Pheburane® Coated Pellets:
Designed to mask the awful taste of sodium phenylbutyrate (NaPB)
FDA-approved safe, effective, and palatable option for the treatment of certain Urea Cycle Disorders (UCDs) used along with a specific diet.
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.
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).
- PALATABLE - Special coating designed to mask the awful taste of sodium phenylbutyrate (NaPB)
- PROVEN - FDA-approved Safe & Effective Treatment used along with a specific diet
- PELLETS - Very small coated oral pellets - no mixing or syringes needed!
- PRICE - Offered at a significant discount to other nearly tasteless/taste-masked treatments based on published pricing information.
Do you hate the taste of your sodium phenylbutyrate? Ask your doctor about PHEBURANE®
P=PALATABLE
P=PELLETS
What is Pheburane®? Pheburane® is an FDA-approved prescription medicine, used along with a specific diet, for the long-term management of adults and children with certain UCDs.
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 of acute hyperammonemia, which can be life-threatening and requires emergency medical treatment.
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).
The FIRST oral pellet treatment for certain UCDs with a special coating designed to mask the awful taste of NaPB.
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What are Urea Cycle Disorders?
Urea Cycle Disorders (UCDs) are rare inherited diseases that do not allow the body to remove waste properly when breaking down protein. Protein is found in a variety of foods such as meat, fish, dairy products, nuts, and even grains. The waste product will create ammonia which will build up in the blood and become toxic. High levels of ammonia in the blood can cause serious health problems. For the most severe UCDs, symptoms typically appear shortly after birth, and the baby can show symptoms such as sluggishness, not wanting to feed, vomiting, seizures and more. For less severe UCDs, symptoms may not appear for months or even years after birth, and symptoms can include avoiding high protein foods, vomiting, mental disturbances, and more.
How Pheburane® Helps
Urea Cycle Disorders are life-long diseases that can be managed with diet and prescription treatments. It is important that treatment occurs as soon as possible after diagnosis. It is very important that you or your child follow a low protein diet and take your prescribed medication as directed by your doctor to reduce ammonia levels in your body.
Pheburane® helps to eliminate waste product (nitrogen), and thereby may help reduce the amount of toxic ammonia in the body for certain UCDs.
While taking Pheburane®, it is still possible to experience an acute excess of ammonia in the blood. If this happens, you may develop symptoms such as feeling sick (nausea), being sick (vomiting), confusion, combativeness, slurred speech, difficulty walking, and even loss of consciousness. This is a medical emergency, and medical assistance should be sought immediately.
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How to Take Pheburane®
2 Ways Pheburane® can be taken with food consumption (meal or snack):
- swallowed with a beverage - e.g., water, fruit juices, protein-free infant formulas
- sprinkled on soft food - apple sauce or carrot puree* - immediately before eating.
It is important to swallow right away (within 10 seconds) to prevent the coating from starting to dissolve.
* Administration of Pheburane® oral pellets with other foods has not been studied and is not recommended. Additionally, administration with soft food is only recommended in patients old enough to consume soft foods.
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Suggested Tips When Taking Pheburane®
You can take your divided mealtime dose in one mouthful or little bit at a time until the whole dose has been taken.
Be sure to always pour Pheburane® into the tube portion of the dosing spoon.
HOW TO GET PHEBURANE®P=PRICE
Expanded Commercial & Medicaid Coverage!
Better coverage & 50-70% less expensive than other nearly tasteless/taste-masked UCD treatments (based on published pricing information).
Medunik USA offers Pheburane® through its UNIK Support Program - designed to support each unique patient. Unik Support (pronounced yoo·neek) offers a Savings Program as well as additional specialized support services.
By enrolling in the UNIK Patient Support Program, you will gain access to a variety of specialized support programs to help you or your child, including:
- Clinical Coordinator Outreach
- Offering personalized guidance on Urea Cycle Disorders, How to Take Pheburane®, and more!
- Copay Program
- Mail Order Pharmacy Services
Enroll in the Patient Support Program:
Important Safety Information
What is Pheburane®Important Safety Information
What is Pheburane®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.