Details for: CEREBYX

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CEREBYX. Talk about any health conditions or problems you may have, including if you:

• Have ever had a rash or unusual reaction while taking fosphenytoin sodium or any other antiepileptic drug
• Have kidney or liver problems. Your healthcare professional may need to adjust the dose
• Drink alcohol. Drinking alcohol with CEREBYX may make you less alert and may make feelings of anger, confusion or sadness worse
• Suffer from seizures that spread to the whole brain
• Are pregnant or planning to become pregnant You must only take CEREBYX during pregnancy if your healthcare professional tells you to
• If you become pregnant while taking CEREBYX, talk to your healthcare professional about registering with the North American Antiepileptic Drug (NAAED) Pregnancy RegistryThe purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy You can enroll in this registry by calling 1-888-233-2334 Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/
• Are nursing or plan to nurse your baby Nursing while you are taking CEREBYX is not recommended
• Are taking birth control
• CEREBYX may make hormonal birth control such as “the pill” less effective
• Use other forms of safe and effective birth control when taking CEREBYX
• You need to use other forms of birth control until the end of your menstrual cycle after stopping treatment
• Have low blood pressure
• Have heart problems
• Are diabetic
• Are of Asian or African descent. You may be at a higher risk of developing serious skin reactions
• Have a blood disorder (such as; porphyria)
• Have a family history of hypersensitivity to CEREBRYX, phenytoin or other hydantoins
• Are being treated with irradiation and corticosteroids
• Have low bone density.

Other warnings you should know about:

• Ask your healthcare professional about signs and symptoms of life threatening skin reactions such as Stevens Johnson Syndrome (SJS; a skin reaction with rash and blisters) and Toxic Epidermal Necrolysis (TEN; a skin rash often with blisters, lesions and lifting skin) that have been reported during CEREBRYX treatment. Closely monitor for skin reactions. Most often, SJS or TEN happen in the first weeks of treatment. If symptoms or signs of SJS or TEN are present, CEREBYX treatment should be stopped. The best results in managing SJS and TEN come from early detection and stopping the drug treatment right away (see table of Serious Side Effects and What to do About Them, below).
• Anti-epileptic drugs, including CEREBRYX, should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus.

DURING treatment with CEREBRYX, tell your healthcare professional if you develop:

• Thoughts of suicide or self harm
• Abnormal vision (blurry or double vision)

Driving and using machines:

Before doing tasks that require special attention, wait until you know how you respond to CEREBYX. Being dizzy or drowsy can occur. Be careful to avoid accidental injury or falls.

There are many drugs that may increase or decrease CEREBYX levels. Also, CEREBYX may affect the levels of many drugs. Therefore, tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines as there may be a need to adjust your medication or monitor you more carefully.