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trademark for a preparation of tamoxifen, an antiestrogen used for breast cancer.

tamoxifen citrate

Apo-Tamox, Gen-Tamoxifen, Nolvadex, Nolvadex-D, Novo-Tamoxifen, PMS-Tamoxifen, Soltamox, Tamofen

Pharmacologic class: Nonsteroidal antiestrogen

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Box Warning

For women with ductal carcinoma in situ or high risk of breast cancer, serious and life-threatening events associated with drug use in riskreduction setting include stroke, pulmonary embolism, and uterine cancer. Some of these events were fatal. Discuss potential benefits versus potential risks of these events with these patients. In women already diagnosed with breast cancer, drug's benefits outweigh risks.


Competes with estrogen receptors in tumor cells for binding to target tissues (such as breast); reduces DNA synthesis and estrogen response


Oral solution: 10 mg/5 ml

Tablets: 10 mg, 20 mg

Tablets (enteric-coated): 20 mg

Indications and dosages

Adjunctive treatment of breast cancer

Adults: 20 to 40 mg P.O. daily for 5 years. Daily dosages of 20 mg may be taken as a single dose; daily dosages above 20 mg should be divided and taken b.i.d. (morning and evening).

To reduce breast cancer incidence in high-risk women; treatment of ductal carcinoma in situ

Adults: 20 mg P.O. daily for 5 years

Off-label uses

• Mastalgia

• Ovulation stimulation


• Hypersensitivity to drug

• Concurrent warfarin use

• Women with a history of deep-vein thrombosis or pulmonary embolism

• Pregnancy or breastfeeding


Use cautiously in:

• decreased bone marrow reserve, leukopenia, thrombocytopenia, cataracts, hyperlipidemia

• females of childbearing age.


• Don't break or crush enteric-coated tablets.

• Know that drug is indicated for reducing breast cancer risk only in high-risk women, defined as those older than age 35 who have at least a 1.67% chance of developing breast cancer over 5 years.

Adverse reactions

CNS: confusion, depression, headache, weakness, fatigue, light-headedness

CV: chest pain, deep-vein thrombosis

EENT: blurred vision, ocular lesion, retinopathy, corneal opacity

GI: nausea, vomiting, abdominal cramps, anorexia

GU: vaginal bleeding, discharge, or dryness; irregular menses; amenorrhea; oligomenorrhea; ovarian cyst; pruritus vulvae; endometrial or uterine cancer

Hematologic: leukopenia, thrombocytopenia

Metabolic: hypercalcemia, fluid retention

Musculoskeletal: bone pain

Respiratory: cough, pulmonary embolism

Skin: skin changes, hair thinning or partial hair loss

Other: altered taste, weight loss, tumor flare, tumor pain, hot flashes, edema


Drug-drug. Aminoglutethimide, estrogens: decreased tamoxifen effects

Antineoplastics: increased risk of thromboembolic events

Bromocriptine: increased tamoxifen blood level

Warfarin: increased anticoagulant effect

Drug-diagnostic tests. Aspartate aminotransferase, bilirubin, calcium, creatinine, hepatic enzymes: increased levels

Platelets, white blood cells: decreased counts

Patient monitoring

• Monitor lipid panel, calcium level, mammography results, and gynecologic exam results.

Watch for signs and symptoms of thromboembolic events, including cerebrovascular accident and pulmonary embolism.

• Monitor menstrual cycle pattern for changes that may signal endometrial or uterine cancer.

Patient teaching

• Tell patient to swallow enteric-coated tablets whole without breaking or crushing.

Instruct patient to immediately report leg or calf pain, swelling, or tenderness; unexpected shortness of breath; sudden chest pain; coughing up blood; new breast lumps; vaginal bleeding; menstrual irregularities; changes in vaginal discharge; pelvic pain or pressure; and vision changes.

• Inform patient that increase in bone or tumor pain usually means drug will be effective. Advise her to discuss pain management with prescriber.

• Stress importance of undergoing regular blood tests, mammograms, and gynecologic exams to identify early signs of serious adverse reactions.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


A trademark for the drug tamoxifen.


a trademark for an antiestrogen (tamoxifen).
References in periodicals archive ?
which would like to sell Nolvadex not only to women with breast cancer but to every woman on the planet.
Special Considerations: In the study that led to the approval, the side effects of Nolvadex in women with DCIS were similar to those in other trials of Nolvadex and included hot flashes and vaginal discharge.
Soon after the trial results were released, Zeneca applied to the FDA for approval to market Nolvadex for breast cancer prevention.
AstraZeneca has seen Zestril hit by generic competition since July while Prilosec was affected from December and Nolvadex will be hit from February.
An FDA advisory panel said tamoxifen, sold as Nolvadex by British-based Zeneca Group Plc, could reduce the risk of breast cancer in the short term in women who might be predisposed to get it.
For example, the ACE inhibitor Monopril and the cancer drug Nolvadex are among brand name medications slated for patent expiration this year.
WASHINGTON -- A number of generic drug manufacturers have received Food and Drug Administration approval to market their versions of Nolvadex, AstraZeneca PLC's breast cancer drug.
The preliminary injunction against Eli Lilly came as the result of a suit filed by AstraZeneca PLC (which makes Nolvadex, the only drug currently approved for the reduction of the risk of breast cancer) and Barr Laboratories Inc.
Zeneca noted that Evista's approval by the Food and Drug Administration is only for the prevention of osteoporosis and claims that Nolvadex (tamoxifen citrate), patented by Zeneca, is the only drug proven effective for reducing breast cancer.
The Food and Drug Administration recently gave the Delaware-based drug manufacturer its endorsement for the drug, which Zeneca is marketing under the Nolvadex name.