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LUCIFINE Finerenone Tablets

What is LUCIFINE Finerenone Tablets

LUCIFINE Finerenone Tablets Is a non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline end stage kidney disease, cardiovascular death non-fatal myocardial infarction, and hospitalization for hear failure in adult patients with chronic kidney disease(CKD) associated with type 2 diabetes T2D).

Who Makes Lucifine Finerenone Tablets And Are They Safe?

LUCIFINE Finerenone Tablets are produced by the well-known Laotian generic pharmaceutical factory, LUCIUS Pharmaceutical Co., Ltd. LUCIUS Pharmaceutical Co., Ltd., established in 2014 in the pharmaceutical hub of Hyderabad, India, boasts significant reserves of pharmaceutical technology and skilled personnel, making it one of the world’s leading companies in the field of generic pharmaceutical capabilities.

LUCIUS Pharmaceutical (Laos) Co., Ltd. has officially established a 25,000-square-meter factory in Laos, equipped with comprehensive facilities including a high-end formulation international project integrated formulation workshop, office building, staff dormitory, and a swimming pool.

Can Lucifine Finerenone Tablets Treat Diabetic Kidney Disease?

On October 26, 2020, Bayer held a global media briefing during the American Society of Nephrology’s 2020 Kidney Week to present the results of the FIDELIO-DKD Phase III clinical study for the investigational drug Finerenone. This presentation focused on the significant risks associated with the co-occurrence of chronic kidney disease and type 2 diabetes, shedding light on the latest findings from the FIDELIO-DKD Phase III clinical trial.

Dr. Richard Nkulikiyinka, the Clinical Development Head for Cardiology and Nephrology at Bayer in Germany, introduced Finerenone as an investigational, novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). Research has shown that it can prevent various damages caused by the excessive activation of the mineralocorticoid receptor. The overactivation of this receptor leads to inflammation and fibrosis, which are significant factors in the damage to the kidneys and cardiovascular system.

Finerenone was discovered after screening over a million compounds, and it differs from existing mineralocorticoid receptor antagonists in that it is fundamentally non-steroidal, often referred to as a non-steroidal mineralocorticoid receptor antagonist. Extensive animal studies have shown its effective anti-inflammatory and anti-fibrotic properties in both the kidneys and the heart. Moreover, Phase II clinical trial ARTS-DN demonstrated that it can improve a patient’s proteinuria without being influenced by blood pressure. Hence, when conducting the FIDELIO-DKD clinical study, it was assumed that the MR antagonistic action of this drug would slow the progression of kidney disease in chronic kidney disease and type 2 diabetes patients while reducing the incidence of cardiovascular disease and mortality.

Basic Information Of LUCIFINE Finerenone Tablets

LUCIFINE Finerenone Tablets

—–DOSAGE AND ADMINISTRATION—–
The recommended starting dosage is 10 mg or 20 mg orally once daily based on estimated glomerular filtration rate (eGFR) and serum potassium thresholds.(2.1)

increase dosage after 4 weeks to the target dose of 20 mg once dally, based on eGFR and serum potassium thresholds.(2.3)

Tablets may be taken with or without food (2.2)

—–DOSAGE FORMS AND STRENGTHS —–
Tablets:10 mg

—–CONTRAINDICATIONS—–
Concomitant use with strong CYP3A4 inhibitors.(4.7.1)
Patients with adrenal insufficiency. (4)

—–WARNINGSAND PRECAUTIONS—–
Hyperkalemia. Patients with decreased kidney function and higher baseline potassium levels are atincreased risk. Monitor serum potassium levels and adjust dose as needed.(2.1,2.2,2.3,5.1)
—–ADVERSE REACTIONS—–
Adverse reactions occurring in ≥1% of patients on LUCIFINE and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia.(6.1)
—–DRUG INTERACTIONS—–
Strong CYP3A4 Inhibitors: Use iscontraindicated.(7.1)
Grapefruit or grapefruit juice: Avoid concomitant use.(7.1)
Moderate or weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either LUCIFINE or the moderate or weak CYP3A4 inhibitor, and adjust LUCIFINE dosage appropriate (7.1)
Strong or moderate CYP3A4 Inducers: Avoid concomitant use.(7.1)
—–USE IN SPECIFIC POPULATIONS—–
Lactation: Breastfeeding not recommended(8.2)

LUCIFINE Finerenone Tablets
LUCIFINE Finerenone Tablets
LUCIFINE Finerenone Tablets
LUCIFINE Finerenone Tablets

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LUCIFINE Finerenone Tablets Indications And Usage

LUCIFINE Finerenone Tablets 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).

LUCIFINE Finerenone Tablets Dosage And Administration

2.1 Prior to lnitiation of LUCIFINE

Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation Do not initiate treatment if serum potassium is 5.0 mEq/L [see Warnings and Precautions].

2.2 Recommended Starting Dosage

The recommended starting dose of LUCIFINE is based on eGFR and is presented in Table 1

Table 1: Recommended Starting Dosage Starting Dosage

eGFR(mL/min/173m2)Starting Dose
≥6020 mg once daily
≥25t0<6010 mg once daily
<25Initiation is not recommended
Table 1: Recommended Starting Dosage Starting Dosage

For patients who are unable to swallow whole tablets LUCIFINE may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally.

2.3 Monitoring and Dose Adjustment

The target daily dose of LUCIFINE is 20 mg. Measure serum potassium 4 weeks after initiating treatment and adjust dose (see Table 2); if serum potassium levels are >4.8 to 5.0 mEa/L, initiation of LUCIFINE treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassiume lvels [see Warnings and Precautions (5.1).]

Monitor serum potassium 4 weeks after a dose adjustment and throughout treatment, and adjus tthe dose as needed (see Table 2)[see Warnings and Precautions(5.1) and Drug interactions7.1].

Table 2: Dose Adjustment Based on Current Serum Potassium Concentration and Current Dose

Current LUCIFINE Dose
 10 mg once daily20 mg once daily
CurrentSerumPotassium(mEq/L)≤4.8Increase the dose to20 mg once daily.*Maintain 20 mg oncedaily.
 CurrentSerumPotassium(mEq/L)>4.8-5.5Maintain 10 mg oncedaily.Maintain 20 mg oncedaily.
 CurrentSerumPotassium(mEq/L)>5.5Withhold LUCIFINEConsider restartingat 10 mg once dailywhen serumpotassium≤5.0mEq/L.Withhold LUCIFINERestart at 10 mgonce daily whenserumpotassium<5.0 mEq/L
IF eGFR has decreased by more than 30% compared to previous measurement,maintain 10 mg dose.

2.4 Missed doses

Directa patient to take a missed dose as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed.

LUCIFINE Finerenone Tablets Dosage Forms And Strengths

lUCIFINE 10 mg as reddish-brown, roundshaped,film-coated tablets debossed with the Lus’on one side.

LUCIFINE Finerenone Tablets Contraindications

LUCIFINE is contraindicated in patients:

Who are receiving concomitant treatment with strong CYP3A4 inhibitors [see Drug Interactions (7.1)].

With adrenal insufficiency.

LUCIFINE Finerenone Tablets Warnings and Precautions

5.1 Hyperkalemia

LUCIFINE can cause hyperkalemia [see Adverse reactions (6.1)].

The risk for developing hyperkalemia increases with decreasing kidney function and is greater inpatients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with LUCIFINE and dose accordingly [see Dosage and Administration(2.1)]. Do not initiate LUCIFINE if serum potassium is >5.0 mEa/L.

Measure serum potassium periodically during treatment with LUCIFINE and adjust dose accordingly [see Dosage and Administration(2.3)]. 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 [see Drug lnteractions (7.1.7.2)].

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LUCIFINE Finerenone Tablets Adverse Reactions 

The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions(5.1)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of a drug and may not reflect the rates observed in practice.

The safety of LUCIFINE was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKDin which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively.

Overall, serious adverse events occurred in 32% of patients receiving LUCIFINE and in 34% of patients receiving placebo in the FIDELIO-DKD study: the findings were similar in the FIGARODKD study. Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving LUCIFINE and in 5-6% of patients receiving placebo).

The most frequently reported (≥10%)adverse reaction in both studies was hyperkalemia [see Warnings and Precautions(5.1)]. Hospitalization due to Hyperkalemia for the LUCIFINE was 0.9% vs 0.2% in the placebo group across both studies. Hyperkalemia led to permanent discontinuation of treatment in 1.7% receiving LUCIFINE versus 0.6% of patients receiving placebo across both studies.

Table 3 shows adverse reactions that occurred more commonly on LUCIFINE than on placebo and in at least 1% of patients treated with LUCIFINE

Table 3: Adverse reactions reported in >1% of patients on LUCIFINE and more frequently than placebo (Pooled data from FIDELIO-DKD and FIGARO-DKD)

Adverse reactionsLUCIFINEN=6510n(%)PlaceboN =6489n(%)
Hyperkalemia912(14.0)448(6.9)
Hypotension302(4.6)194(3.9)
Hyponatremia82(1.3)47(0.7)
Laboratory Tes1

LUCIFINE Finerenone Tablets Drug Interactions

7.1 CYP3A4 Inhibitors and inducers

Strong CYP3A4 Inhibitors

LUCIFINE is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases Finerenone exposure, which may increase the risk of LUCIFINE adverse reactions. Concomitant Use of LUCIFINE with strong CYP3A4 inhibitors is contraindicated see Contraindications (4) Avoid concomitant intake of grapefruit or grapefruit juice.

Moderate and Weak CYP3A4 Inhibitors LUCIFINE is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases Finerenone exposure, which may increase the risk of LUCIFINE adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either LUCIFINE or the moderate or weak CYP3A4 inhibitor, and adjust LUCIFINE dosage as appropriate [(see Dosing and Administration (2.3) and Drug interaction (7 .2)]. Strong and Moderate CYP3A4 inducers.

LUCIFINE is a CYP3A4 substrate. Concomitant use of LUCIFINE with a strong or moderate CYP3A4 inducer decreases Finerenone exposure. which may reduce the efficacy of LUCIFINE. Avoid concomitant use of LUCIFINE with strong or moderate CYP3A4 inducers.

7.2 Drugs That Affect Serum Potassium

More frequent serum potassium monitoring is warranted in patients receiving concomitant therapy with drugs or supplements that increase serum potassium.[see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].

LUCIFINE Finerenone Tablets Use In Specific Populations

8.1 Pregnancy

Risk Summary

There are no available data on LUCIFINE use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about4 times those expected in humans (see Data). The clinical significance of these findings is unclear The estimated background risk of major birth defects and miscarriage for the indicated population is unknown All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

Data

Animal Data

In the embryo-fetal toxicity study in rats, Finerenone resulted in reduced placental weights and signs of fetal toxicity, including reduced fetal weights and retarded ossification at the maternal toxic dose of 10 mg/kg/day corresponding to an AUCunbound of 19 times that in humans At 30mg/kg/day, the incidence of visceral and skeletal variations was increased (slight edema shortened umbilical cord, slightly enlarged fontanelle) and one fetus showed complex malformations including a rare malformation (double aortic arch) at an AUCunbound of about 25 times that in humans. The doses free of any findings (low dose in rats, high dose in rabbits) provide safety margins of 10 to 13 times for the AUCunbound expected in humans.

When rats were exposed during pregnancy and lactation in the pre-and postnatal developmental toxicity study increased pup mortality and other adverse effects (lower pup weight, delayed pinna unfolding) were observed at about 4 times the AUCunbound expected in humans. In addition, the offspring showed slightly increased locomotor activity, but no other neurobehavioral changes starting at about 4 times the AUCunbound expected in humans. The dose free of findings provides a safety margin of about 2 times for the AUCunbound expected in humans.

8.2 Lactation

Risk Summary

There are no data on the presence of Finerenone or its metabolite in human milk the effects on the breastfed infant or the effects of the drug on milk production. ln a pre-and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at about 4 times the AUCunbound expected in humans. These findings suggest that Finerenone is present in rat milk see Use in Specific Populations (8.1) and Data When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to LUCIFINE avoid breastfeeding during treatment and for 1 day after treatment.

8.3 Pediatric Use

The safety and efficacy of LUCIFINE have not established in patients below 18 years of age.

8.4 Geriatric Use

Of the 6510 patients who received LUCIFINE in the FIDELIO-DKD and FIGARO-DKD studies 55% of patients were 65 years and older, and 14% were 75 years and older. No overall difference! safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.

8.5 Hepatic Lmpairment

Avoid use of LUCIFINE in patients with severe hepatic impairment (Child Pugh C). No dosage adjustment is recommended inpatients with mild or moderate hepatic impairment(Child Pugh A or B).

Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B)[see Dosing and Administration2.3).

LUCIFINE Finerenone Tablets Overdosage

in the event of suspected overdose, immediately interrupt LUCIFINE treatment. The most likely manifestation of overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated.

Finerenone is unlikely to be efficiently removed by hemodialysis given its fraction bound to plasma proteins of about 90%.

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How Supplied/Storage And Handling

10.1 How Supplied

LUCIFINE 10mg as reddish-brown, round-shaped, film-coated tablets debossed with the Lus’on one side. LUCIFINE 10 mg is available in bottles of 30 tablets.

10.2 Storage and Handling

Store at 20°C to 25°C (68°F to 77); excursions are permitted from 15°C to 30°C(59Fto 86F)[see USP Controlled Room Temperature].

A diabetic kidney disease patient regained his life by taking LUCIFINE Finerenone


Patient Name: Mr. Lee

Gender: Male

Age: 50 years

Medical History: Diabetic for 20 years

Physical Condition:

Height: 181 cm

Weight: 106 kg

Body Type: Obese

Disease Progression: Long-term efforts to control blood sugar, developed into diabetic kidney disease in recent years

Treatment and Financial Burden: Long-term medication, significant financial burden

Mr. Lee, a 50-year-old, came to DKD Care Center in July seeking advice, reflecting on his 20-year struggle with diabetes. Mr. Lee is tall, but his weight clearly exceeds the recommended limit, a visible sign of his long battle with diabetes. Once proud of his weight, it has now become a burden to his health.

Diabetes is not Mr. Lee’s only challenge. Over time, he developed complications, especially diabetic kidney disease. He recalls the days when he had to cut down on family expenses to afford expensive medications. However, despite all efforts, his condition did not seem to fundamentally improve.

Just when Mr. Lee felt uncertain about the future, he came across information about DKD Care Center on a diabetic kidney disease Facebook group. Holding onto his last shred of hope, Mr. Lee decided to consult with DKD Care Center online. The doctors at DKD Care Center first understood Mr. Lee’s basic physical condition and then asked him to provide his medical reports, including physical examination, blood tests, and urine analysis reports.

Considering Mr. Lee’s physical condition and financial situation, the doctors at DKD Care Center introduced him to a new medication for diabetic kidney disease—LUCIFINE Finerenone. This drug, developed by a pharmaceutical company in Laos, has shown excellent therapeutic effects for diabetic kidney disease and is very affordable. This medication ignited new hope in Mr. Lee’s heart. He started the treatment, adjusting his lifestyle and diet under the guidance of the doctors. Miraculously, his health began to show significant improvement.

With gradual weight loss and stabilized blood sugar, Mr. Lee felt like he was reborn. He reengaged in community activities and shared joyful moments with his family. Finerenone is not just a medication; for Mr. Lee, it is a gateway to a new life.

6 Symptoms Indicating You Might Have Diabetic Kidney Disease

Why Choose LUCIFINE Finerenone Tablets

It’s widely known that the treatment for type 2 diabetes, RYBELSUS® (semaglutide) tablets, comes with a high cost of up to $995 for 30 tablets. Similarly, the medication for treating diabetic kidney disease, Kerendia finerenone tablets, can be as expensive as $670 for 30 tablets. The exorbitant prices of these medications undoubtedly add to the challenges faced by patients in their daily lives.

Is there an equally effective but more affordable medication available? The answer is LUCIFINE finerenone tablets produced by Lucius Pharmaceuticals. LUCIFINE finerenone tablets are a diabetes kidney disease treatment that has received approval from the Laotian Ministry of Health and is manufactured in Lucius Pharmaceuticals’ GMP factory in Laos, as approved by the U.S. FDA.

LUCIFINE finerenone tablets are not only a legitimately authorized medication but also come at a very affordable price, being only one-third the cost of Kerendia finerenone tablets while delivering the same efficacy.

DKD Care Center serves as the authoritative global distributor for LUCIFINE finerenone tablets, and we possess the necessary authorization certificates from Lucius Pharmaceuticals. The introduction of this new medication comes with significant discounts. If you have been suffering from diabetic kidney disease for an extended period, please don’t hesitate to contact us promptly:

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Phone: +852 6993858

Whatsapp: +856 9506 4225

Email: service@finerenonediabeticnephropathy.com

Website: finerenonediabeticnephropathy.com

LUCIFINE Finerenone Tablets Letter of authorization