Product image of Modigraf (Tacrolimus) supplied by GNH India

Modigraf

Active Ingredient:
Tacrolimus
Origin:
EU

Modigraf (Tacrolimus)

Tacrolimus, the active ingredient in Modigraf, is a calcineurin inhibitor presented as an oral formulation for oral use. It is employed to reduce immune‑mediated rejection in organ transplant recipients and to modulate immune activity in selected autoimmune conditions.

GNH India supplies Modigraf as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and pharmacies worldwide.

Manufacturer / TM Owner

Astellas Pharma Europe B.V.

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Indications & Clinical Uses

Tacrolimus is used in transplantation medicine to inhibit T‑cell activation and prevent graft rejection.

  • Kidney transplant: lowers the incidence of acute rejection and supports graft survival.
  • Liver transplant: reduces early rejection episodes and improves long‑term graft function.
  • Heart transplant: diminishes the risk of cellular rejection and prolongs graft longevity.

How It Works

  • Tacrolimus binds to the intracellular protein FKBP‑12, forming a complex that inhibits the phosphatase activity of calcineurin. This blockade prevents dephosphorylation of nuclear factor of activated T‑cells (NF‑AT), thereby suppressing interleukin‑2 gene transcription and subsequent T‑cell activation, leading to reduced immune response.

Side Effects

Tacrolimus may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Headache: mild to moderate intensity.
  • Nausea: occasional gastrointestinal upset.
  • Tremor: fine shaking of hands or limbs.
  • Hypertension: elevated blood pressure readings.
  • Hyperglycemia: increased blood glucose levels.
  • Elevated serum creatinine: mild renal function changes.

Serious or Rare Side Effects

  • Nephrotoxicity: significant decline in kidney function.
  • Neurotoxicity: seizures, confusion, or severe tremor.
  • Infections: opportunistic bacterial, viral, or fungal infections.
  • Malignancy: increased risk of lymphomas and skin cancers.
  • Severe allergic reactions: rash, angioedema, or anaphylaxis.
  • Hepatotoxicity: abnormal liver enzymes or liver injury.

Precautions & Warnings

When prescribing or dispensing tacrolimus, several safety considerations are essential.

  • Renal monitoring: regularly assess serum creatinine and glomerular filtration rate.
  • Blood pressure control: monitor and manage hypertension throughout therapy.
  • Glucose surveillance: check fasting glucose and HbA1c for hyperglycemia.
  • Lipid profile: evaluate cholesterol and triglycerides periodically.
  • Infection vigilance: screen for latent infections and advise on infection signs.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Tacrolimus interacts with many medicines that affect its metabolism or toxicity profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise tacrolimus levels dramatically.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): can lower tacrolimus concentrations.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): increase risk of nephrotoxicity.
  • Azole antifungals (e.g., fluconazole): elevate tacrolimus exposure.
  • Macrolide antibiotics (e.g., erythromycin): potentiate tacrolimus levels.

Moderate Interactions (Monitor Closely)

  • Calcium channel blockers (e.g., diltiazem): may modestly increase tacrolimus.
  • Diuretics (e.g., furosemide): can affect renal handling.
  • ACE inhibitors or ARBs: monitor blood pressure and renal function.
  • Anticoagulants (e.g., warfarin): watch for altered INR.
  • Live vaccines: risk of infection due to immunosuppression.

Frequently Asked Questions

Modigraf contains tacrolimus, an immunosuppressant used primarily to prevent acute rejection in organ transplant recipients such as kidney, liver, and heart transplants. It works by dampening the immune response that can damage the transplanted organ.

Tacrolimus binds to the intracellular protein FKBP‑12, and the resulting complex inhibits calcineurin. This blocks the activation of nuclear factor of activated T‑cells, reducing interleukin‑2 production and ultimately suppressing T‑cell activation and proliferation.

The dosage of Modigraf is individualized. A qualified prescriber determines the exact amount based on the type of transplant, patient weight, renal function, and therapeutic drug monitoring results. No fixed regimen is provided here.

Safety data for tacrolimus in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs possible risks to the fetus or infant, and this decision must be made by a healthcare professional.

To order Modigraf, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Both tacrolimus (Modigraf) and cyclosporine are calcineurin inhibitors, but tacrolimus is generally more potent on a milligram‑per‑milligram basis and may have a different side‑effect profile, including lower incidence of gum hyperplasia but higher risk of nephrotoxicity. Choice depends on clinical judgment and patient tolerance.

Modigraf should be stored at ambient temperature, below 25 °C, in its original container to protect it from moisture and light. Keep the product out of reach of children and do not use it after the expiry date printed on the label.

Modigraf is taken orally, usually as whole tablets or capsules. It can be taken with or without food, but consistency with meals is recommended to maintain stable blood levels. Swallow the dose whole; do not crush or chew unless specifically instructed by a clinician.

The most serious risks include nephrotoxicity (potential kidney damage), severe infections due to immunosuppression, malignancies such as post‑transplant lymphoproliferative disorder, and neurotoxicity manifesting as seizures or severe tremor. Patients should be monitored closely for these events.

Modigraf is contraindicated in individuals with known hypersensitivity to tacrolimus or any excipients, uncontrolled systemic infections, severe liver impairment, and in patients where the risk of graft rejection is not present. Clinicians must evaluate each case before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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