Abalam Adverse Reactions

Abacavir sulfate and Lamivudine tablets contains abacavir and lamivudine, therefore the adverse events associated with these may be expected.
For many of the adverse events listed it is unclear whether they are related to the active substance, the wide range of other medicinal products used in the management of HIV infection, or whether they are a result of the underlying disease process.
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 Abacavir sulfate and Lamivudine tablets has 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 Precautions).
The adverse reactions considered at least possibly related to abacavir or lamivudine are listed by body system, organ class and absolute frequency. Frequencies are defined as very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10,000, < 1/1000), very rare (< 1/10,000). (See Table 3.)

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Paediatric population: The safety database to support once daily dosing with Abacavir sulfate and Lamivudine tablets in paediatric patients comes from the ARROW Trial (COL105677) in which 669 HIV-1 infected paediatric subjects received abacavir and lamivudine either once or twice daily (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). Within this population, 104 HIV-1 infected paediatric subjects weighing at least 25 kg received abacavir and lamivudine as Abacavir sulfate and Lamivudine tablets once daily. No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults. (See Table 4.)

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Description of Selected Adverse Reactions: Hypersensitivity (see Warnings): 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 as follows. 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. (See Table 5.)

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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 previously mentioned) 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 Warnings and Precautions.