Does Kerendia lower blood pressure?
Yes, low blood pressure (hypotension) has been reported as a common side effect with Kerendia, occurring in at least 1% (1 out of every 100) of patients. In studies, low blood pressure (hypotension) occurred in 4.6% of patients taking Kerendia compared to 3.9% of patients taking a placebo.
In patients treated with Kerendia, the mean systolic blood pressure (the first or top number) decreased by 3 mmHg and the mean diastolic blood pressure (the second or bottom number) decreased by 1-2 mmHg during the first month, but remained stable thereafter. A normal blood pressure reading is usually less than 120/80 mmHg.
Kerendia can also cause high potassium levels and low sodium levels.
- Hyperkalemia (high potassium levels) occurred in 18.3% of patients taking Kerendia compared to 9% on placebo.
- Hyponatremia (low sodium levels) occurred in 1.3% of patients taking Kerendia vs. 0.7% of those in the placebo group.
Before starting treatment and while you are taking Kerendia, your doctor will monitor your potassium levels and kidney function using a simple blood test from your vein.
If you have any side effects, contact your doctor immediately to discuss them. Your doctor may need to change your dose, but do not change doses or stop the medication on your own. Call your healthcare provider for medical advice about side effects.
When was Kerendia approved by the FDA?
The FDA approved Bayer’s Kerendia (finerenone) in July 2021. It is a first-in-class non-steroidal, selective mineralocorticoid receptor antagonist (MRA) for the treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Kerendia is approved to reduce the risk of:
- worsening of kidney disease
- kidney failure
- death due to cardiovascular (heart-related) disease
- heart attack
- hospitalization due to heart failure
In Phase 3 studies, 5,674 patients received either Kerendia (2833) or placebo (2841) and were followed for 2.6 years. Kerendia use in adults lowered the risk of:
- sustained eGFR decline (a measure of how well your kidneys work)
- kidney failure or kidney death
- the combined risk for a cardiovascular (heart-related) death; non-fatal myocardial infarction (non-fatal heart attack), non-fatal stroke or hospitalization for heart failure
The mechanism of how Kerendia works is thought to be due to blocking the overactive mineralocorticoid receptor that may contribute to fibrosis (tissue scarring), inflammation and permanent kidney damage in patients with type 2 diabetes.
This is not all the information you need to know about Kerendia (finerenone) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.
Related questions
References
- Kerendia (finerenone) prescribing information. Sept. 2022. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. Accessed Feb 22, 2023 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215341s001lbl.pdf
- Kerendia.com. Resources and Q&As. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. Accessed Feb 22, 2023 at https://www.kerendia-us.com/resources-questions-answers#What-are-the-most-common-side-effects-I-should-look-out-for-3837057085
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Drug information
- Kerendia Information for Consumers
- Kerendia prescribing info & package insert (for Health Professionals)
- Side Effects of Kerendia (detailed)
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