Lucielafib Elafibranor 80mg Tablets 30's

Elafibranor is an oral peroxisome proliferator-activated receptor (PPAR) agonist used to treat primary biliary cholangitis (PBC), a chronic autoimmune liver disease in which the small bile ducts become progressively damaged.

In combination with ursodeoxycholic acid (UDCA) when the patient has had an inadequate response to UDCA, or

As monotherapy when the patient cannot tolerate UDCA.

Elafibranor is not recommended in patients with decompensated cirrhosis, such as those with ascites, variceal bleeding, or hepatic encephalopathy.

Primary Biliary Cholangitis (PBC)

It is indicated in adults with PBC who:

• Have an inadequate response to UDCA, or
• Cannot tolerate UDCA.

It may therefore be used either with UDCA or alone, depending on the patient's clinical situation.

Through PPAR activation, elafibranor helps modify abnormal metabolic and inflammatory processes associated with PBC.

One of the clinically important effects is a reduction in alkaline phosphatase (ALP), a biochemical marker associated with cholestatic liver disease.

In simple terms:

PBC → bile-duct injury → impaired bile flow → cholestatic liver injury

Elafibranor → PPAR activation → modulation of bile-acid/metabolic pathways → reduction in biochemical markers such as ALP

The recommended dose is 80 mg orally once daily.

Elafibranor can be taken:

• With or without food
• At approximately the same time each day
• As directed by the treating physician.

Before starting treatment

The healthcare provider should:

• Evaluate the patient for muscle pain or myopathy.
• Confirm that females of reproductive potential are not pregnant.

Common:

• Weight gain
• Diarrhea
• Abdominal pain
• Nausea
• Vomiting
• Joint pain/stiffness (arthralgia)
• Constipation
• Muscle injury
• Bone fractures
• Gastroesophageal reflux disease (GERD)
• Dry mouth
• Weight loss
• Rash

Serious:

• Muscle pain
• Muscle weakness
• Myopathy
• Elevated CPK
• Rarely, rhabdomyolysis, a potentially serious form of muscle injury.

Patients should promptly report:

• Unexplained muscle pain
• Muscle tenderness
• Muscle weakness
• Severe muscle symptoms
• Dark-colored urine

The physician may temporarily interrupt treatment and evaluate CPK and other laboratory parameters.

Several interactions are clinically important.

Hormonal contraceptives

Elafibranor may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol.

Women of reproductive potential should avoid ethinyl-estradiol-containing contraceptives and use an alternative.

Statins

When used with HMG-CoA reductase inhibitors (statins), there may be an increased risk of muscle injury.

Rifampin

Rifampin may reduce exposure to elafibranor and its active metabolite and potentially result in a delayed or suboptimal biochemical response.

If rifampin is started during treatment, the physician should monitor the patient's biochemical response, including ALP and bilirubin.

• Store at 15°C–30°C (59°F–86°F).
• In the original bottle/carton
• Protected from moisture and light
• Out of reach of children.

Do not transfer the tablets to another container unless specifically instructed by the pharmacist.

• Take 80 mg once daily exactly as prescribed.
• It can be taken with or without food.
• Take it at approximately the same time every day.
• Tell your doctor about all medicines and supplements.
• Inform the doctor if you are taking a statin, fibrate, rifampin, or bile-acid sequestrant.
• Report unexplained muscle pain or weakness immediately.
• Report symptoms suggesting liver injury.
• Report severe upper-right abdominal pain or jaundice.
• Maintain appropriate bone health and discuss fracture risk with your physician.
• Do not use ethinyl-estradiol-containing hormonal contraception during treatment without discussing alternatives with your doctor.
• Attend scheduled liver function and other laboratory monitoring.
• Elafibranor is not recommended in decompensated cirrhosis.
• Do not stop or change the dose without consulting your treating physician.