NOLVADEX 10/MG TAB 30/TAB

Indications

Approved Uses

Treatment of estrogen receptor-positive metastatic breast cancer in women and men, Adjuvant treatment of early-stage estrogen receptor-positive breast cancer, Reduction of risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS) after breast surgery and radiation, Reduction in the incidence of breast cancer in women at high risk.

Off-Label Uses

Ovulation induction (anovulatory infertility), mastalgia, gynecomastia (including pubertal), and desmoid tumors (aggressive fibromatosis).

Dosage & Administration

Dosing by Condition

Breast cancer adjuvant therapy: 20 mg once daily for 5-10 years. Metastatic breast cancer: 20-40 mg daily (in divided doses if >20 mg). Breast cancer risk reduction (DCIS/high-risk): 20 mg once daily for 5 years. Male breast cancer: 20-40 mg daily

Initial Dose

20mg orally daily.

Maintenance Dose

20mg orally daily.

Maximum Dose

40mg daily for metastatic breast cancer, although doses above 20mg have not shown additional benefit.

Children's Dosage

Not approved for children under 2 years; for McCune-Albright syndrome in girls 2-10 years: 20 mg/day has been used off-label

How to Take

Swallow the tablet whole with water; may be taken with or without food; take at the same time each day.

Safety & Warnings

Contraindications

NOLVADEX is contraindicated in patients with known hypersensitivity to the drug or any inactive ingredient. Reduction in Breast Cancer Incidence In High Risk Women: NOLVADEX is contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE). Pregnancy: NOLVADEX is contraindicated during pregnancy

Warnings & Precautions

Key warnings/precautions: increased risk of endometrial cancer (promptly evaluate abnormal vaginal bleeding); thromboembolic events including DVT/PE/stroke (use caution in patients with VTE risk); ocular effects/cataracts; hepatic effects (monitor if clinically indicated); possible hypercalcemia/tumor flare in metastatic disease; avoid pregnancy and use effective non-hormonal contraception during therapy and for ~2 months after stopping; avoid strong CYP2D6 inhibitors when possible.

Age Restriction

No specific age cutoff in labeling; use is indication-dependent (approved/standard in adults; pediatric use is off-label and specialist-directed).

Drug Interactions

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children under 2 years; for McCune-Albright syndrome in girls 2-10 years: 20 mg/day has been used off-label

Elderly

Standard adult dosing; no specific dose reduction required, but monitor more closely for thromboembolic events and endometrial changes

Liver Impairment

No defined dose adjustment; use with caution in hepatic impairment and monitor, as tamoxifen is hepatically metabolized and can cause liver abnormalities.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop without prescriber guidance; typical adjuvant duration is 5 years and may be extended to 10 years in selected patients.

Patient Counseling

Take once daily at the same time with or without food; do not stop without prescriber advice; report abnormal vaginal bleeding/pelvic pain, leg swelling/pain, chest pain or shortness of breath, or vision changes urgently; use effective non-hormonal contraception during therapy and for 2 months after stopping; inform clinicians about tamoxifen and avoid strong CYP2D6 inhibitors (e.g., paroxetine/fluoxetine) when possible; keep follow-up for gynecologic and VTE monitoring.

Monitoring Requirements

Monitor for thromboembolic events; prompt evaluation of abnormal vaginal bleeding with regular gynecologic assessment; baseline and periodic liver function tests and complete blood count/platelets as clinically indicated; ophthalmic evaluation if visual symptoms (and consider periodic eye exams in long-term use).

Pharmacology

Mechanism of Action

Selective estrogen receptor modulator (SERM) that competitively binds estrogen receptors, acting as an antagonist in breast tissue and partial agonist in other tissues (e.g., bone and endometrium), altering estrogen-responsive gene transcription.

Onset of Action

Anti-estrogen (endocrine) effects may begin within days; measurable clinical tumor response typically occurs over weeks (often ~4-12 weeks).

Duration of Effect

With regular oral dosing, pharmacologic effect is sustained. After discontinuation, effects may persist for days to weeks due to long half-lives of tamoxifen (~5-7 days) and active metabolites (e.g., endoxifen ~9-14 days). Clinical treatment courses (e.g., adjuvant therapy) are typically continued for 5-10 years depending on indication and risk.

Half-Life

Tamoxifen: approximately 5-7 days; N-desmethyltamoxifen: approximately 14 days (steady-state achieved in about 8 weeks); endoxifen half-life not specified in search results

Bioavailability

Orally well absorbed; absolute bioavailability is not well defined/commonly reported (extensive first-pass metabolism).

Metabolism

Extensive hepatic metabolism mainly via CYP3A4/5 and CYP2D6 to multiple metabolites including N-desmethyltamoxifen, 4-hydroxytamoxifen, and endoxifen (clinically important active metabolite).

Product Information

Available Dosage Forms

Tablet (this SFDA-registered product).

Composition per Dose

Each tablet: 10 mg tamoxifen (as tamoxifen citrate)

Generic Availability

Yes

Primary Use

Hormonal treatment and prevention of estrogen receptor-positive breast cancer

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