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 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.

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Pregnancy

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
Severe hepatic impairment

Contains lactose
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

Pregnancy

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.

Lactation

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.

Side Effects

Alanine aminotransferase increased
Altered liver function tests
Anaemia
Aspartate aminotransferase increased
Blood urea increased
Creatine kinase increased
Decrease in glomerular filtration rate
Diarrhoea
Gout
Haemoglobin decrease
Hyperuricaemia
Increase in serum ALT/AST
Muscle spasm
Nausea
Painful extremities

Presentation

Oral formulations of bempedoic acid.

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 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.

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Pregnancy

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
Severe hepatic impairment

Contains lactose
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

Pregnancy

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.

Lactation

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.

Side Effects

Alanine aminotransferase increased
Altered liver function tests
Anaemia
Aspartate aminotransferase increased
Blood urea increased
Creatine kinase increased
Decrease in glomerular filtration rate
Diarrhoea
Gout
Haemoglobin decrease
Hyperuricaemia
Increase in serum ALT/AST
Muscle spasm
Nausea
Painful extremities

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: Nilemdo 180mg tablets. Daiichi Sankyo UK Limited. Revised April 2020.