Inegy

IMPORTANT: The INEGY 10 mg/80 mg strength contains simvastatin 80 mg. The MHRA has restricted the use of simvastatin 80 mg due to an increased risk of myopathy and rhabdomyolysis at this dose. Inegy 10/80 mg should only be prescribed to patients who are already established and stable on simvastatin 80 mg (or Inegy 10/80 mg) and who have not experienced muscle toxicity. It should not be initiated in new patients or used to titrate patients who are not already on this dose.

For patients whose LDL cholesterol is not adequately controlled on a statin alone, adding a cholesterol absorption inhibitor through a single combination tablet can simplify treatment while delivering dual-mechanism lipid management. Inegy tablets combine ezetimibe 10 mg and simvastatin in a single once-daily tablet, available in three strengths. Ezetimibe blocks cholesterol absorption in the intestine while simvastatin reduces cholesterol synthesis in the liver, making Inegy a well-established ezetimibe and statin combination in cardiovascular therapy. A prescription can only be issued following a clinical consultation.

Inegy is a branded prescription combination medicine manufactured by Organon. Each tablet contains ezetimibe 10 mg plus simvastatin at one of three strengths: 20 mg, 40 mg, or 80 mg. The first number in each strength refers to the ezetimibe dose (always 10 mg) and the second to the simvastatin dose. Inegy is available as 10/20 mg, 10/40 mg, and 10/80 mg tablets.

Inegy is licensed in the UK for the treatment of primary hypercholesterolaemia and homozygous familial hypercholesterolaemia (HoFH) in adults as adjunctive therapy to diet, when a statin alone or ezetimibe alone has not provided adequate LDL reduction. Inegy is also licensed for the prevention of cardiovascular events in adults with established coronary heart disease. These indications reflect the evidence from the IMPROVE-IT trial, in which adding ezetimibe to simvastatin reduced cardiovascular events compared to simvastatin alone in post-acute coronary syndrome patients.

Inegy is indicated for use in patients who are already on simvastatin and require the addition of ezetimibe, or who are already on ezetimibe and simvastatin as separate tablets and wish to simplify to a single combination tablet. It is not intended to initiate both medicines simultaneously in patients new to either component.

Inegy lowers LDL cholesterol through two complementary mechanisms that act at different points in cholesterol metabolism.

Ezetimibe: Intestinal Cholesterol Absorption Inhibition. Ezetimibe selectively blocks the NPC1L1 transporter in the small intestine, preventing dietary and biliary cholesterol from being absorbed into the body. Unabsorbed cholesterol is excreted in the faeces. When less cholesterol is delivered to the liver from the intestine, liver cells upregulate their LDL receptors to capture more LDL from the bloodstream, contributing to a fall in circulating LDL levels.

Simvastatin: HMG-CoA Reductase Inhibition. Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. By reducing the liver's internal cholesterol production, simvastatin further drives upregulation of LDL receptors. The result is a significant fall in plasma LDL cholesterol from the combined reduction in both intestinal cholesterol absorption and hepatic cholesterol synthesis.

The two mechanisms are complementary and additive. Simvastatin alone at 40 mg reduces LDL by approximately 35 to 40 per cent. Adding ezetimibe produces a further 15 to 20 per cent reduction on top of the statin effect, giving Inegy a combined LDL lowering effect substantially greater than either component alone.

Always take Inegy exactly as your prescriber instructs. Read the Patient Information Leaflet supplied with your medicine before starting treatment.

• Take one Inegy tablet once daily, in the evening. The simvastatin component is more effective when taken in the evening because cholesterol synthesis is highest during sleep.
• Inegy can be taken with or without food.
• Swallow the tablet whole with a glass of water.
• Avoid large quantities of grapefruit juice throughout treatment, as it inhibits CYP3A4 and can increase simvastatin blood levels.
• If you are also taking a bile acid sequestrant (such as colestyramine or Colestid), take Inegy at least two hours before or four or more hours after.

If you miss a dose, take it as soon as you remember on the same day. If you only remember the following day, skip the missed dose and continue as normal. Do not take two doses on the same day. Do not stop taking Inegy without speaking to your prescriber first.

Your prescriber will arrange blood tests to monitor lipid levels, typically four to twelve weeks after starting treatment. Liver function may also be checked.

Inegy is available in three strengths. The ezetimibe dose is fixed at 10 mg in all strengths. The simvastatin dose varies.

Inegy 10 mg/20 mg Tablets: The lowest simvastatin dose available in the combination, suitable for patients requiring additional LDL reduction beyond simvastatin 20 mg alone, or switching from separate tablets for convenience.

Inegy 10 mg/40 mg Tablets: The most commonly prescribed Inegy strength for most adults. The 40 mg simvastatin component provides a greater degree of LDL reduction than the 20 mg strength.

Inegy 10 mg/80 mg Tablets: The 80 mg simvastatin dose carries an increased risk of myopathy and rhabdomyolysis. The MHRA has restricted this strength: Inegy 10/80 mg must not be initiated in new patients and must not be used to titrate patients not already established on simvastatin 80 mg or Inegy 10/80 mg. Only appropriate for patients already stable on this specific dose who have not experienced muscle related toxicity. Do not change your strength without medical advice.

Inegy can cause side effects from either of its active components.

Common Side Effects (may affect up to 1 in 10 people):

• Muscle aches, pains, or weakness (myalgia). Contact your prescriber promptly if you experience unexplained muscle pain, particularly if severe or accompanied by dark urine.
• Gastrointestinal effects including abdominal pain, nausea, flatulence, and diarrhoea.
• Headache.
• Raised liver enzymes on blood tests.

Uncommon Side Effects (may affect up to 1 in 100 people):

• Raised creatine kinase (a marker of muscle damage) on blood tests.
• Sleep disturbances or insomnia.
• Fatigue.
• Skin rash.
• A small increase in the risk of developing type 2 diabetes, associated with the statin component.

Serious Side Effects — Seek Urgent Medical Attention: Go to your nearest accident and emergency department or call 999 immediately if you experience severe muscle pain, weakness, or cramps, particularly with dark, tea coloured urine (rhabdomyolysis risk, higher with the 10/80 mg strength); signs of significant liver problems such as yellowing of the skin or eyes, severe abdominal pain, or very dark urine; or signs of a severe allergic reaction such as sudden swelling of the face, lips, tongue, or throat.

Inegy tablets may be suitable if you:

• Are an adult with primary hypercholesterolaemia whose LDL cholesterol is not adequately controlled on simvastatin alone, and your prescriber has recommended adding ezetimibe.
• Have homozygous familial hypercholesterolaemia under specialist supervision.
• Have established coronary heart disease and are prescribed this combination for cardiovascular risk reduction.
• Are already taking separate simvastatin and ezetimibe tablets and wish to simplify to the single Inegy combination tablet.
• Are already prescribed Inegy and require a repeat prescription through an online prescribing service.

Inegy tablets are not suitable if you:

• Require initiation with Inegy 10/80 mg. This strength is restricted to patients already established on simvastatin 80 mg or Inegy 10/80 mg.
• Are pregnant or planning to become pregnant. Simvastatin is contraindicated in pregnancy.
• Are breastfeeding.
• Have active liver disease or persistently elevated liver enzymes of unknown cause.
• Are taking a medicine that interacts significantly with simvastatin at the 80 mg dose, such as amiodarone, verapamil, diltiazem, or amlodipine.
• Have a known allergy or hypersensitivity to ezetimibe, simvastatin, or any excipient listed in the SmPC.

Important Drug Interactions: Grapefruit juice in large quantities increases simvastatin blood levels. Strong CYP3A4 inhibitors (itraconazole, ketoconazole, HIV protease inhibitors, ciclosporin, clarithromycin, erythromycin) significantly increase simvastatin levels — several combinations are contraindicated. Amiodarone, verapamil, diltiazem, and amlodipine require limiting the simvastatin dose. Gemfibrozil is contraindicated with simvastatin. Bile acid sequestrants reduce ezetimibe absorption — timing required. Warfarin's effect may be modestly enhanced — INR monitoring advisable. Fibrates other than gemfibrozil increase myopathy risk.

Inegy is a Prescription Only Medicine. The clinical consultation is the essential first step. A prescription will only be issued if a registered prescriber concludes, based on their individual assessment of your circumstances, that Inegy is clinically appropriate for you.

During your online consultation with Pharmacy Planet, a registered prescriber will review your cholesterol and lipid levels, current lipid-lowering medicines, cardiovascular history, current medicines, and other relevant information. The prescriber will determine the appropriate Inegy strength, confirm that the 10/80 mg restriction does not apply in a way that would prevent prescribing, and assess whether online prescribing is suitable for your situation.

Not all consultations will result in a prescription. The prescriber may recommend a different statin, a different combination approach, or advise that a full cardiovascular risk assessment by your GP is needed before prescribing proceeds.