Femara 2,5 mg Pharma Gerke

Description

Side effects

In clinical trials, generally good tolerability was reported for both first- and second-line therapy in patients with advanced breast cancer and in patients with early-stage invasive breast cancer as adjuvant therapy and prolonged adjuvant therapy after completion of tamoxifen treatment.

Adverse effects (HP) were reported in approximately one-third of patients treated for metastatic breast cancer and as neoadjuvant therapy, in approximately 81% of patients with advanced breast cancer (in both the letrozole and tamoxifen groups), in 87-88% of patients, HP was reported in 87-88% of patients receiving adjuvant therapy in continuing clinical trials with a median duration of therapy of 60 months, and in approximately 80% of patients in clinical trials receiving extended adjuvant therapy (HP was reported in both the letrozole and placebo groups with a median duration of therapy of 60 months). Overall, the HPs reported were mild to moderately severe, and many were associated with inhibition of oestrogen synthesis.

The most commonly reported side effects in clinical trials were hot flashes, joint pain, nausea and increased fatigue. Many HPs may be standard pharmacological consequences of estrogen synthesis suppression (e.g. hot flashes, alopecia, vaginal bleeding).

Adverse drug reactions (ADRs) reported in clinical trials and during post-registration use are listed below according to their incidence.

The incidence was assessed as follows: “very common” – ≥10%, “common” – ≥1 – <10%, “rare”. – ≥0.1% – <1%, “rare” – ≥0.01 – <0.1%, “very rarely” – <0.01%, including single reports, frequency unknown (cannot be determined from available data). Within each frequency category, HPs are categorised in descending order of incidence.