Aromasin: Advanced Estrogen Control for Breast Cancer Therapy
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Synonyms | |||
Aromasin (exemestane) is a steroidal aromatase inactivator specifically designed for the treatment of estrogen receptor-positive breast cancer in postmenopausal women. As a third-generation aromatase inhibitor, it works by permanently binding to the aromatase enzyme, effectively suppressing estrogen production throughout the body. This targeted mechanism offers a sophisticated endocrine therapy option with a well-established efficacy and safety profile, making it a cornerstone in both adjuvant and metastatic treatment settings. Clinical evidence supports its role in significantly reducing recurrence risk and improving survival outcomes.
Features
- Active ingredient: Exemestane 25 mg
- Pharmacological class: Irreversible steroidal aromatase inactivator
- Administration: Oral tablet formulation
- Bioavailability: Approximately 42% following oral administration
- Protein binding: 90% to plasma proteins (primarily albumin)
- Metabolism: Extensive hepatic metabolism via CYP3A4
- Elimination half-life: Approximately 24 hours
- Excretion: Primarily fecal (approximately 42%) and urinary (approximately 42%)
Benefits
- Significantly reduces the risk of breast cancer recurrence in postmenopausal women
- Demonstrates superior efficacy compared to tamoxifen in adjuvant treatment settings
- Irreversible enzyme binding provides sustained estrogen suppression
- Generally well-tolerated with a manageable side effect profile
- Oral administration allows for convenient once-daily dosing
- May preserve bone mineral density better than non-steroidal aromatase inhibitors
Common use
Aromasin is primarily indicated for the adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received 2-3 years of tamoxifen and are switched to exemestane for completion of a total of 5 years of adjuvant hormonal therapy. It is also approved for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. The medication may be used as first-line treatment in advanced hormone receptor-positive breast cancer in specific clinical scenarios. Off-label uses include estrogen suppression in fertility treatments and gynecomastia prevention, though these applications require careful risk-benefit assessment.
Dosage and direction
The recommended dosage of Aromasin is one 25 mg tablet taken orally once daily after a meal. Administration with food significantly enhances drug absorption and bioavailability. Treatment should continue until disease progression or for the prescribed duration in the adjuvant setting, typically completing a total of 5 years of endocrine therapy. Dosage adjustment is not necessary for elderly patients, but careful monitoring is recommended. For patients with hepatic or renal impairment, no specific dosage adjustments are required, though caution is advised in severe hepatic impairment. Tablets should be swallowed whole with water and not crushed or chewed.
Precautions
Patients should undergo comprehensive bone mineral density assessment before initiating therapy and at regular intervals during treatment due to the potential for accelerated bone loss. Regular monitoring of lipid profiles is recommended as aromatase inhibitors may affect cholesterol metabolism. Caution is advised in patients with pre-existing osteoporosis or risk factors for fracture. Vitamin D and calcium supplementation should be considered prophylactically. Patients should be monitored for emerging cardiovascular risk factors throughout treatment. Those with a history of hypercholesterolemia require close lipid monitoring. Caution is warranted in patients with severe hepatic impairment, though no formal dosage adjustment is required.
Contraindications
Aromasin is contraindicated in premenopausal women, as it does not effectively suppress ovarian estrogen production and may lead to hormonal imbalance. It is contraindicated in patients with known hypersensitivity to exemestane or any component of the formulation. The medication should not be used in pregnant women, as it may cause fetal harm, or during breastfeeding. Concomitant use with estrogen-containing medications or therapies is contraindicated due to potential interference with pharmacological action. Patients with severe hepatic impairment (Child-Pugh Class C) should generally avoid use unless potential benefits outweigh risks.
Possible side effects
The most commonly reported adverse reactions include hot flashes (approximately 25-30% of patients), fatigue (15-22%), arthralgia and arthritis (15-20%), headache (10-15%), insomnia (10-14%), and increased sweating (10-12%). Musculoskeletal pain and stiffness affect approximately 15-18% of patients. Gastrointestinal disturbances such as nausea (10-15%) and diarrhea (5-8%) may occur. Less common but clinically significant side effects include osteoporosis (8-12% with long-term use), fractures (5-7%), elevated cholesterol (6-9%), and depression (5-8%). Rare but serious adverse events may include cardiovascular events, severe hypersensitivity reactions, and hepatic enzyme elevations.
Drug interaction
Aromasin interacts significantly with CYP3A4 inducers and inhibitors. Strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, and St. John’s wort may substantially decrease exemestane concentrations, potentially reducing efficacy. Concomitant use with estrogen-containing therapies may antagonize the drug’s therapeutic effect. Medications that affect bone metabolism, such as corticosteroids, may exacerbate bone mineral density loss. Caution is advised with drugs that prolong QT interval, though exemestane itself has minimal effect on cardiac repolarization. No clinically significant interactions have been observed with tamoxifen, anastrozole, or letrozole.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. Consistency in dosing is important for maintaining stable estrogen suppression, but occasional missed doses are unlikely to significantly impact overall treatment efficacy. Patients should be advised to maintain a regular dosing routine, preferably at the same time each day, to minimize the risk of missed doses.
Overdose
There is limited clinical experience with Aromasin overdose. Single doses up to 800 mg have been administered to healthy volunteers without severe adverse effects. In case of suspected overdose, symptomatic and supportive treatment should be initiated. Gastric lavage may be considered if ingestion was recent. Since exemestane is highly protein-bound, dialysis is unlikely to be effective. Monitoring should include observation for potential estrogen-like effects due to the steroid-like structure of the medication. There is no specific antidote for exemestane overdose. Medical supervision is recommended for any suspected overdose situation.
Storage
Aromasin tablets should be stored at room temperature between 15°C and 30°C (59°F and 86°F) in their original container. Protect from light and moisture. Keep the medication out of reach of children and pets. Do not store in bathrooms or other areas with high humidity. Tablets should not be used beyond the expiration date printed on the packaging. Proper disposal of unused medication is important to prevent accidental ingestion or environmental contamination. Patients should consult their pharmacist regarding appropriate disposal methods according to local regulations.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with a qualified healthcare professional familiar with the patient’s specific medical history and current condition. The prescribing physician should be consulted for complete prescribing information, including boxed warnings and medication guide. Individual patient responses to therapy may vary, and monitoring by a healthcare provider is essential throughout treatment.
Reviews
Clinical studies demonstrate that Aromasin achieves a significant reduction in breast cancer recurrence risk, with the TEAM trial showing improved disease-free survival compared to tamoxifen. The IES study demonstrated a 32% reduction in risk of recurrence when switching to exemestane after 2-3 years of tamoxifen. Patients generally report acceptable quality of life during treatment, though musculoskeletal symptoms remain a common challenge. Many clinicians appreciate the irreversible mechanism of action and predictable pharmacokinetic profile. Long-term follow-up data confirm sustained efficacy with manageable toxicity profile over extended treatment periods.