Relyvrio

This medication is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). It helps slow down loss of physical function due to this disease. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness.

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth or through a feeding tube before a meal as directed by your doctor, usually once a day for the first 3 weeks, then twice a day from then on. This medication must be mixed before taking. Open 1 sachet and mix all of the contents in a cup (8 ounces or 250 milliliters) of room temperature water. Stir well, and take the mixture within 1 hour after mixing. This medication has a bitter aftertaste. To reduce bitterness, you may use mint-flavored mouth strips or mouth spray just before or after taking this medication, or you may eat a snack or meal or honey, or drink milk after taking it. Avoid drinking fruit juice at the same time when you take this medication.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

If you are also taking an antacid that contains aluminum, take it at least 2 hours before or 2 hours after taking this medication. (See also Drug Interactions section.) Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Nausea, diarrhea or constipation, decreased appetite, change in how food tastes, stomach/abdominal pain, gas, dizziness, drowsiness, tiredness, or abnormal skin odor may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including fast/slow/irregular heartbeat, mental/mood changes (such as depression, thoughts of suicide).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to sodium phenylbutyrate or ursodoxicoltaurine; or to bile salts; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of heart problems (such as congestive heart failure), kidney problems, liver problems, swelling (edema), digestive problems, problems with your pancreas, a certain inherited condition (glucose-galactose malabsorption).

This medication contains salt (sodium). Before taking this medication, tell your doctor or pharmacist if you are on a low-salt diet.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. This medication may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 30 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are aluminum-containing antacids, bile acid-binding resins (such as cholestyramine, colestipol, colesevelam).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not take more or double the dose to catch up.

Do not share this medication with others.

Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments.