Aromasin: Advanced Estrogen Control for Optimal Hormone Therapy
| Product dosage: 25mg | |||
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Synonyms | |||
Aromasin (exemestane) is a potent, steroidal aromatase inhibitor designed for the management of estrogen-sensitive conditions in postmenopausal women. It is specifically indicated for adjuvant treatment of early breast cancer in those who have received two to three years of tamoxifen and are switched to Aromasin for completion of a total of five years of adjuvant hormonal therapy, as well as for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. By irreversibly binding to the aromatase enzyme, Aromasin effectively suppresses estrogen synthesis, offering a targeted approach to hormone receptor-positive breast cancer management. Its unique inactivation mechanism provides a sustained therapeutic effect, making it a cornerstone in modern endocrine treatment strategies.
Features
- Active ingredient: Exemestane 25 mg
- Pharmacological class: Irreversible, steroidal aromatase inactivator
- Administration: Oral tablet
- Bioavailability: Approximately 42% following oral administration
- Protein binding: 90% bound to plasma proteins
- Metabolism: Extensive hepatic metabolism via CYP 3A4
- Elimination half-life: Approximately 24 hours
- Excretion: Primarily fecal (approximately 42%) and urinary (approximately 42%)
Benefits
- Significantly reduces estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogens
- Lowers the risk of cancer recurrence in hormone receptor-positive early breast cancer when used as extended adjuvant therapy after initial tamoxifen treatment
- Demonstrates efficacy in advanced breast cancer cases that have progressed on antiestrogen therapy
- Offers a favorable side effect profile compared to some other hormonal therapies, with manageable tolerability for long-term use
- Provides once-daily dosing convenience, supporting adherence to treatment regimens
- Does not require concomitant corticosteroid replacement, unlike some earlier generation aromatase inhibitors
Common use
Aromasin is primarily used in the treatment of hormone receptor-positive breast cancer in postmenopausal women. It is approved for two main indications: as extended adjuvant treatment of early breast cancer in postmenopausal women who have received two to three years of tamoxifen and are switched to Aromasin to complete a total of five years of adjuvant hormonal therapy, and for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. The medication works by blocking the enzyme aromatase, which is responsible for converting androgens into estrogens in peripheral tissues. This action significantly reduces circulating estrogen levels, thereby depriving estrogen-dependent cancer cells of the hormonal stimulation needed for growth and proliferation.
Dosage and direction
The recommended dosage of Aromasin is one 25 mg tablet taken orally once daily, after a meal. Treatment should be continued until tumor progression is observed in patients with advanced disease. For adjuvant treatment of early breast cancer, the recommended duration of treatment is two to three years after initial tamoxifen therapy, completing a total of five years of adjuvant hormonal therapy. Tablets should be swallowed whole with water and should not be crushed or chewed. Administration with food enhances drug absorption and improves bioavailability. No dosage adjustment is necessary for patients with renal impairment or mild to moderate hepatic impairment. In patients with severe hepatic impairment, caution is advised, though specific dosage recommendations have not been established.
Precautions
Patients should be monitored regularly for bone mineral density, as aromatase inhibitors are associated with increased bone loss. Calcium and vitamin D supplementation is recommended, and bone mineral density should be assessed at baseline and periodically during treatment. Liver function tests should be performed periodically due to potential hepatotoxicity. Patients should be advised about the potential for dizziness and fatigue and cautioned about driving or operating machinery until they know how Aromasin affects them. Regular monitoring of lipid profiles is recommended, as changes in cholesterol levels have been observed. Patients should be informed about the possibility of hot flashes and other menopausal symptoms. Those with a history of osteoporosis or at high risk for fractures should be carefully evaluated before initiation of therapy.
Contraindications
Aromasin is contraindicated in patients with known hypersensitivity to exemestane or any component of the formulation. It should not be used in premenopausal women, as it does not inhibit ovarian estrogen production and may not be effective. The medication is contraindicated in pregnant women, as it may cause fetal harm, and in nursing mothers, as it is not known whether exemestane is excreted in human milk. Concomitant use with estrogen-containing medications is contraindicated, as these agents would counteract the therapeutic effect of Aromasin. Patients with severe hepatic impairment should use Aromasin with caution, though specific contraindication criteria have not been established for this population.
Possible side effect
Common adverse reactions include hot flashes (12-28%), fatigue (8-22%), arthralgia (8-29%), headache (9-17%), insomnia (8-15%), and increased sweating (6-16%). Gastrointestinal disturbances such as nausea (9-18%) and diarrhea (4-11%) may occur. Musculoskeletal pain and stiffness are frequently reported. Less common but potentially serious side effects include osteoporosis and fractures, which occur in approximately 3-10% of patients. Elevated cholesterol levels are observed in approximately 5-9% of patients. Depression and anxiety have been reported in 5-13% of cases. Rare but serious adverse effects may include hepatotoxicity, allergic reactions, and cardiovascular events. Most side effects are mild to moderate in severity and often decrease in frequency with continued treatment.
Drug interaction
Aromasin is primarily metabolized by CYP 3A4 enzymes. Strong CYP 3A4 inducers such as rifampicin, phenytoin, carbamazepine, and St. John’s wort may decrease exemestane concentrations, potentially reducing efficacy. Concomitant use with estrogen-containing therapies is contraindicated as it may antagonize the therapeutic effect. Drugs that inhibit CYP 3A4, such as ketoconazole, may increase exemestane concentrations, though dosage adjustment is not routinely recommended. No clinically significant interactions have been observed with tamoxifen, though concurrent use is not recommended due to potential mutual inhibition of metabolic pathways. Caution is advised when coadministering with other medications that are substrates of CYP 3A4, though specific interaction studies are limited.
Missed dose
If a dose is missed, it should be taken as soon as remembered, unless it is almost 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. Maintaining consistent dosing is important for optimal estrogen suppression, but occasional missed doses are unlikely to significantly impact overall treatment efficacy. Patients should be advised to contact their healthcare provider if they have questions about missed doses or if they frequently forget to take their medication. Setting daily reminders or using pill organizers may help improve adherence to the prescribed regimen.
Overdose
There is limited experience with Aromasin overdose in humans. Single doses of up to 800 mg have been administered to healthy volunteers without serious adverse effects. In case of suspected overdose, symptomatic and supportive treatment should be initiated. Gastric lavage may be considered if ingestion occurred within a short time frame. Since exemestane is highly protein-bound, dialysis is unlikely to be effective. Medical supervision is recommended, particularly monitoring for potential gastrointestinal disturbances, dizziness, or headache. There is no specific antidote for exemestane overdose. Treatment should focus on management of symptoms and supportive care. Patients should be advised to store medication properly to prevent accidental ingestion by children or pets.
Storage
Aromasin tablets should be stored at room temperature between 15°C and 30°C (59°F and 86°F). Protect from light and moisture, and keep in the original container with the lid tightly closed. Do not store in bathrooms or other areas with high humidity. Keep out of reach of children and pets. Do not use tablets that are discolored, damaged, or beyond the expiration date printed on the packaging. Proper storage conditions help maintain drug stability and efficacy throughout the treatment period. Patients should be advised to check expiration dates regularly and properly dispose of any expired medication according to local regulations.
Disclaimer
This information is provided for educational purposes only and is not intended as medical advice. Aromasin is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual patient responses may vary, and treatment decisions should be based on the clinical judgment of a physician familiar with the patient’s specific medical situation. The complete prescribing information should be consulted before initiating therapy. Patients should not adjust their dosage or discontinue treatment without consulting their healthcare provider. This information does not cover all possible uses, directions, precautions, or adverse effects.
Reviews
Clinical studies have demonstrated Aromasin’s efficacy in reducing the risk of breast cancer recurrence. The Intergroup Exemestane Study showed a significant improvement in disease-free survival when patients were switched to exemestane after 2-3 years of tamoxifen therapy. Many oncologists report positive experiences with Aromasin in clinical practice, noting its generally favorable tolerability profile compared to other aromatase inhibitors. Patients often report satisfactory management of side effects with appropriate supportive care. Some clinical trials have reported a 32% reduction in the risk of recurrence compared to continued tamoxifen therapy. Long-term follow-up data continue to support its role in adjuvant hormone therapy. Patient satisfaction surveys indicate generally good quality of life maintenance during treatment, though individual experiences with side effects may vary.