Ravicti (glycerol phenylbutyrate) is a medication used to treat people with urea cycle disorders (UCDs). It's usually added onto a low-protein diet. This medication is available as a liquid taken by mouth at least 3 times per day.
Ravicti (glycerol phenylbutyrate) is a urea cycle disorder agent. It removes ammonia (a toxic waste product) from your body. The medication attaches to it and changes it to a chemical that's removed from your body through your urine.
| Common Brands | Ravicti |
|---|---|
| Drug Class | Urea cycle disorder agent |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
Ravicti (glycerol phenylbutyrate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Ravicti (glycerol phenylbutyrate) can cause nervous system side effects, such as sleepiness, fatigue, lightheadedness, and headache. Other related side effects can include a numbing or tingling sensation, changes in taste, partial hearing loss, and confusion. In clinical studies, these side effects were typically reversible and may have been due to high blood levels of Ravicti (glycerol phenylbutyrate). Contact your provider if you have any of these symptoms. Your provider will likely measure your ammonia level to see if your symptoms are due to Ravicti (glycerol phenylbutyrate), high ammonia levels, or some other cause. If they're due to Ravicti (glycerol phenylbutyrate), you might need to take a lower dose of the medication.
Ravicti (glycerol phenylbutyrate) might not work as well in people with pancreas or intestine problems, because the medication might not get fully absorbed into your body. Certain proteins in your pancreas help your body absorb Ravicti (glycerol phenylbutyrate) from your intestines, but pancreas and intestine problems can interfere with this process. Make sure to tell your provider about all of your medical conditions before starting Ravicti (glycerol phenylbutyrate).
Bottle of liquid| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 25ml of 1.1g/ml | 7 bottles | $29,846.50 | $4,263.79 |
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ravicti (glycerol phenylbutyrate) will not be safe for you to take.
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The urea cycle is a process in your body where certain enzymes (proteins) help change ammonia (a toxic waste product) into urea. Urea is then filtered out of your blood by your kidneys and removed from your body when you urinate. Urea cycle disorders (UCDs) are a group of genetic problems where your body is missing some of the enzymes required to change ammonia to urea. This causes high levels of ammonia in your blood (hyperammonemia). Symptoms of hyperammonemia can include confusion, headache, dizziness, and vomiting, but can even cause serious problems like seizures and coma. Ravicti helps keep ammonia levels low by changing ammonia into a chemical that can be removed through your urine.
Even though Ravicti helps get rid of ammonia from your body, it's important to continue to limit your protein intake while taking this medication. This helps the medication work as best as it can to keep your blood ammonia levels low. Your body breaks down protein from foods and beverages into ammonia. But with a UCD, your body can't get rid of this ammonia. Eating or drinking too much protein while taking Ravicti might counteract what the medication is trying to do.
No, don't take more Ravicti than what's prescribed to you. If you're experiencing symptoms of high blood ammonia levels (hyperammonemia) like confusion, dizziness, headache, vomiting, or tiredness, get medical help right away. Ravicti isn't used to treat short-term hyperammonemia, so you'll need to go to the hospital to receive appropriate treatment.
Both Ravicti and sodium phenylbutyrate (Buphenyl) contain the same active ingredient (phenylbutyrate) and work well to treat UCDs, but there are several differences between the medications. Sodium phenylbutyrate (Buphenyl) is available as a tablet or powder and tends to have a strong odor and salty taste. On the other hand, Ravicti is an odorless, nearly tasteless liquid. Additionally, with sodium phenylbutyrate (Buphenyl), you might need to take up to 40 tablets per day, whereas with Ravicti, you might only need to take up to 17.5 mL (or 3.5 teaspoons) per day. Talk to your provider to see which medication is right for you.
Ravicti hasn't been well studied in human pregnancy, so it's not known whether this medication is safe or works well in pregnant females. However, some animal studies have suggested that Ravicti could harm babies and sometimes mothers during pregnancy at doses higher than what's typically used for humans. If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of taking Ravicti during pregnancy. If you're pregnant and are prescribed Ravicti, let your provider know. It's recommended to report the pregnancy to the manufacturer (Horizon Therapeutics) by calling 1-866-479-6742.
