Frequently asked questions
Hyperkalemia is a warning and a common adverse reaction for KERENDIA.
The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.
Hyperkalemia was reported in 14% of patients on KERENDIA vs 6.9% for the placebo group; hospitalization due to hyperkalemia for the KERENDIA group was 0.9% vs 0.2% for the placebo group. Hyperkalemia led to permanent discontinuation of treatment in 1.7% of patients receiving KERENDIA vs 0.6% of patients receiving placebo.
Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L.
Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.
eGFR=estimated glomerular filtration rate.
View referencesIn adult patients with CKD associated with T2D who were treated with KERENDIA, the mean SBP decreased by 3 mmHg and the mean DBP decreased by 1 to 2 mmHg at month 1, remaining stable thereafter.
From the pooled data of 2 placebo-controlled studies, hypotension was reported in 4.6% patients treated with KERENDIA vs 3.9% patients treated with placebo.
SBP was measured as part of the laboratory parameter safety evaluation in the pivotal studies. For more information, visit the Pharmacodynamics section of this website.
KERENDIA has not been studied for and is not indicated for the treatment of hypertension.
CKD=chronic kidney disease; DBP=diastolic blood pressure; SBP=systolic blood pressure; T2D=type 2 diabetes.
View referencesKERENDIA is recommended by ADA® and KDIGO guidelines regardless of patients being on any glucose-lowering medications, including SGLT2 inhibitors. Based on clinical study results, KERENDIA not only provides renal benefits, but is proven to reduce CV risk and the risk of CV events.
For more information, visit the Clinical trial data section of this website.
ADA=American Diabetes Association®; CKD=chronic kidney disease; CV=cardiovascular; KDIGO=Kidney Disease: Improving Global Outcomes; SGLT2=sodium-glucose cotransporter 2.
KERENDIA has been added to several key kidney disease and diabetes guidelines. View guidelines.
The use of KERENDIA is recommended by the American Diabetes Association, the American Association of Clinical Endocrinology, and the Kidney Disease: Improving Global Outcomes (KDIGO) foundation as well as the ADA/KDIGO Consensus Statement for appropriate patients with CKD associated with T2D who are experiencing persistent albuminuria despite maximized doses of ACE/ARB therapy to lower cardiorenal risk.
ACE=angiotensin-converting enzyme; ADA=American Diabetes Association®; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; T2D=type 2 diabetes.
View references
INDICATION:
KERENDIA is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Concomitant use with strong CYP3A4 inhibitors
- Patients with adrenal insufficiency
WARNINGS AND PRECAUTIONS:
Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L
Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium
MOST COMMON ADVERSE REACTIONS:
- From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3.9%), and hyponatremia (1.3% vs 0.7%)
DRUG INTERACTIONS:
- Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice
- Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate
- Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers
USE IN SPECIFIC POPULATIONS:
- Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment
- Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)
Please read the Prescribing Information for KERENDIA.
