IQIRVO 80 MG (ELAFIBRANOR)

📌 What Is IQIRVO?

Iqirvo (elafibranor) is commonly used to treat primary biliary cholangitis (PBC). PBC is a rare liver disease that occurs when your body’s immune system incorrectly attacks your bile ducts. Bile ducts are tubes that carry bile (a fluid that helps with digestion) out of the liver. Damage to the bile ducts can cause a backup of bile, which can lead to inflammation and damage to the liver.

📌 What Is IQIRVO?

• Generic Name: Elafibranor

• Brand Name: IQIRVO

• Drug Class: Oral PPAR α/δ agonist (peroxisome proliferator-activated receptor)

🏥 Indication :

• • In combination with ursodeoxycholic acid (UDCA) for those with an inadequate response

  • Or as monotherapy for patients intolerant to UDCA

• Limitation: Not recommended in decompensated cirrhosis (e.g., ascites, variceal bleeding)

🧪 How It Works

Activates PPAR α and δ, regulating bile acid synthesis, reducing cholestatic inflammation, and improving lipid metabolism

📊 Clinical Evidence

• ELATIVE Phase III trial:

  • 51% of patients achieved biochemical response (reduced alkaline phosphatase) at 52 weeks vs. 4% with placebo

  • 15% reached full normalization of ALP vs. 0% with placebo

  • Also showed improvement in pruritus and fatigue

💊 Dosage & Administration

• Dose: 80 mg orally once daily, with or without food

• Before starting: Check for muscle symptoms/myopathy and confirm pregnancy status in women of reproductive potential

⚠️ Safety & Side Effects

Muscle Effects

• Risk of myalgia, myopathy, and rhabdomyolysis—especially with statins. Monitor CPK and discontinue with severe muscle symptoms

Common Adverse Effects

• Gastrointestinal: diarrhea, abdominal pain, nausea, vomiting, constipation, reflux

• Others: weight gain or loss, arthralgia, rash, dry mouth, fractures

Lab/Metabolic Effects

• Improved lipid profiles seen; monitor liver enzymes and bilirubin

• Limited data on long-term outcomes like survival or cirrhosis prevention

🚫 Drug Interactions & Special Precautions

• No significant CYP interactions noted, but monitor carefully when co-administered with statins

• Avoid use in patients with moderate/severe hepatic impairment or decompensated cirrhosis

• Pregnancy & breastfeeding: safety not established—avoid during treatment and for 3 weeks after last dose

✅ Summary

IQIRVO is a first-in-class dual PPAR agonist for PBC patients not controlled with UDCA. It significantly reduces ALP and improves symptoms like itching and fatigue. Key benefits include once-daily dosing and positive lipid effects; main risks include muscle toxicity and GI effects. It’s approved under accelerated pathways and further confirmatory trials are underway.