Nolvadex: Targeted Estrogen Blockade for Breast Cancer Treatment
Nolvadex
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| Product dosage: 20mg | |||
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Synonyms
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Nolvadex, with the active ingredient tamoxifen citrate, represents a cornerstone in the endocrine therapy of hormone receptor-positive breast cancer. As a selective estrogen receptor modulator (SERM), it exerts its therapeutic effects by competitively inhibiting estrogen binding at receptor sites in breast tissue, thereby impeding the proliferative signals that fuel certain cancer types. Its well-established efficacy profile and extensive clinical history make it a first-line option for both early and advanced-stage disease in pre- and postmenopausal women. This agent is also utilized in risk reduction settings for high-risk individuals, underscoring its dual role in treatment and prevention within oncology.
Features
- Active pharmaceutical ingredient: Tamoxifen citrate
- Pharmacological class: Selective Estrogen Receptor Modulator (SERM)
- Available formulations: Oral tablets (10 mg and 20 mg)
- Standard packaging: Blister packs of 30 tablets
- Manufacturer: AstraZeneca (originator) and various generic suppliers
- Regulatory status: Prescription-only medication
Benefits
- Significantly reduces the risk of recurrence in hormone receptor-positive early breast cancer.
- Lowers the incidence of contralateral breast cancer in treated patients.
- Provides a non-chemotherapeutic, well-tolerated oral option for long-term maintenance therapy.
- Offers a risk reduction strategy for women at high risk of developing breast cancer.
- Can be used in both premenopausal and postmenopausal populations.
- May have beneficial effects on bone mineral density in postmenopausal women.
Common use
Nolvadex is primarily indicated for the treatment of estrogen receptor-positive (ER+) breast cancer. It is used across the disease spectrum: as adjuvant therapy following primary treatment (surgery, radiation, or chemotherapy) for early-stage cancer to prevent recurrence; for the treatment of metastatic disease; and as a preventive agent in women deemed at high risk for developing breast cancer. Its use is predicated on the presence of hormone receptor positivity, typically determined by immunohistochemical staining of tumor tissue.
Dosage and direction
The standard adult dosage for breast cancer treatment is 20 mg orally once daily, though dosing may range from 20 mg to 40 mg daily based on disease stage and clinical response. For metastatic disease, doses up to 40 mg per day may be employed. Tablets should be taken with water, with or without food, though consistency in administration relative to meals is advised. Treatment duration for adjuvant therapy is typically continued for 5 to 10 years, as per current oncological guidelines. Dosage adjustments are required in patients with hepatic impairment.
Precautions
Patients should undergo baseline ophthalmological examinations due to the risk of retinopathy and corneal changes. Regular gynecological assessments are mandatory to monitor for endometrial changes, including hyperplasia and malignancy. Liver function tests should be performed periodically. Caution is advised in patients with histories of thromboembolic events or hyperlipidemia. Patients should be advised that Nolvadex may alter menstrual regularity in premenopausal women. Sun exposure should be limited due to potential photosensitivity reactions.
Contraindications
Nolvadex is contraindicated in patients with known hypersensitivity to tamoxifen citrate or any component of the formulation. Its use is prohibited concomitantly with anastrozole therapy. It should not be administered to patients with a history of deep vein thrombosis or pulmonary embolism. Contraindication exists for those with anticipated pregnancy or during pregnancy (Pregnancy Category D). It is not recommended for use in patients with significant hepatic impairment or those undergoing cataract surgery.
Possible side effect
Common adverse reactions include hot flashes (approximately 25-80% of patients), vaginal discharge and dryness, and menstrual irregularities. Gastrointestinal disturbances such as nausea and vomiting occur in roughly 10-20% of patients. More serious but less frequent side effects encompass venous thromboembolism (1-2%), endometrial cancer (risk increased 2- to 3-fold), stroke, and cataracts. Hematological changes including transient thrombocytopenia and leukopenia have been reported. Mood alterations, depression, and headache occur in a minority of patients.
Drug interaction
Nolvadex is metabolized primarily by CYP2D6 and CYP3A4 enzymes. Concomitant use with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) may significantly reduce plasma concentrations of active metabolites, potentially diminishing efficacy. Warfarin coadministration requires careful INR monitoring due to increased anticoagulant effect. Aromatase inhibitors should not be used concurrently. Drugs that induce CYP3A4 (e.g., rifampin, phenobarbital) may decrease tamoxifen concentrations. Bromocriptine may increase tamoxifen levels.
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. Doubling of doses to make up for missed doses is not recommended. Patients should be educated on maintaining adherence given the chronic nature of therapy, and use of pill organizers or reminder systems is encouraged for optimal therapeutic outcomes.
Overdose
Acute overdose may manifest as tremor, hyperreflexia, unsteady gait, dizziness, and nausea. There is no specific antidote for tamoxifen overdose. Management should include supportive care with monitoring of vital signs and ECG. Gastric lavage may be considered if presentation is early after ingestion. Symptomatic treatment for central nervous system effects should be instituted. Due to the drug’s long half-life (5-7 days), extended monitoring may be necessary.
Storage
Store at controlled room temperature (20-25°C or 68-77°F) in the original container. Protect from light and moisture. Keep tightly closed and out of reach of children. Do not use if tablets show evidence of discoloration or physical deterioration. Do not transfer to alternative containers that lack appropriate desiccant properties. Proper disposal of unused medication should follow local regulations for pharmaceutical waste.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be consulted for specific dosage recommendations and management of adverse effects. Full prescribing information should be reviewed before initiation of therapy.
Reviews
Clinical trials spanning decades have established Nolvadex as a fundamental component of breast cancer management. The NSABP B-14 trial demonstrated a 50% reduction in recurrence risk with 5 years of adjuvant therapy. The IBIS-I prevention trial showed a 38% reduction in breast cancer incidence in high-risk women. Long-term follow-up data confirm sustained benefit with 10-year therapy in appropriate patients. While newer agents have emerged, Nolvadex remains a validated, cost-effective option with a well-characterized safety profile.