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Aromasin

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Aromasin

Aromasin

Aromasin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aromasin (exemestane) is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox) for 2 to 3 years. Aromasin is an antineoplastic agent. Common side effects include hot flashes, hair loss, joint/bone/muscle pain, tiredness, unusual sweating, nausea, diarrhea, dizziness, and trouble sleeping.

The recommended dose of Aromasin in early and advanced breast cancer is one 25 mg tablet once daily after a meal. Aromasin may interact with rifampin, St. John's wort, or seizure medication. Discuss all medications you are taking with your doctor. Aromasin must not be used during pregnancy. It may harm a fetus. Aromasin is used mainly in women after menopause. If you are near menopause or have not gone through menopause and your doctor has prescribed this for you, discuss with your doctor whether you need to use reliable forms of birth control. Do not use birth control products containing estrogen. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor immediately. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Aromasin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aromasin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • new or unusual bone pain;
  • vision problems;
  • swelling in your hands or feet;
  • feeling short of breath, even with mild exertion; or
  • chest pain, sudden numbness or weakness, sudden headache, confusion, problems with vision, speech, or balance.

Less serious side effects may include:

  • hot flashes;
  • headache, tired feeling;
  • anxiety;
  • joint pain;
  • upset stomach;
  • depressed mood;
  • sleep problems (insomnia); or
  • increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aromasin (Exemestane) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Aromasin Overview - Patient Information: Side Effects

SIDE EFFECTS: Hot flashes, hair loss, joint/bone/muscle pain, tiredness, unusual sweating, nausea, diarrhea, dizziness, and trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone fractures, mental/mood changes (such as depression, anxiety), vaginal bleeding.

This medication (and cancer) may rarely cause serious problems from blood clots (such as heart attack or stroke). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, slurred speech, swelling of arms/legs, weakness on one side of the body, vision changes, sudden/severe headache.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea/vomiting, unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat/neck), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Aromasin (Exemestane)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aromasin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

AROMASIN was generally well tolerated and adverse events were usually mild to moderate.

In the adjuvant treatment of early breast cancer, adverse events occurring in ≥ 10% of patients in any treatment group (AROMASIN vs. tamoxifen) were hot flushes (21.2% vs. 19.9%), fatigue (16.1% vs. 14.7%), arthralgia (14.6% vs. 8.6%), headache (13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%), and increased sweating (11.8% vs. 10.4%). Discontinuation rates due to AEs were similar between AROMASIN and tamoxifen (6.3% vs. 5.1%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were AROMASIN 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: AROMASIN 0.4%, tamoxifen 0.3%.

In the treatment of advanced breast cancer, the most common adverse events were mild to moderate and included hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs. 6%) for AROMASIN and megestrol acetate, respectively.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adjuvant Therapy

The data described below reflect exposure to AROMASIN in 2325 postmenopausal women with early breast cancer. AROMASIN tolerability in postmenopausal women with early breast cancer was evaluated in two well-controlled trials: the IES study (14.1) 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).

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.

Certain adverse events, which were 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.

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 respectively 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 2.

Table 2: Incidence (%) of Adverse Events of all Grades1 and Illnesses Occurring in ( ≥ 5%) of Patients in Any Treatment Group in Study IES in Postmenopausal Women with Early Breast Cancer

Body system and Adverse Event by MedDRA dictionary % of patients
AROMASIN 25 mg daily
(N=2252)
Tamoxifen 20 mg daily2
(N=2280)
Eye
  Visual disturbances3 5.0 3.8
Gastrointestinal
  Nausea3 8.5 8.7
General Disorders
  Fatigue3 16.1 14.7
Musculoskeletal
  Arthralgia 14.6 8.6
  Pain in limb 9.0 6.4
  Back pain 8.6 7.2
  Osteoarthritis 5.9 4.5
Nervous System
  Headache3 13.1 10.8
  Dizziness3 9.7 8.4
Psychiatric
  Insomnia3 12.4 8.9
  Depression 6.2 5.6
Skin & Subcutaneous Tissue
  Increased sweating3 11.8 10.4
Vascular
  Hot flushes3 21.2 19.9
  Hypertension 9.8 8.4
1Graded according to Common Toxicity Criteria;
275 patients received tamoxifen 30 mg daily;
3Event actively sought.

In the IES study, as compared to tamoxifen, AROMASIN was associated with a higher incidence of events in musculoskeletal disorders and in 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% vs. < 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 in study 027 are described in Table 3.

Table 3: Incidence of Selected Treatment-Emergent Adverse Events of all CTC Grades* Occurring in ≥ 5% of Patients in Either Arm in Study 027

Adverse Event Exemestane
N=73
(% incidence)
Placebo
N=73
(% incidence)
Hot flushes 32.9 24.7
Arthralgia 28.8 28.8
Increased sweating 17.8 20.6
Alopecia 15.1 4.1
Hypertension 15.1 6.9
Insomnia 13.7 15.1
Nausea 12.3 16.4
Fatigue 11.0 19.2
Abdominal pain 11.0 13.7
Depression 9.6 6.9
Diarrhea 9.6 1.4
Dizziness 9.6 9.6
Dermatitis 8.2 1.4
Headache 6.9 4.1
Myalgia 5.5 4.1
Edema 5.5 6.9
Anxiety 4.1 5.5
* Most events were CTC grade 1-2

Treatment of Advanced Breast Cancer

A total of 1058 patients were treated with exemestane 25 mg once daily in the clinical trials program. 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%) for AROMASIN and megestrol acetate, respectively. 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 4 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.

Table 4: Incidence (%) of Adverse Events of all Grades* and Causes Occurring in ≥ 5% of Advanced Breast Cancer Patients In Each Treatment Arm in the Comparative Study

Body system and Adverse Event by WHO ART dictionary AROMASIN 25 mg once daily
(N=358)
Megestrol Acetate 40 mg QID
(N=400)
Autonomic Nervous
  Increased sweating 6 9
Body as a Whole
  Fatigue 22 29
  Hot flashes 13 6
  Pain 13 13
  Influenza-like symptoms 6 5
  Edema (includes edema, peripheral edema, leg edema) 7 6
Cardiovascular
  Hypertension 5 6
Nervous
  Depression 13 9
  Insomnia 11 9
  Anxiety 10 11
  Dizziness 8 6
  Headache 8 7
Gastrointestinal
  Nausea 18 12
  Vomiting 7 4
  Abdominal pain 6 11
  Anorexia 6 5
  Constipation 5 8
  Diarrhea 4 5
  Increased appetite 3 6
Respiratory
  Dyspnea 10 15
  Coughing 6 7
* Graded according to Common Toxicity Criteria

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.

Cases of hypersensitivity, urticaria, and pruritus have been reported.

Read the entire FDA prescribing information for Aromasin (Exemestane) »

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Aromasin - User Reviews

Aromasin User Reviews

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Here is a collection of user reviews for the medication Aromasin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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