Sodium Phenylbutyrate Oral Granules

What is this medication?

SODIUM PHENYLBUTYRATE (SOE dee um fen il BUE ti rate) treats urea cycle disorders (UCDs). It works by helping your body decrease the amount of ammonia in your blood. This lowers the risk of serious health problems. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Pheburane

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Diet low in salt
• Heart failure
• Kidney disease
• Low levels of potassium in the blood
• Liver disease
• Swelling of the ankles, feet, hands
• An unusual or allergic reaction to sodium phenylbutyrate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Use a specially marked spoon to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Swallow with water, fruit juice, protein-free infant formula, or sprinkle the dose in 1 teaspoon of soft food, like applesauce. Swallow the medication right away. Do not chew the medication or applesauce. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

This medication is used in combination with a low protein diet. Some patients may also need to take dietary supplements.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Haloperidol
• Probenecid
• Steroid medications like prednisone or cortisone
• Valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
• Swelling of the ankles, hands, or feet

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Body odor
• Change in taste
• Irregular menstrual cycles or spotting
• Loss of appetite

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication 45 days after opening.

It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.