Aromasin Side Effects

Generic Name: exemestane

Please note - some side effects for Aromasin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aromasin - for the Consumer

Aromasin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aromasin:

Anxiety; back, joint, muscle, or limb pain; constipation; coughing; diarrhea; dizziness; fatigue; flu-like symptoms; hair loss; headache; hot flashes; increased or decreased appetite; increased sweating; joint pain; nausea; stomach pain or upset; tiredness; trouble sleeping; weight gain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; depression; numbness of an arm or leg; numbness or tingling in the skin, hands, or feet; one-sided weakness; severe or sudden bone pain; severe stomach pain; shortness of breath; sudden, severe dizziness, headache, vomiting, or fainting; sudden, unusual weight gain; swelling of the hands, legs, or feet; vision or speech changes.

Aromasin Side Effects - for the Professional

Aromasin

Adjuvant Treatment of Early Breast Cancer

Aromasin tolerability in postmenopausal women with early breast cancer was evaluated in two well-controlled trials: the IES study and the 027 study (a randomized, placebo-controlled, double-blind, parallel group study specifically designed to assess the effects of exemestane on bone metabolism, hormones, lipids and coagulation factors over 2 years of treatment).

Certain adverse events, expected based on the known pharmacological properties and side effect profiles of test drugs, were actively sought through a positive checklist. Signs and symptoms were graded for severity using CTC in both studies. Within the IES study, the presence of some illnesses/conditions was monitored through a positive checklist without assessment of severity. These included myocardial infarction, other cardiovascular disorders, gynecological disorders, osteoporosis, osteoporotic fractures, other primary cancer, and hospitalizations.

The median duration of adjuvant treatment was 27.4 months and 27.3 months for patients receiving Aromasin or tamoxifen, respectively, within the IES study and 23.9 months for patients receiving Aromasin or placebo within the 027 study. Median duration of observation after randomization for Aromasin was 34.5 months and for tamoxifen was 34.6 months. Median duration of observation was 30 months for both groups in the 027 study.

Aromasin was generally well tolerated and adverse events were usually mild to moderate. Within the IES study discontinuations due to adverse events occurred in 6.3% and 5.1% of patients receiving Aromasin and tamoxifen, respectively, and in 12.3% and 4.1% of patients receiving exemestane or placebo within study 027. Deaths due to any cause were reported for 1.3% of the exemestane-treated patients and 1.4% of the tamoxifen-treated patients within the IES study. There were 6 deaths due to stroke on the exemestane arm compared to 2 on tamoxifen. There were 5 deaths due to cardiac failure on the exemestane arm compared to 2 on tamoxifen.

The incidence of cardiac ischemic events (myocardial infarction, angina and myocardial ischemia) was 1.6% in exemestane treated patients and 0.6% in tamoxifen treated patients in the IES study. Cardiac failure was observed in 0.4% of exemestane treated patients and 0.3% of tamoxifen treated patients.

Treatment-emergent adverse events and illnesses including all causalities and occurring with an incidence of ≥5% in either treatment group of the IES study during or within one month of the end of treatment are shown in Table 8.

In the IES study, as compared to tamoxifen, Aromasin was associated with a higher incidence of events in the musculoskeletal disorders and in the nervous system disorders, including the following events occurring with frequency lower than 5% (osteoporosis [4.6% vs. 2.8%], osteochondrosis and trigger finger [0.3% vs 0 for both events], paresthesia [2.6% vs. 0.9%], carpal tunnel syndrome [2.4% vs. 0.2%], and neuropathy [0.6% vs. 0.1%]. Diarrhea was also more frequent in the exemestane group (4.2% vs. 2.2%). Clinical fractures were reported in 94 patients receiving exemestane (4.2%) and 71 patients receiving tamoxifen (3.1%). After a median duration of therapy of about 30 months and a median follow-up of about 52 months, gastric ulcer was observed at a slightly higher frequency in the Aromasin group compared to tamoxifen (0.7% versus <0.1%). The majority of patients on Aromasin with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.

Tamoxifen was associated with a higher incidence of muscle cramps [3.1% vs. 1.5%], thromboembolism [2.0% vs. 0.9%], endometrial hyperplasia [1.7% vs. 0.6%], and uterine polyps [2.4% vs. 0.4%].

Common adverse events occurring on study 027 are described in Table 9.

Treatment of Advanced Breast Cancer

A total of 1058 patients were treated with exemestane 25 mg once daily in the clinical trials program. Exemestane was generally well tolerated, and adverse events were usually mild to moderate. Only one death was considered possibly related to treatment with exemestane; an 80-year-old woman with known coronary artery disease had a myocardial infarction with multiple organ failure after 9 weeks on study treatment. In the clinical trials program, only 3% of the patients discontinued treatment with exemestane because of adverse events, mainly within the first 10 weeks of treatment; late discontinuations because of adverse events were uncommon (0.3%).

In the comparative study, adverse reactions were assessed for 358 patients treated with Aromasin and 400 patients treated with megestrol acetate. Fewer patients receiving Aromasin discontinued treatment because of adverse events than those treated with megestrol acetate (2% vs. 5%). Adverse events that were considered drug related or of indeterminate cause included hot flashes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs. 6%). The proportion of patients experiencing an excessive weight gain (>10% of their baseline weight) was significantly higher with megestrol acetate than with Aromasin (17% vs. 8%). Table 10 shows the adverse events of all CTC grades, regardless of causality, reported in 5% or greater of patients in the study treated either with Aromasin or megestrol acetate.

Less frequent adverse events of any cause (from 2% to 5%) reported in the comparative study for patients receiving Aromasin 25 mg once daily were fever, generalized weakness, paresthesia, pathological fracture, bronchitis, sinusitis, rash, itching, urinary tract infection, and lymphedema.

Additional adverse events of any cause observed in the overall clinical trials program (N = 1058) in 5% or greater of patients treated with exemestane 25 mg once daily but not in the comparative study included pain at tumor sites (8%), asthenia (6%) and fever (5%). Adverse events of any cause reported in 2% to 5% of all patients treated with exemestane 25 mg in the overall clinical trials program but not in the comparative study included chest pain, hypoesthesia, confusion, dyspepsia, arthralgia, back pain, skeletal pain, infection, upper respiratory tract infection, pharyngitis, rhinitis, and alopecia.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Aromasin. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cases of hepatitis including cholestatic hepatitis have been observed in clinical trials and reported through post-marketing surveillance.

Side Effects by Body System

Musculoskeletal

Musculoskeletal side effects including arthralgia (14.6% to 28.8%), pain in limb (9%), osteoarthritis (5.9%), myalgia (5.5%), back pain, pathological fracture, and skeletal pain have been reported. Reductions in bone mineral density over time have also been reported.

General

General side effects including fatigue (11% to 22%), hot flushes (13% to 32.9%), pain (13%), edema (5.5% to 7%), influenza like symptoms (6%), asthenia (6%), and fever (5%) have been reported.

Immunologic

Immunologic side effects including grade 3 or 4 lymphocytopenia (20% of patients in clinical trials for advanced breast cancer) and infection have been reported.

Of the advanced breast cancer patients with grade 3 or 4 lymphocytopenia, 89% had a preexisting lower grade lymphopenia. Forty percent of patients either recovered or improved to a lesser severity while on treatment.

Gastrointestinal

Gastrointestinal side effects including nausea (8.5% to 18%), dyspepsia (16%), abdominal pain (6% to 11%), diarrhea (4% to 9.6%), vomiting (7%), anorexia (6%), constipation (5%), and increased appetite (3%) have been reported.

Dermatologic

Dermatologic side effects including increased sweating (11.8% to 17.8%), alopecia (15.1%), dermatitis (8.2%), hypoesthesia, rash, and itching have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (5% to 15.1%) and chest pain have been reported.

Hepatic

In the comparative study in advanced breast cancer patients, CTC grade 3 or 4 elevation of gamma glutamyl transferase without documented evidence of liver metastasis was reported in 2.7% of patients treated with exemestane and in 1.8% of patients treated with megestrol acetate.

Hepatic side effects including elevations of serum levels of AST, ALT, alkaline phosphatase, and gamma glutamyl transferase greater than five times the upper value of the normal range have rarely been reported in patients treated for advanced breast cancer (but appear mostly attributable to the underlying presence of liver and/or bone metastases).

In early breast cancer patients, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving exemestane than either tamoxifen or placebo. Alkaline phosphatase elevations of any CTC grade (13.7% to 15.0%), treatment emergent bilirubin elevations (any CTC grade) (5.3% to 6.9%), CTC grade 3 to 4 increases in bilirubin (0.9%), and creatinine elevations (5.5% to 5.8%) have been reported.

Psychiatric

Psychiatric side effects including insomnia (12.4% to 13.7%), depression (6.2% to 9.6%), and anxiety (4.1%) have been reported.

Nervous system

Nervous system side effects including headache (6.9% to 13.1%), depression (13%), insomnia (11%), anxiety (10%), dizziness (8% to 9.7%), confusion, and paresthesia have been reported.

Respiratory

Respiratory side effects including dyspnea (10%), coughing (6%), upper respiratory tract infection, pharyngitis, rhinitis, bronchitis, and sinusitis have been reported.

Local

Local side effects including pain at tumor sites (8%) have been reported.

Ocular

Ocular side effects including visual disturbances (5%) have been reported.

Oncologic

Oncologic side effects reported from animal studies have included an increased incidence of hepatocellular adenomas and/or carcinomas as well as an increased incidence of renal tubular adenomas. Exemestane has also been clastogenic in human lymphocytes in vitro without metabolic activation.

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