Medical Editor: John P. Cunha, DO, FACOEP
Kivexa (abacavir and lamivudine) is a combination of antiviral drugs called nucleoside analogues that is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age. Epzicom is the name for the drug equivalent in the U.S. Common side effects of Kivexa include:
- hypersensitivity reactions (fever and/or rash),
- nausea,
- vomiting,
- diarrhea,
- abdominal pain,
- mouth sores,
- shortness of breath,
- cough,
- sore throat,
- fever,
- fatigue,
- feeling unwell (malaise),
- headache,
- elevated liver function tests, and
- muscle pain
The recommended dose of Kivexa tablets in adults and adolescents is one tablet once daily. Kivexa may interact with methadone, retinoids, sorbitol-containing medicines, trimethoprim/sulfamethoxazole, and emtricitabine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Kivexa; it is unknown how it would affect a fetus. It is unknown if Kivexa passes into breast milk. Breastfeeding is not recommended because of the potential for HIV transmission from mother to child.
Our Kivexa (abacavir and lamivudine) Film-Coated Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
A Timeline of the HIV/AIDS Pandemic See SlideshowSIDE EFFECTS
KIVEXA tablets contain abacavir and lamivudine, therefore adverse events would be expected to be similar to those experienced by patients on separate preparations of lamivudine and abacavir. For many of the adverse events listed it is unclear whether they are related to specific antiretroviral agents, or the wide range of other medications taken by HIV-infected patients, or whether they are a result of the underlying disease process.
Description Of Selected Adverse Effects
Hypersensitivity to abacavir (see Section WARNINGS AND PRECAUTIONS).
Abacavir hypersensitivity reaction (HSR) has been identified as a common adverse reaction with abacavir therapy. The signs and symptoms of this hypersensitivity reaction are listed below. These have been identified either from clinical studies or post marketing surveillance. Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Almost all patients developing hypersensitivity reactions will have fever and/or rash (usually maculopapular or urticarial) as part of the syndrome, however, reactions have occurred without rash or fever. Other key symptoms include gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise.
Skin: rash (usually maculopapular or urticarial)
Gastrointestinal tract: nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Respiratory tract: dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure
Miscellaneous: fever, fatigue, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Neurological/psychiatry: headache, paraesthesia
Haematological: lymphopenia
Liver/pancreas: elevated liver function tests, hepatic failure
Musculoskeletal: myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Urology: elevated creatinine, renal failure
Restarting abacavir following an abacavir HSR results in a prompt return of symptoms within hours. This recurrence of the HSR is usually more severe than on initial presentation, and may include life-threatening hypotension and death. Reactions have also occurred infrequently after restarting abacavir in patients who had only one of the key symptoms of hypersensitivity (see above) prior to stopping abacavir; and on very rare occasions have also been seen in patients who have restarted therapy with no preceding symptoms of a HSR (i.e., patients previously considered to be abacavir tolerant).
For details of clinical management in the event of a suspected abacavir HSR see Section WARNINGS AND PRECAUTIONS.
Clinical Trial Data
Table 1 lists the most common adverse events, occurring at an incidence of 5% or more, reported in the controlled pivotal clinical trial CNA30021, irrespective of the investigator's assessment of possible relationship to the study drug:
Many of the adverse events listed occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity. Therefore, patients with any of these symptoms should be carefully evaluated for the presence of this hypersensitivity reaction. If KIVEXA tablets have been discontinued in patients due to experiencing any one of these symptoms and a decision is made to restart abacavir, this must be done only under direct medical supervision (see Special considerations following an interruption of KIVEXA therapy in Section WARNINGS AND PRECAUTIONS).
Table 1: Most Common (Greater than or equal to 5% Incidence) Grade 2 to 4 Adverse Events (Safety Population - CNA30021)
| Adverse Event | ABC once/day N=384 n (%) |
ABC twice/day N=386 n (%) |
| Subjects with ANY Grade 2 to 4 AE | 267 (70%) | 276 (72%) |
| Drug hypersensitivity | 35 (9%) | 27 (7%) |
| Insomnia | 26 (7%) | 36 (9%) |
| Depression | 25 (7%) | 26 (7%) |
| Diarrhea | 21 (5%) | 25 (6%) |
| Nausea | 21 (5%) | 25 (6%) |
| Headache | 21 (5%) | 21 (5%) |
| Rash | 21 (5%) | 19 (5%) |
| Fatigue | 20 (5%) | 29 (8%) |
| Dizziness | 19 (5%) | 19 (5%) |
| Pyrexia | 19 (5%) | 13 (3%) |
| Abnormal dreams | 15 (4%) | 19 (5%) |
| Anxiety | 12 (3%) | 20 (5%) |
Table 2: Grade 3 to 4 Treatment Emergent Laboratory Abnormalities (Safety Population - CNA30021)
| Grade 3 and 4 Laboratory Abnormalities | ABC once/day N=384 N(%) |
ABC twice/day N=386 N(%) |
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| Clinical Chemistry | Gr 3 | Gr 4 | Gr 3-4 | Gr 3 | Gr 4 | Gr 3-4 |
| Elevated ALT | 14 (4%) | 9 (2%) | 23 (6%) | 18 (5%) | 6 (2%) | 24 (6%) |
| Elevated AST | 10 (3%) | 13 (3%) | 23 (6%) | 9 (2%) | 5 (1%) | 14 (4%) |
| Alkaline phosphatase | 1 (<1%) | 0 | 1 (<1%) | 0 | 1 (<1%) | 1 (<1%) |
| Amylase | 13 (3%) | 2 (<1%) | 15 (4%) | 12 (3%) | 0 | 12 (3%) |
| Bilirubin | 0 | 2 (<1%) | 2 (<1%) | 1 (<1%) | 1 (<1%) | 2 (<1%) |
| Creatine kinase | 13 (3%) | 31 (8%) | 44 (12%) | 13 (3%) | 22 (6%) | 35 (9%) |
| Creatinine | 0 | 0 | 0 | 0 | 1 (<1%) | 1 (<1%) |
| Glucose | 4 (1%) | 1 (<1%) | 5 (1%) | 5 (1%) | 0 | 5 (1%) |
| Sodium | 2 (<1%) | 0 | 2 (<1%) | 1 (<1%) | 0 | 1 (<1%) |
| Triglycerides | 13 (3%) | 5 (1%) | 18 (5%) | 13 (3%) | 8 (2%) | 21 (6%) |
| Hematology | ||||||
| Hemoglobin | 0 | 1 (<1%) | 1 (<1%) | 0 | 0 | 0 |
| Neutrophils absolute | 6 (2%) | 3 (<1%) | 9 (2%) | 4 (1%) | 1 (<1%) | 5 (1%) |
| Platelets | 2 (<1%) | 0 | 2 (<1%) | 2 (<1%) | 0 | 2 (<1%) |
| WBC | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (<1%) |
Postmarketing Data
In addition to the adverse events included from clinical trial data, the following adverse events listed in Table 3 below have been identified during post-approval use of abacavir and lamivudine. These events have been chosen for inclusion due to a potential causal connection to abacavir and/or lamivudine.
Table 3: Adverse Events Identified Post Approval
| Body system | Abacavir | Lamivudine |
| Blood and lymphatic systems disorde | Very rare: pure red cell aplasia | |
| Metabolism and nutrition disorders | Common: hyperlactataemia Rare: lactic acidosis1 |
Common: hyperlactataemia Rare: lactic acidosis1 |
| Nervous system disorders | Very rare: paraesthesiae, peripheral neuropathy has been reported although a causal relationship to treatment is uncertain | |
| Gastrointestinal disorders | Rare: pancreatitis, but a causal relationship to abacavir is uncertain | Rare: rises in serum amylase, pancreatitis, although a causal relationship to lamivudine is uncertain |
| Skin and subcutaneous tissue disorders | Common: rash (without systemic symptoms) Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis |
Common: alopecia |
| Musculoskeletal and connective tissue disorders | Common: arthralgia,muscle disorders Rare: rhabdomyolysis |
|
| 1See Section WARNINGS AND PRECAUTIONS | ||
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.
Read the entire FDA prescribing information for Kivexa (Abacavir and Lamivudine Film-coated Tablets)
QUESTION
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