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Tacrograf 1mg Capsule 1 Strip
Tacrograf, a calcineurin inhibitor, is an immunosuppressant used for the prophylaxis of organ rejection in both adult and pediatric patients undergoing:
- Liver transplant
- Kidney transplant
- Heart transplant
- Lung transplant
It is used in combination with other immunosuppressants, such as corticosteroids, azathioprine, or mycophenolate mofetil (MMF).
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✅ Description:
Tacrograf contains tacrolimus, which binds to the intracellular protein FKBP-12. This binding forms a complex with calcium, calmodulin, and calcineurin, thereby inhibiting calcineurin's phosphatase activity.
Key pharmacological effects:
- Cytokine inhibition: Reduces the expression and/or production of cytokines, including:
- IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10
- γ-Interferon
- Tumor necrosis factor-alpha (TNF-α)
- Immune suppression:
- Inhibits activation and proliferation of T-lymphocytes.
- Suppresses T-helper cell-dependent B-cell responses.
- Reduces nitric oxide release and induces apoptosis.
Outcome: Prevents immune-mediated rejection of transplanted organs
Relevant Products / প্রাসঙ্গিক পণ্য
✔️ Dosage & Administration: General Guidelines:
- Administer orally every 12 hours.
- Begin the initial dose 6 hours after transplantation for liver, heart, or lung transplants.
- For kidney transplants, administer within 24 hours of transplantation after ensuring renal function recovery.
- Target trough concentrations of tacrolimus in the blood should guide dose adjustments.
✔️ Important Notes:
- Use of tacrolimus should be individualized based on transplant type, patient condition, and concurrent immunosuppressive therapy.
- Patients with hepatic or renal impairment may require dose modifications.
- Consult your physician for detailed guidance based on the specific transplant scenario.
✔️ Dosage for Adults:
| Transplant Type | Initial Oral Dose (mg/kg/day) | Whole Blood Trough Concentration (ng/mL) |
|---|---|---|
| Kidney transplant | ||
| With azathioprine | 0.2 mg/kg/day | Month 1–3: 7–20; Month 4–12: 5–15 |
| With MMF/IL-2 receptor antagonist | 0.1 mg/kg/day | Month 1–12: 4–11 |
| Liver transplant | 0.1–0.15 mg/kg/day | Month 1–12: 5–20 |
| Heart transplant | 0.075 mg/kg/day | Month 1–3: 10–20; Month ≥4: 5–15 |
| Lung transplant | 0.075 mg/kg/day | Month 1–3: 10–15; Month 4–12: 8–12 |
Note: Patients with cystic fibrosis undergoing lung transplants may require higher doses due to reduced bioavailability. Monitor trough levels closely.
✔️ Dosage for Pediatric Patients:
| Transplant Type | Initial Oral Dose (mg/kg/day) | Whole Blood Trough Concentration (ng/mL) |
|---|---|---|
| Kidney transplant | 0.3 mg/kg/day | Month 1–12: 5–20 |
| Liver transplant | 0.15–0.2 mg/kg/day | Month 1–12: 5–20 |
| Heart transplant | 0.3 mg/kg/day | Month 1–12: 5–20 |
| Lung transplant | 0.3 mg/kg/day | Week 1–2: 10–20; Week 2 to Month 12: 10–15 |
Note: Like adults, pediatric cystic fibrosis patients undergoing lung transplants may require dose adjustments due to reduced bioavailability.
✔️ Monitoring and Adjustments:
- Monitor whole blood trough concentrations regularly to ensure therapeutic efficacy and minimize toxicity.
- Adjust doses based on the patient’s clinical response, drug levels, and side effects.
✔️ Common adverse reactions (≥15%):
- Renal: Abnormal renal function, nephrotoxicity.
- Metabolic: Hyperglycemia, diabetes mellitus, hyperlipemia, hyperkalemia, hypomagnesemia.
- Cardiovascular: Hypertension, pericardial effusion.
- Infections: CMV infection, urinary tract infection, bronchitis.
- Neurological: Tremor, headache, paresthesia, insomnia, neurotoxicity (e.g., PRES).
- GI: Constipation, diarrhea, nausea, abdominal pain.
- Hematologic: Leukopenia, anemia.
- Other: Fever, peripheral edema.
✔️ Drug Interactions:
Mycophenolic Acid (MPA) Products:
- Tacrograf can increase MPA exposure after switching from cyclosporine.
- Recommendation: Monitor for MPA-related adverse reactions and adjust the dose of MMF (mycophenolate mofetil) or MPA accordingly.
Nelfinavir and Grapefruit Juice:
- Both inhibit CYP3A enzymes, increasing tacrolimus concentrations.
- Recommendation: Avoid concomitant use.
CYP3A Inhibitors:
- Increase tacrolimus concentrations.
- Recommendation: Monitor tacrolimus levels and adjust the dose as necessary.
CYP3A4 Inducers:
- Decrease tacrolimus concentrations.
- Recommendation: Monitor tacrolimus levels and adjust the dose accordingly.
Cannabidiol (CBD):
- May require therapeutic drug monitoring and potential dose reduction for Tacrograf.
✔️ Contraindications:
- Hypersensitivity:
- To tacrolimus or HCO-60 (polyoxyl 60 hydrogenated castor oil).
✔️ Overdose Effects:
- Acute overdose symptoms:
- Tremors, abnormal renal function, hypertension, peripheral edema.
- Treatment:
- General supportive care and symptom management.
- Activated charcoal has been used, but its efficacy is not well-established.
✔️ Pregnancy & Lactation:
- Pregnancy:
- Tacrograf can cause fetal harm.
- Advice: Inform pregnant women of potential risks.
- Lactation:
- Insufficient data; use caution and consult with a physician.
✔️ Precautions & Warnings:
Not Interchangeable:
- Extended-release Tacrograf formulations differ; ensure correct medication is administered.
New Onset Diabetes After Transplant (NODAT):
- Recommendation: Monitor blood glucose levels post-transplant.
Nephrotoxicity:
- Risk of acute or chronic renal impairment.
- Action: Reduce dose and monitor kidney function.
Neurotoxicity:
- May cause Posterior Reversible Encephalopathy Syndrome (PRES) or other neurologic abnormalities.
- Action: Reduce or discontinue Tacrograf if symptoms occur.
Hyperkalemia:
- Monitor serum potassium; use caution with other hyperkalemia-inducing drugs.
Hypertension:
- Management: Use antihypertensive therapy as needed while monitoring drug-drug interactions.
Anaphylaxis (IV Formulation):
- Risk of anaphylactic reactions.
- Action: Observe patients closely during IV administration.
Not Recommended with Sirolimus:
- Increases risk of serious adverse reactions in liver and heart transplants.
Myocardial Hypertrophy:
- Action: Consider reducing or discontinuing dose in case of cardiac complications.
Immunizations:
- Avoid live vaccines during therapy.
Pure Red Cell Aplasia (PRCA):
- Action: Consider discontinuing Tacrograf.
Thrombotic Microangiopathy (TMA):
- Includes Hemolytic Uremic Syndrome (HUS) and Thrombotic Thrombocytopenic Purpura (TTP).
- Action: Monitor for symptoms, especially with infections or certain medications.
✔️ Storage Conditions:
- Store below 30°C in a dry place, away from light and moisture.
- Keep out of the reach of children.
⚠️Disclaimer:
At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.
