Tafnat Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Summary of the safety profile: Assessment of adverse reactions is based on safety data from the analysis performed through to the Week 72 analysis (median duration of exposure of 88 weeks), from 2 Phase 3 studies in which 866 HBV-infected patients received tenofovir alafenamide 25 mg once daily. The most frequently reported adverse reactions were headache (11%), nausea (6%), and fatigue (6%).
Tabulated summary of adverse reactions: The following adverse drug reactions have been identified with tenofovir alafenamide in patients with chronic hepatitis B (Table 4). The adverse reactions are listed as follows by body system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000). (See Table 4.)

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tenofovir alafenamide

Manufacturer:

Natco Pharma

Distributor:

Integrated Market Services