USE and IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about BUPHENYL?
BUPHENYL may cause serious side effects, including:
Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of BUPHENYL, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking BUPHENYL:
- sleepiness
- weakness
- lightheadedness
- problems with memory
- worsening of numbness, tingling, or burning in your hands or feet
- change in taste
- problems with hearing
- confusion
- headache
What is BUPHENYL?
- BUPHENYL® (sodium phenylbutyrate) Tablets is a prescription medicine that can be taken by mouth and BUPHENYL® (sodium phenylbutyrate) Powder is a prescription medicine that can be taken by mouth or feeding tube for the long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD).
- BUPHENYL only treats high blood levels of ammonia in patients with carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) and argininosuccinic acid synthetase (AS) deficiencies.
- BUPHENYL can be used in infants up to 28 days old who have a complete enzyme deficiency, and in patients 1 month of age and older who have a partial enzyme deficiency and have a history of brain damage from high blood levels of ammonia.
- BUPHENYL must be used along with a low-protein diet and in some cases, dietary supplements.
- BUPHENYL is not used to treat acute (severe) hyperammonemia, which is a medical emergency.
Do not take BUPHENYL if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you experience an allergic reaction while taking BUPHENYL.
Before taking BUPHENYL, tell your doctor about all of your medical conditions, including if you:
- have heart failure or decreased kidney function, which may lead to retention of the sodium content of BUPHENYL with potentially serious consequences, such as worsening heart failure, high blood pressure, and swelling.
- are pregnant or plan to become pregnant. It is not known if BUPHENYL will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if BUPHENYL passes into your breast milk. Breastfeeding is not recommended during treatment with BUPHENYL. Talk to your doctor about the best way to feed your baby if you take BUPHENYL.
What are possible side effects of BUPHENYL?
BUPHENYL may cause serious side effects, including:
- See “What is the most important information I should know about BUPHENYL?”
The most common side effects of BUPHENYL include:
- decreased appetite
- body odor
- bad taste
- absent or irregular periods in women
These are not all of the possible side effects of BUPHENYL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For additional Important Safety Information, click here for the Patient Package Insert and discuss with your doctor.