Nolvadex: Advanced Estrogen Receptor Modulation for Breast Cancer
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Synonyms
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Nolvadex (tamoxifen citrate) is a cornerstone selective estrogen receptor modulator (SERM) used in the treatment and risk reduction of hormone receptor-positive breast cancer. It functions as a competitive antagonist of estradiol at estrogen receptors in breast tissue, thereby inhibiting the proliferative effects of estrogen on mammary epithelium. This oral therapeutic agent represents a critical component of adjuvant endocrine therapy, significantly improving disease-free and overall survival rates in eligible patient populations. Its well-established efficacy and manageable safety profile have solidified its position in international oncology guidelines for both premenopausal and postmenopausal women.
Features
- Active pharmaceutical ingredient: Tamoxifen citrate
- Standard dosage forms: 10 mg and 20 mg oral tablets
- Mechanism: Selective estrogen receptor modulator (SERM) with tissue-specific agonist/antagonist properties
- Bioavailability: High oral absorption with extensive enterophepatic circulation
- Metabolism: Hepatic, primarily via CYP2D6 and CYP3A4 isoenzymes
- Elimination half-life: Approximately 5-7 days for tamoxifen and 14 days for active metabolites
- Protein binding: >99% bound to plasma proteins
Benefits
- Significantly reduces the risk of recurrence in early-stage, hormone receptor-positive breast cancer
- Lowers incidence of contralateral breast cancer in high-risk populations
- Provides effective palliative treatment for advanced or metastatic hormone-sensitive breast malignancies
- Offers fertility preservation option by serving as an alternative to ovarian ablation in premenopausal women
- Demonstrates favorable bone mineral density preservation effects in postmenopausal patients
- Establishes cardioprotective lipid profile modifications through estrogen agonist effects in liver
Common use
Nolvadex is primarily indicated for the treatment of hormone receptor-positive breast cancer across various disease stages. In adjuvant settings, it is prescribed for 5-10 years following primary treatment to reduce recurrence risk. For metastatic disease, it provides systemic control of estrogen-sensitive tumors. Additionally, it is FDA-approved for risk reduction in women with high lifetime breast cancer risk, including those with lobular carcinoma in situ (LCIS) or atypical hyperplasia. Off-label applications include management of gynecomastia and infertility treatments in certain clinical scenarios.
Dosage and direction
The standard adult dosage for breast cancer treatment is 20 mg orally once daily, though doses may range from 20-40 mg daily based on disease stage and clinical response. For risk reduction in high-risk patients, the recommended dose is 20 mg daily for 5 years. Administration should occur at approximately the same time each day, with or without food. Tablets should be swallowed whole with water and not crushed or chewed. Treatment duration typically spans 5-10 years for adjuvant therapy, though individual treatment plans should be determined by the treating oncologist based on comprehensive risk assessment.
Precautions
Regular monitoring of endometrial thickness via transvaginal ultrasound is recommended due to increased risk of endometrial changes. Periodic ophthalmologic examinations are advised to monitor for retinal changes or cataracts. Liver function tests should be performed at baseline and periodically during treatment. Patients should be cautioned about potential hypercalcemia during initial treatment of bone metastases. Those with history of thromboembolic events require careful risk-benefit assessment. Premenopausal women should use non-hormonal contraception during therapy due to potential teratogenic effects.
Contraindications
Nolvadex is contraindicated in patients with known hypersensitivity to tamoxifen citrate or any component of the formulation. Concurrent administration with warfarin requires careful monitoring due to potentiation of anticoagulant effect. It is contraindicated in women requiring concomitant estrogen-containing therapies. Patients with history of deep vein thrombosis or pulmonary embolism should generally avoid therapy unless potential benefits substantially outweigh risks. Use during pregnancy is contraindicated due to potential fetal harm.
Possible side effect
Common adverse reactions (>10%) include hot flashes, vaginal discharge and dryness, and menstrual irregularities. Moderate frequency effects (1-10%) encompass nausea, fatigue, skin rash, and elevated liver enzymes. Serious but less common (<1%) side effects include endometrial cancer, thromboembolic events, stroke, pulmonary embolism, and ocular toxicity including retinopathy and corneal changes. Additional reported effects include hypertriglyceridemia, mood disturbances, and reduced bone mineral density in premenopausal women.
Drug interaction
Strong CYP2D6 inhibitors (paroxetine, fluoxetine) may reduce conversion to active metabolites, potentially diminishing efficacy. Warfarin coadministration increases anticoagulant effect requiring frequent INR monitoring. Aromatase inhibitors may antagonize therapeutic effects when used concomitantly. CYP3A4 inducers (rifampin, St. John’s Wort) may reduce tamoxifen concentrations. Serotonergic drugs may increase risk of serotonin syndrome. Tamoxifen may enhance hepatotoxicity of other potentially hepatotoxic medications.
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 double the dose to make up for a missed administration. Consistent daily dosing is important for maintaining stable drug levels, so establishing a routine administration time is recommended. If multiple doses are missed, consultation with the prescribing physician is advised.
Overdose
Symptoms of acute overdose may include tremor, hyperreflexia, unsteady gait, dizziness, and nausea. Severe overdose may manifest as prolonged QT interval, seizures, or cardiac arrhythmias. There is no specific antidote for tamoxifen overdose. Management should include supportive care with ECG monitoring and symptomatic treatment. Gastric lavage may be considered if presentation is early after ingestion. Activated charcoal may be administered if the patient presents within one hour of ingestion. Dialysis is not likely to be effective due to high protein binding.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Keep in the original container with the lid tightly closed. Do not store in bathroom or other areas with high humidity. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly dispose of any unused medication through medication take-back programs.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Nolvadex is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual response to therapy may vary, and treatment decisions should be based on comprehensive medical evaluation. Patients should discuss potential risks and benefits with their treating physician before initiating therapy. Never discontinue or modify dosage without medical consultation.
Reviews
Clinical studies consistently demonstrate Nolvadex’s efficacy in reducing breast cancer recurrence by approximately 50% during the first five years of treatment. The NSABP P-1 trial showed a 49% reduction in invasive breast cancer incidence among high-risk women. Long-term follow-up data from multiple trials confirm sustained benefit with 10-year therapy. Patient-reported outcomes indicate generally good tolerability, though vasomotor symptoms remain the most commonly reported adverse effect affecting quality of life. Oncology guidelines consistently recommend tamoxifen as first-line endocrine therapy for premenopausal women with hormone receptor-positive disease.