Taclimus 1 | POT

✔️ Dosage & Administration

Taclimus should be started orally when the patient can tolerate oral treatment.

For liver, heart, and lung transplant recipients, the first oral dose should generally be given at least 6 hours after transplantation. In kidney transplant patients, treatment may begin within 24 hours, but initiation should be delayed until kidney function has recovered.

Adults:

• Kidney transplant:
  • With azathioprine: 0.2 mg/kg/day, divided every 12 hours.
  • With MMF/IL-2 receptor antagonist: 0.1 mg/kg/day, divided every 12 hours.
• Liver transplant: With corticosteroids, 0.10–0.15 mg/kg/day, divided every 12 hours.
• Heart transplant: With azathioprine or MMF, 0.075 mg/kg/day, divided every 12 hours.
• Lung transplant: With azathioprine or MMF, 0.075 mg/kg/day, divided every 12 hours.

Tacrolimus blood trough levels should be monitored regularly and the dose adjusted according to the transplant type, treatment period, clinical condition, and measured concentration. Patients with cystic fibrosis undergoing lung transplantation may require higher doses because oral absorption can be reduced.

Children:

• Kidney transplant: 0.3 mg/kg/day
• Liver transplant: 0.15–0.2 mg/kg/day
• Heart transplant: 0.3 mg/kg/day
• Lung transplant: 0.3 mg/kg/day

Pediatric doses should also be divided every 12 hours and adjusted according to blood trough concentrations.

✔️ Common adverse effects may include:

• Abnormal kidney function
• High blood pressure
• Diabetes or increased blood glucose
• Tremor
• Infections, including CMV infection and bronchitis
• Low white blood cell count and anemia
• Urinary tract infection
• Constipation or diarrhea
• Headache and abdominal pain
• Insomnia and tingling sensations
• Peripheral edema
• Nausea
• High potassium levels
• Low magnesium levels
• Increased blood lipids
• Pericardial effusion

✔️ Interaction

• CYP3A inhibitors may increase tacrolimus levels, potentially increasing toxicity. Blood concentrations should be monitored and the dose adjusted when necessary.
• CYP3A4 inducers can lower tacrolimus concentrations and may reduce its effectiveness; monitoring and dose adjustment may be required.
• Nelfinavir and grapefruit juice can increase tacrolimus exposure and should be avoided.
• Mycophenolic acid products may have increased exposure after switching from cyclosporine to tacrolimus; monitor for related adverse effects.
• When used with cannabidiol, therapeutic drug monitoring and possible tacrolimus dose reduction should be considered.

✔️ Taclimus should not be used in patients with:

• Hypersensitivity to tacrolimus
• Hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil)

✔️ Pregnancy & Lactation

Tacrolimus may cause fetal harm. Pregnant women should be informed about the potential risks to the fetus, and treatment should be used under careful medical supervision.

✔️ Safety Information:

• Do not interchange Taclimus capsules with extended-release tacrolimus products, as their dosing and absorption characteristics differ.
• Blood glucose should be monitored because new-onset diabetes can occur after transplantation.
• Tacrolimus can cause kidney toxicity; caution is required, particularly when used with other medicines that can affect kidney function.
• Neurotoxicity, including posterior reversible encephalopathy syndrome (PRES), may occur. Neurological symptoms require prompt evaluation.
• Monitor blood potassium because hyperkalemia may develop.
• Blood pressure should be monitored, as hypertension is common and may require treatment.
• Patients receiving intravenous tacrolimus should be observed for signs of severe allergic or anaphylactic reactions.
• Tacrolimus is generally not recommended with sirolimus in liver and heart transplant recipients because of the increased risk of serious adverse effects.
• Dose reduction or discontinuation may be considered in cases of myocardial hypertrophy.
• Live vaccines should be avoided during treatment.
• Pure red cell aplasia may require discontinuation of tacrolimus.
• Thrombotic microangiopathy, including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura, may occur, particularly in the presence of certain infections or interacting medicines.

✔️ Storage:

Store below 30°C in a dry place, protected from light and moisture. Keep the medicine out of the reach of children.