KIVEXA SIDE EFFECTS

SIDE 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).