Fluvastatin Capsules

Statins remain the cornerstone of lipid management and cardiovascular risk reduction in UK clinical practice, recommended by NICE for millions of adults who require cholesterol lowering. Fluvastatin capsules are a prescription-only statin available in 20 mg and 40 mg strengths, used in adults for primary hypercholesterolaemia and mixed dyslipidaemia. Fluvastatin is one of the earlier synthetic statins to reach the UK market and has a distinct metabolism pathway compared to most other statins, being metabolised predominantly by CYP2C9 rather than CYP3A4. A prescription can only be issued following a clinical consultation.

Fluvastatin capsules are an oral prescription medicine containing fluvastatin sodium as the active ingredient. Fluvastatin belongs to the statin class of lipid-lowering medicines, also known as HMG-CoA reductase inhibitors. Like all statins, fluvastatin reduces LDL cholesterol by inhibiting cholesterol synthesis in the liver. Fluvastatin was one of the first fully synthetic statins and is available in immediate-release capsule form at 20 mg and 40 mg.

Fluvastatin capsules are licensed in the UK for treatment of primary hypercholesterolaemia and mixed dyslipidaemia in adults, as an adjunct to diet when dietary measures alone have been insufficient, and when the risk of first cardiovascular disease event is considered to be elevated. They are also licensed for slowing the progression of coronary atherosclerosis in patients with coronary heart disease as an adjunct to diet. Additionally, fluvastatin is licensed for secondary prevention of major adverse cardiac events in adults with coronary heart disease following percutaneous coronary intervention.

A separate extended release tablet formulation, fluvastatin XL 80 mg, is also available as a distinct product. This page covers the immediate release 20 mg and 40 mg capsule formulations only. The capsule and tablet formulations have different dosing schedules and are not interchangeable without prescriber guidance.

Fluvastatin lowers cholesterol by inhibiting the key enzyme in the liver's cholesterol synthesis pathway.

HMG-CoA Reductase Inhibition. The liver produces cholesterol through a multi-step biosynthetic pathway. A rate-limiting step in this pathway is catalysed by the enzyme HMG-CoA reductase. Fluvastatin selectively and competitively inhibits this enzyme, reducing the amount of cholesterol synthesised within liver cells. In response, liver cells increase the number of LDL receptors on their surface to capture more LDL cholesterol from the bloodstream, further lowering circulating LDL levels.

CYP2C9 Metabolism: A Distinct Interaction Profile. Most statins (atorvastatin, simvastatin, lovastatin) are metabolised primarily by the CYP3A4 enzyme pathway. Fluvastatin is different — it is metabolised predominantly by CYP2C9. This means fluvastatin is not significantly affected by grapefruit juice or CYP3A4 inhibitors such as itraconazole and erythromycin, which can raise levels of other statins. However, fluvastatin is affected by CYP2C9 inhibitors such as fluconazole (an antifungal) and amiodarone (a cardiac medicine). Patients taking these medicines alongside fluvastatin require careful prescriber assessment.

Fluvastatin is classified as a low to medium-intensity statin. At the 40 mg twice daily dose, fluvastatin approaches medium intensity statin territory. At the 20 mg and 40 mg once-daily capsule doses, it is a lower intensity option. NICE guideline NG238 recommends high intensity statins for most adults requiring lipid management for cardiovascular risk reduction. Your prescriber will determine whether fluvastatin is the most appropriate statin for your individual circumstances.

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

• Fluvastatin capsules can be taken at any time of day, with or without food.
• Swallow the capsule whole with a glass of water. Do not open or chew the capsule.
• The 40 mg capsule may be prescribed once or twice daily depending on your prescriber's instructions and the degree of LDL reduction required.
• Grapefruit juice does not significantly affect fluvastatin blood levels, unlike most other statins.

If you miss a dose, take it as soon as you remember. 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 fluvastatin without speaking to your prescriber first.

Your prescriber will arrange lipid level monitoring before starting and typically four to twelve weeks after beginning treatment. Liver function may also be checked.

Fluvastatin 20 mg Capsules: The lower available strength, used as a starting dose in patients new to fluvastatin, those more sensitive to statin effects, or when a lower degree of LDL reduction is appropriate. Taken once daily.

Fluvastatin 40 mg Capsules: The standard maintenance strength for many patients, taken once daily for moderate LDL reduction. For patients requiring greater LDL lowering, the SmPC supports taking 40 mg twice daily (morning and evening). For patients requiring high intensity statin therapy as defined by NICE NG238, a higher intensity statin such as atorvastatin 40 mg or 80 mg would typically be considered. All dose decisions are made by your prescriber. Do not change your dose without medical advice.

Like all statins, fluvastatin can cause side effects.

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, tenderness, or weakness, particularly if severe or accompanied by dark urine.
• Gastrointestinal effects including nausea, abdominal pain, diarrhoea, or constipation.
• Headache.
• Insomnia or sleep disturbances.

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

• Raised liver enzymes on blood tests, usually asymptomatic and monitored periodically.
• Dizziness.
• Skin rash.
• A small increase in the risk of developing type 2 diabetes, outweighed by cardiovascular benefit in eligible patients.

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); 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, or difficulty breathing.

Fluvastatin capsules may be suitable if you:

• Are an adult with primary hypercholesterolaemia or mixed dyslipidaemia requiring LDL reduction where dietary measures have been insufficient.
• Have coronary heart disease and require secondary prevention of cardiovascular events, or require slowing of coronary atherosclerosis progression.
• Have had a percutaneous coronary intervention and your prescriber has recommended fluvastatin for secondary prevention.
• Are already prescribed fluvastatin and require a repeat prescription through an online prescribing service.

Fluvastatin capsules are not suitable if you:

• Are pregnant or planning to become pregnant. Fluvastatin is contraindicated in pregnancy. Effective contraception is required during treatment and for an appropriate period after stopping.
• Are breastfeeding.
• Have active liver disease or persistently elevated liver enzymes of unknown cause.
• Have a known allergy or hypersensitivity to fluvastatin or any excipient listed in the SmPC.

Important Drug Interactions — CYP2C9 Pathway: Fluconazole is a potent CYP2C9 inhibitor that can significantly increase fluvastatin blood levels, raising muscle-related side effect risk — caution or avoidance advised. Amiodarone inhibits CYP2C9 and can raise fluvastatin levels. Rifampicin induces CYP2C9 and can reduce fluvastatin effectiveness. Warfarin's anticoagulant effect can be increased — INR monitoring recommended. Ciclosporin significantly increases fluvastatin blood levels, raising myopathy risk — dose limiting advised. Fibrates increase myopathy risk when combined with any statin. Colchicine may increase myopathy risk. Grapefruit juice does not significantly interact with fluvastatin, unlike most other statins.

Fluvastatin 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 fluvastatin is clinically appropriate for you.

During your online consultation with Pharmacy Planet, a registered prescriber will review your cholesterol levels, cardiovascular risk assessment, current medicines, relevant medical history, and the indication for statin therapy. The prescriber will determine whether fluvastatin is appropriate, which dose is needed, and whether online prescribing is suitable for your individual situation.

Not all consultations will result in a prescription. The prescriber may recommend a different statin or a higher-intensity option, request blood test results, or advise that a full cardiovascular risk assessment by your GP is needed.