Kivexa, pills 600mg+300mg, 30pcs

Composition

1 tablet contains abacavir sulfate 702 mg, which corresponds to the content of abacavir 600 mg,

lamivudine 300 mg.

Auxiliary substances:  

microcrystalline cellulose 309 mg,

sodium carboxymethyl starch (type A) 55 mg,

magnesium stearate 9 mg

Pharmacological action

Abacavir and lamivudine belong to the group of nucleoside reverse transcriptase inhibitors and are powerful selective inhibitors of HIV-1 and HIV-2. Abacavir and lamivudine are sequentially metabolized by intracellular kinases to the corresponding triphosphates (TF), which act as active metabolites.

Lamivudine-TF and carbovir-TF (active abacavir triphosphate) act as a substrate and are competitive HIV reverse transcriptase (RT) inhibitors. However, the main antiviral effect of drugs is due to the incorporation of monophosphate into the DNA chain, which leads to a break in replication. Abacavir and lamivudine triphosphates have significantly lower affinity for host cell DNA polymerases.

A study in which 20 HIV-infected patients took abacavir (300 mg 2 times / day daily and 1 time 24 hours before taking the material for analysis) showed that the geometric mean terminal intracellular T1 / 2 of carbovir-TF at steady state is 20.6 hours.

At the same time, the geometric mean T1 / 2 of abacavir from plasma in this study was 2.6 h. The steady-state pharmacokinetic parameters when taking abacavir 600 mg 1 time/day were the same as those when taking abacavir 300 mg 2 times / day in a cross-sectional clinical study on 27 HIV-infected patients.

The intracellular content of carbovir triphosphate in peripheral blood mononuclears was higher when taking abacavir at a dosage of 600 mg 1 time/day compared to taking abacavir 300 mg 2 times/day (an increase in the area under the “concentration-time” curve at steady state for 24 hours ( AUC24, ss) by 32% of the maximum daily concentration at steady state ( Cmax 24, ss)- by 99%).

In patients receiving lamivudine 300 mg once daily, the terminal intracellular T1 / 2 of lamivudine-TF increased from 16 to 19 hours, and the plasma T1/2 of lamivudine increased from 5 to 7 hours.

A study of the pharmacokinetics of lamivudine taken in a dose of 300 mg 1 time/day for 7 days compared with the lamivudine treatment with 150 mg 2 times/day for 7 days to 60 healthy volunteers showed that the values of AUC 24,24 ss and Cmax, ss for the concentration of intracellular lamivudine-TP in peripheral blood mononuclear cells were the same, but the minimum value when receiving lamivudine 300 mg 1 time/day was lower than when taking lamivudine 150 mg 2 times/day.

The variability in the concentration of lamivudine metabolites inside the cell is higher than in plasma. These results are confirmed by the data obtained when taking 300 mg of lamivudine and 600 mg of abacavir 1 time / day daily (the effectiveness and safety of this combination when taking drugs 1 time / day daily was also confirmed during the reference clinical study CNA 30021).

Lamivudine acts synergistically with zidovudine, effectively inhibiting HIV replication in cell culture. Under in vitro conditions, abacavir acts synergistically in combination with amprenavir, nevirapine and zidovudine and additively with didanosine, salzitabine, stavudine and lamivudine.

HIV-1 resistance to lamivudine is caused by a mutation in the M184V codon located close to the active site of viral RT. This mutation is observed both in vitro and in HIV-1-infected patients who received combination therapy including lamivudine.

Mutation in the M184V codon significantly reduces the sensitivity to lamivudine and significantly reduces the ability of the virus to replicate according to in vitro studies.

In vitro studies have also shown that zidovudine-resistant virus isolates may become susceptible to the drug if lamivudine resistance develops in these isolates later. However, the clinical significance of such changes has not yet been definitively determined.

Abacavir-resistant HIV-1 isolates were obtained in vitro. These isolates are characterized by certain genotypic changes in the OT codons (codons M184V, K65R, L74V, and Y115F).

HIV resistance to abacavir in vitro and in vivo is slow to develop. For a clinically significant increase in the inhibitory concentration against 50% of IC50 strains (an 8-fold increase in ic50 (inhibitory concentration in 50% of cases) relative to the “wild” virus strain), multiple mutations of the viral genome are required.

Abacavir-resistant isolates may also have reduced sensitivity to lamivudine, salzitabine, tenofovir, emtricitabine and / or didanosine, but remain sensitive to zidovudine and stavudine.

The development of cross-resistance between abacavir and lamivudine and other classes of antiretroviral drugs (for example, protease inhibitors [IP] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) is unlikely. HIV isolates with reduced sensitivity to abacavir were isolated from patients with uncontrolled viral replication, in whom previous treatment with other nucleoside reverse transcriptase inhibitors was ineffective.

Clinical virus isolates that have three or more mutations associated with resistance to nucleoside reverse transcriptase inhibitors (NRTIs) are likely also resistant to abacavir. Cross-resistance due to the M-184V mutation of RT is limited to the class of nucleoside inhibitors of RT. Zidovudine, stavudine, abacavir, and tenofovir retain their antiretroviral activity against lamivudine-resistant HIV-1 isolates carrying only the M184V mutation.

Indications

Human immunodeficiency virus (HIV) infection as part of combined antiretroviral therapy in adults and adolescents over 12 years of age.

Use during pregnancy and lactation

The safety of using Kivexa in pregnant women has not been established. Data were obtained in animal reproductive studies of lamivudine and abacavir. In this regard, the question of prescribing the drug during pregnancy should be considered only if the benefit to the mother exceeds the possible risk to the fetus.

The drug should be used in accordance with current recommendations for the use of antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.

Since HIV passes through breast milk, women are not recommended to breastfeed their babies to avoid transmission of the virus to the baby through breast milk.

Lamivudine is excreted in milk at a concentration close to that in the blood serum. Abacavir is also expected to be excreted in milk, although this has not been confirmed.

Contraindications

Hypersensitivity to abacavir or lamivudine, or other components of the drug;

age less than 12 years (no possibility of dose adjustment); impaired liver function.

Side effects

Since Kivexa is a combination drug, it is possible to show side effects characteristic of abacavir and lamivudine.

For many of the side effects listed below, it remains unclear whether their occurrence is due to the action of the active substances of this drug, the simultaneous use of other drugs (used to treat HIV), or they are a manifestation of the underlying disease.

Hypersensitivity to abacavir

In clinical trials conducted prior to screening for the HLA-B*5701 allele, approximately 5% of patients taking abacavir developed a hypersensitivity reaction, which in rare cases led to a fatal outcome. This reaction is characterized by the appearance of symptoms that indicate multiple organ damage.

Almost all patients who experience hypersensitivity reactions experience an increase in body temperature and/or the appearance of a rash (usually maculopapular or urticular), however, there have been cases of a hypersensitivity reaction that was not accompanied by the appearance of a rash and an increase in body temperature.

Symptoms of a hypersensitivity reaction may occur at any time during treatment with abacavir, but they usually appear within the first six weeks after starting the drug (the average is 11 days).

Signs and symptoms of a hypersensitivity reaction are listed below. Signs and symptoms reported in at least 10% of patients with a hypersensitivity reaction are shown in bold.

From the side of the skin:  rash (usually maculopapular or urticular)

From the gastrointestinal tract:  nausea, vomiting, diarrhea, abdominal pain, mouth ulceration

Respiratory system disorders:  shortness of breath, cough, sore throat, respiratory distress syndrome, respiratory failure

Nervous system disorders:  headache, paresthesia.

From the side of the blood system:  lymphopenia.

From the side of the hepatobiliary system:  increased liver function tests, liver failure

Musculoskeletal disorders:  myalgia, rarely-myolysis, arthralgia, increased CPK levels.

From the urinary system:  increased creatinine levels, renal failure.

Other services:  fever, fatigue, malaise, edema, lymphadenopathy, low blood pressure, conjunctivitis, anaphylaxis.

Patients with a hypersensitivity reaction may initially mistake it for a respiratory disease (pneumonia, bronchitis, pharyngitis, respiratory viral infection), gastroenteritis, or for adverse reactions associated with taking other medications. Continuing to take the drug Kivexa with the development of a hypersensitivity reaction, as well as resuming its use after the symptoms subside, is fraught with serious consequences, up to a fatal outcome.

Therefore, if any of the listed symptoms appear, a thorough examination of the patient is necessary to exclude a hypersensitivity reaction. If a hypersensitivity reaction cannot be excluded, then repeated use of Kivex or other abacavir-containing drugs (such as Ziagen, Trizivir) is strictly contraindicated.

If patients continue to take the drug Kivexa with the development of a hypersensitivity reaction, the clinical manifestations become more pronounced, and when the drug Kivexa is discontinued, they usually reverse development.

If patients with a history of hypersensitivity reactions resume taking Kivex, they will develop a second reaction within a few hours. A repeated hypersensitivity reaction can be more severe than the first, and manifest itself in life-threatening arterial hypotension, up to a fatal outcome.

If a hypersensitivity reaction develops, the patient, regardless of the carrier of the HLA-B*5701 allele, should permanently abandon the use of Kivex and other drugs containing abacavir (such as Ziagen, Trizivir).

Sometimes a hypersensitivity reaction develops when resuming therapy with the drug after its withdrawal, caused by the appearance of only one of the main symptoms of this reaction (rash, fever, malaise, fatigue, disorders of the gastrointestinal tract or respiratory system).

In rare cases, this reaction occurs when patients who have not experienced any symptoms of hypersensitivity before discontinuation of the drug resume taking Kivex.

Side effects of abacavir or lamivudine are presented in the tables below and grouped by body systems and absolute frequency. Side effects are divided into: very common (> 1/10), common (>> 1/100, >>< 1/10), non-distributed (> 1/1,000, < 1/10), non-distributed (>< 1/100), rare (> 1/10,000, < 1/100), rare (>< 1/1000) and very rare (

Many of the presented side effects (nausea, vomiting, diarrhea, fever, apathy, rash) often occur in patients with hypersensitivity to abacavir. Therefore, patients with any of these symptoms should be carefully evaluated to rule out a hypersensitivity reaction. If Kivexa has been discontinued due to the occurrence of one of these symptoms, and then a decision has been made to resume taking abacavir, it should be started only under the direct supervision of a doctor.

Interaction

The spectrum of interactions of the drug Kivexa is determined by the nature of interactions between abacavir and lamivudine, among which, to date, no clinically significant ones have been identified. Abacavir and lamivudine are slightly metabolized by cytochrome P450 enzymes (for example: CYP3A4, CYP2C9, or CYP2D6) and do not have an inhibitory or inducing effect on this enzyme system.

Therefore, the probability of interaction of the drug with antiretroviral non-nucleoside protease inhibitors and other drugs that are metabolized with the participation of the main enzymes of the cytochrome P450 system is low.

The probability of metabolic interactions with lamivudine is low, since it is poorly metabolized, poorly bound to plasma proteins, and is excreted almost exclusively by the kidneys. Lamivudine is mainly excreted by active organic cationic secretion. The possibility of interaction with other drugs should be considered, especially in cases where the kidneys are the main route of excretion of drugs.

Drug interactions caused by the presence of abacavir

Ethanol: the metabolism of abacavir is impaired when co-administered with ethanol, which leads to an increase in the AUC of abacavir by approximately 41%. Given the safety profile of abacavir, these data are not considered clinically significant. Abacavir has no effect on ethanol metabolism.

Methadone: in a study of the pharmacokinetics of drugs with simultaneous use of abacavir (at a dose of 600 mg 2 times / day) and methadone, there was a 35% decrease in the C of mahabacavir and a decrease in the time to reach Cmax by 1 h, but the AUC remained unchanged. Changes in the pharmacokinetics of abacavir were not found to be clinically significant.

In this study, abacavir increased the average total clearance of methadone by 22%. This change was not found to be clinically significant in most patients, but sometimes it may be necessary to adjust the dose of methadone.

Drug interactions caused by the presence of lamivudine

Trimethoprim: taking trimethoprim / sulfamethaxozole 160 mg / 800 mg (co-trimoxazole) causes a 40% increase in lamivudine exposure due to the presence of trimethoprim. However, with the exception of patients with renal insufficiency, no dose adjustment of lamivudine is required.

Lamivudine has no effect on the pharmacokinetics of trimethoprim and sulfamethaxosol. Concomitant use of lamivudine with higher doses of co-trimoxazole used for the treatment of pneumonia (caused by Pneumocystis carinii ) and toxoplasmosis, not studied.

Zalcitabine: lamivudine may inhibit intracellular phosphorylation of salzitabine when these drugs are co-administered. In this regard, it is not recommended to take the drug Kivexa in combination with salzitabine.

How to take, course of use and dosage

Therapy should be performed by a doctor who has experience in HIV treatment.

Due to the impossibility of dose adjustment when using combination tablets with fixed dosages of ingredients, Kivexa should not be prescribed to adults and adolescents whose body weight is less than 40 kg.

Kiwex tablets can be taken regardless of food intake.

Combination medications with fixed-dose ingredients should not be used when dose adjustment may be necessary, for example, with creatinine clearance less than 50 ml / min, as well as with hepatic insufficiency. Abacavir (Ziagen) or lamivudine (Epivir) should be prescribed as monopreparations if you stop taking Kivexa or if you need to adjust the dose. In such situations, the doctor should read the instructions for using these medications.

Adults and children 12 years and older are prescribed 1 tablet. 1 time / day daily.

It is not recommended to use the drug Kivexa for the treatment of children under 12 years of age due to the lack of possibility of dose adjustment. For the selection of therapy, attending physicians are recommended to refer to the instructions for use of lamivudine and abacavir.

The pharmacokinetics of abacavir and lamivudine in patients over 65 years of age have not been studied. When treating elderly patients, it is necessary to take into account the increased frequency of liver, kidney, heart disorders, and other concomitant diseases, as well as the use of other medications.

While no dose adjustment of abacavir is required in patients with impaired renal function, lamivudine should be reduced in proportion to the decrease in creatinine clearance. In this regard, it is not recommended to use the drug Kivexa with creatinine clearance less than 50 ml / min.

Patients with impaired liver function

Patients with mild hepatic impairment may need to reduce the dose of abacavir. Due to the impossibility of reducing the dose when using the drug Kivexa, a drug containing only abacavir should be used. The drug is contraindicated in patients with moderate to severe hepatic impairment.

Overdose

Symptoms: the symptoms of acute overdose of abacavir and lamivudine correspond to the symptoms of side effects of the drug (see the section “Side effects”).

Treatment: in case of overdose, the patient should be under the supervision of a doctor (in order to detect signs of toxic effects of the drug). If necessary, standard maintenance therapy is performed.

Due to the fact that lamivudine can be eliminated from the body by dialysis, treatment of overdose should include continuous hemodialysis (although studies to study the possibilities of hemodialysis in overdose of the drug have not been conducted).

Currently, it is not known whether peritoneal dialysis and hemodialysis contribute to the elimination of abacavir from the body.

Special instructions

Hypersensitivity to abacavir

According to clinical studies conducted prior to screening for the HLA-B*5701 allele, approximately 5% of patients taking abacavir develop hypersensitivity to the drug, in rare cases with a fatal outcome.

Risk factors

In clinical studies, it has been shown that carriage of the HLA-B*5701 allele significantly increases the risk of developing a hypersensitivity reaction to abacavir. In the prospective clinical trial CNA106030 (PREDICT-1), patients with the HLA-B*5701 allele were not prescribed abacavir, which significantly reduced the incidence of clinically suspected hypersensitivity reactions from 7.8% (66 patients out of 847) to 3.4% (27 patients out of 803) (p

Clinicians are advised to screen for carriage of the HLA-B*5701 allele in HIV-infected patients who have not previously been prescribed drugs containing abacavir.

Screening for carriage of the HLA-B*5701 allele is recommended before re-prescribing an abacavir-containing drug in patients with unknown HLA-B*5701 status who previously tolerated abacavir-containing drug therapy well.

The use of abacavir preparations is not recommended in such patients and should be considered only in exceptional cases with careful medical supervision, when the potential benefit outweighs the risk of using the drug.

The clinical diagnosis of a suspected hypersensitivity reaction should remain the basis for deciding whether to use drugs containing abacavir in all patients. Even in the absence of the HLA-B*5701 allele, abacavir should be discontinued and not resumed in all cases where a hypersensitivity reaction cannot be excluded based on clinical data, due to the potential risk of serious adverse effects or even death.

Clinical picture

A hypersensitivity reaction is characterized by the appearance of symptoms of multiple organ damage. At the same time, most patients experience fever and/or rash.

Other possible symptoms of hypersensitivity include: weakness, malaise, gastrointestinal symptoms (such as nausea, vomiting, diarrhea, abdominal pain), respiratory symptoms (such as shortness of breath, sore throat, cough), and chest X-ray signs (mainly limited infiltrates). Symptoms of a hypersensitivity reaction during treatment with abacavir can occur at any time, but usually appear within the first six weeks of taking the drug. With continued treatment, the severity of symptoms increases, and they can become life-threatening. In most cases, these symptoms disappear when abacavir is discontinued.

Some hypersensitivity patients were initially thought to be suffering from respiratory problems (pneumonia, bronchitis, pharyngitis) or flu-like illnesses, gastroenteritis, or reactions to other medications. In this regard, a hypersensitivity reaction was not immediately diagnosed, and patients continued (or resumed) taking the drug. This led to the development of a more severe hypersensitivity reaction (up to a fatal outcome). Taking this into account, it is necessary to consider the possibility of developing such a reaction and exclude it in patients with symptoms of these diseases. If it is impossible to exclude the presence of a hypersensitivity reaction, you should not resume taking the drug Kivex or any other drug containing abacavir (Ziagen, Trizivir).

Symptoms associated with a hypersensitivity reaction increased with continued treatment and usually disappeared after discontinuation of abacavir.

Resuming abacavir after a hypersensitivity reaction for several hours leads to a rapid return of symptoms. Relapse of a hypersensitivity reaction may be more severe than the first reaction and may be accompanied by a life-threatening decrease in blood pressure (up to a fatal outcome). Patients who have experienced such a hypersensitivity reaction should stop and never resume taking the drug Kivex, as well as any other medications containing abacavir (Ziagen, Trizivir).

There have been isolated reports of a hypersensitivity reaction following the resumption of abacavir, which is discontinued when certain key hypersensitivity symptoms (rash, fever, weakness/malaise, gastrointestinal disorders or respiratory symptoms) appear. In very rare cases, a hypersensitivity reaction has been reported after resuming the drug in patients who previously had no symptoms of hypersensitivity.

Treatment

Patients, regardless of their HLA-B*5701 status, who show signs and symptoms of hypersensitivity SHOULD immediately contact their healthcare provider for advice. If a diagnosis of hypersensitivity is made, you SHOULD immediately stop taking the drug Kivexa. NEVER resume treatment with Kivexa and other medications containing abacavir (such as Ziagen, Trizivir) after a hypersensitivity reaction occurs. This is due to the threat of severe symptoms (including life-threatening hypotension) that can lead to death within a few hours after resuming taking the drug.

To prevent delayed detection and reduce the risk of developing life-threatening hypersensitivity, you should completely stop taking Kivexa if it is impossible to exclude hypersensitivity, even if other diseases are potentially present (respiratory diseases, flu-like diseases, gastroenteritis, reactions to other medications). Do not resume treatment with Kivexa and other medications containing abacavir (such as Ziagen, Trizivir), even if symptoms of hypersensitivity occur with repeated use of other medications.

A warning card with information for patients about hypersensitivity reactions is included in the package.

Special instructions for treatment after a break in therapy with Kivexa

In case of discontinuation of treatment, regardless of the carrier of the HLA-B*5701 allele, with Kivexa, before resuming the drug, the reason for refusal to use the drug should be carefully studied and make sure that the patient does not have symptoms of a hypersensitivity reaction. Do not resume taking the drug Kivexa and other medications containing abacavir (such as Ziagen, Trizivir), if it is impossible to exclude a hypersensitivity reaction.

A few cases of hypersensitivity reactions have been described when abacavir treatment is resumed after discontinuation due to the appearance of any of the typical symptoms of hypersensitivity (rash, fever, malaise, fatigue, gastrointestinal disorders and respiratory disorders). Since in all such cases it is impossible to exclude a hypersensitivity reaction and, taking into account the data on its more severe course with repeated use of abacavir, resumption of therapy with Kivexa or other abacavir-containing drugs (such as Ziagen, Trizivir) in these patients is not recommended.

A hypersensitivity reaction was observed, although extremely rarely, even when patients who had not previously experienced symptoms of this reaction resumed treatment with this drug, and the interruption in taking the abacavir-containing drug was associated with other causes. In this case, it is possible to resume taking the drug, but it requires that the patient or people around him have quick access to medical care.

Screening for carriage of the HLA-B*5701 allele is recommended before re-prescribing abacavir-containing drug in patients with unknown HLA-B*5701 status who previously tolerated abacavir-containing drug therapy well.

Repeated use of abacavir-containing drug to patients with the HLA-B*5701 allele is not recommended and can only be considered in exceptional cases under close medical supervision, when the potential benefits of treatment with the drug outweigh all possible risks.

Important information for patients

The doctor who prescribes the drug, must ensure that the following information about hypersensitivity reactions have been communicated to the patient in full:

— patients should be warned about the risk of developing hypersensitivity reactions to abacavir, which can lead to life-threatening complications or deaths and the increased risk of hypersensitivity reactions in carriers of the allele HLA-B*5701;

— the patient should be warned that even in the absence of the allele HLA-B*5701 may develop a hypersensitivity reaction. Therefore, ALL patients with symptoms that may be due to a hypersensitivity reaction should immediately consult their doctor;

– patients with hypersensitivity to abacavir should never take Kivexa and other medications containing abacavir (such as Ziagen, Trizivir). regardless of HLA-B*5701 status;

— to avoid the risk of a resumption of taking the drug, patients who have had a hypersensitivity reaction must return the remaining pills the doctor who ordered the drug;

the patients stopped taking the drug Epzicom for any reason (for example, in connection with the development of side effects) before resumption of taking the drug should consult with your doctor;

— every patient should read the Warning card that came with the drug;

patients should be reminded, that they should always carry a Warning card that came with the drug.

Lactic acidosis, hepatomegaly, and fatty liver disease

When using antiretroviral nucleoside analogues (including abacavir and lamivudine), taken both separately and in combination, the development of lactic acidosis, hepatomegaly and severe fatty liver disease, including cases that ended in death, was noted. Similar phenomena were observed mainly in women.

Clinical signs of developing lactic acidosis are: general weakness, anorexia, sudden causeless weight loss, symptoms of respiratory damage (shortness of breath, rapid breathing) and gastrointestinal tract.

Caution should be exercised when prescribing Kivexa to all patients, especially those with risk factors for liver damage.The drug should be discontinued if there are clinical or laboratory signs of lactic acidosis or hepatotoxicity (which include hepatomegaly and steatosis, even in the absence of a significant increase in the level of aminotransferases).

Lipodystrophy

Some patients who received combined antiretroviral therapy showed a redistribution/accumulation of body fat, an increase in the amount of fat on the back of the neck and back (“buffalo hump”), a decrease in the amount of peripheral fat deposits, emaciation of the face, enlargement of the mammary glands, an increase in glucose and serum lipids.

Lipodystrophy can develop when taking any drugs from the class of protease inhibitors or nucleoside reverse transcriptase inhibitors. However, the available data suggest that the risk of developing these side effects varies when taking different drugs of these classes.

In addition, many factors contribute to the development of lipodystrophy. The presence of HIV infection, advanced age, and duration of antiretroviral therapy play an important and possibly mutually potentiating role.

During a clinical examination, you should pay attention to signs of redistribution of fat in the body. It is necessary to carefully monitor the level of serum lipids and blood glucose. If necessary, appropriate treatment of fat metabolism disorders is carried out.

Patients with concomitant viral hepatitis B

Clinical studies and post-marketing data on the use of lamivudine suggest that some patients with concomitant viral hepatitis B (HBV) may show clinical or laboratory signs of hepatitis recurrence after discontinuation of lamivudine. Discontinuation of lamivudine may have more severe consequences in patients with decompensated liver damage. As a result, patients with concomitant hepatitis B virus should monitor liver function tests and regularly determine the level of hepatitis B virus replication when Quivex is discontinued.

Immune recovery syndrome

If HIV-infected patients with severe immunodeficiency have asymptomatic or low-symptomatic opportunistic infections at the time of initiation of antiretroviral therapy (ART), such therapy may lead to increased symptoms of opportunistic infections or other serious consequences. These reactions usually occur within the first weeks or months after starting ART. Typical examples are cytomegalovirus retinitis, generalized or focal infection caused by mycobacteria, and pneumonia caused by Pneumocystis jiroveci (P. carinii). The appearance of any symptoms of inflammation requires immediate examination and, if necessary, treatment.

Opportunistic infections

The use of Kivex or other antiretroviral drugs does not exclude the possibility of developing opportunistic infections or other complications of HIV infection, so patients should remain under the supervision of a doctor who has experience in treating these diseases.

Transmission of infection

Modern antiretroviral therapy, including the drug Kivexa, does not prevent HIV transmission through sexual contact or contact with infected blood. Keep in mind that appropriate security measures must be followed.

Myocardial infarction

As a result of a prospective, observational, epidemiological study to study the incidence of myocardial infarction in patients receiving combined antiretroviral therapy, a link was found between the previous 6-month intake of abacavir and an increased risk of myocardial infarction. According to a generalized analysis of clinical trials sponsored by Glaxo Smith Kline, there was no increase in the risk of myocardial infarction associated with taking abacavir. The biological mechanisms that explain the potentially increased risk are unknown. In general, the available data obtained from cohort observations and controlled clinical trials do not allow us to unambiguously determine the relationship between abacavir therapy and the risk of myocardial infarction.

However, caution should be exercised when prescribing antiretroviral therapy, including drugs containing abacavir, to patients with a possible risk of CHD. All measures should be taken to minimize risk factors (such as hypertension, dyslipidemia, diabetes mellitus, and smoking).

Influence on the ability to drive motor vehicles and manage mechanisms

Special studies of the effect of lamivudine on the ability to concentrate attention when driving vehicles/mechanisms have not been conducted. It is unlikely that the drug will negatively affect the ability to perform tasks that require concentration, motor or cognitive skills. However, when assessing the patient’s ability to concentrate, it is necessary to take into account his general condition, as well as the nature of side effects that may appear against the background of taking the drug Kivex.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Abacavir, Lamivudine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Indications

HIV infection