Pronunciation:

SOE-dee-um fen-il-BUE-ti-rate, taur-ur-so-DYE-ol

Brand Names:

• Relyvrio

Dosage Forms:

• Powder for Suspension

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Histone Deacetylase Inhibitor

Uses of This Medicine:

Sodium phenylbutyrate and taurursodiol combination is used to treat patients with amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig's disease

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sodium phenylbutyrate and taurursodiol combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sodium phenylbutyrate and taurursodiol combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abemaciclib
• Acalabrutinib
• Alfentanil
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Astemizole
• Axitinib
• Bosutinib
• Brigatinib
• Ceritinib
• Cholestyramine
• Cisapride
• Clindamycin
• Cobimetinib
• Colchicine
• Colesevelam
• Colestipol
• Conivaptan
• Crizotinib
• Cyclosporine
• Dasatinib
• Digoxin
• Dihydroergotamine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Docetaxel
• Dofetilide
• Dronedarone
• Entrectinib
• Ergotamine
• Everolimus
• Fentanyl
• Flibanserin
• Gemfibrozil
• Ivosidenib
• Levomethadyl
• Lomitapide
• Mexiletine
• Midostaurin
• Neratinib
• Nilotinib
• Olaparib
• Oxycodone
• Paclitaxel
• Pazopanib
• Pimavanserin
• Pimozide
• Pomalidomide
• Probenecid
• Quinidine
• Quinine
• Ribociclib
• Ruxolitinib
• Sirolimus
• Sonidegib
• Sunitinib
• Tacrolimus
• Tamoxifen
• Temsirolimus
• Theophylline
• Tizanidine
• Tolvaptan
• Warfarin
• Zanubrutinib

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel problems (eg, diarrhea, intestinal malabsorption) or
• Liver disease or
• Pancreas problems (eg, pancreatic insufficiency)—Use with caution. May increase risk for more serious side effects.

• Heart failure or
• Hypertension (high blood pressure) or
• Kidney disease—This medicine has a high salt content. Patients with these conditions should limit the amount of salt in their diet.

• Kidney disease, moderate to severe or
• Liver disease, moderate to severe—Use is not recommended in these patients.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine before a snack or meal.

To use:

• This medicine can be taken by the mouth or given through a feeding tube.
• Empty one packet of this medicine in a cup containing 8 ounces of room temperature water and stir well. Take the mixture within 1 hour after mixing.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (powder for suspension):
  • For amyotrophic lateral sclerosis (ALS):
    • Adults—At first, one packet per day for 3 weeks. After 3 weeks, your doctor may increase your dose to one packet 2 times a day. Each packet contains 3 grams (g) sodium phenylbutyrate and 1 g taurursodiol.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused liquid 1 hour after mixing.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are using this medicine to see if the medicine is working properly and to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

nausea

stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

chills

cough

ear congestion

fever

headache

loss of voice

sneezing

sore throat

stuffy or runny nose

trouble breathing

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.