Aromasin: Advanced Estrogen Control for Breast Cancer Therapy
Aromasin
| Product dosage: 25mg | |||
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Synonyms | |||
Aromasin (exemestane) is a potent, steroidal aromatase inactivator specifically formulated for the treatment of estrogen receptor-positive early and advanced breast cancer in postmenopausal women. As a third-generation aromatase inhibitor, it offers a targeted mechanism of action by irreversibly binding to the aromatase enzyme, leading to a significant and sustained reduction in circulating estrogen levels. This makes it a cornerstone in hormonal therapy, particularly following initial treatment with tamoxifen, where it has demonstrated superior efficacy in reducing recurrence risk and improving long-term outcomes. Its unique irreversible inhibition profile differentiates it from other agents in its class, providing a predictable pharmacokinetic profile and a well-established safety record in clinical practice.
Features
- Contains exemestane 25 mg as the active pharmaceutical ingredient
- Irreversible, steroidal aromatase inactivator (type I inhibitor)
- Oral tablet formulation for once-daily administration
- Bioavailability of approximately 42% following oral ingestion
- Extensive protein binding (90%) primarily to albumin and α1-acid glycoprotein
- Metabolized primarily by CYP3A4 isoenzyme with elimination half-life of approximately 24 hours
- Excreted equally in urine and feces as metabolites
Benefits
- Significantly reduces estrogen synthesis by permanently deactivating the aromatase enzyme system
- Demonstrated improvement in disease-free survival when used as extended adjuvant therapy after 2-3 years of tamoxifen
- Provides effective hormonal control in advanced breast cancer that has progressed following antiestrogen therapy
- Favorable side effect profile compared to traditional chemotherapy regimens
- Oral administration enables convenient outpatient treatment and improved quality of life
- Established long-term safety data supporting extended duration therapy
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 Aromasin to complete 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. Clinical trials have demonstrated that switching to exemestane after 2-3 years of tamoxifen therapy significantly improves disease-free survival compared with continuing tamoxifen for 5 years. The medication is specifically designed for postmenopausal women, as it would be ineffective and potentially harmful in premenopausal patients due to feedback mechanisms that could stimulate ovarian estrogen production.
Dosage and direction
The recommended dosage of Aromasin is one 25 mg tablet taken orally once daily after a meal, as food significantly enhances drug absorption. Treatment should be continuous unless disease progression or unacceptable toxicity occurs. For adjuvant treatment, therapy should continue for the remainder of the 5-year hormonal treatment period. Tablets should be swallowed whole with water and not crushed or chewed. No dosage adjustment is necessary for elderly patients or those with mild to moderate hepatic impairment. For patients with severe hepatic impairment, caution is advised, though specific dosage recommendations have not been established. Renal impairment does not significantly affect exemestane pharmacokinetics, and no dosage adjustment is required for patients with mild to moderate renal impairment.
Precautions
Patients should be monitored regularly for bone mineral density, as Aromasin use is associated with increased bone loss and elevated fracture risk. Calcium and vitamin D supplementation, along with regular weight-bearing exercise, are recommended. Liver function tests should be performed periodically, as elevations in hepatic enzymes have been observed. Patients with a history of cardiovascular disease or hypercholesterolemia should be monitored, as aromatase inhibitors may affect lipid metabolism. Caution is advised in patients with severe hepatic impairment, though no formal dosage recommendations exist. Patients should be informed about potential effects on driving and operating machinery, as fatigue and dizziness have been reported. Regular follow-up and adherence to prescribed dosing schedules are essential for optimal therapeutic outcomes.
Contraindications
Aromasin is contraindicated in women who are premenopausal, pregnant, or breastfeeding, as the drug can cause fetal harm and is excreted in breast milk. It must not be used in patients with known hypersensitivity to exemestane or any component of the formulation. Concomitant use with estrogen-containing medications is contraindicated, as these would counteract the therapeutic effect. The medication is not indicated for use in pediatric populations. Patients with severe hepatic impairment should not use Aromasin unless the potential benefit justifies the potential risk, due to limited clinical data in this population. Those with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should avoid this medication due to the lactose content in the tablet formulation.
Possible side effect
The most frequently reported adverse reactions include hot flashes (approximately 22%), fatigue (16%), arthralgia (15%), headache (13%), insomnia (11%), and increased sweating (10%). Musculoskeletal pain and stiffness affect approximately 29% of patients, while nausea occurs in approximately 9%. Less common but clinically significant side effects include osteoporosis (7%), depression (6%), anxiety (5%), and dizziness (5%). Laboratory abnormalities may include increased ALT and AST levels (2-5% of patients) and elevated bilirubin (1-2%). Cardiovascular effects such as hypertension (5%) and edema (4%) have been observed. Most adverse reactions are mild to moderate in severity and often diminish with continued treatment. Regular monitoring can help manage and mitigate these effects through appropriate supportive care measures.
Drug interaction
Coadministration with estrogen-containing therapies should be avoided as they may diminish the pharmacological effect of Aromasin. Drugs that induce CYP3A4 activity, such as rifampicin, phenytoin, carbamazepine, and St. John’s wort, may significantly decrease exemestane concentrations, potentially reducing efficacy. Conversely, strong CYP3A4 inhibitors like ketoconazole, itraconazole, and clarithromycin may increase exemestane exposure, though dose adjustment is not routinely recommended. No clinically significant interactions have been observed with warfarin, though monitoring of coagulation parameters is advised during concomitant therapy. The medication does not appear to affect the pharmacokinetics of other drugs metabolized by cytochrome P450 enzymes. Healthcare providers should review all concomitant medications, including over-the-counter products and herbal supplements, before initiating therapy.
Missed dose
If a dose is missed, patients should take it 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 never take a double dose to make up for a missed one. Maintaining consistent dosing is important for sustained aromatase inhibition, but occasional missed doses are unlikely to significantly impact overall efficacy. Patients should be educated about the importance of adherence and encouraged to establish a routine, such as taking the medication with the same meal each day. If multiple doses are missed or patterns of non-adherence develop, patients should contact their healthcare provider for guidance rather than attempting to adjust dosing independently.
Overdose
There is limited clinical experience with Aromasin overdose. Single doses up to 800 mg have been administered to healthy volunteers without serious adverse effects. In case of suspected overdose, symptomatic and supportive care is recommended. Gastric lavage may be considered if performed soon after ingestion. As exemestane is highly protein-bound, dialysis is unlikely to be beneficial. Monitoring should include observation for potential estrogen-like effects due to the androgenic structure of exemestane, though these are not typically expected. There is no specific antidote for exemestane overdose. Patients should be monitored for signs of hormonal effects and provided with appropriate supportive measures based on clinical presentation. Any suspected overdose should prompt immediate medical consultation, even in the absence of symptoms.
Storage
Aromasin tablets should be stored at room temperature between 15°C and 30°C (59°F and 86°F) in their original container to protect from light and moisture. The medication should be kept out of reach of children and pets. Tablets should not be stored in bathrooms or other areas with high humidity. Do not use tablets that appear discolored, damaged, or beyond their expiration date. Proper storage ensures maintenance of pharmaceutical stability and efficacy throughout the shelf life. Patients should be advised to check expiration dates regularly and properly dispose of any unused or expired medication according to local regulations, typically through medication take-back programs rather than flushing or household trash disposal.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Aromasin is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Treatment decisions must be based on individual patient characteristics, including comprehensive medical history, current health status, and specific diagnostic findings. The prescribing physician should be consulted for complete information regarding indications, dosage, warnings, and precautions. Patients should not alter their treatment regimen without medical supervision. While every effort has been made to ensure accuracy, medical knowledge evolves, and new information may become available that could affect therapeutic recommendations.
Reviews
Clinical studies demonstrate that Aromasin receives positive evaluation from oncologists for its efficacy in hormonal therapy sequencing. The IES (Intergroup Exemestane Study), involving 4,724 patients, showed a significant 32% reduction in the risk of recurrence when switching to exemestane after 2-3 years of tamoxifen compared to continuing tamoxifen for 5 years. TEAM (Tamoxifen Exemestane Adjuvant Multinational) trial data further support its role in early breast cancer treatment. Patient-reported outcomes indicate generally good tolerability, though musculoskeletal symptoms and vasomotor effects are commonly noted. Healthcare providers appreciate its irreversible mechanism of action and predictable pharmacokinetic profile. The medication maintains high adherence rates compared to other hormonal therapies, attributed to its once-daily dosing and generally manageable side effect profile when appropriately managed with supportive care strategies.