- Patients who received Hepsera® for up to 5 years in Study 438 reported AEs similar in nature and severity to those reported in the first year of treatment and the incidence of AEs related to treatment increased only slightly.1
Safety and tolerability evaluated in 2,000 patients in clinical trials10
Long-term carcinogenicity studies in animal models were negative for carcinogenic findings1
Incidence of adverse events similar to placebo up to 1 year
(Studies 437 and 438)1
Treatment-related adverse events (grades 1-4) reported in ≥3% of all Hepsera-treated patients in the pooled 437 and 438 studies (0-48 weeks)1
Grade 3-4 laboratory abnormalities reported in ≥1% of all Hepsera-treated patients in the pooled 437 and 438 studies (0-48 weeks)1
- No grade 3 or 4 abnormalities in serum creatinine1,3
- 4/125 (3%) of patients experienced a confirmed increase in serum creatinine of 0.5 mg/dL from baseline.1
- The creatinine elevation resolved in 1 patient who permanently discontinued treatment and remained stable in 3 patients who continued treatment.1
The most common treatment-related adverse events with a 2% frequency or higher and potential causal relationship with Hepsera include asthenia, abdominal pain, headache, nausea, vomiting, diarrhea, pruritus, rash, increased creatinine, renal failure, hypophosphatemia, and abnormal renal function.- Increases in serum creatinine ≥0.3 mg/dL from baseline were observed in 37% and 53% of pre-liver transplantation patients by weeks 48 and 96, respectively, and in 32% and 51% of post-liver transplantation patients by weeks 48 and 96, respectively.
|