Winolip EZ

• Heterozygous familial hypercholesterolemia
• Atherosclerotic cardiovascular disease
• Patients requiring additional LDL-C lowering despite maximally tolerated statin therapy

Bempedoic acid is an ATP-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. ACL is an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway. Bempedoic acid is activated in the liver by very-long-chain acyl-CoA synthetase 1 (ACSVL1).

Ezetimibe is a potent and selective inhibitor of cholesterol absorption that reduces the overall delivery of cholesterol to the liver, promoting LDL receptor synthesis and subsequent reduction of serum LDL-C.

Recommended Dose: 180 mg Bempedoic acid + 10 mg Ezetimibe, once daily, orally.

May be taken with or without food. Should be used in combination with maximally tolerated statin therapy.

With Simvastatin: Avoid concomitant use with simvastatin greater than 20 mg.

With Pravastatin: Avoid concomitant use with pravastatin greater than 40 mg.

• Upper respiratory tract infection
• Muscle spasms
• Hyperuricemia
• Back pain
• Abdominal pain or discomfort
• Bronchitis
• Pain in extremity
• Anemia
• Elevated liver enzymes

[CONSULT YOUR DOCTOR] There are no adequate data on use in pregnant women. Discontinue when pregnancy is recognized unless the benefits outweigh the potential risks to the fetus.

• Hyperuricemia: Bempedoic acid may increase serum uric acid levels. Monitor uric acid levels periodically. Inform your doctor if you have a history of gout.
• Tendon Rupture: Tendon rupture has been reported. Discontinue at the first sign of tendon pain, swelling, or inflammation. Avoid use in patients with a history of tendon disorders or tendon rupture.
• Discontinue when pregnancy is recognized unless benefits outweigh risks.
• Not recommended during breastfeeding.

No specific antidote for overdose. Provide symptomatic and supportive treatment.

Store below 30°C, away from light and moisture. Keep out of reach of children.