Bempedoic acid with ezetimibe oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of bempedoic acid with ezetimibe.
Drugs List
Therapeutic Indications
Uses
Mixed dyslipidaemia: adjunct to diet and exercise
Primary hypercholesterolaemia: lipid lowering therapy adjunct to diet
Treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
Dosage
Adults
One tablet daily.
Additional Dosage Information
Bempedoic acid with ezetimibe dosing should occur either at least 2 hours before or at least 4 hours after administration of a bile acid sequestrant.
Concomitant doses of simvastatin should be limited to 20mg daily. A dose of 40mg daily may be used in patients with severe hypercholesterolaemia and high risk cardiovascular complications, who have not achieved their treatment goals on the lower doses and when the benefits are expected to outweigh the potential risks.
Contraindications
Children under 18 years
Breastfeeding
Galactosaemia
Moderate hepatic impairment
Pregnancy
Unexplained elevated serum transaminases
Precautions and Warnings
Females of childbearing potential
End stage renal disease
Glucose-galactose malabsorption syndrome
History of gout
Lactose intolerance
Renal impairment - eGFR below 30ml/minute/1.73m sq
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Perform liver function tests before commencing therapy
Discontinue treatment immediately if pregnancy is suspected
Monitor patients receiving concurrent anticoagulants
Monitor patients with severe renal impairment for adverse effects
Advise patients to report muscle pain/tenderness/weakness
Discontinue if myopathy is suspected
May cause hyperuricaemia
May precipitate gout
Discontinue if ALT or AST persistently exceed 3 x ULN
Discontinue if CPK rises to > or equal to 10 x upper limit of normal
Discontinue if hyperuricaemia with gout symptoms occur
Female: Ensure adequate contraception during treatment
Myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and can lead to fatality.
If symptoms of myopathy occur whilst receiving bempedoic acid treatment and a statin, a lower maximum dose of the same statin or alternative statin, or discontinuation of bempedoic acid and initiation of an alternative lipid-lowering therapy should be considered under close monitoring.
If cholelithiasis is suspected in patients receiving bempedoic acid with ezetimibe and fenofibrate, perform gallbladder investigations and discontinue therapy.
Pregnancy and Lactation
Pregnancy
Bempedoic acid with ezetimibe is contraindicated during pregnancy.
Use of bempedoic acid with ezetimibe during pregnancy is contraindicated by the manufacturer. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out. Bempedoic acid should be discontinued prior to conception or as soon as pregnancy is recognised.
Lactation
Bempedoic acid with ezetimibe is contraindicated during breastfeeding.
Use of bempedoic acid with ezetimibe when breastfeeding is contraindicated by the manufacturer. The presence of bempedoic acid in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal pain
Alanine aminotransferase increased
Altered liver function tests
Anaemia
Anaphylaxis
Angioedema
Arthralgia
Aspartate aminotransferase increased
Asthenia
Back pain
Blood urea increased
Chest pain
Cholecystitis
Cholelithiasis
Constipation
Cough
Creatine kinase increased
Decrease in glomerular filtration rate
Decreased appetite
Depression
Diarrhoea
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Erythema multiforme
Fatigue
Flatulence
Gamma glutamyl transferase (GGT) increased
Gastritis
Gastroesophageal reflux
Gout
Haemoglobin decrease
Headache
Hepatitis
Hot flushes
Hypersensitivity reactions
Hypertension
Hyperuricaemia
Muscle spasm
Muscle weakness
Myalgia
Myopathy
Nausea
Neck pain
Pain - generalised
Painful extremities
Pancreatitis
Paraesthesia
Peripheral oedema
Pruritus
Rash
Rhabdomyolysis
Thrombocytopenia
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2020
Reference Sources
Summary of Product Characteristics: Nustendi 180mg/10mg film coated tablets. Daiichi Sankyo UK Limited. Revised March 2020.
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