RAVICTI- glycerol phenylbutyrate liquid 
Hyperion Therapeutics, Inc.

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MEDICATION GUIDE
RAVICTI (rah-VIK- tee)
(glycerol phenylbutyrate)
oral liquid

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

RAVICTI may cause serious side effects, including:

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

What is RAVICTI?

RAVICTI is a prescription medicine used in adults and children 2 years of age and older for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called 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 treatment of hyperammonemia in people with UCD.

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

It is not known if RAVICTI is safe and effective in children 2 months to less than 2 years of age.

Who should not take RAVICTI?

What should I tell my doctor before taking RAVICTI?

Before you take RAVICTI, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take RAVICTI?

For people who have a nasogastric or gastric tube in place, RAVICTI should be given as follows:

What are the possible side effects of RAVICTI?

RAVICTI may cause serious side effects, including:

The most common side effect of RAVICTI in children include:

Tell your doctor if you have any side effect that bothers you or that does not go away. 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.

How should I store RAVICTI?

Keep RAVICTI and all medicines out of the reach of children.

General information about the safe and effective use of RAVICTI

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RAVICTI for a condition for which it was not prescribed. Do not give RAVICTI to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about RAVICTI that is written for health professionals.

For more information call 1-855-823-7878 or go to www.RAVICTI.com.

What are the ingredients in RAVICTI?

Active ingredient: glycerol phenylbutyrate

This Medication Guide has been approved by the U.S. Food and Drug
Administration.

Manufactured by:
Lyne Laboratories, Inc.
Brockton, MA 02301

Manufactured for:
Hyperion Therapeutics Inc.
601 Gateway Boulevard, Suite 200
South San Francisco, CA 94080

Issued: February 2013

© Hyperion Therapeutics, Inc.
All rights reserved.

RAVICTI is a trademark of Hyperion Therapeutics, Inc.

Revised: 02/2013
 
Hyperion Therapeutics, Inc.