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Tacrolimus Intravenous INFUSION for Adults

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Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

  • Intravenous tacrolimus may ONLY be used in consultation with nephrology consultant
  • Not normally stocked in GUH
  • Sublingual tacrolimus (unlicensed) may be an option for short term use (a dose conversion will be necessary). Its use MUST be discussed with the nephrology consultant on call via switch
  • See monitoring requirements below
  • There are numerous important interactions - check current BNF
  • Non-PVC infusion devices and giving sets required- see below
  • Consider intravenous to oral switch as soon as possible; IV therapy should not normally exceed 7 days
  • Risk of anaphylaxis due to polyoxyl castor oil - caution in patients who have previously received preparations containing polyoxyethylene castor oil (by IV route) and in patients with an allergic predisposition. Risk of anaphylaxis may be reduced by using a slow rate of infusion, or giving an antihistamine prior to tacrolimus infusion.
  • Must have access to facilities for managing hypersensitivity reactions including anaphylaxis

Available preparations

Prograf 5mg per 1ml ampoule

Reconstitution

Already in solution

Draw up using a 5 micron filter needle

Dilute further prior to administration

Infusion fluids

Sodium Chloride 0.9% or Glucose 5%

Methods of intravenous administration

Continuous intravenous infusion (only) (administer using an electronically controlled infusion pump device)

  • Dilute the required dose to a final concentration of 4 to 100 micrograms/ml. Final volume can be from 20ml to 500ml, given over 24 hours
  • Incompatible with PVC. Non-PVC infusion container (e.g.Braun Ecoflac or Baxter Viaflo are suitable) and a low adsorption giving set (e.g. Baxter VMC9606, or Braun 8700110SP) must be used. (available from pharmacy)
  • Alternatively a syringe pump and a low adsorption administration set (e.g. Vygon Lectro-spiral 1155.80 or Braun Original Perfusor - Leitung PE 8723060 ) can be used and may be more suitable in fluid restricted patients.

Dose in adults

  • For transplantation, various dosing regimens are used in specialist centres.
  • Higher doses are used initially and maintenance treatment is adjusted according to response.
  • Contact specialist centre for detailed guidance.

For use in patients normally on the ORAL formulation who require temporary IV use

  • The daily intravenous dose is one-fifth of the total oral daily dose, and subsequent dose adjustment is based on plasma levels of tacrolimus (ref 1)
  • e.g patient on 2mg bd po the equivalent iv dose is 0.8mg/24 hours

Hepatic impairment

  • Dose reduction may be necessary in patients with severe hepatic impairment in order to maintain blood trough levels -under direction of transplant team

Monitoring

  • Observe patient for at least 30 minutes after starting the infusion and at frequent intervals thereafter, including neurological and visual status
  • Markedly nephrotoxic, monitor kidney function. Need to distinguish between rejection and tacrolimus induced nephrotoxicity if serum creatinine rises
  • Monitor ECG, liver function, blood pressure, fasting blood glucose, serum potassium, magnesium, lipids, FBC, coagulation values, plasma protein values, neurological and visual status

Therapeutic drug monitoring recommended

  • Monitor whole blood trough level. Take level from the arm that is not being infused
  • During the early post-transplantation period - twice weekly
  • Following dose adjustment
  • Change of route
  • Co-administration with interacting drug
  • During episodes of altered bowel habits
  • At regular intervals during maintenance therapy.
  • Need to state dose regimen, time and date of last dose and of blood sample
  • It is necessary to consider the clinical condition of the patient when interpreting whole blood levels

Suggested whole blood trough level (but specialist centres must be contacted)

Early post transplant

  • Liver transplant: 5 to 20 ng/ml
  • Kidney and heart transplant: 10 to 20 ng/ml

Maintenance therapy

  • Liver, heart and kidney transplant: 5 to 15 ng/ml

Further information

  • Irritant if extravasation occurs
  • Consider ethanol content of injection (638mg/ml)
  • Contraindicated if hypersensitive to macrolides
  • Vaccinations may be less effective; avoid live attenuated vaccines
  • If sublingual tacrolimus is being used as an alternative to oral tacrolimus, an initial dose of 50% of the oral dose is suggested (ie if a patient is on tacrolimus 1mg bd PO- then 0.5mg bd sublingually may be considered). Monitor tacrolimus levels and renal function if such an approach is used. This approach may only be done on the recommendation of a consultant nephrologist (ref 3,4). Prograf immediate release capsules to be used for this purpose (unlicensed).

Storage

  • Store below 250C, in the original package to protect from light.
  • Due to the risks of oral to IV switch, and on the advice of nephrology intravenous tacrolimus is NOT stocked in GUH. For advice in patients unable to take oral tacrolimus seek an urgent nephrology opinion and refer to this document.

References

SPC 23 September 2019

(1) Immunosuppressants in solid-organ transplant patients: peri-operative management. Q-PULSE CLN-PHAR/MP-048

(2) Email communication from Dr. D Lappin December 2004

(3) Sublingual tacrolimus as an alternative to oral administration for solid organ transplant recipients. Pennington CA Park JM 2015 PubMed assessed online 3/10/2018 (full text article attached below)

(4) - Email communication with Nephrologists- Oct 2018, on file

Therapeutic classification

Macrolide immunosuppresssant