Lamivudine and tenofovir disoproxil oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation containing lamivudine and tenofovir disoproxil.
Drugs List
Therapeutic Indications
Uses
Treatment of HIV infected adults
Treatment of adults infected with HIV-1.
Dosage
1 tablet (300mg lamivudine and 245mg tenofovir disoproxil) to be taken once daily, to be taken with food.
Patients with Renal Impairment
Creatinine clearance >50ml/minute
1 tablet once a day.
Creatinine clearance <50ml/minute
No dosing recommendations.
Contraindications
Children under 18 years
Breastfeeding
Renal impairment - creatinine clearance below 50ml/minute
Precautions and Warnings
Major risk factors for decreased bone mineral content
Patients over 65 years
Haemodialysis
Hepatic cirrhosis
Hepatitis B
Hepatitis C
Pregnancy
Severe hepatic impairment
Therapy cessation not recommended in decompensated liver disease/cirrhosis
Treatment does not prevent risk of transmission of HIV
Advise patient dizziness may affect ability to drive or operate machinery
Before initiating screen all patients for hepatitis B infection
Treatment should be initiated by doctor experienced in HIV management
Contains soya or soya derivative
Monitor renal function prior to initiating treatment
Autoimmune disorders can occur many months after initiation of treatment
Blood lipid and glucose levels may increase requiring treatment
Monitor patient for 4 hours after administration
Monitor renal function after 2-4 weeks, 3 months and 3-6 monthly thereafter
Monitor renal function in patients with risk factors for renal impairment
On discontinuation, may cause recurrence of hepatitis B
Advise patient to report bone pain, pain in extremities or fractures
Advise patient to seek medical advice if joint aches or pain occur
Inflammatory symptoms should be evaluated and treated appropriately
May cause loss of bone mineral density
Neonate exposed in utero: Risk of mitochondrial dysfunction
Risk of developing opportunistic infections
Discontinue if creatinine clearance falls below 50 ml/minute
Discontinue if pancreatitis is suspected
Discontinue if pancreatitis occurs
Advise patient not to take NSAIDs unless advised by clinician
Lamivudine and tenofovir disoproxil should be avoided with concurrent or recent use of nephrotoxic medical products e.g. high dose or multiple nonsteroidal anti-inflammatory drugs (NSAIDs). Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.
In patients at risk of renal dysfunction, it is recommended that estimated creatinine clearance, serum phosphorus, urine glucose and urine protein be assessed prior to initiation and frequently during treatment.
Consider interruption of treatment if creatinine clearance decrease to below 50ml/minute or serum phosphate decreases to below 1.0mg/dl (0.32mmol/l).
Assessment of bone mineral density should be considered for patients who have a history of pathological bone fracture or other risk factors for osteoporosis or bone loss.
Bone abnormalities may be associated with proximal renal tubulopathy, if bone abnormalities are suspected, appropriate consultation and evaluation should occur.
Discontinue treatment if signs or symptoms of pancreatitis occur.
Pregnancy and Lactation
Pregnancy
Use lamivudine and tenofovir disoproxil with caution during pregnancy.
The manufacturer recommends to avoid the use of lamivudine and tenofovir disoproxil and doravirine during pregnancy as a precautionary measure, and to monitor maternal-foetal outcomes in any patients exposed to doravirine during pregnancy. Encouraging physicians to register patients to the Antiretroviral Pregnancy Registry.
Animal studies with tenofovir disoproxil do not indicate direct or indirect harmful effects with respects to reproductive toxicity. However, animal studies with lamivudine show an increase in early embryonic deaths, and may inhibit cellular DNA replication.
Lactation
Lamivudine and tenofovir disoproxil is contraindicated during breastfeeding.
The manufacturer does not recommend the use of lamivudine and tenofovir disoproxil during breastfeeding, and that mothers should be instructed to not breastfeed due to the potential HIV-1 transmission and potential adverse reactions in the infant.
Lamivudine and tenofovir disoproxil are excreted into breast milk. There is limited published information regarding the use of lamivudine and tenofovir disoproxil during breastfeeding.
Side Effects
Abdominal cramps
Abdominal distension
Abdominal pain
Acute renal failure
Alopecia
Anaemia
Angioedema
Arthralgia
Asthenia
Autoimmune disorders
Cough
Diarrhoea
Elevated amylase levels
Elevation of liver enzymes (transient)
Exacerbation of hepatitis
Fatigue
Fever
Flatulence
Graves' disease
Headache
Hepatic steatosis
Hepatitis
Hypokalaemia
Hypophosphataemia
Increase in creatinine
Insomnia
Interstitial nephritis
Lactic acidosis
Malaise
Muscle disorders
Myopathy
Nasal symptoms
Nausea
Nephritis
Nephrogenic diabetes insipidus
Neutropenia
Osteomalacia
Osteonecrosis
Pancreatitis
Paraesthesia
Peripheral neuropathy
Proximal tubulopathy
Rash
Red cell aplasia
Renal impairment
Renal tubular necrosis
Rhabdomyolysis
Thrombocytopenia
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2019
Reference Sources
Summary of Product Characteristics: Lamivudine/Tenofovir disoproxil 300mg/245mg film coated tablets. Cipla EU Ltd. Revised January 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Lamivudine Last revised: 31 October 2018
Last accessed: 26 November 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Tenofovir Last revised: 07 February 2019
Last accessed: 26 November 2019
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