What is the safety profile of FEMARA®?
FEMARA® (letrozole) offers you and your patients a well-established safety profile in the initial adjuvant setting.1
- FEMARA® is contraindicated in case of known hypersensitivity to the active substance or to any of the excipients, in women with premenopausal endocrine status, and during pregnancy and lactation.1
Most common adverse events were generally mild to moderate in the BIG 1-98 primary core analysis at 26-month follow-up1
Percentage of patients in BIG 1-98 study with grade 1-5 adverse events by frequency (≥5% in any group)2
- Thromboembolic events occurred in less than half as many patients taking FEMARA® versus tamoxifen (1.5% vs 3.2%)1
- Osteoporosis was reported more often with FEMARA® than with tamoxifen (2.2% vs 1.2%)1
Overall cardiovascular events were comparable with FEMARA® and tamoxifen.1,3,4
- In the BIG 1-98 trial, cardiovascular events were reported by 12.2% of patients treated with tamoxifen compared with 10.8% of those treated with FEMARA®
- Other cardiac events occurred in <1% of patients treated with either FEMARA® or tamoxifen, including myocardial infarctions (0.7% vs 0.4%), cardiac failures (0.9% vs 0.4%), and angina pectoris (0.8% vs
0.8%)1
At 73-month median follow-up, safety is consistent with known safety profiles of each agent5
In the initial adjuvant setting, safety matters. Turn to FEMARA® (letrozole) for a generally well-tolerated safety profile.1
See Important Safety Information below.
To read about the significant clinical benefits demonstrated in the FEMARA® BIG 1-98 trial, click here.
FEMARA® (letrozole) also has a demonstrated safety and efficacy profile in the extended adjuvant setting. For more information, click here.
FEMARA® 2.5 mg Film-coated tablets
Presentation: letrozole. Film-coated tablet containing 2.5 mg active substance for oral use.
Indications: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy. First-line treatment in postmenopausal women with hormone dependent advanced breast cancer. Advanced breast cancer in women with natural or artificially induced postmenopausal status, who have previously been treated with antioestrogens. Pre-operative therapy in postmenopausal women with localised hormone receptor positive breast cancer, to allow subsequent breast-conserving surgery in women not originally considered candidates for this type of surgery. Subsequent treatment after surgery should be in accordance with standard of care.
Dosage: 2.5 mg once daily.
Contraindications: Hypersensitivity to letrozole or excipients. Premenopausal endocrine status; pregnancy, breast-feeding.
Precautions/Warnings: Careful consideration of risk/benefit in patients with creatinine clearance
<10 mL/min. Patients with severe hepatic impairment (Child-Pugh score C) should be kept under close supervision. Consider adequate contraception in women who have the potential to become pregnant, including women who are perimenopausal or who recently became postmenopausal, until postmenopausal status is fully established. Monitoring of bone health.
Adverse reactions:•Most frequent adverse reactions: hot flushes, nausea, fatigue, arthralgia. •Common adverse reactions: anorexia, appetite increase, peripheral oedema, headache, dizziness, malaise, vomiting, dyspepsia, constipation, diarrhoea, alopecia, increased sweating, rash, myalgia, bone pain, osteoporosis, bone fractures, weight increase, hypercholesterolemia, depression.•Uncommon, rare or very rare and potentially serious adverse reactions include: leukopenia, cataract, cerebrovascular accident or infarction, thrombophlebitis, pulmonary embolism, arterial thrombosis, general edema, ischemic cardiovascular disease, angioedema, anaphylactic reaction, hepatitis, toxic epidermal necrolysis and erythema multiforme.
Packs and prices: Country specific.
Note: Before prescribing, please read full prescribing information.
Not all indications are approved in every country.
Click here for Important Safety Information for FEMARA®.
References: 1. FEMARA® (letrozole) [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; 2009. 2. Data on file. Novartis Oncology, East Hanover, NJ. 3. The Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists’ Group. Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Lancet Oncol. 2006;7:633-643. 4. Mouridsen H, Keshaviah A, Coates AS, et al. Cardiovascular Adverse Events During Adjuvant Endocrine Therapy for Early Breast Cancer Using Letrozole or Tamoxifen: Safety Analysis of BIG 1-98 trail. J Clin Oncol. 2007;25:5715-5722. 5. Mouridsen H, for the BIG 1-98 Collaborative Group. Letrozole monotherapy vs. tamoxifen monotherapy or vs. letrozole in sequence with tamoxifen for postmenopausal women with endocrine-responsive early breast cancer. Presented at: 31st Annual San Antonio Breast Cancer Symposium (SABCS); December 10-14, 2008; San Antonio, Texas.
