Sodium Phenylbutyrate Granules for Suspension

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): OLPRUVA

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

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

• 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. Take it with food. Each dosing envelope contains 1 dose and contains a packet of Mix-Aid and packet(s) with medication. Dissolve the contents of the Mix-Aid packet into approximately 120 mL (4 ounces) of water in a cup and stir for at least 30 seconds. Then pour the medication (1 or 2 packets) into the cup and stir for at least 15 seconds. Drink within 5 minutes of mixing. Add another 120 mL of water to the cup and drink it right away. Get rid of any mixture that is not taken within 30 minutes. 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 these 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). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• 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, pour 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.