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Kerendia
Finerenone
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Kerendia, known generically as finerenone, represents a significant advancement in the management of chronic kidney disease (CKD) associated with type 2 diabetes. Approved by the FDA, Kerendia stands out as a unique option in the realm of nonsteroidal mineralocorticoid receptor antagonists. This medication is specifically tailored to address the complications arising from CKD in diabetic patients, a condition that significantly impacts health and quality of life.

What is Kerendia?

Generic Name and Pronunciation

Kerendia’s generic name is finerenone, pronounced as “fi-NE-ren-one.” It is a prescription medication available in tablet form.

Classification

Kerendia belongs to a class of drugs known as nonsteroidal mineralocorticoid receptor antagonists (MRAs). This classification is important because it differentiates Kerendia from other MRAs that are steroidal, offering a distinct mechanism of action and side effect profile.

FDA Approval and Uniqueness

The FDA approved Kerendia in 2021, marking it as the only nonsteroidal MRA approved for reducing complications related to CKD in type 2 diabetes patients. Its approval was based on its effectiveness in clinical trials, where it demonstrated a significant impact on reducing the progression of CKD and associated cardiovascular risks.

Medical Uses

Chronic kidney disease, particularly when associated with type 2 diabetes, poses significant health risks, including heart attacks, heart failure, and worsening kidney function. Kerendia is specifically indicated for adults with this condition to mitigate these risks.

Chronic Kidney Disease and Type 2 Diabetes

CKD in the context of type 2 diabetes is a progressive condition where the kidneys gradually lose their filtering ability. This deterioration is often exacerbated by the vascular complications arising from diabetes, making effective management crucial.

Role of Kerendia in Managing CKD

Kerendia’s role in managing CKD associated with type 2 diabetes is multifaceted. It helps in reducing the risk of worsening kidney function, which is a primary concern in CKD. Additionally, it lowers the risk of cardiovascular events like heart attacks and hospitalization due to heart failure. By addressing both renal and cardiovascular aspects, Kerendia provides a comprehensive approach to managing the complications of CKD in diabetic patients.

How Kerendia Works

Kerendia, with its active ingredient finerenone, functions uniquely as a nonsteroidal mineralocorticoid receptor (MR) antagonist. This mechanism is pivotal in managing chronic kidney disease (CKD) and associated cardiovascular risks in patients with type 2 diabetes. Here’s an expanded view of how Kerendia works:

  1. Targeting Mineralocorticoid Receptors: MRs are found in various tissues, including the kidneys, heart, and blood vessels. They play a crucial role in regulating blood pressure and fluid balance. In conditions like type 2 diabetes, MRs can become overactive, leading to detrimental effects.
  2. Overactivity of MRs and Its Consequences: The overactivity of MRs in diabetes is linked to several pathological processes. This includes increased inflammation and fibrosis (scarring) in the kidneys and heart. In the kidneys, this can accelerate the progression of CKD, while in the heart and blood vessels, it can lead to cardiovascular complications.
  3. Action of Kerendia: Finerenone, by selectively blocking MRs, reduces their overactivity. Unlike older steroidal MR antagonists, finerenone is nonsteroidal, which contributes to its unique profile and potentially fewer side effects like gynecomastia (breast tissue growth in men) and hormonal imbalances.
  4. Reducing Inflammation and Fibrosis: By inhibiting MRs, Kerendia effectively reduces inflammation and fibrosis in the kidneys and cardiovascular system. This action is crucial in slowing down the progression of CKD and reducing the risk of cardiovascular events, such as heart attacks and heart failure.
  5. Clinical Benefits: The reduction in MR activity leads to decreased proteinuria (protein in urine), a marker of kidney damage. This indicates improved kidney function and a slower progression of CKD. Additionally, by mitigating cardiovascular risks, Kerendia helps in improving overall outcomes for patients with type 2 diabetes.
  6. Comprehensive Management of CKD in Diabetes: Kerendia’s ability to address both renal and cardiovascular aspects makes it a comprehensive treatment option. It not only slows the progression of kidney disease but also contributes to the overall cardiovascular health of the patient, which is a major concern in diabetes management.

Kerendia’s unique action as a nonsteroidal MR antagonist makes it an effective medication for managing CKD and associated cardiovascular risks in patients with type 2 diabetes. Its ability to reduce inflammation and fibrosis in key organs like the kidneys and heart is central to its therapeutic effects.

Dosage and Administration

Dosage Forms and Strengths

Kerendia is available in tablet form, with two dosage strengths: 10 mg and 20 mg. The choice of dosage depends on the patient’s kidney function and potassium levels.

Recommended Dosages

The starting dose of Kerendia is determined by the patient’s estimated glomerular filtration rate (eGFR). For eGFR ?60 mL/min/1.73 m², the starting dose is 20 mg once daily, and for eGFR 25-60 mL/min/1.73 m², it’s 10 mg once daily. Kerendia is not recommended for patients with eGFR <25 mL/min/1.73 m². After four weeks, the dosage may be adjusted based on eGFR and serum potassium levels.

Administration Instructions

Kerendia can be taken with or without food. For patients who have difficulty swallowing tablets, the tablet can be crushed and mixed with water or soft foods like applesauce. This mixture should be consumed immediately and not stored for future use.

Side Effects

Common Side Effects

Common side effects of Kerendia include low blood pressure (hypotension), low levels of sodium in the blood (hyponatremia), and dizziness or lightheadedness. These side effects are generally mild and may decrease over time as the body adjusts to the medication.

Serious Side Effects and Allergic Reactions

Serious side effects include high levels of potassium in the blood (hyperkalemia), which can be life-threatening if not managed properly. Symptoms of hyperkalemia include muscle weakness, slow or irregular heartbeat, and nausea. Allergic reactions to Kerendia are rare but can occur, presenting as rash, itching, swelling, severe dizziness, or trouble breathing.

Long-term Risks

Long-term use of Kerendia may require regular monitoring due to the risk of hyperkalemia. Patients with severe kidney impairment or those taking other medications that increase potassium levels should be closely monitored. Regular blood tests to check potassium and sodium levels, as well as kidney function, are recommended throughout the treatment.

Warnings and Precautions

Risks Associated with Kerendia

While Kerendia offers significant benefits in managing chronic kidney disease associated with type 2 diabetes, it also presents certain risks that require careful management:

  1. Hyperkalemia (High Potassium Levels): This is the most notable risk associated with Kerendia. Hyperkalemia can lead to serious cardiac issues if not managed properly. Patients with advanced kidney disease or those taking other medications that elevate potassium levels (like ACE inhibitors, ARBs, or certain diuretics) are particularly at risk. Symptoms of hyperkalemia include muscle weakness, fatigue, and heart palpitations, and it requires immediate medical attention.
  2. Hypotension (Low Blood Pressure): Kerendia may cause a drop in blood pressure, particularly in patients who are dehydrated, on diuretics, or have a low blood volume. This can lead to dizziness or fainting, and it’s important for patients to be aware of these symptoms, especially when standing up quickly from a sitting or lying position.

Conditions Under Which Kerendia Should Not Be Used

Kerendia’s use is contraindicated or should be approached with caution in certain conditions:

  1. Severe Renal Impairment: Patients with an eGFR below 15 mL/min/1.73 m², or those with end-stage kidney disease, should not use Kerendia due to the increased risk of hyperkalemia and other complications. In such cases, the risks outweigh the potential benefits.
  2. Adrenal Insufficiency: In patients with adrenal insufficiency, Kerendia should be used with caution. This condition can already predispose patients to elevated potassium levels, and adding Kerendia might exacerbate this risk.

Necessary Medical Tests Before and During Treatment

To ensure safe use of Kerendia, certain medical tests are recommended:

  1. Serum Potassium and eGFR Levels: Before initiating treatment, it’s crucial to check serum potassium and eGFR levels. These tests help in determining whether Kerendia is safe to start and at what dosage.
  2. Regular Monitoring: Once on Kerendia, regular monitoring of serum potassium is essential, particularly during the first month or after any dose adjustments. This helps in early detection and management of hyperkalemia. Monitoring kidney function through eGFR is also important to assess the ongoing impact of the medication and to make any necessary adjustments in therapy.
  3. Patient Education: Patients should be educated about the signs and symptoms of hyperkalemia and hypotension. They should also be advised on the importance of maintaining scheduled lab tests and follow-up appointments.

While Kerendia is a valuable medication for managing CKD in type 2 diabetes, it requires careful monitoring and consideration of patient-specific factors to ensure its safe use. Regular medical tests and patient awareness are key components of its effective management.

Interactions with Other Medications

Information on Drug Interactions

Kerendia’s interactions with other medications can significantly impact its effectiveness and safety profile:

  1. Strong CYP3A4 Inhibitors: These include certain antifungal medications (like ketoconazole and itraconazole) and antibiotics (such as clarithromycin). When used with Kerendia, these drugs can increase the levels of finerenone in the body, potentially leading to an increased risk of side effects, most notably hyperkalemia.
  2. Drugs Increasing Potassium Levels: Medications such as ACE inhibitors (like lisinopril), angiotensin receptor blockers (ARBs, such as losartan), and potassium-sparing diuretics (like spironolactone) can raise potassium levels in the blood. When combined with Kerendia, there is a heightened risk of hyperkalemia, which can have serious cardiac implications.
  3. Other Potential Interactions: Other drugs that may interact with Kerendia include lithium (used in bipolar disorder), nonsteroidal anti-inflammatory drugs (NSAIDs), and certain blood pressure medications. These interactions can affect how Kerendia or the other medications work or increase the risk of side effects.

Special Considerations for Use with Other Medications

When Kerendia is used in conjunction with other medications, special considerations are necessary:

  1. Close Monitoring: Patients taking Kerendia along with other medications that can affect potassium levels or kidney function should be closely monitored. This includes regular blood tests to check potassium levels and kidney function.
  2. Dosage Adjustments: Depending on the patient’s response and the presence of side effects, adjustments in the dosage of Kerendia or the concomitant medications may be required. This is particularly important when starting or stopping a medication known to interact with Kerendia.
  3. Patient Education: Patients should be educated about the potential for drug interactions and advised to inform their healthcare provider about all medications they are taking, including over-the-counter drugs and supplements. They should also be aware of the signs and symptoms of hyperkalemia and other potential side effects.
  4. Consultation with Healthcare Providers: Before starting any new medication, including over-the-counter drugs and herbal supplements, patients should consult with their healthcare provider to assess the risk of interactions with Kerendia.

Use in Specific Populations

Considerations for Use in Children

The use of Kerendia in pediatric populations requires careful consideration due to the lack of established data:

  1. Lack of Clinical Data: Currently, there are no sufficient studies or clinical trials that specifically evaluate the safety and efficacy of Kerendia in children. Without this data, it’s challenging to determine how the drug might affect younger patients, whose bodies can respond differently to medications compared to adults.
  2. Potential Risks: Given the lack of data, there are potential unknown risks that could arise from using Kerendia in pediatric patients. These risks might include unforeseen side effects or different pharmacokinetic properties in children.
  3. Recommendation: Due to these uncertainties, Kerendia is not recommended for use in children. Healthcare providers typically prefer to prescribe medications that have been thoroughly studied and proven safe and effective in pediatric populations.

Considerations for Use in the Elderly

Elderly patients often require special consideration when prescribing medications like Kerendia:

  1. Increased Sensitivity: Older adults may be more sensitive to the effects of Kerendia. This increased sensitivity can manifest as a higher susceptibility to hypotension (low blood pressure) and changes in renal function. These effects are particularly concerning in elderly patients who may already have compromised kidney function or other age-related health issues.
  2. Monitoring and Dosage Adjustments: Due to these risks, it’s important for healthcare providers to closely monitor elderly patients on Kerendia. This monitoring might include regular blood pressure checks and kidney function tests. Dosage adjustments may be necessary based on the patient’s response to the medication and the presence of side effects.
  3. Polypharmacy Considerations: Elderly patients are often on multiple medications (polypharmacy), increasing the risk of drug interactions. Careful review of all medications is essential to avoid interactions that could enhance the side effects of Kerendia or reduce its efficacy.
  4. Individualized Treatment: Treatment plans for elderly patients should be individualized, taking into account their overall health, existing medical conditions, and any other medications they are taking. This personalized approach helps to ensure the safe and effective use of Kerendia in this population.