Letrocord 2.5 Adverse Reactions

Summary of the safety profile: The frequencies of adverse reactions for Letrozole are mainly based on data collected from clinical trials.
Up to approximately one third of the patients treated with Letrozole in the metastatic setting and approximately 80% of the patients in the adjuvant setting as well as in the extended adjuvant setting experienced adverse reactions. The majority of the adverse reactions occurred during the first few weeks of treatment.
The most frequently reported adverse reactions in clinical studies were hot flashes, hypercholesterolaemia, arthralgia, fatigue, increased sweating and nausea.
Important additional adverse reactions that may occur with Letrozole are: Skeletal events such as osteoporosis and/or bone fractures and cardiovascular events (including cerebrovascular and thromboembolic events). The frequency category for these adverse reactions is described in Table 1.
Tabulated listing of adverse reactions: The frequencies of adverse reactions for Letrozole are mainly based on data collected from clinical trials.
The following adverse drug reactions, listed in Table 1, were reported from clinical studies and from post-marketing experience with Letrozole.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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); very rare (<1/10,000); not known (cannot be estimated from the available data). (See Table 1.)

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Description of selected adverse reactions: Cardiac adverse reactions: In the adjuvant setting, in addition to the data presented in Table 2, the following adverse events were reported for Letrozole and tamoxifen, respectively (at median treatment duration of 60 months plus 30 days): angina requiring surgery (1.0% vs. 1.0%); cardiac failure (1.1% vs. 0.6%); hypertension (5.6% vs. 5.7%); cerebrovascular accident/transient ischaemic attack (2.1% vs. 1.9%).
In the extended adjuvant setting for Letrozole (median duration treatment of 5 years) and placebo (median duration treatment of 3 years), respectively: angina requiring surgery (0.8% vs. 0.6%); new or worsening angina (1.4% vs. 1.0%); myocardial infarction (1.0% vs. 0.7%); thromboembolic event* (0.9% vs. 0.3%); stroke/transient ischaemic attack* (1.5% vs. 0.8%) were reported.
Events marked * statistically significantly different in the two treatment arms.
Skeletal adverse reactions: For skeletal safety data from the adjuvant setting, refer to Table 2.
In the extended adjuvant setting, significantly more patients treated with Letrozole experienced bone fractures or osteoporosis (bone fractures, 10.4% and osteoporosis, 12.2%) then patients in the placebo arm (5.8% and 6.4%, respectively). Median duration of treatment was 5 years for Letrozole, compared with 3 years for placebo. (See Tables 2 and 3).

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