Relyvrio

About Relyvrio 

• Relyvrio received approval from the US FDA administration on September 29, 2022. 
• Relyvrio belongs to the class called miscellaneous central nervous system agents. 
• Relyvrio (sodium phenylbutyrate and taurursodiol) is a prescription medication used to treat adults with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. 
• ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. It causes muscle weakness and atrophy, which eventually leads to death.
• Relyvrio is a combination of two drugs called sodium phenylbutyrate and taurursodiol. 
• Sodium phenylbutyrate is a histone deacetylase (HDAC) inhibitor. HDACs are enzymes that repress gene expression. By inhibiting HDACs, sodium phenylbutyrate can promote the expression of genes that are important for nerve cell survival and function.
• Taurursodiol is a bile acid that has been shown to protect nerve cells from damage. It is thought to do this by reducing inflammation and oxidative stress.
• Relyvrio is taken orally, once a day. It is available in capsule form.
• In a clinical trial of adults with ALS, Relyvrio was shown to slow the progression of disability by 28%. This means that people who took Relyvrio were able to maintain their ability to walk, talk, and perform other daily activities for a longer period of time.

Strength

Oral suspension: 3 g Sodium Phenylbutyrate and 1 g Taurursodiol in single dose packets

Recommended Dosage

Mix the contents of one packet of RELYVRIO oral suspension in 8 ounces of room temperature water, stirring vigorously. Take the reconstituted suspension orally or administer it through a feeding tube within 1 hour of preparation. You can store the reconstituted suspension for up to 1 hour at room temperature. Administer RELYVRIO before a snack or meal. The initial recommended dosage is 1 packet daily (3 g sodium phenylbutyrate and 1 g taurursodiol) for the first 3 weeks, followed by an increase to the maintenance dosage of 1 packet twice daily after this initial period.

• The suggested starting dose for RELYVRIO oral suspension is one packet (containing 3 g sodium phenylbutyrate and 1 g taurursodiol) per day during the initial 3 weeks. 
• Following this period, the maintenance dosage should be elevated to one packet twice daily.

Important

To consume an oral suspension, shake it well before measuring the accurate dose with the provided dosing cup or oral syringe. Rinse your mouth if recommended. Follow dietary restrictions and complete the entire prescribed course, and consult your healthcare provider or pharmacist for any questions or concerns about administration.

Consult your healthcare provider for advice on alcohol use and driving while taking Relyvrio. Follow their guidance, as alcohol can interact with medications. Inform your provider about alcohol intake and other medications for personalized recommendations based on your health. Exercise caution in activities like driving until you understand the effects of the medication.

Warnings & Precautions

• Do not receive Relyvrio if you are allergic to Sodium Phenylbutyrate and Taurursodiol or any of its ingredients. Seek advice from your doctor if you’re unsure.
• If you have disorders affecting bile acid circulation, pancreas, or intestines, it’s crucial to consult with a specialist before using RELYVRIO. 
• Keep a close eye on any new or worsening diarrhea symptoms. These conditions may affect the absorption of RELYVRIO components. 
• Additionally, be aware that RELYVRIO has a high sodium content, so if you are sensitive to salt intake, carefully consider the daily sodium intake with each dose and monitor it appropriately. 
• Before undergoing RELYVRIO treatment, it is crucial to provide your doctor with a comprehensive overview of your medical history. 
• Highlight specific conditions, such as a history of heart failure, including congestive heart failure, high blood pressure, and any existing kidney problems. 
• This information allows your healthcare provider to conduct a thorough evaluation, ensuring a tailored and safe approach to your treatment plan. 

Common Relyvrio Side Effects:

• Diarrhea
• Abdominal pain
• Nausea
• Upper respiratory tract infection.
• Changes in bile acid levels  
• Salt (sodium) retention

Use in Specific Population

• Usage of Relyvrio in pregnant women can pose a risk of fetal harm. Inform your doctor if you are pregnant, planning to become pregnant, or suspect pregnancy. 
• If you are breastfeeding, consult your doctor, as it is unclear whether Relyvrio passes into human breast milk. 
• The use of RELYVRIO in children has not been studied for safety and effectiveness. Patients with mild kidney conditions do not require a dose adjustment, but the medication should be avoided in those with moderate or severe kidney impairment.
• Similarly, individuals with mild liver impairment do not need a dose adjustment, but the medication should be avoided in those with moderate or severe liver impairment.

Storage and Handling

• Keep in a cool, dry place at temperatures between 20°C to 25°C (68°F to 77°F), with allowed excursions between 15°C to 30°C (59°F to 86°F).
• Do not freeze.
• Keep Relyvrio out of the reach of children and pets.

**Dosage: 

Initial dosage: 1 packet daily for the first 3 weeks 

maintenance dosage: 1 packet twice daily thereafter