Before starting

Required

• Baseline
  • Blood pressure
  • Clotting screening
  • ECG · for hypertropic changes
  • Fasting blood glucose
  • Full blood count
  • Liver function tests
  • Plasma proteins
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate
  • Urea and electrolytes · potassium particularly important

Consider in patients at risk of infection

• Baseline
  • Hepatitis B
  • Hepatitis C
  • HIV

Continued until stable

Required following renal, liver or heart transplant

• Twice each week
  • Whole blood trough tacrolimus level

Interpreting whole blood levels

Clinical study analysis suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20ng/mL.

In clinical practice, in the early post-transplant period, whole blood trough levels are generally between 5-20ng/mL for liver transplant recipients and 10-20ng/ml for kidney and heart transplant patients.

Lower doses and especially close monitoring of blood concentrations may be required in patients with severe hepatic impairment (Child-Pugh score of 10 or higher) because of reduced clearance and prolonged half-life.

Consider following renal, liver or heart transplant

• Routinely at clinic visits (indicatively weekly)
  • Plasma proteins
  • Clotting screening
  • Visual acuity
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate
  • Urea and electrolytes
  • Fasting blood glucose
  • Blood pressure
  • Full blood count
• At 3 months; and then again between 9 and 12 months
  • ECG

Ongoing once stable

Required following renal, liver or heart transplant

• When interacting medicines prescribed; dose or formulation changed; or unexplained graft dysfunction
  • Whole blood trough tacrolimus level

Interpreting whole blood levels

During maintenance therapy blood concentrations are generally between 5-15ng/ml for liver, kidney and heart transplant recipients.

Lower doses and especially close monitoring of blood concentrations may be required in patients with severe hepatic impairment (Child-Pugh score of 10 or higher) because of reduced clearance and prolonged half-life.

Consider following renal, liver or heart transplant

• Routinely at clinic visits (indicatively from 3 months, every 2-4 weeks; from 4 months, every 4-6 weeks; from 12 months, every 3-6 months)
  • Plasma proteins
  • Clotting screening
  • Visual acuity
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate
  • Urea and electrolytes
  • Fasting blood glucose
  • Blood pressure
  • Full blood count
• At least twice annually for first 5 years; then annually
  • Skin examination
• Annually
  • Lipids
  • Hepatitis B surface antibodies · revaccinate if titre below 10mIU/mL

Abnormal results

Cardiac changes

Consider dose reduction or discontinuation; discuss with specialist.

Dyslipidaemia

Manage actively in liver transplant patients in particular. Dietary interventions have little effect.

Diabetes

Manage according to local unit protocol.

Notes

Advice to patients

Advise patients to:

• Report any signs of high blood sugar such as confusion, feeling sleepy, increased thirst, increased hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Avoid excessive exposure to UV and sunlight. Consider covering the skin and use of total sunblock (SPF≥50).

Brand prescribing and dispensing

Prescribe and dispense by brand name only.

Switching between brands requires careful supervision and therapeutic monitoring by an appropriate specialist.

Bibliography

• Sandoz Limited. Summary of Product Characteristics – Adoport 1 mg Hard Capsules. Last revised June 2020 [cited 30/7/2020]
• Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [cited 30/08/2020]
• National Institute for Health and Care Excellence (NICE). Hepatitis B and C testing: people at risk of infection [PH43]. Dec 2012 [Mar 2013; cited June 2020]
• Baker R J, Mark P B, Patel R K, et al. Bio Medical Central – Nephrology. The Renal Association. Renal association clinical practice guideline in post-operative care in the kidney transplant recipient. BMC Nephrology (2017) 18:174 [cited 30/07/2020]
• Medicines and Healthcare products Regulatory Agency (MHRA). Oral tacrolimus products: reminder to prescribe and dispense by brand name only. Drug Safety Update volume 11, issue 4; November 2017: 3. [cited 30/07/2020]
• Millson C, Considine A, Cramp M E et al. Adult liver transplantation: UK clinical guideline – part 2: surgery and post-operation. Frontline Gastroenterology 2020;11:385-396 [cited 30/07/2020]