BIOMUS 0.25MG CAPSULE

Brand Name: Biomus

Molecule: Tacrolimus

Strength: 0.25 mg

Quantity: 10 Capsules

Form: Capsule

Packaging Type: Strip

Manufacturer/Marketed By: Alniche Life Sciences Private Limited

Country of Origin: India

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Overview

- Introduction
- Benefits
- Indications and Usage
- How it Works
- Dosage & Administration
- Side Effects
- Warning and Precaution
- Patient Guidance
- Clinical Trial & Approvals
- References

Description

Biomus 0.25mg Capsule is an immunosuppressant. It works by suppressing your body's immune response following the transplant of an organ (e.g., liver, kidney, heart). This helps your body to accept the new organ as if it were your own.

Benefits

Biomus 0.25mg Capsule is used along with other medicines to prevent your body from rejecting a new organ (e.g., liver, kidney, or heart) after transplant.

Indications and Usage

The main uses of the Biomus 0.25mg capsule are:

Prevention of organ rejection in patients receiving an allogeneic (from a donor) kidney, liver, or heart transplant.
It is typically used as part of a combination therapy with other medicines to weaken the body’s immune system, which helps the body accept the new organ as its own.

Off-label and Other Potential Uses
In some cases, and under strict medical supervision, it may also be used for other immune-mediated disorders when standard treatments are ineffective:

Treatment of refractory (resistant) rejection in existing transplant patients.
Management of certain severe autoimmune diseases, such as rheumatoid arthritis or Crohn’s disease.
Management of autoimmune liver diseases or autoimmune eye conditions (uveitis).
Prevention of graft-versus-host disease after a bone marrow or stem cell transplant.

How it Works

BIOMUS 0.25MG CAPSULE (active ingredient: tacrolimus) is an immunosuppressant medication. It works by weakening the body’s immune system to prevent it from attacking and rejecting a transplanted organ.

Dosage & Administration

Dosage

The exact daily dose is determined by your physician and depends on:

The type of organ transplant (kidney, liver, heart, etc.).
Your body weight.
Your individual response to the medication.
Other medicines you may be taking concurrently.

Your doctor will perform regular blood tests to monitor the levels of tacrolimus in your blood and adjust the dosage to ensure it is within the safe and effective range.

Administration

Take Biomus 0.25mg capsules exactly as prescribed by your doctor, preferably on an empty stomach (1 hour before or 2-3 hours after a meal) for best absorption. Swallow the capsule whole with water; do not crush, chew, or open it. Take the dose at the same time daily for consistent blood levels. Do not stop taking the medication suddenly, as this can lead to organ rejection. If a dose is missed, take it when you remember, but skip it if it’s close to the next scheduled dose. Never double the dose.

Side Effects

Common Side Effects

Most common side effects are temporary, but you should consult your doctor if they persist or worsen.

Tremors (shakiness)
Headache
Insomnia (difficulty sleeping)
Nausea, vomiting, stomach pain, and/or diarrhea
High blood pressure (hypertension)
Increased blood sugar levels (hyperglycemia), which may lead to diabetes
Abnormal liver function tests
Increased blood creatinine and impaired kidney function
Anemia and low white blood cell count
Burning or tingling sensation (paresthesia)

Warning and Precaution

It is crucial to consult your doctor or healthcare provider for personalized medical advice and monitoring while taking this medication.

Key Warnings and Serious Precautions

Increased Risk of Infection: Because Biomus suppresses the immune system, you are more susceptible to infections, which can be serious or fatal. Report any signs of infection (fever, chills, sore throat, cough, flu-like symptoms, unusual skin sores) to your doctor immediately.
Increased Cancer Risk: Long-term use of immunosuppressants can increase the risk of developing certain cancers, particularly skin cancer and lymphoma. You should limit exposure to natural and artificial UV light (sunlamps, tanning beds) and wear protective clothing and high-SPF sunscreen when outdoors.
Kidney and Liver Problems: Biomus can cause or worsen kidney and liver problems. Regular blood tests to monitor kidney and liver function are essential.
Diabetes and High Blood Pressure: The medication can increase blood sugar levels (potentially causing new-onset diabetes) and raise blood pressure. Your blood pressure and glucose levels will need frequent monitoring.
Pregnancy and Breastfeeding: Biomus is generally not recommended during pregnancy or breastfeeding as it may harm the baby. Both men and women should use effective birth control during treatment to prevent pregnancy.
Nervous System Effects: The medicine may cause tremors, headaches, vision changes, or dizziness. Avoid driving or operating machinery if you experience these symptoms.

Important Precautions and Interactions

Do Not Stop Abruptly: Never stop taking Biomus without consulting your doctor first, as sudden discontinuation can lead to organ rejection.
Vaccinations: Avoid live vaccines (e.g., measles, mumps, rubella, chickenpox, yellow fever) while on this medication, as they may not be effective or could cause infection.
Alcohol and Grapefruit: Avoid consuming alcohol and grapefruit or grapefruit juice, as they can interfere with the drug’s metabolism and increase the risk of side effects or toxicity.
Medication Interactions: Inform your doctor about all other medications, supplements, and herbal preparations you are taking, as many can interact with tacrolimus. Certain antibiotics, antifungals, and blood pressure medications require caution.
Monitoring: You will need regular medical tests (blood counts, kidney/liver function, blood pressure, glucose, potassium, magnesium levels) to monitor your progress and adjust the dose as needed.
Administration: Take the capsule as a whole on an empty stomach, at least one hour before or two to three hours after a meal, at the same time each day. Do not crush, chew, or break the capsule.

Patient Guidance

Key Usage Instructions

Take the capsule whole on an empty stomach, at least one hour before or two to three hours after eating. Do not crush, chew, or break the capsule. Take your dose at the same time each day for consistent blood levels. Do not stop taking the medication abruptly, as this can lead to organ rejection. If you miss a dose, take it when you remember, but skip it if it’s almost time for your next dose; never double up.

Important Precautions and Warnings

This medication requires supervision by a specialist. You will need regular medical tests to monitor tacrolimus levels, organ function, blood pressure, and blood glucose. Avoid grapefruit and grapefruit juice due to interactions that can raise tacrolimus levels. Alcohol should be avoided, and the medicine is generally not advised during pregnancy or breastfeeding. Biomus increases your risk of infection, so report any signs of illness to your doctor. Limit sun and UV exposure and use protection due to increased skin cancer risk. Avoid live vaccines and consult your doctor before any vaccination.

Clinical Trial & Approvals

Regulatory Approvals of Tacrolimus

Tacrolimus (brand name Prograf) received primary regulatory approvals in the 1990s and has since been approved for various transplant indications.

U.S. Food and Drug Administration (FDA): Tacrolimus was first approved by the FDA on April 8, 1994, for the prophylaxis (prevention) of organ rejection in patients receiving liver transplants. Subsequent approvals expanded its use to kidney, heart, and lung transplants in both adult and pediatric patients.
European Medicines Agency (EMA) / European Union: Tacrolimus was first approved in the EU in 1994 (initially in the UK for liver and kidney transplantation). A harmonized marketing authorization for the brand Prograf was issued by the European Commission on April 10, 2006.
Biomus (Generic) Approval: Biomus is a generic version of tacrolimus marketed by Alniche Life Sciences in India. Generic medications are approved based on demonstrating bioequivalence to the original, brand-name drug, meaning they work in the same way and provide the same clinical effect. They do not undergo the same large-scale, de novo clinical trials as the original patented drug.

Key Clinical Trial Findings

The efficacy and safety of tacrolimus have been confirmed through numerous clinical trials conducted over several decades.

Organ Transplant Prevention: Multiple large-scale, multicenter clinical trials have demonstrated that tacrolimus is a highly effective primary immunosuppressant, significantly reducing acute rejection rates in kidney, liver, and heart transplant recipients compared to other medications like cyclosporine.
Long-Term Benefits: Studies show that tacrolimus-based immunosuppression may lead to improved long-term graft function and survival rates.
Side Effect Profile: Clinical trials identified specific side effects associated with tacrolimus use, such as diabetes mellitus and neuro/nephrotoxicity, which are more common than with cyclosporine; however, its overall efficacy profile has made it a cornerstone therapy in transplantation medicine.

References

Biomus 0.25mg Capsule is used along with other medicines to prevent your body from rejecting a new organ

2 reviews for BIOMUS 0.25MG CAPSULE

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Test Review – December 10, 2025

Rated 5 out of 5
Delivery process is very good, and the support system is very good.
good one – December 10, 2025

Rated 5 out of 5
best delivery and support system and most affordibility

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