Shared Care Policy and Prescribing Information for General Practitioners for
Tenofovir (Adults only, non-renal, gastroenterology patients)
Publish public
Coordinator
Gastroenterology
Signature:
Dr A Fraser,
L Crighton
Applies to: NHS Grampian
Authorised for issue by
Medicines Guidelines
and Policies Group
Signature:
Dr C Hind
Version 1
Document no:
NHSG/SCPa/Ten/MGPG354
Effective date: June 2010
Review Date: June 2012
Supersedes: n/a
Please keep this document in the patient’s notes
PATIENT NAME
UNIT NUMBER
CHI NUMBER

WARD
TELEPHONE NO
CONSULTANT (print name)
ADDRESS
DATE OF BIRTH

Insert patient sticker here
HOSPITAL

DATE
SIGNATURE
THERAPEUTIC INDICATION: Tenofovir is a nucleoside reverse transcriptase inhibitor. It inhibits viral
polymerase by directly competing with the natural deoxyribonucleotide substrate and after incorporation into
deoxyribonucleic acid, by DNA chain termination. It is licensed for the treatment of chronic hepatitis B in
adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum
alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Within NHS Grampian, tenofovir will be used in patients with active chronic hepatitis B infection e-antigen
(HBeAg) positive and negative as indicated by at least two out of following three criteria:
 HBV DNA (>10,000 copies/mL)
 Persistently abnormal ALT values (>1.3 x ULN)
 Signs of chronic hepatitis and/or fibrosis either on liver biopsy or non-invasive test
DOSAGE/PREPARATION/ROUTE/FREQUENCY OF ADMINISTRATION:
Tenofovir is available as a film coated tablet containing 245mg of tenofovir disoproxil. The recommended
dose is 245mg once daily taken orally with food. The dose of tenofovir should be adjusted in renal
impairment (see details overleaf). The optimal duration of therapy is unknown. In patients who are HBeAg
positive who sero-convert to becoming eAb positive with undetectable HBV DNA as a result of therapy
discontinuation of tenofovir one year after seroconversion may be appropriate in the absence of cirrhosis.
Current recommendation for patients who are HBeAg negative with detectable DNA is for life-long therapy.
SAFE PRACTICE IS THAT THE CLINICIAN WHO ORDERS THE TEST MUST ACT ON THE RESULT
CARE WHICH IS THE RESPONSIBILITY OF
THE HOSPITAL CONSULTANT
 Patient will be assessed at out-patient
clinic prior to initiating treatment and
measurement of body weight, urea and
electrolytes (including phosphate), full blood
count, liver function tests and HBV-DNA
levels will be performed.
 Prescription of tenofovir appropriate will be
recommended to the GP after specialist
assessment at out-patient clinic
 Patients on therapy will be seen every 3
months for the first 12 months then at least 6
monthly thereafter. At each clinic visit body
weight, urea and electrolytes (including
phosphate), full blood count, liver function
tests (and HBV-DNA levels as indicated) will
be performed.
 After each clinic visits a formal letter
detailing clinical review, blood results and
recommendations will be sent to GP.
CARE WHICH IS THE RESPONSIBILITY OF THE
GENERAL PRACTITIONER (GP)
 Prescribing of medication.
 Prior to prescribing medication the GP should review the
results from the last out-patient clinic and ensure they are
within the normal range.
 Monitoring of all blood tests will be performed at the out-patient
clinic for the first 12 months. After the first 12 months of treatment
- monitoring of urea and electrolytes (including phosphate), full
blood count, liver function tests will continue every 3 months. As
the patients will be seen at the out-patient clinic every 6 months,
this will require GP to perform above blood monitoring twice per
year (3 months after each clinic review).
When writing laboratory request forms always include
details of the patient’s medication
NOTE: in addition to absolute values, a rapid change or a
consistent trend in any value should prompt caution and extra
vigilance.
If something unexpected occurs contact consultant.
Notify the consultant if the drug is stopped.
UNCONTROLLED WHEN PRINTED Review Date: June 2012 (sooner if recommendations change)
NHSG/SCPa/Ten/MGPG354
SCP and Prescribing Information for GPs for Tenofovir - Version 1, June 2010.
http://intranet.grampian.scot.nhs.uk/foi/files/SCPaTen.doc
-1-
Shared Care Policy and Prescribing Information for General Practitioners for
TENOFOVIR (Adults only continued)
MONITORING: - Discuss with consultant if the following occurs






>2-fold rise in ALT or Alk Phos (from baseline). Note elevated ALT is indication for initiating
treatment
Creatinine Clearance < 50mL/min
Phosphate < 0.65mmol/L
WBC <4.0 x 109/L
Neutrophils <2 x 109/L
May be a sign of portal hypertension rather than adverse drug reaction
Platelets <140 x 109/L
A rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance
In the event of a suspected drug reaction or monitoring concern contact consultant.
FOR SPECIFIC PRODUCT INFORMATION PLEASE CONSULT THE CURRENT SUMMARY OF
PRODUCT CHARACTERISTICS (http://emc.medicines.org.uk/) AND THE BNF (http://www.bnf.org/bnf/)
Dose adjustment in renal impairment:
Tenofovir is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal
dysfunction. There is limited data available on the use of tenofovir in renal impairment and therefore it should
only be used if the potential benefits outweigh the potential risks. Renal function and serum phosphate
should be measured regularly, particularly in patients at risk of renal impairment.
The dose of tenofovir should be adjusted in renal impairment as follows
Creatinine Clearance (mL/min)
>50
245mg daily
30-49
245mg every 48 hours
10-29
245mg twice weekly
<10 and non-haemodialysis
Not recommended
Haemodialysis (give dose after haemodialysis) 245mg weekly
To calculate an estimated creatinine clearance:
For males
CrCl =
(140 – age) x weight
(mL/min)
(0.81) x serum creatinine (micromol/L)
For females CrCl = 0.85 x male value
Age of patient (years)
Weight of patient; use ideal body weight (kg). Use actual body weight if patient is underweight due to
possible over estimations of renal function in severely underweight patients.
IBW (kg):
Males 50kg + 2.3kg for every 2.5cm > 152cm
Females 45.5kg + 2.3kg for every 2.5cm > 152cm
See http://www.bnf.org/bnf/extra/current/450019.htm for online calculator to estimate creatinine clearance.
Adverse Effects and Drug Interactions
Tenofovir should not be administered concurrently with adefovir, didanosine or any other medicinal product
containing tenofovir (Truvada® or Atripla®).
As tenofovir is principally eliminated via the kidney, care should be taken with other medicines that reduce
renal function. If concomitant use of tenofovir and nephrotoxic agents is unavoidable, renal function should
be monitored weekly.
The most frequent side effects noted with tenofovir are headache, gastrointestinal disturbance and fatigue.
Tenofovir is a black triangle drug and any suspected adverse drug reaction should be reported to CHM/MHRA
using the yellow card system (www.yellowcard.gov.uk) and to the hospital consultant.
UNCONTROLLED WHEN PRINTED Review Date: June 2012 (sooner if recommendations change)
NHSG/SCPa/Ten/MGPG354
SCP and Prescribing Information for GPs for Tenofovir - Version 1, June 2010.
http://intranet.grampian.scot.nhs.uk/foi/files/SCPaTen.doc
-2-
Precautions and Contra-Indications
Tenofovir is contraindicated in patients with known hypersensitivity to tenofovir or any of its excipients.
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient
increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum
HBV DNA levels decline. In patients with compensated liver disease, these increases in serum ALT are
generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation,
and therefore should be monitored closely during therapy.
Pregnancy
Discuss with consultant. The effect of tenofovir on the unborn foetus is unknown at present. Therefore it is
recommended that woman of childbearing potential should use effective contraception during treatment.
There is limited data on tenofovir exposure during pregnancy and therefore tenofovir should not be used
during pregnancy unless absolutely necessary. Advise to contact their physician immediately should
pregnancy occur.
Breast-feeding
Discuss with Aberdeen Maternity Hospital. It is not known if tenofovir is excreted in human milk so it is
recommended that mothers being treated with tenofovir do not breast-feed.
As a rule it is recommended that HBV infected mothers do not breast-feed their infants in order to avoid
transmission of HBV to the infant.
Contact Points
Secretary to Dr A Fraser
Tel:
Fax:
Hepatology Clinical Nurse Specialists
Tel:
Email:
Pharmacy contact - Medicines Information Tel:
01224 552287
01224 550711
01224 554931
Grampian.livernurses@nhs.net
01224 552316
RESPONSIBILITIES OF GPS UNDERTAKING MONITORING
A GP agreeing to monitor tenofovir should:
 Ensure that the relevant monitoring requirements are undertaken at the correct frequency
 Ensure that the test results are checked for any abnormality as soon as the results are available
 Ensure abnormal results are acted upon
 Only continue to prescribe tenofovir if it is being satisfactorily monitored
 Contact the consultant in the event of a drug reaction or monitoring abnormality or anything you are
unhappy about
 Be alert for any of the known adverse reactions.
*** The patient should be encouraged to ensure blood tests are taken at the correct intervals ***
UNCONTROLLED WHEN PRINTED Review Date: June 2012 (sooner if recommendations change)
NHSG/SCPa/Ten/MGPG354
SCP and Prescribing Information for GPs for Tenofovir - Version 1, June 2010.
http://intranet.grampian.scot.nhs.uk/foi/files/SCPaTen.doc
-3-