Finerenone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing finerenone.
Drugs List
Therapeutic Indications
Uses
Stage 3 & 4 CKD (with albuminuria) associated with type 2 diabetes
Treatment of chronic kidney disease (stage 3 and 4 with albuminuria) in adults, secondary to type 2 diabetes.
Dosage
Adults
The recommended target dose is 20mg once daily.
Initiation of treatment Prior to treatment initiation with finerenone, serum potassium and estimated glomerular filtration rate (eGFR) must be measured to determine if treatment can be initiated and to determine the starting dose. If serum potassium is equal to or less than 4.8mmol/L, treatment with finerenone can be initiated. If serum potassium is between 4.8mmol/L and 5mmol/L, treatment with finerenone may be considered, with additional potassium monitoring for the first 4 weeks of treatment based on the patient characteristics and serum potassium levels. If serum potassium is greater than 5mmol/L, treatment with finerenone should not be initiated.
Recommended dose at initiation of treatment If eGFR is greater than or equal to 60ml/minute/1.73msquared, starting dose is 20mg once daily. If eGFR is between 25ml/minute/1.73msquared and 60ml/minute/1.73msquared, starting dose is 10mg once daily. If eGFR is less than 25ml/minute/1.73msquared, treatment is contraindicated.
Continuation of treatment and dose adjustment If current serum potassium measures less than or equal to 4.8mmol/L and current finerenone dose is 10mg once daily, treatment may be increased to 20mg once daily. However, if eGFR has decreased more than 30% compared to the previous measurement, a dose of 10mg once daily must be maintained. If current serum potassium measures less than or equal to 4.8mmol/L and current finerenone dose is 20mg once daily, this dose may be maintained. If current serum potassium measures between 4.8mmol/L and 5.5mmol/L and current finerenone dose is 10mg once daily, this dose may be maintained. If current serum potassium measures between 4.8mmol/L and 5.5mmol/L and current finerenone dose is 20mg once daily, this dose may be maintained. If current serum potassium measures more than 5.5mmol/L, suspend treatment with finerenone. If the current daily dose is 10mg, consider re-starting treatment at 10mg once daily once serum potassium measure equal to or less than 5mmol/L. If the current daily dose is 20mg, treatment may be re-started at 10mg once daily once serum potassium measure equal to or less than 5mmol/L.
Additional Dosage Information
Missed dose In the event of a missed dose, the missed dose should only be taken if the patient notices on the same day.
Crushing of tablets
Finerenone tablets may be crushed and mixed with water or soft foods such as apple sauce directly before use, in patients who are unable to swallow whole tablets.
Contraindications
Baseline serum potassium above 5 mmol/L
Children under 18 years
Addison's disease
Breastfeeding
Galactosaemia
Renal impairment - eGFR below 25ml/minute/1.73m sq at baseline
Severe hepatic impairment
Precautions and Warnings
Females of childbearing potential
Congestive cardiac failure with reduced left ventricular ejection fraction
Glucose-galactose malabsorption syndrome
History of hyperkalaemia
Hyperkalaemia
Lactose intolerance
Moderate hepatic impairment
New York Heart Association class II failure
Pregnancy
Reduce dose in patients with renal impairment
Contains lactose
Monitor renal function prior to initiating treatment
Monitor serum potassium levels before treatment
Monitor renal function regularly
Monitor serum potassium regularly
Advise patient to seek advice at first indications of pregnancy
Discontinue if eGFR falls below 15ml/minute/1.73m squared
Suspend treatment if serum potassium levels above 5.5mmol/L
Advise patient not to take St John's wort concurrently
Advise patient peppermint oil products may increase plasma level
Advise patient Seville (sour) orange products may increase plasma level
Advise patient that blueberry products may increase plasma level
Advise patient that cranberry products may increase plasma level
Advise patient to avoid grapefruit products
Female: Ensure adequate contraception during treatment
Serum potassium and eGFR must be assessed 4 weeks after initiation and then measured periodically thereafter. Serum potassium and eGFR must also be monitored before re-starting treatment or increasing dose.
Pregnancy and Lactation
Pregnancy
Use finerenone with caution during pregnancy. The manufacturer does not recommend using finerenone during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Finerenone should only be used during pregnancy if the benefit to the mother outweighs the risk to the foetus.
Lactation
Finerenone is contraindicated during breastfeeding. The manufacturer advises that the patient either discontinues finerenone or discontinues breastfeeding. Animal data reports the presence of finerenone in breast milk however presence in human breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Decrease in glomerular filtration rate
Decrease in haemoglobin
Electrolyte disturbances
Hyperkalaemia
Hyponatraemia
Hypotension
Pruritus
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: July 2022
Reference Sources
Summary of Product Characteristics: Kerendia 10mg film coated tablets. Bayer plc. Revised March 2022.
Summary of Product Characteristics: Kerendia 20mg film coated tablets. Bayer plc. Revised March 2022..
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 July 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.