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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:
ePharma sole intention is to ensure that its consumers get proper
information as musch as possible. Although we do not guarantee the
accuracy and the completeness of the information that provided and
here information is for informational purposes only.
The information contained herein should NOT be used as a substitute
for the advice of a qualified physician. This may not cover
everything about particular health conditions,
lab tests, medicines, all possible side effects, drug interactions,
warnings, alerts, etc. Please consult your healthcare professional
and discuss all your queries related to any disease or medicine. We
intend to support, not replace, the doctor-patient relationship.
