Lyvelsa 10 Tablet

✔️ The most commonly reported side effects include:

• High potassium levels (hyperkalemia)
• Low blood pressure (hypotension)
• Low sodium levels (hyponatremia)

✔️ The recommended starting dose depends on kidney function (eGFR):

• eGFR ≥60 mL/min/1.73 m²: 20 mg once daily
• eGFR 25 to <60 mL/min/1.73 m²: 10 mg once daily
• eGFR <25 mL/min/1.73 m²: Use is not recommended

After 4 weeks, the dose may be increased to 20 mg once daily if serum potassium levels and kidney function remain appropriate.

• Tablets may be taken with or without food.
• If swallowing is difficult, the tablet may be crushed and mixed with water or soft food.
• Children: Safety and effectiveness have not been established in patients under 18 years.
• Older adults: No dose adjustment is generally required.
• Hepatic impairment: Avoid use in severe liver disease (Child-Pugh C). No dose adjustment is required for mild to moderate impairment, although additional potassium monitoring may be appropriate in moderate hepatic impairment.

Missed dose: Take the missed dose as soon as you remember on the same day. If the entire day has passed, skip the missed dose and continue with the next scheduled dose. Do not take two doses on the same day.

✔️ Before starting treatment and during therapy:

• Check serum potassium and eGFR
• Do not start treatment if serum potassium is greater than 5.0 mEq/L
• Recheck potassium 4 weeks after starting treatment, after any dose adjustment, and periodically thereafter

✔️ Drug Interactions

Use caution with medications that affect Finerenone metabolism or potassium levels.

• Strong CYP3A4 inhibitors are contraindicated because they significantly increase Finerenone levels.
• Moderate or weak CYP3A4 inhibitors may require closer potassium monitoring and dose adjustments.
• Strong or moderate CYP3A4 inducers may reduce the medicine's effectiveness and should generally be avoided.
• Avoid consuming grapefruit or grapefruit juice during treatment.

✔️ Overdose

An overdose is most likely to cause hyperkalemia. If an overdose is suspected, discontinue the medicine immediately and provide appropriate medical treatment. Finerenone is not effectively removed by hemodialysis due to its high protein binding.

✔️ Do not use Lyvelsa in patients with:

• Hypersensitivity to the drug or its ingredients
• Adrenal insufficiency
• Concomitant treatment with strong CYP3A4 inhibitors

✔️ Pregnancy & Breastfeeding

Pregnancy: There is limited human data regarding the use of Finerenone during pregnancy. It should only be used if the expected benefit outweighs the potential risk to the fetus.

Breastfeeding: It is unknown whether Finerenone passes into human breast milk. Due to the potential risk to the nursing infant, breastfeeding should be avoided during treatment and for 1 day after the last dose.

✔️ Precautions & Warnings

Lyvelsa may increase the risk of hyperkalemia, especially in patients with reduced kidney function or those taking other medicines that raise potassium levels.

Before and during treatment:

• Monitor serum potassium and kidney function regularly.
• More frequent monitoring may be required in patients at higher risk of elevated potassium.

✔️ Storage:

• Store below 30°C.
• Protect from light and moisture.
• Keep out of the reach of children.