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ABACAVIR/LAMIVUDINE MYLAN is a brand name for Abacavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Abacavir/Lamivudine is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele…
Verbatim from this product's MHRA label. Tap a section to expand.
Therapy should be prescribed by a physician experienced in the management of HIV infection.
Posology Adults, adolescents and children weighing at least 25 kg:
The recommended dose of Abacavir/Lamivudine is one tablet once daily.
Children Under 25 kg:
Abacavir/Lamivudine should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Abacavir/Lamivudine is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments.
Separate preparations of abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated. In these cases the physician should refer to the individual product information for these medicinal products.
Special Populations:
Elderly: No pharmacokinetic data are currently available in patients over 65 years of age. Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
2). No dose adjustment is required in patients with mild or moderate renal impairment. 4).
Hepatic impairment:
Abacavir is primarily metabolised by the liver. No clinical data are available in patients with moderate or severe hepatic impairment, therefore the use of Abacavir/Lamivudine is not recommended unless judged necessary. 2).
Paediatric population:
The safety and efficacy of abacavir/lamivudine in children weighing less than 25 kg has not been established. 2 but no recommendation on posology can be made. Method of administration Oral use. Abacavir/Lamivudine can be taken with or without food.
8 Description of selected adverse reactions). Restarting abacavir in such patients must be done in a setting where medical assistance is readily available. Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Lipid disorders should be managed as clinically appropriate. Pancreatitis Pancreatitis has been reported, but a causal relationship to lamivudine and abacavir is uncertain.
Risk of virological failure - Triple nucleoside therapy:
There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen. 1). Liver disease The safety and efficacy of abacavir/lamivudine has not been established in patients with significant underlying liver disorders.
2). Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. Patients co-infected with chronic hepatitis B or C virus Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
The special warnings and precautions relevant to abacavir and lamivudine are included in this section. There are no additional precautions and warnings relevant to abacavir/lamivudine. 8) characterised by fever and/or rash with other symptoms indicating multi-organ involvement.
HSRs have been observed with abacavir, some of which have been life-threatening, and in rare cases fatal, when not managed appropriately. The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
However, abacavir HSRs have been reported at a lower frequency in patients who do not carry this allele. Therefore the following should be adhered to: • HLA-B*5701 status must always be documented prior to initiating therapy. • Abacavir/Lamivudine should never be initiated in patients with a positive HLA- B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen.
g. Ziagen, Trizivir, Triumeq) • Abacavir/Lamivudine must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected. Delay in stopping treatment with Abacavir/Lamivudine after the onset of hypersensitivity may result in a life-threatening reaction.
g. Ziagen, Trizivir, Triumeq) must never be re-initiated. • Restarting abacavir containing products following a suspected abacavir HSR can result in a prompt return of symptoms within hours. This recurrence is usually more severe than on initial presentation, and may include life- threatening hypotension and death.
• In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Abacavir/Lamivudine tablets. • Clinical Description of abacavir HSR Abacavir HSR has been well characterised through clinical studies and during post marketing follow-up.
1. 8.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products. If lamivudine is being used concomitantly for the treatment of HIV and hepatitis B virus (HBV), additional information relating to the use of lamivudine in the treatment of hepatitis B infection can be found in the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV.
If Abacavir/Lamivudine is discontinued in patients co-infected with HBV, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV).
Mitochondrial dysfunction following exposure in utero Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine. There have been reports of mitochondrial dysfunction in HIV- negative infants exposed in utero and/or post-natally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia). These reactions have often been transitory. Late-onset neurological disorders have been rarely reported (hypertonia, convulsion, abnormal behaviour).
Whether such neurological disorders are transient or permanent is currently unknown. The findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown etiology, particularly neurologic findings.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. Immune Reactivation Syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. Opportunistic infections Patients should be advised that abacavir/lamivudine or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases. Cardiovascular events Although the available data from clinical and observational studies with abacavir show inconsistent results, several studies suggest […]
Symptoms usually appeared within the first six weeks (median time to onset 11 days) of initiation of treatment with abacavir, although these reactions may occur at any time during therapy. Almost all HSR to abacavir include fever and/or rash.
8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms. Importantly, such symptoms may lead to misdiagnosis of HSR as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
The symptoms related to HSR worsen with continued therapy and can be life- threatening. These symptoms usually resolve upon discontinuation of abacavir. 8 Description of selected adverse reactions). Restarting abacavir in such patients must be done in a setting where medical assistance is readily available.
Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate. Pancreatitis Pancreatitis has been reported, but a causal relationship to lamivudine and abacavir is uncertain.
Risk of virological failure - Triple nucleoside therapy:
There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen. 1). Liver disease The safety and efficacy of abacavir/lamivudine has not been established in patients with significant underlying liver disorders.
2). Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. Patients co-infected with chronic hepatitis B or C virus Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products. If lamivudine is being used concomitantly for the treatment of HIV and hepatitis B virus (HBV), additional information relating to the use of lamivudine in the treatment of hepatitis B infection can be found in the Summary of Product Characteristics for products containing lamivudine that are indicated for the treatment of HBV.
If Abacavir/Lamivudine is discontinued in patients co-infected with HBV, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see the Summary of Product Characteristics for products containing lamivudine that are […]