rash, vesicular rash
Adverse Pooled Pooled megestrol
Reaction Femara Femara acetate aminoglutethimide
2.5 mg 0.5 mg 160 mg 500 mg
(N=359) (N=380) (N=189) (N=178)
% % % %
Body as a Whole
Fatigue 8 6 11 3
Chest Pain 6 3 7 3
Peripheral Edema1 5 5 8 3
Asthenia 4 5 4 5
Weight Increase 2 2 9 3
Cardiovascular
Hypertension 5 7 5 6
Digestive System
Nausea 13 15 9 14
Vomiting 7 7 5 9
Constipation 6 7 9 7
Diarrhea 6 5 3 4
Pain-Abdominal 6 5 9 8
Anorexia 5 3 5 5
Dyspepsia 3 4 6 5
Infections/Infestations
Viral Infection 6 5 6 3
Lab Abnormality
Hypercholesterolemia 3 3 0 6
Musculoskeletal System
Musculoskeletal2 21 22 30 14
Arthralgia 8 8 8 3
Nervous System
Headache 9 12 9 7
Somnolence 3 2 2 9
Dizziness 3 5 7 3
Respiratory System
Dyspnea 7 9 16 5
Coughing 6 5 7 5
Skin and Appendages
Hot Flushes 6 5 4 3
Rash3 5 4 3 12
Pruritus 1 2 5 3
Other less frequent (<5%) adverse reactions considered consequential and reported in at least 3 patients treated with Femara, included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating and vertigo.
6.6 First and Second-Line Treatment of Advanced Breast CancerIn the combined analysis of the first- and second-line metastatic trials and post-marketing experiences other adverse reactions that were reported were cataract, eye irritation, palpitations, cardiac failure, tachycardia, dysesthesia (including hypesthesia/paresthesia), arterial thrombosis, memory impairment, irritability, nervousness, urticaria, increased urinary frequency, leukopenia, stomatitis cancer pain, pyrexia, vaginal discharge, appetite increase, dryness of skin and mucosa (including dry mouth), and disturbances of taste and thirst.
6.7 Postmarketing ExperienceCases of blurred vision, increased hepatic enzymes, angioedema, anaphylactic reactions, toxic epidermal necrolysis, erythema multiforme, and hepatitis have been reported. Cases of carpal tunnel syndrome and trigger finger have been identified during post approval use of Femara.
7 DRUG INTERACTIONS
Tamoxifen
Coadministration of Femara and tamoxifen 20 mg daily resulted in a reduction of letrozole plasma levels of 38% on average |
