Support and Resources – OLPRUVA® OLPRUVA® Support and Resources

FDA APPROVED

FOR THE TREATMENT OF

CERTAIN UREA CYCLE DISORDERS

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Support and Resources

Support and resources from the start And all the way through treatment with OLPRUVA® (sodium phenylbutyrate) for oral suspension

OLPRUVA Doctor Discussion Guide

This discussion guide is designed to help you start the conversation with your doctor about OLPRUVA.

Download

OLPRUVA Patient Guide

This guide features important information to help you understand your OLPRUVA. The brochure is supplied in each OLPRUVA Starter Kit (see below), but you can also download a PDF version here.

Download

OLPRUVA Starter Kit

This comprehensive kit contains important materials to help you or your loved one get started on OLPRUVA treatment. You will receive the kit with your first shipment of OLPRUVA.

Included in the first OLPRUVA shipment

We hope you find these resources useful

FAQs

What is the polymer coating designed to do?

The polymer coating is designed for palatability. Each OLPRUVA dose should be taken within a 5-minute window after it is prepared to help prevent the coating from dissolving. 

To start the conversation with your doctor and find out if OLPRUVA is right for you or your loved one, download the Doctor Discussion Guide.

Should I or my loved one be taking OLPRUVA?

Your doctor will decide if OLPRUVA is right for you or your loved one, considering factors including your or your loved one’s condition, weight, and body surface area.

Before taking OLPRUVA, tell your or your child’s healthcare provider about all of 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 you doctor 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 takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Will my insurance cover OLPRUVA?

Once the OLPRUVA Prescription Enrollment Form is submitted, the specialty pharmacy will work with your insurance company to determine coverage. If you do not have insurance coverage for OLPRUVA, your OLPRUVA Navigator Team will help determine if other financial assistance or support options are available.

What support is available during OLPRUVA treatment?

The OLPRUVA Navigator Team offers personalized education and support, including financial support and assistance for eligible patients. The OLPRUVA Navigator Team does not offer medical advice or replace discussions with a healthcare provider. You can access the OLPRUVA Navigator Team Monday – Friday, 8 AM – 6 PM Central Time, at 1-888-668-4198.

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 m.2.

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 your doctor 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 m.2.

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 your doctor 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.