FDA APPROVED

FOR THE TREATMENT OF

UREA CYCLE DISORDERS

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Why Olpruva

Convenient single-dose envelopes provide people with UCDs

Ammonia control

on the go

Welcome to OLPRUVA™ (sodium phenylbutyrate) for oral suspension!
OLPRUVA is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic synthetase (AS).

OLPRUVA is not for the treatment of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment.

Each single-dose envelope contains the premeasured OLPRUVA packet(s) and Mix-Aid packet needed to mix 1 dose.

The unique formulation of OLPRUVA is designed with you or your loved one in mind

The unique formulation of OLPRUVA is designed with you or your loved one in mind

OLPRUVA provides the effectiveness of sodium phenylbutyrate powder with a unique formulation in single-dose envelopes for ammonia control on the go

OLPRUVA is:

  • Palatable—Dual-coating* formulation designed for palatability
  • Premeasured—Convenient individual dose packets support dosing accuracy
  • Portable—Discreet single-dose envelopes are easily carried when you or your loved one is on the go

*The active ingredient of OLPRUVA is covered by a seal coating and an outer polymer coating.

Call your healthcare provider right away if you or your child gets any of these nervous system problems (neurotoxicity) during treatment with OLPRUVA: sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, or confusion.

OLPRUVA is supplied as convenient, premeasured doses contained in easily carried envelopes

  • Each dose is based on the patient’s weight and body surface area (no dose measuring needed)
  • No syringes necessary
  • Do not administer via gastrostomy or nasogastric tubes

After OLPRUVA is prepared with water, drink the suspension within a 5-minute window to help prevent the coating from dissolving.

Learn more about taking or
giving OLPRUVA >

The active ingredient of OLPRUVA is sodium phenylbutyrate. Sodium phenylbutyrate powder was approved for treating UCDs in 1996 and has been foundational treatment for UCDs for over 20 years

Like other UCD medications, OLPRUVA helps the body get rid of excess nitrogen to help avoid dangerous buildup of ammonia

The US Food and Drug Administration (FDA) approved OLPRUVA:

  • Because it provides an equivalent amount of medicine in the body as sodium phenylbutyrate powder
  • Based on FDA evaluation of the safety and effectiveness of sodium phenylbutyrate powder

If you or a loved one is experiencing symptoms or needs help managing a UCD, talk to your doctor as soon as possible.

Find out if OLPRUVA is right for you or your loved one. Download the Doctor Discussion Guide to get the conversation started.

Get the Doctor Discussion Guide

If you or a loved one is experiencing symptoms or needs help managing a UCD, talk to your doctor as soon as possible.

Find out if OLPRUVA is right for you or your loved one. Download the Doctor Discussion Guide to get the conversation started.

Get the Doctor Discussion Guide

Summary of Important Safety Information for OLPRUVA
OLPRUVA [ol proo vah] (sodium phenylbutyrate) for oral suspension

This summary does not include all information about OLPRUVA and is not meant to take the place of discussions with your healthcare provider about your or your child’s treatment. Please read this important information carefully and discuss any questions about OLPRUVA with your healthcare provider.

What is OLPRUVA?

  • OLPRUVA is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).
  • Episodes of rapid increase of ammonia in the blood (acute hyperammonemia) may happen in people during treatment with OLPRUVA. OLPRUVA is not for the treatment of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment.
  • OLPRUVA is not approved in children weighing less than 44 pounds (20 kg) or in children weighing 44 pounds (20 kg) or greater with a BSA of less than 1.2 m2.

Before taking OLPRUVA, tell your or your child’s healthcare provider about all your medical conditions, including if you:

  • have heart problems
  • have kidney or liver problems
  • are pregnant or plan to become pregnant. It is not known if OLPRUVA will harm your unborn baby. If you become pregnant during treatment with OLPRUVA, call Acer Therapeutics Inc. at 1-833-657-7882 to report the pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if OLPRUVA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take OLPRUVA.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Especially tell your healthcare provider if you or your child take:

  • corticosteroids
  • valproic acid
  • haloperidol
  • probenecid

Know the medicines you take. Keep a list of them to show your or your child’s healthcare provider and pharmacist when you get a new medicine. Keep OLPRUVA and all medicines out of the reach of children.

How should I or my child take OLPRUVA?

Read the detailed Instructions for Use that comes with OLPRUVA for information about the right way to prepare and take a dose of OLPRUVA.

  • Take OLPRUVA exactly as prescribed by your healthcare provider.
  • Your healthcare provider may change your dose if needed. Do not change your dose unless your healthcare provider tells you to.
  • Your healthcare provider will prescribe OLPRUVA based on your or your child’s weight.
  • Take your OLPRUVA dose with food.
  • If you miss a dose of OLPRUVA, take it as soon as possible that same day.
  • Do not give or take OLPRUVA through a gastrostomy or nasogastric tube.
  • If you take too much OLPRUVA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of OLPRUVA?

OLPRUVA can cause serious side effects, including:

  • Nervous system problems (neurotoxicity). Call your healthcare provider right away if you or your child get any of the following symptoms during treatment with OLPRUVA:
    • sleepiness
    • nausea
    • tiredness
    • headache
    • lightheadedness
    • confusion
    • vomiting
  • Low potassium levels in your blood (hypokalemia). Your healthcare provider will monitor your blood potassium levels during treatment with OLPRUVA and treat if needed.
  • Conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Your healthcare provider will decide if OLPRUVA is right for you if you have certain medical conditions that cause edema, such as heart failure, liver problems or kidney problems.

The most common side effects of OLPRUVA include:

  • absent or irregular menstrual periods
  • body odor
  • decreased appetite
  • bad taste or avoiding foods that you ate prior to getting sick (taste aversion)

Your healthcare provider may do certain blood tests to check you or your child for side effects during treatment with OLPRUVA.

These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

For additional Important Safety Information see full Prescribing Information and Patient Information, including Instructions for Use, and discuss with your doctor.

Summary of Important Safety Information for OLPRUVA
OLPRUVA [ol proo vah] (sodium phenylbutyrate) for oral suspension

This summary does not include all information about OLPRUVA and is not meant to take the place of discussions with your healthcare provider about your or your child’s treatment. Please read this important information carefully and discuss any questions about OLPRUVA with your healthcare provider.

What is OLPRUVA?

  • OLPRUVA is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).
  • Episodes of rapid increase of ammonia in the blood (acute hyperammonemia) may happen in people during treatment with OLPRUVA. OLPRUVA is not for the treatment of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment.
  • OLPRUVA is not approved in children weighing less than 44 pounds (20 kg) or in children weighing 44 pounds (20 kg) or greater with a BSA of less than 1.2 m2.

Before taking OLPRUVA, tell your or your child’s healthcare provider about all your medical conditions, including if you:

  • have heart problems
  • have kidney or liver problems
  • are pregnant or plan to become pregnant. It is not known if OLPRUVA will harm your unborn baby. If you become pregnant during treatment with OLPRUVA, call Acer Therapeutics Inc. at 1-833-657-7882 to report the pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if OLPRUVA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take OLPRUVA.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Especially tell your healthcare provider if you or your child take:

  • corticosteroids
  • valproic acid
  • haloperidol
  • probenecid

Know the medicines you take. Keep a list of them to show your or your child’s healthcare provider and pharmacist when you get a new medicine. Keep OLPRUVA and all medicines out of the reach of children.

How should I or my child take OLPRUVA?

Read the detailed Instructions for Use that comes with OLPRUVA for information about the right way to prepare and take a dose of OLPRUVA.

  • Take OLPRUVA exactly as prescribed by your healthcare provider.
  • Your healthcare provider may change your dose if needed. Do not change your dose unless your healthcare provider tells you to.
  • Your healthcare provider will prescribe OLPRUVA based on your or your child’s weight.
  • Take your OLPRUVA dose with food.
  • If you miss a dose of OLPRUVA, take it as soon as possible that same day.
  • Do not give or take OLPRUVA through a gastrostomy or nasogastric tube.
  • If you take too much OLPRUVA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of OLPRUVA?

OLPRUVA can cause serious side effects, including:

  • Nervous system problems (neurotoxicity). Call your healthcare provider right away if you or your child get any of the following symptoms during treatment with OLPRUVA:
    • sleepiness
    • nausea
    • tiredness
    • headache
    • lightheadedness
    • confusion
    • vomiting
  • Low potassium levels in your blood (hypokalemia). Your healthcare provider will monitor your blood potassium levels during treatment with OLPRUVA and treat if needed.
  • Conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Your healthcare provider will decide if OLPRUVA is right for you if you have certain medical conditions that cause edema, such as heart failure, liver problems or kidney problems.

The most common side effects of OLPRUVA include:

  • absent or irregular menstrual periods
  • body odor
  • decreased appetite
  • bad taste or avoiding foods that you ate prior to getting sick (taste aversion)

Your healthcare provider may do certain blood tests to check you or your child for side effects during treatment with OLPRUVA.

These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

For additional Important Safety Information see full Prescribing Information and Patient Information, including Instructions for Use, and discuss with your doctor.

Sources

  1. OLPRUVA™ (sodium phenylbutyrate) for oral suspension. Prescribing information. Newton, MA: Acer Therapeutics Inc.
  2. Appel LE, Shockey JR, Schelling DC, inventors; Acer Therapeutics Inc, assignee. Palatable compositions including sodium phenylbutyrate and uses thereof. US patent 11,154,521 (B2). October 26, 2021.
  3. Keating AV, Soto J, Tuleu C, Forbes C, Zhao M, Craig DQM. Solid state characterisation and taste masking efficiency evaluation of polymer based extrudates of isoniazid for paediatric administration. Int J Pharm. 2018;536(2):536-546.
  4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Determining Whether to Submit an ANDA or a 505(b)(2) Application: Guidance for Industry. Food and Drug Administration; May 2019. Accessed April 25, 2022. https://www.fda.gov/media/124848/download
  5. Osaka S, Nakano S, Mizuno T, et al. A randomized trial to examine the impact of food on pharmacokinetics of 4-phenylbutyrate and change in amino acid availability after a single oral administration of sodium 4-phenylbutyrarte in healthy volunteers. Mol Genet Metab. 2021;132(4):220-226.
  6. Cederbaum SD, Edwards J, Kellmeyer T, Peters Y, Steiner RD. Taste-masked formulation of sodium phenylbutyrate (ACER-001) for the treatment of urea cycle disorders. Mol Genet Metab. 2023;138(4):107558.