Bempedoic acid oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of bempedoic acid.
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 statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
alone or in combination with other lipid-lowering therapies in patients for who statin is contraindicated or who are statin-intolerant.
180mg once daily.
Additional Dosage Information
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.
Children under 18 years
Precautions and Warnings
Females of childbearing potential
End stage renal disease
Glucose-galactose malabsorption syndrome
History of gout
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment
Perform liver function tests before commencing therapy
Discontinue treatment immediately if pregnancy is suspected
Monitor hepatic function in patients with severe hepatic impairment
Monitor patients with severe renal impairment for adverse effects
Advise patients to report muscle pain/tenderness/weakness
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
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.
Pregnancy and Lactation
Bempedoic acid is contraindicated during pregnancy.
Use of bempedoic acid 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.
Bempedoic acid is contraindicated during breastfeeding.
Use of bempedoic acid when breastfeeding is contraindicated by the manufacturer. The presence of bempedoic acid in human breast milk and the effects on exposed infants are unknown.
Alanine aminotransferase increased
Altered liver function tests
Aspartate aminotransferase increased
Blood urea increased
Creatine kinase increased
Decrease in glomerular filtration rate
Increase in serum ALT/AST
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 ).
Last Full Review Date: October 2020
Summary of Product Characteristics: Nilemdo 180mg tablets. Daiichi Sankyo UK Limited. Revised April 2020.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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