Glycerol Phenylbutyrate, Oral

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KEY POINTS

• This medicine is taken by mouth to manage high levels of ammonia in people with urea cycle disorder. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: nitrogen-binding medicine

Generic and brand names: glycerol phenylbutyrate, oral; Ravicti

What is this medicine used for?

This medicine is taken by mouth to manage high levels of ammonia in people with urea cycle disorder. This medicine must be used along with a low protein diet and in some cases dietary supplements.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease
• Pancreas or intestinal problems

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider, along with any other medicine your healthcare provider may prescribe. Do not take more of this medicine than directed by your healthcare provider.

Check with your healthcare provider before using this medicine in children under age 2. Do not use this medicine in children under 2 months of age.

Shake the liquid well before using. Use the dosing syringe or medicine cup provided to put the medicine into your mouth. Take this medicine with food.

You will need to follow a low protein diet while taking this medicine. Follow your healthcare provider's directions exactly.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You need to have tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause drowsiness, dizziness, confusion, or trouble concentrating. Do not drive or operate machinery until you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; severe rash; trouble breathing; tightness in your chest; swelling of your lips; tongue; and throat).

Serious (Report these to your healthcare provider right away.): Wheezing; shortness of breath; cough; severe headache; dizziness or lightheadedness; flushing; drowsiness; nausea; vomiting; worsening numbness, tingling, or burning in your hands or feet; unusual tiredness or weakness; confusion; memory problems; trouble hearing; change in sense of taste; seizures.

Other: Diarrhea, heartburn, stomach pain, decreased appetite.

What products might interact with this medicine?

When you take this medicine with other medicines; it can change the way this or any of the other medicines work. Nonprescription medicines; vitamins; natural remedies; and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Haloperidol (Haldol)
• Probenecid
• Valproic acid (Depacon, Depakene, Depakote)

Do not drink alcohol while you are taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact; ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines; nonprescription medicines; supplements; natural remedies; and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat; high humidity; and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.