DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises if concurrent use of moderate
inducers of CYP3A4, dabrafenib, modafinil or
telotristat ethyl is unavoidable, increase doravirine
dose to 100 mg twice daily. Manufacturer advises
increasing doravirine dose to 100 mg twice daily with
rifabutin. The extra doravirine 100 mg dose should be
taken approximately 12 hours after the dose of
l INTERACTIONS → Appendix 1: doravirine . lamivudine . tenofovir disoproxil
l PREGNANCY Manufacturer advises avoid.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment—no information available.
l RENAL IMPAIRMENT Manufacturer advises avoid if
creatinine clearance less than 50 mL/minute.
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
Driving and skilled tasks Manufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of fatigue,
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25, 3
▶ Delstrigo (Merck Sharp & Dohme Ltd) A
Doravirine 100 mg, Tenofovir disoproxil (as Tenofovir disoproxil
fumarate) 245 mg, Lamivudine 300 mg Delstrigo
100mg/300mg/245mg tablets | 30 tablet P £578.55
HIV infection in combination with other antiretroviral
drugs when no suitable alternative available and when
prescribed for shortest period possible
▶ Adult (body-weight up to 60 kg): 30 mg every 12 hours, to
be taken preferably at least 1 hour before food
▶ Adult (body-weight 60 kg and above): 40 mg every
12 hours, to be taken preferably at least 1 hour before
(especially when used in combination with didanosine)—
use only if alternative regimens are not suitable
▶ Lactic acidosis Lactic acidosis associated with hepatomegaly
and hepatic steatosis has been reported with stavudine.
Use with caution in patients with hepatomegaly, hepatitis,
or other risk factors for liver disease and hepatic steatosis
(including obesity and alcohol abuse). Discontinue
treatment if symptoms of hyperlactataemia, lactic
acidosis, progressive hepatomegaly or rapid deterioration
of liver function become apparent.
l INTERACTIONS → Appendix 1: stavudine
disorders . paraesthesia . peripheral neuropathy (switch to
another antiretroviral if peripheral neuropathy develops). sleep disorders .thinking abnormal
▶ Uncommon Anxiety . arthralgia . emotional lability . gynaecomastia . hepatic disorders
▶ Rare or very rare Diabetes mellitus . hyperglycaemia . muscle weakness . neutropenia
SIDE-EFFECTS, FURTHER INFORMATION Metabolic effects
may occur with stavudine; plasma lipids and blood glucose
concentrations should be measured routinely.
l PREGNANCY Manufacturer advises use only if potential
l RENAL IMPAIRMENT Risk of peripheral neuropathy.
Dose adjustments Use half normal dose every 12 hours if
Use half normal dose every 24 hours if eGFR less than
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include cherry.
l LESS SUITABLE FOR PRESCRIBING Stavudine (especially in
combination with didanosine) is associated with a higher
risk of lipoatrophy and should be used only if alternative
regimens are not suitable; it is considered to be less
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Zerit (Bristol-Myers Squibb Pharmaceuticals Ltd)
Stavudine 20 mg Zerit 20mg capsules | 56 capsule P £139.46
Stavudine 30 mg Zerit 30mg capsules | 56 capsule P £146.25
Stavudine 40 mg Zerit 40mg capsules | 56 capsule P £150.66
HIV infection in combination with other antiretroviral
drugs | Chronic hepatitis B infection with compensated
liver disease (with evidence of viral replication, and
histologically documented active liver inflammation or
fibrosis)| Chronic hepatitis B infection with
DOSE EQUIVALENCE AND CONVERSION
▶ 7.5 scoops of granules contains approx. 245 mg
tenofovir disoproxil (as fumarate).
l INTERACTIONS → Appendix 1: tenofovir disoproxil
▶ Common or very common Abdominal distension . flatulence
▶ Uncommon Proximal renal tubulopathy
l HEPATIC IMPAIRMENT Manufacturer advises caution in
decompensated hepatic disease (limited information
Dose adjustments Granules: 132 mg once daily if eGFR
Tablets: 245 mg every 2 days if eGFR
; 245 mg every 3–4 days if eGFR
Monitoring Monitor renal function—interrupt treatment if
▶ Test renal function and serum phosphate before
treatment, then every 4 weeks (more frequently if at
increased risk of renal impairment) for 1 year and then
every 3 months, interrupt treatment if renal function
deteriorates or serum phosphate decreases.
▶ When treating chronic hepatitis B with tenofovir, monitor
liver function tests every 3 months and viral markers for
hepatitis B every 3–6 months during treatment (continue
monitoring for at least 1 year after discontinuation—
recurrent hepatitis may occur on discontinuation).
l DIRECTIONS FOR ADMINISTRATION Granules: mix 1 scoop
of granules with 1 tablespoon of soft food (e.g. yoghurt,
apple sauce) and take immediately without chewing. Do
not mix granules with liquids.
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer tenofovir granules.
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Tenofovir disoproxil for the treatment of chronic hepatitis B
Tenofovir is an option for the treatment of chronic
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Viread (Gilead Sciences International Ltd)
Tenofovir disoproxil (as Tenofovir disoproxil fumarate) 33 mg per
1 gram Viread 33mg/g granules | 60 gram P £54.50
CAUTIONARY AND ADVISORY LABELS 21
▶ Tenofovir disoproxil (Non-proprietary)
▶ Viread (Gilead Sciences International Ltd)
Tenofovir disoproxil (as Tenofovir disoproxil fumarate)
123 mg Viread 123mg tablets | 30 tablet P £102.60 DT = £102.60
Tenofovir disoproxil (as Tenofovir disoproxil fumarate)
163 mg Viread 163mg tablets | 30 tablet P £135.98 DT = £135.98
Tenofovir disoproxil (as Tenofovir disoproxil fumarate)
204 mg Viread 204mg tablets | 30 tablet P £170.19 DT =
Tenofovir disoproxil 245 mg Viread 245mg tablets | 30 tablet P £204.39 DT = £30.25
HIV infection in combination with other antiretroviral
▶ Adult: 250–300 mg twice daily
Prevention of maternal-fetal HIV transmission
▶ BY MOUTH, OR BY INTRAVENOUS INFUSION
▶ Adult: Seek specialist advice (combination therapy
preferred) (consult local protocol)
HIV infection in combination with other antiretroviral
drugs in patients temporarily unable to take zidovudine
▶ Adult: 0.8–1 mg/kg every 4 hours usually for not more
than 2 weeks, dose approximating to 1.2–1.5 mg/kg
l CONTRA-INDICATIONS Abnormally low haemoglobin
concentration (consult product literature). abnormally low
neutrophil counts (consult product literature)
l CAUTIONS Elderly . lactic acidosis .risk of haematological
▶ Lactic acidosis Lactic acidosis associated with hepatomegaly
and hepatic steatosis has been reported with zidovudine.
Use with caution in patients with hepatomegaly, hepatitis,
or other risk factors for liver disease and hepatic steatosis
(including obesity and alcohol abuse). Discontinue
treatment if symptoms of hyperlactataemia, lactic
acidosis, progressive hepatomegaly or rapid deterioration
of liver function become apparent.
l INTERACTIONS → Appendix 1: zidovudine
▶ Common or very common Leucopenia . malaise . neutropenia
▶ Uncommon Bone marrow disorders . dyspnoea . fever. flatulence . generalised pain . myopathy
discolouration . oral discolouration . paraesthesia . pure
red cell aplasia . seizure .taste altered . urinary frequency
▶ Frequency not known Lipoatrophy
SIDE-EFFECTS, FURTHER INFORMATION Anaemia and
If anaemia or myelosuppression occur, reduce dose or
interrupt treatment according to product literature, or
Metabolic effects may occur with zidovudine; plasma
lipids and blood glucose concentrations should be
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate to severe impairment (increased risk of
Dose adjustments Manufacturer advises consider dose
reduction in moderate to severe impairment—consult
Dose adjustments Reduce oral dose to 300–400 mg daily in
divided doses or intravenous dose to 1 mg/kg 3–4 times
daily if eGFR is less than 10 mL/minute/1.73 m2
l MONITORING REQUIREMENTS Monitor full blood count
after 4 weeks of treatment, then every 3 months.
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use For intermittent intravenous infusion,
dilute to a concentration of 2 mg/mL or 4 mg/mL with
Glucose 5% and give over 1 hour.
l PRESCRIBING AND DISPENSING INFORMATION The
abbreviation AZT which is sometimes used for zidovudine
has also been used for another drug.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Retrovir (ViiV Healthcare UK Ltd)
Zidovudine 10 mg per 1 ml Retrovir IV 200mg/20ml concentrate for
solution for infusion vials | 5 vial P £52.48
▶ Retrovir (ViiV Healthcare UK Ltd)
Zidovudine 10 mg per 1 ml Retrovir 50mg/5ml oral solution sugarfree | 200 ml P £20.91
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