ABAMUNE-L Tablets

Description

Hypersensitivity Reactions and Exacerbations of Hepatitis B

Hypersensitivity Reactions

·         Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir-containing products

·         Hypersensitivity to abacavir is a multi-organ clinical syndrome

·         Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir.

·         ABAMUNE-L Tablets is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients.

·         Discontinue ABAMUNE-L Tablets as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue ABAMUNE-L Tablets if hypersensitivity cannot be ruled out, even when other diagnoses are possible.

·         Following a hypersensitivity reaction to ABAMUNE-L Tablets, never restart ABAMUNE-L Tablets or any other abacavir-containing product

Exacerbations of Hepatitis B

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, which is a component of ABAMUNE-L Tablets. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.