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Overview: Ravicti is used to manage urea cycle disorders (UCDs), which are genetic conditions where the body is unable to properly remove the waste products from protein digestion. It works by removing excess ammonia (a product of protein digestion) from the body. Common side effects include diarrhea, gas, and headache. Serious side effects include neurological problems.

Uses

What is Ravicti used for?

Ravicti (glycerol phenylbutyrate) is commonly used to manage urea cycle disorders (UCDs), which are genetic conditions where the body is unable to properly remove the waste products from protein digestion.

Ravicti may also be used for other conditions as determined by your health care provider.

How does Ravicti work (mechanism of action)?

People with urea cycle disorders are unable to properly process nitrogen (a product of normal protein digestion), which can lead to toxic buildup of ammonia in your blood. Ravicti binds to excess ammonia in the body and helps remove it from the body.

How is Ravicti supplied (dosage forms)?

Brands and other names

  • Ravicti

Dosage forms and strengths

  • 1.1 grams per milliliter (mL) oral liquid

How should I store Ravicti?

Ravicti should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Throw away the bottle 28 days after opening it. If water or moisture gets into the bottle, the contents will turn cloudy. If this happens, stop using that bottle of Ravicti, and return it to the pharmacy.

Side Effects

What are the most common side effects of Ravicti?

The most common side effects of Ravicti are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea
  • Gas
  • Headache

There may be other side effects of Ravicti that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ravicti?

While less common, the most serious side effects of Ravicti are described below, along with what to do if they happen.

Severe Allergic Reactions. Ravicti may cause allergic reactions, which can be serious. Stop taking Ravicti and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Brain or Central Nervous System (CNS) Effects. Ravicti can affect your brain or central nervous system (CNS), especially at high doses. Talk to your health care provider if you have any of the following neurological symptoms.

  • Sleepiness
  • Tiredness
  • Lightheadedness
  • Headache
  • Changes in how things taste
  • Hearing loss
  • Disorientation
  • Memory problems
  • Worsening of existing nerve problems, such as nerve pain

Warnings & Precautions

Who should not use Ravicti?

Allergies to Ingredients. People who are allergic to any of the following should not take Ravicti.

  • Phenylbutyrate
  • Ravicti
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ravicti.

What should I know about Ravicti before using it?

Do not take Ravicti unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Ravicti with other people, even if they have the same condition as you. It may harm them.

Keep Ravicti out of the reach of children.

Use the provided oral syringe to administer Ravicti directly into the mouth. Throw away the used syringe after each dose, and use a new syringe with each dose.

Do not rinse the reclosable bottle cap adapter.

Your health care provider may regularly check your ammonia levels during treatment to make sure Ravicti is safe for you to take. Keep all the appointments you make with your health care provider.

What should I tell my health care provider before using Ravicti?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ravicti is right for you.

In particular, make sure that you discuss any of the following.

Other Medicines and Supplements. Ravicti may interact with other medicines and supplements. Before taking Ravicti, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Nerve problems (neuropathy)
  • Pancreatic problems
  • Intestinal problems
  • Liver problems
  • Kidney problems

Pregnancy. It is not known if or how Ravicti could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking Ravicti, you can report the exposure to the drugmaker by calling 1-866-479-6742.

Breastfeeding. It is not known if Ravicti passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Ravicti.

How can I get more information about Ravicti?

For more information about Ravicti, you can visit the drugmaker’s website at www.ravicti.com or call them at 855-823-7878.

Interactions

Does Ravicti interact with foods or drinks?

Ravicti should be taken with food or formula. For children who are breastfed, Ravicti should be given just before breastfeeding.

It is unknown if drinking alcohol will affect Ravicti.

Does Ravicti interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Ravicti.

  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • Divalproex sodium, valproate sodium (Depakote and others), and valproic acid, which are medicines used for seizures and other conditions
  • Haloperidol, which is an antipsychotic medicine for certain mental health conditions
  • Probenecid, which is a medicine commonly used for gout
  • Midazolam, which is benzodiazepine medicine used to treat seizures or induce anesthesia
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
  • Quinidine, which is a medicine used to treat malaria or control your heart rate or rhythm

Ravicti may alter the blood levels of many other medicines. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ravicti. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ravicti?

If you or someone else has used too much Ravicti, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ravicti?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.