAVICTI. Call your doctor for medical advice about  side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional Important Safety Information, please review the Medication Guide at RAVICTI.com and discuss with your doctor.

Read 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.

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-milliliter bottle of RAVICTI, a reclosable bottle cap adapter, and an oral syringe.

When dosing RAVICTI, be sure to use a new dry oral syringe. 

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 reclosable bottle cap 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 syringe into the reclosable bottle cap adapter. 

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

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

Withdraw the prescribed dose of RAVICTI with the dry oral syringe by pulling the plunger back.

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 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 syringe, put the cap on the oral syringe, and set it aside.

Close the tab on the reclosable bottle cap 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. 

For patients who have a nasogastric tube or gastrostomy tube in place, give RAVICTI as follows:

  • Use an oral syringe to withdraw the prescribed dosage of RAVICTI from the bottle.
  • Place the tip of the syringe into the tip of the gastrostomy/nasogastric tube.
  • Using the plunger of the syringe, push RAVICTI into the tube.
  • Flush once with 10 mL of water or formula and allow the flush to drain.
  • If needed, flush a second time with an additional 10 mL of water or formula to clear the tube.

You can use 1 oral syringe and 1 reclosable bottle cap adapter for all doses each day. 

You can also choose to use a new oral syringe with each dose. 

Do not rinse the reclosable bottle cap adapter or oral syringe between doses. 

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

Take the exact amount of RAVICTI Oral Liquid as instructed by your doctor.

Your doctor may change your dose if needed.

Take RAVICTI with food or formula.

In an infant who is breastfeeding, give RAVICTI just prior to breastfeeding.

Use a new reclosable bottle cap adapter with each new bottle of RAVICTI that is opened.

Use a new dry oral syringe to withdraw each prescribed dose of RAVICTI.

If you take too much RAVICTI, call your doctor or the Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away. 

Do not stop taking RAVICTI unless your doctor tells you to stop.

If you miss a dose of RAVICTI, take it as soon as possible.

Do not take 2 doses of RAVICTI at the same time.

If you miss more than 1 dose and are not feeling well, call your doctor or nurse right away.

If you still have questions about how to take RAVICTI with an oral syringe, please contact your doctor for more information.

1. 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. 

If RAVICTI is in contact with water, it will become cloudy in appearance. 

If the contents are in contact with water or cloudy, then do not use  the remaining RAVICTI and contact your prescribing doctor or pharmacy.

Discard bottle and any remaining contents 28 days after opening. 

Ask your pharmacist for oral syringes and a reclosable bottle cap adapter for each bottle you receive if you do not have them.

USE and IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RAVICTI?

RAVICTI may cause serious side effects, including: Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of RAVICTI, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking RAVICTI: 

  • sleepiness 
  • lightheadedness 
  • change in taste 
  • problems with hearing 
  • confusion 
  • problems with memory 
  • worsening of numbness, tingling, or burning in your hands or feet  
  • headache 
  • feeling very tired (fatigue) 
  • nausea 
  • vomiting 

Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.

What is RAVICTI? 

  • RAVICTI (glycerol phenylbutyrate) Oral Liquid 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 for the acute treatment of hyperammonemia in people with UCD.
  • It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.

Before taking RAVICTI, tell your doctor about all of your medical conditions, including if you:

  • have liver or kidney problems.
  • have pancreas or bowel (intestine) problems.
  • are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby. If you become pregnant during treatment with RAVICTI, call Horizon at 1‐866‐479‐6742 to report the pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. Breastfeeding is not recommended during treatment with RAVICTI. Talk to your doctor about the best way to feed your baby if you take RAVICTI.

What are possible side effects of RAVICTI?

RAVICTI may cause serious side effects, including:

  • See “What is the most important information I should know about RAVICTI?”

The most common side effects of RAVICTI in adults include:

  • diarrhea
  • gas
  • headache
  • abdomen (stomach) pain
  • vomiting 
  • tiredness
  • decreased appetite
  • indigestion or heartburn

The most common side effects of RAVICTI in children 2 years to 17 years of age include:

  • upper abdomen (stomach) pain
  • rash
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache

The most common side effects of RAVICTI in children 2 months to less than 2 years of age include:

  • low white blood cell count (neutropenia)
  • vomiting
  • constipation
  • diarrhea
  • fever
  • reduced food intake
  • cough
  • stuffy nose 
  • runny nose
  • skin rash
  • small round bumps on the skin

The most common side effects of RAVICTI in children less than 2 months of age include:

  • vomiting
  • rash
  • gastroesophageal reflux
  • increased levels of liver enzymes in the blood
  • decreased appetite and reduced food intake
  • low red blood cell count (anemia)
  • cough
  • loss of too much body fluid (dehydration)
  • too much acid in the blood (acidosis)
  • high blood platelet count (thrombocytosis)
  • low blood platelet count (thrombocytopenia) 
  • low blood neutrophil count (type of white blood cell) (neutropenia)
  • high white blood cell count (lymphocytosis)
  • diarrhea
  • gas
  • constipation
  • fever
  • drowsiness (lethargy)
  • irritability 
  • agitation

These are not all of the possible   side effects of RAVICTI. Call your doctor for medical advice about  side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional Important Safety Information, please review the Medication Guide at RAVICTI.com and discuss with your doctor.

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 Amgen 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

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 Amgen 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.