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Abacavir with lamivudine oral


Oral formulation containing abacavir (as sulfate) and lamivudine

Drugs List

  • abacavir 600mg and lamivudine 300mg film coated tablets
  • KIVEXA film coated tablets
  • Therapeutic Indications


    HIV infection - combination therapy


    Before treatment with abacavir, all patients irrespective of racial origin should be screened for the carriage of HLA-B*5701 allele. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. Presence of this allele confers an increased risk of severe hypersensitivity reactions to abacavir. Abacavir should be avoided in patients carrying the HLA-B*5701 allele unless no other therapeutic option is available based on treatment history and resistance testing.

    When one of the active substances needs to be discontinued or when dosage needs to be adjusted, separate preparations of abacavir and lamivudine should be used. For further information, refer to the individual summary of products characteristics of these medicinal products.


    Bodyweight equal to or greater than 25 kg
    One tablet daily.

    Abacavir with lamivudine as a once daily regimen is mainly based on studies of abacavir with lamivudine in therapy-experienced patients and in combination with efavirenz in antiretroviral-naive adult patients.


    Bodyweight equal to or greater than 25 kg
    One tablet daily.

    No pharmacokinetic data is currently available in patients over 65 years of age.

    Special care is advised due to age associated changes such as decreased renal function and changes in haematological parameters.


    Bodyweight equal to or greater than 25 kg
    One tablet daily.


    Children weighing less than 25kg
    Renal impairment - creatinine clearance below 50ml/minute

    Precautions and Warnings

    Patients over 65 years
    Risk factors for cardiovascular disorder
    Abnormal liver function test
    Hepatitis B
    Hepatitis C
    Mild hepatic impairment

    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Confirm negative HLA-B 5701 allele status in all patients
    Intermittent therapy increases the risk of hypersensitivity reactions
    Must be used in combination with other antiretrovirals
    Treatment should be initiated by doctor experienced in HIV management
    Contains sunset yellow (E110) - may cause allergic reaction
    Never rechallenge treatment after a hypersensitivity reaction
    Reintroduction to the drug must be carried out in a medical setting
    Autoimmune disorders can occur many months after initiation of treatment
    Avoid sorbitol or other polyalcohols, may reduce lamivudine efficacy
    Blood lipid and glucose levels may increase requiring treatment
    Monitor patients with hepatic impairment
    On discontinuation, may cause recurrence of hepatitis B
    Review patients every 2 weeks for the first 2 months
    Advise patient to seek medical advice if joint aches or pain occur
    Advise patient to seek medical advice if movement becomes difficult
    Consider hypersensitivity if any of:rash/fever/G.I/flu-like or resp.dis.
    Contact doctor immediately with any signs of hypersensitivity reactions
    Inflammatory symptoms should be evaluated and treated appropriately
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Risk of developing opportunistic infections
    Discontinue if hepatic function deteriorates in pts with hepatic impairment
    Discontinue if hypersensitivity reactions occur
    Discontinue if pancreatitis occurs
    Advise patient not to restart treatment without consulting their doctor
    Advise patient to read the leaflet in the pack
    Advise patient to return remaining medication to the pharmacy
    Advise patients on the importance of taking treatment regularly
    Advise patients that hypersensitivity reactions may be life threatening
    Remind patient of importance of carrying Alert Card with them at all times

    Carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir, which can be life-threatening and fatal, despite taking precautions. Before treatment with abacavir, all patients irrespective of racial origin should be screened for the carriage of HLA-B*5701 allele. Presence of this allele confers an increased risk of severe hypersensitivity reactions to abacavir. Abacavir should not be used in patients carrying the HLA-B*5701 allele unless no other therapeutic option is available based on treatment history and resistance testing. See details below regarding hypersensitivity reactions.
    A high rate of virological failure and the early emergence of resistance has been reported when abacavir with lamivudine was combined with tenofovir as a once daily regimen.

    Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.

    Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally. Adverse reactions such as haematological (anaemia, neutropenia), metabolic (hyperlactataemia, hyperlipasemia) and neurological (hypertonia, convulsions, abnormal behaviour) have been reported. Consider in children exposed to nucleoside or nucleotide analogues in utero (including HIV-negative infants) and who present with neurological symptoms or severe clinical findings of unknown cause.

    Patients with chronic hepatitis B or C who are treated with combination antiretroviral therapy have an increased risk of developing severe and potentially fatal hepatic adverse effects, and therefore should be closely monitored during treatment. If hepatic disease worsens in these patients, interruption or discontinuation of therapy should be considered.
    When combination antiretroviral therapy is initiated in HIV-infected patients with severe immune deficiency, an inflammatory reaction to asymptomatic or residual opportunist pathogens may arise. This can lead to the aggravation of symptoms or other serious clinical conditions such as cytomegalovirus retinitis, mycobacterial infections or Pneumocystis carinii pneumonia. These reactions are usually observed within the first few weeks or months after treatment initiation. Any inflammatory symptoms should be evaluated and treated appropriately.

    Observational studies have shown an association between abacavir and myocardial infarction. At the time of writing there is no established biological mechanism to explain a potential increase in risk but when prescribing abacavir action should be taken to try and minimise all modifiable risk factors (such as smoking, hypertension and hyperlipidaemia).

    Hypersensitivity reactions
    Reactions are characterised by symptoms indicating multi-organ system involvement. Almost all reactions include the symptoms of fever and/or rash. Special care is needed in patients taking concurrent products known to induce skin toxicity (e.g. non nucleoside reverse transcriptase inhibitors) as it is difficult to differentiate between rashes caused by these products and abacavir related hypersensitivity.
    Other signs and symptoms may include respiratory symptoms (such as dyspnoea, sore throat, cough, abnormal chest X-ray) and gastrointestinal symptoms (such as nausea, vomiting, diarrhoea, abdominal pain). These may lead to a misdiagnosis of hypersensitivity as being a respiratory disease (pneumonia, bronchitis, pharyngitis, etc.) or gastroenteritis. Other symptoms of hypersensitivity reactions that are observed frequently include lethargy or malaise and musculoskeletal symptoms such as myalgia, myolysis (rare), or arthralgia.
    Symptoms of hypersensitivity worsen with continued treatment and can become life-threatening. Symptoms usually resolve once treatment is discontinued.

    Hypersensitivity reactions usually appear within the first 6 weeks of treatment with abacavir, although the reactions may occur at any time during therapy. Patients should be monitored closely, especially during the first 2 months of treatment, with consultations every 2 weeks.

    If a hypersensitivity reaction is diagnosed during therapy, this product must be discontinued immediately, regardless of HLA-B*5701 status, and must never be restarted.

    Abacavir with lamivudine must be permanently discontinued if hypersensitivity cannot be ruled out, even if other diagnoses are possible (e.g. respiratory disease, gastroenteritis, reactions to other medication, etc.. This action avoids delay in diagnosis and minimises the risk of potentially life-threatening reactions. Reintroduction can only be considered if previous discontinuation was not due to a hypersensitivity reaction.
    Very rarely cases of erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis have occurred and abacavir hypersensitivity could not be excluded. If these symptoms occur, products containing abacavir should be permanently discontinued.

    Hypersensitivity symptoms return within hours if abacavir is restarted. The symptoms are usually more severe than the previous reaction and may lead to life-threatening hypotension and death.
    Possible life-threatening hypersensitivity reactions with rapid onset have occurred when therapy is restarted in patients who had only one of the key symptoms of hypersensitivity (such as skin rash, fever, gastrointestinal, respiratory or constitutional symptoms such as malaise and lethargy) before abacavir treatment was stopped.
    On very rare occasions, hypersensitivity reactions have been reported when therapy was restarted in patients who had no preceding symptoms of a hypersensitivity reaction. If the reintroduction of abacavir is ever judged necessary, it must be done in a setting where medical assistance is readily available.

    Screening for carriage of the HLA B*5701 allele is recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. Re-initiation of abacavir in such patients who test positive for the HLA B*5701 allele is not recommended and should be considered only under exceptional circumstances where potential benefit outweighs the risk and with close medical supervision.

    Pregnancy and Lactation


    Use abacavir with lamivudine with caution in pregnancy.

    Animal data suggests that abacavir is a moderate risk. Although the human pregnancy does not suggest structural anomalies, other potential development toxicities require study. Antiretroviral nucleosides have been shown to have a direct dose-related cytotoxic effect on pre-implantation mouse embryos. This toxicity has not been studied in humans. Mitochondrial dysfunction in offspring exposed in utero or postnatally to nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been reported. Abacavir crosses the human placenta. Animal and human data suggest that lamivudine is a low risk to the developing foetus for structural malformations. Theoretically, exposure to agents in this class at the time of implantation could result in impaired fertility as a result of embryonic cytotoxicity, but this has not been studied in humans. The risk of mitochondrial dysfunction needs confirmation. Lamivudine is believed to cross the human placenta. The risk of mortality and morbidity from HIV infection outweighs the risk of mitochondrial dysfunction. If indicated, the drug should not be withheld because of pregnancy (Briggs 2011).

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Abacavir with lamivudine is contraindicated during breastfeeding.

    HIV can be transmitted from mother to child through breast milk. HIV-infected mothers should not breastfeed their infants in order to avoid transmission of HIV. However, guidelines recommend exclusive breastfeeding for 6 months in regions where a lack of clean water for preparing infant formula and feeding equipment could pose a greater risk to the infant.

    Lamivudine is excreted in human breast milk at similar concentrations to those found in serum. Abacavir and its metabolites are secreted into breast milk of lactating rats. It is expected that these will also be secreted into human breast milk.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal cramps
    Abdominal pain
    Adult respiratory distress syndrome
    Altered liver function tests
    Autoimmune hepatitis
    Creatine phosphokinase increased
    Elevated amylase levels
    Erythema multiforme
    Graves' disease
    Hepatic impairment
    Hypersensitivity reactions
    Immune Reactivation/Reconstitution Syndrome
    Increase in creatinine
    Increase in serum ALT/AST
    Insulin resistance
    Lactic acidosis
    Maculopapular rash
    Metabolic changes
    Mouth ulcers
    Muscle disorders
    Nasal symptoms
    Peripheral neuropathy
    Red cell aplasia
    Renal failure
    Respiratory failure
    Sore throat
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2015

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 11 February 2015.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 11 February 2015.

    Summary of Product Characteristics: Kivexa film-coated tablets. ViiV Healthcare UK Ltd. Revised October 2018.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Abacavir and lamivudine. Last revised: 01 August 2014
    Last accessed: 12 February 2015.

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