Relyvrio (Sodium Phenylbutyrate And Taurursodiol) To Treat Amyotrophic Lateral Sclerosis (ALS) In Adult Patients.

Introduction

Relyvrio is a prescription medicine used to treat amyotrophic lateral sclerosis (ALS) in adults. ALS, commonly referred to as Lou Gehrig’s disease, is a neurodegenerative disease caused by motor neuron death in the brain and spinal cord. Relyvrio contains two ingredients, sodium phenylbutyrate and taurursodiol, which work together to reduce motor neuron cell death and inflammation and slow down disease progression.

FDA Approval

Relyvrio (Sodium phenylbutyrate and Taurursodiol) received FDA approval for treating amyotrophic lateral sclerosis (ALS) in adults on September 29, 2022. This approval was granted following encouraging results from a compact phase 2 clinical trial with the identifier NCT03127514. Relyvrio is manufactured by Amylyx Pharmaceuticals, Inc.

Indication 

• Relyvrio is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults. 

Amyotrophic lateral sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) is a neurological disorder that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing. ALS causes loss of muscle control, and it is characterized by progressive degeneration of nerve cells in the spinal cord and brain. 

ALS often begins with muscle twitching and weakness in an arm or leg, trouble swallowing or slurred speech. Eventually, ALS affects the control of the muscles needed to move, speak, eat, and breathe. ALS does not affect intelligence, thinking, seeing, or hearing. 

Treatment of ALS focuses on managing or minimizing symptoms as much as possible. Medications can help manage ALS symptoms, such as muscle cramps and stiffness, extra saliva, pain, depression, sleep problems, and constipation. Physical therapy can help people with ALS remain independent and safe for as long as possible. 

Researchers are conducting studies to increase their understanding of genes that may cause the mechanisms that can trigger motor neurons to degenerate in ALS and approaches to stop the progress leading to cell death.

Mechanism Of Relyvrio

Relyvrio’s mechanism involves the collaborative action of its components, sodium phenylbutyrate, and taurursodiol. They work synergistically to reduce motor neuron cell death, exert anti-inflammatory effects, provide neuroprotection, and collectively slow down the progression of amyotrophic lateral sclerosis (ALS) in adults.

Dosage And Administration

The recommended dosage for Relyvrio involves taking one packet, comprising 3 g of sodium phenylbutyrate and 1 g of taurursodiol, orally or through a feeding tube. The initial dosage of Relyvrio oral suspension one packet daily for the first 3 weeks, followed by a maintenance dosage of one packet twice daily thereafter. To prepare, empty the packet into 8 ounces of room temperature water, stir vigorously, and consume within 1 hour. Administer Relyvrio before a snack or meal for optimal effectiveness.

Relyvrio is available in the form of an oral suspension, with each packet containing 3 g of sodium phenylbutyrate and 1 g of taurursodiol. If you have any questions about the dosage or administration, it’s recommended to consult with a healthcare professional for personalized advice.

Contraindications

The Safety and effectiveness of Relyvrio in pediatric patients have not been established. Relyvrio is contraindicated in patients with a known hypersensitivity to any of the ingredients in the product.

Warnings and Precautions

• Before taking Relyvrio oral suspension, patients should inform their healthcare provider about all of their medical conditions. Relyvrio may cause serious side effects, including diarrhea, abdominal pain, nausea, and upper respiratory tract infection. 
• Patients should avoid taking antacids that contain aluminum while receiving treatment with Relyvrio. If they need an antacid, they should talk to their healthcare provider about the best one for them to take.
• In patients with disorders affecting bile acid circulation, pancreatic disorders, or intestinal disorders, consulting with a specialist is recommended, and regular monitoring for new or worsening diarrhea is advised. 
• These conditions may impact the absorption of components in Relyvrio. Additionally, due to its high sodium content, careful consideration of daily sodium intake is crucial for individuals sensitive to salt when taking Relyvrio, with appropriate monitoring measures in place.

Prior to receiving Relyvrio, inform your doctor of all your medical conditions. This includes disclosing if you have:

1. Pancreas, liver, or intestinal issues.
2. History of heart failure, including congestive heart failure.
3. High blood pressure.

Usage of Relyvrio in Special Populations

Pregnancy

There is currently insufficient data on the usage of Relyvrio in pregnant women, preventing an evaluation of potential risks associated with major birth defects, miscarriage, or other adverse outcomes for both the mother and the fetus.

Breastfeeding

No data is available regarding the presence of sodium phenylbutyrate or taurursodiol in human milk, their impact on the breastfed infant, or their effects on milk production. 

Pediatric Use

The safety and effectiveness of Relyvrio in pediatric patients have not been established.

Geriatric Use

No notable differences in safety or effectiveness were observed between patients aged 65 and older and those younger than 65. 

Renal Impairment

No dose adjustment is necessary for patients with mild renal impairment. However, the use of Relyvrio should be avoided in patients with moderate or severe renal impairment.

Hepatic Impairment

No dose adjustment is required for patients with mild hepatic impairment. However, the use of Relyvrio is not recommended for patients with moderate or severe hepatic impairment.

Side Effects of Relyvrio

Relyvrio, like any medication, can cause side effects. Although not everyone experiences them, it’s important to be aware of the potential risks before starting treatment. Here’s a breakdown of the most common side effects of Relyvrio:

Very Common:

• Diarrhea
• Nausea
• Fatigue
• Abdominal pain
• Upper respiratory tract infection

How To Buy Relyvrio Online? 

Getting Relyvrio has become easier with online options. If you’re looking for this medication, which is only available in the US and Europe, you might want to contact the SANSFRO team or other companies that specialize in importing. 

To find out the Relyvrio price, which can depend on different factors, get in touch with our Patient Support Team at (91) 9315705373 or send an email to help@sansfro.com. Stay informed about the correct pricing in the Indian market with our dedicated team. We’re here to make the process smoother for you.

Conclusion

In summary, Relyvrio is a prescription medicine used to treat ALS in adults which contains two ingredients. Patients should inform their healthcare provider about all of their medical conditions before taking Relyvrio. There are no known drug interactions with Relyvrio. Relyvrio should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). For more information, it is advised to contact the health care professional.

Reference:

1.  https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216660s000lbledt.pdf 
2.  https://www.drugs.com/Relyvrio.html 
3.  https://www.Relyvrio.com 
4.  https://www.Relyvrio.com/Relyvrio-Directions-For-Use.pdf 
5. https://reference.medscape.com/drug/Relyvrio-sodium-phenylbutyrate-taurursodiol-4000269