Shared Care Guideline TACROLIMUS (Prograf , Adoport , Tacni , Vivadex , Advagraf ) in Renal Transplants Prepared by Caroline Ashley, Lead Renal Pharmacist, Royal Free Hospital, In agreement with NHS North Central London (Camden Borough), July 2011, review June 2013.
SHARED CARE CRITERIA Patients will have been stabilised, receiving a therapeutic dose of a specified brand of tacrolimus with time allowed for common adverse events and side effects to have occurred before referral to the GP. A minimum period of 3 months stabilisation is necessary prior to sharing care. RESPONSIBILITIES
Consultant and Specialist Nurse 1. Ensure that patient is fully counselled and educated regarding transplantation and immunosuppression 2. Supply the specified brand of tacrolimus until the patient is clinically stable. 3. Send a letter to the GP suggesting that shared care is agreed for this patient. 4. Clinical and laboratory supervision (including therapeutic drug monitoring) of patient by routine 1-3 monthly clinic
5. Alterations to tacrolimus brand, and alterations to, or re-titration of dosage, and communication of these and other
changes to patient’s therapy to the GP as soon as possible.
6. Institution and communication of other significant changes in patient’s therapy To provide a record card on which
details of drug therapy will be kept and advise the patient to take this to any GP or secondary care appointment.
7. Evaluation of adverse effects reported by the GP or patient (if applicable). 8. Communicating the results of all clinical and laboratory tests performed in secondary care to GP within 5 days. 9. Provide a review date and identify whether specialist doctor or nurse will perform this 10. Provide back-up advice at all times (see below).
General Practitioner 1. To reply to the Consultant, accepting or declining shared care for tacrolimus within 2 weeks of receiving the
2. Monitoring the patient’s overall health and well being. 3. Adverse drug reaction/ drug interaction monitoring. 4. Prescribing (though not altering dose or updating the patient held record card) of the specified brand of
5. Reporting to and seeking advice from the specialist on any aspect of patient care which is of concern to the GP.
Patient 1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 2. Share any concerns in relation to treatment with tacrolimus. 3. Inform specialist or GP of any other medication being taken, including over-the-counter products. 4. Report any adverse effects or warning symptoms (sore throat, mouth ulcers, nausea, vomiting, fever, abdominal
discomfort, shortness of breath) to the specialist or GP whilst taking tacrolimus.
PCT 1. To support GPs in making the decision over whether or not to accept clinical responsibility for prescribing. 2. To support Trusts in resolving issues that may arise as a result of shared care. LICENSED INDICATIONS Prevention of graft rejection following renal transplant. DOSE AND ADMINISTRATION Starting dose usually 0.15mg/kg-body weight daily in 2 divided doses taken 12 hours apart. Dose is adjusted according to blood levels (target range – 8-12ng/ml reducing to 5-8 ng/ml at 1 year), renal and liver function, presence of infection and length of time post transplant. FORMULATION Numerous formulations of tacrolimus are now available:- • Prograf®, Adoport®, Tacni® and Vivadex® are all standard-release formulations, with other generic formulations
expected soon. They are prescribed as a twice-daily dose, and patients must not be switched between brands except under the supervision of the Renal Transplant Unit.
• Advagraf® is a modified release preparation and is prescribed as a once-daily dose.
• It is imperative that tacrolimus is prescribed by BRAND name, due to the associated risk of either toxicity or rejection should the patient receive the wrong formulation. The information contained in this guideline is issued on the understanding that it is accurate based on the resources at the time of issue. For further information please refer to the relevant data sheet or contact a member of the transplant team. Page 1 of 2
The Royal Free Renal Transplant unit will specify the brand of tacrolimus to be prescribed for each patient. MONITORING
• The following will be monitored on a routine basis in secondary care at clinic visits to the Transplant Centre: blood pressure, neurological and visual status, fasting blood glucose levels, electrolytes, liver and renal function tests, full blood count, coagulation status, and blood tacrolimus levels. It is not necessary for GPs to duplicate these tests.
• The results of tests performed in secondary care to be communicated to the GP within 5 days.
SIDE EFFECTS
• Tremor and burning sensation in hands and feet
• Malignancies and lymphoproliferative disorders
DRUG INTERACTIONS Drugs that induce/inhibit microsomal P450 oxidation system: Drugs that reduce blood levels Drugs that increase blood levels
• Calcium-channel blockers (diltiazem, nicardipine, verapamil)
Note – nifedipine and amlodipine are not known to have this effect
• Triazole antifungals (e.g. fluconazole)
• Nephrotoxic agents – increased risk of nephrotoxicity
• HMG-CoA-reductase inhibitors – increased risk of myopathy
• Grapefruit/grapefruit juice should be avoided as they may raise tacrolimus levels
• Live vaccinations contraindicated due to immunosuppression
PREGNANCY AND LACTATION Human data show that tacrolimus is able to cross the placenta. Limited data from organ transplant recipients show no evidence of an increased risk of adverse effects on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products. To date, no other relevant epidemiological data are available. Due to the need of treatment, tacrolimus can be considered in pregnant women when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus. In case of in utero exposure, monitoring of the newborn for the potential adverse effects of tacrolimus is recommended (in particular the effects on the kidneys). There is a risk for premature delivery (<37 week) as well as for hyperkalaemia in the newborn, which, however, normalizes spontaneously. Human data demonstrate that tacrolimus is excreted into breast milk. As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving tacrolimus. COST One month’s therapy with tacrolimus (Prograf®) at a dose of 4mg BD - £382.34
One month’s therapy with tacrolimus (Adoport®) at a dose of 4mg BD - £314.50
CONTACT NUMBERS
Royal Free Hospital Renal Unit Switchboard 020 7794 0500 Renal Transplant Consultants Dr G.Jones Ext 36847 Specialist Pharmacists Caroline Ashley Bleep 1409 Bleep1650 Pharmacy Medicines Information 020 7830 2983 (Mon-Fri - 9.00-5.30) Transplant Sisters The information contained in this guideline is issued on the understanding that it is accurate based on the resources at the time of issue. For further information please refer to the relevant data sheet or contact a member of the transplant team. Page 2 of 2
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Shared Care Guideline