Important Safety Information

What is Pheburane®?

  • Pheburane® is a prescription medicine, used along with a specific diet, for the long-term management of adults and children with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinate synthetase (AS).
  • Episodes of sudden, rapid increase of ammonia in the blood (acute hyperammonemia) may happen in people during treatment with Pheburane®. Pheburane® is not used for the treatment of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment.

Before taking Pheburane®, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have kidney or liver problems.
  • have diabetes (Pheburane® contains sucrose), or have a history of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency.
  • are pregnant or plan to become pregnant. It is not known if Pheburane® will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Pheburane® passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby during treatment with Pheburane®.

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 Pheburane®. 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.

What are the possible side effects of Pheburane®?

Pheburane® can cause serious side effects, including: Nervous system problems (neurotoxicity).

 

Call your healthcare provider right away if you get any of the following symptoms during treatment with Pheburane®:

  • sleepiness
  • tiredness
  • lightheadedness
  • vomiting
  • nausea
  • headache
  • confusion

Low potassium levels in your blood (hypokalemia). Your healthcare provider will monitor your blood potassium levels during treatment with PHEBURANE and treat if needed.

Conditions related to swelling (edema). Pheburane® contains salt (sodium), which can cause swelling from salt and water retention. Your healthcare provider will decide if PHEBURANE is right for you if you have certain medical conditions that can cause swelling, such as heart failure, liver problems or kidney problems.

The most common side effects of Pheburane® include:

  • absent or irregular menstrual periods
  • decreased appetite
  • body odor
  • 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 Pheburane®.

 

These are not all the possible side effects of Pheburane®.

 

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.

 

Please read the Full Prescribing Information., the Patient Information. and the Instruction for Use. before taking Pheburane® oral pellets and each time you get a refill.

Important Safety Information

What is Pheburane®
Pheburane® is a prescription medicine, used along with a specific diet, for the long-term management of adults and children with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinate synthetase (AS).
Episodes of sudden, rapid increase of ammonia in the blood (acute hyperammonemia) may happen in people during treatment with Pheburane®. Pheburane® is not used for the treatment of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment. Read more

Important Safety Information

What is Pheburane®
Pheburane® is a prescription medicine, used along with a specific diet, for the long-term management of adults and children with urea cycle disorders (UCDs).
Pheburane® is not used for the treatment of acute hyperammonemia. Read more

Important Safety Information

What is Pheburane®?

  • Pheburane® is a prescription medicine, used along with a specific diet, for the long-term management of adults and children with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinate synthetase (AS).
  • Episodes of sudden, rapid increase of ammonia in the blood (acute hyperammonemia) may happen in people during treatment with Pheburane®. Pheburane® is not used for the treatment of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment.

Beforetaking Pheburane®, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems.
  • have kidney or liver problems.
  • have diabetes (Pheburane® contains sucrose), or have a history of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency.
  • are pregnant or plan to become pregnant. It is not known if Pheburane® will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Pheburane® passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby during treatment with Pheburane®.

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 Pheburane®. 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.

What are the possible side effects of Pheburane®?

Pheburane® can cause serious side effects, including: Nervous system problems (neurotoxicity).

 

Call your healthcare provider right away if you get any of the following symptoms during treatment with Pheburane®:

  • sleepiness
  • tiredness
  • lightheadedness
  • vomiting
  • nausea
  • headache
  • confusion

Low potassium levels in your blood (hypokalemia). Your healthcare provider will monitor your blood potassium levels during treatment with PHEBURANE and treat if needed.

Conditions related to swelling (edema).Pheburane® contains salt (sodium), which can cause swelling from salt and water retention. Your healthcare provider will decide if PHEBURANE is right for you if you have certain medical conditions that can cause swelling, such as heart failure, liver problems or kidney problems.

The most common side effects of Pheburane® include:

  • absent or irregular menstrual periods
  • decreased appetite
  • body odor
  • 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 Pheburane®.

 

These are not all the possible side effects of Pheburane®.

 

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.

 

Please read the Full Prescribing Information, the Patient Information. and the Instruction for Use. before taking Pheburane® oral pellets and each time you get a refill.