Lanzotred Adverse Reactions

Summary of the safety profile: The most common adverse reactions are asthenia/fatigue, hot flush, fractures, and hypertension. Other important adverse reactions include fall, cognitive disorder, and neutropenia.
Seizure occurred in enzalutamide-treated patients.
Rare cases of posterior reversible encephalopathy syndrome have been reported in enzalutamide-treated patients.
Tabulated summary of adverse reactions: Adverse reactions observed during clinical studies are listed as follows by frequency category. Frequency categories are defined as follows: very common; common; uncommon; rare; very rare; not known. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)

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Description of selected adverse reactions: Seizure: Dose appears to be an important predictor of the risk of seizure, as reflected by available data. In the available data, patients with prior seizure or risk factors for seizure were excluded.
The mechanism by which enzalutamide may lower the seizure threshold is not known, but could be related to data showing that enzalutamide and its active metabolite bind to and can inhibit the activity of the GABA-gated chloride channel.
Ischemic Heart Disease: Ischemic heart disease occurred in patients treated with enzalutamide plus ADT.