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Nolvadex

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Nolvadex

Nolvadex

WARNINGS

Effects in Metastatic Breast Cancer Patients

As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with NOLVADEX (tamoxifen citrate) . If hypercalcemia does occur, appropriate measures should be taken and, if severe, NOLVADEX (tamoxifen citrate) should be discontinued.

Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma

An increased incidence of uterine malignancies has been reported in association with NOLVADEX (tamoxifen citrate) treatment. The underlying mechanism is unknown, but may be related to the estrogen-like effect of NOLVADEX (tamoxifen citrate) . Most uterine malignancies seen in association with NOLVADEX (tamoxifen citrate) are classified as adenocarcinoma of the endometrium. However, rare uterine sarcomas, including malignant mixed mullerian tumors (MMMT), have also been reported. Uterine sarcoma is generally associated with a higher FIGO stage (III/IV) at diagnosis, poorer prognosis, and shorter survival. Uterine sarcoma has been reported to occur more frequently among long-term users ( ≥ 2 years) of NOLVADEX (tamoxifen citrate) than non-users. Some of the uterine malignancies (endometrial carcinoma or uterine sarcoma) have been fatal.

In the NSABP P-1 trial, among participants randomized to NOLVADEX (tamoxifen citrate) there was a statistically significant increase in the incidence of endometrial cancer (33 cases of invasive endometrial cancer, compared to 14 cases among participants randomized to placebo (RR=2.48, 95% CI: 1.27-4.92). The 33 cases in participants receiving NOLVADEX (tamoxifen citrate) were FIGO Stage I, including 20 IA, 12 IB, and 1 IC endometrial adenocarcinomas. In participants randomized to placebo, 13 were FIGO Stage I (8 IA and 5 IB) and 1 was FIGO Stage IV. Five women on NOLVADEX (tamoxifen citrate) and 1 on placebo received postoperative radiation therapy in addition to surgery. This increase was primarily observed among women at least 50 years of age at the time of randomization (26 cases of invasive endometrial cancer, compared to 6 cases among participants randomized to placebo (RR=4.50, 95% CI: 1.78-13.16). Among women ≤ 49 years of age at the time of randomization there were 7 cases of invasive endometrial cancer, compared to 8 cases among participants randomized to placebo (RR=0.94, 95% CI: 0.28-2.89). If age at the time of diagnosis is considered, there were 4 cases of endometrial cancer among participants ≤ 49 randomized to NOLVADEX (tamoxifen citrate) compared to 2 among participants randomized to placebo (RR=2.21, 95% CI: 0.4-12.0). For women ≥ 50 at the time of diagnosis, there were 29 cases among participants randomized to NOLVADEX (tamoxifen citrate) compared to 12 among women on placebo (RR=2.5, 95% CI: 1.3-4.9). The risk ratios were similar in the two groups, although fewer events occurred in younger women. Most (29 of 33 cases in the NOLVADEX (tamoxifen citrate) group) endometrial cancers were diagnosed in symptomatic women, although 5 of 33 cases in the NOLVADEX (tamoxifen citrate) group occurred in asymptomatic women. Among women receiving NOLVADEX (tamoxifen citrate) the events appeared between 1 and 61 months (average=32 months) from the start of treatment.

In an updated review of long-term data (median length of total follow-up is 6.9 years, including blinded follow-up) on 8,306 women with an intact uterus at randomization in the NSABP P-1 risk reduction trial, the incidence of both adenocarcinomas and rare uterine sarcomas was increased in women taking NOLVADEX (tamoxifen citrate) . During blinded follow-up, there were 36 cases of FIGO Stage I endometrial adenocarcinoma (22 were FIGO Stage IA, 13 IB, and 1 IC) in women receiving NOLVADEX (tamoxifen citrate) and 15 cases in women receiving placebo [14 were FIGO Stage I (9 IA and 5 IB), and 1 case was FIGO Stage IV]. Of the patients receiving NOLVADEX (tamoxifen citrate) who developed endometrial cancer, one with Stage IA and 4 with Stage IB cancers received radiation therapy. In the placebo group, one patient with FIGO Stage 1B cancer received radiation therapy and the patient with FIGO Stage IVB cancer received chemotherapy and hormonal therapy. During total follow-up, endometrial adenocarcinoma was reported in 53 women randomized to NOLVADEX (tamoxifen citrate) (30 cases of FIGO Stage IA, 20 were Stage IB, 1 was Stage IC, and 2 were Stage IIIC), and 17 women randomized to placebo (9 cases were FIGO Stage IA, 6 were Stage IB, 1 was Stage IIIC, and 1 was Stage IVB) (incidence per 1,000 women-years of 2.20 and 0.71, respectively). Some patients received post-operative radiation therapy in addition to surgery. Uterine sarcomas were reported in 4 women randomized to NOLVADEX (tamoxifen citrate) (1 was FIGO IA, 1 was FIGO IB, 1 was FIGO IIA, and 1 was FIGO IIIC) and one patient randomized to placebo (FIGO 1A); incidence per 1,000 women-years of 0.17 and 0.04, respectively. Of the patients randomized to NOLVADEX (tamoxifen citrate) , the FIGO IA and IB cases were a MMMT and sarcoma, respectively; the FIGO II was a MMMT; and the FIGO III was a sarcoma; and the one patient randomized to placebo had a MMMT. A similar increased incidence in endometrial adenocarcinoma and uterine sarcoma was observed among women receiving NOLVADEX (tamoxifen citrate) in five other NSABP clinical trials.

Any patient receiving or who has previously received NOLVADEX (tamoxifen citrate) who reports abnormal vaginal bleeding should be promptly evaluated. Patients receiving or who have previously received NOLVADEX (tamoxifen citrate) should have annual gynecological examinations and they should promptly inform their physicians if they experience any abnormal gynecological symptoms, eg, menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure.

In the P-1 trial, endometrial sampling did not alter the endometrial cancer detection rate compared to women who did not undergo endometrial sampling (0.6% with sampling, 0.5% without sampling) for women with an intact uterus. There are no data to suggest that routine endometrial sampling in asymptomatic women taking NOLVADEX (tamoxifen citrate) to reduce the incidence of breast cancer would be beneficial.

Non-Malignant Effects on the Uterus

An increased incidence of endometrial changes including hyperplasia and polyps have been reported in association with NOLVADEX (tamoxifen citrate) treatment. The incidence and pattern of this increase suggest that the underlying mechanism is related to the estrogenic properties of NOLVADEX (tamoxifen citrate) .

There have been a few reports of endometriosis and uterine fibroids in women receiving NOLVADEX (tamoxifen citrate) . The underlying mechanism may be due to the partial estrogenic effect of NOLVADEX (tamoxifen citrate) . Ovarian cysts have also been observed in a small number of premenopausal patients with advanced breast cancer who have been treated with NOLVADEX (tamoxifen citrate) .

NOLVADEX (tamoxifen citrate) has been reported to cause menstrual irregularity or amenorrhea.

Thromboembolic Effects of NOLVADEX (tamoxifen citrate)

There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during NOLVADEX (tamoxifen citrate) therapy. When NOLVADEX (tamoxifen citrate) is coadminstered with chemotherapy, there may be a further increase in the incidence of thromboembolic effects. For treatment of breast cancer, the risks and benefits of NOLVADEX (tamoxifen citrate) should be carefully considered in women with a history of thromboembolic events. In a small substudy (N=81) of the NSABP P-1 trial, there appeared to be no benefit to screening women for Factor V Leiden and Prothrombin mutations G20210A as a means to identify those who may not be appropriate candidates for NOLVADEX (tamoxifen citrate) therapy.

Data from the NSABP P-1 trial show that participants receiving NOLVADEX (tamoxifen citrate) without a history of pulmonary emboli (PE) had a statistically significant increase in pulmonary emboli (18-NOLVADEX (tamoxifen citrate) , 6-placebo, RR=3.01, 95% CI: 1.15- 9.27). Three of the pulmonary emboli, all in the NOLVADEX (tamoxifen citrate) arm, were fatal. Eighty-seven percent of the cases of pulmonary embolism occurred in women at least 50 years of age at randomization. Among women receiving NOLVADEX (tamoxifen citrate) , the events appeared between 2 and 60 months (average=27 months) from the start of treatment.

In this same population, a non-statistically significant increase in deep vein thrombosis (DVT) was seen in the NOLVADEX (tamoxifen citrate) group (30-NOLVADEX (tamoxifen citrate) , 19-placebo; RR=1.59, 95% CI: 0.86-2.98). The same increase in relative risk was seen in women ≤ 49 and in women ≥ 50, although fewer events occurred in younger women. Women with thromboembolic events were at risk for a second related event (7 out of 25 women on placebo, 5 out of 48 women on NOLVADEX (tamoxifen citrate) ) and were at risk for complications of the event and its treatment (0/25 on placebo, 4/48 on NOLVADEX (tamoxifen citrate) ). Among women receiving NOLVADEX (tamoxifen citrate) , deep vein thrombosis events occurred between 2 and 57 months (average=19 months) from the start of treatment.

There was a non-statistically significant increase in stroke among patients randomized to NOLVADEX (tamoxifen citrate) (24-Placebo; 34-NOLVADEX (tamoxifen citrate) ; RR=1.42; 95% CI 0.82-2.51). Six of the 24 strokes in the placebo group were considered hemorrhagic in origin and 10 of the 34 strokes in the NOLVADEX (tamoxifen citrate) group were categorized as hemorrhagic. Seventeen of the 34 strokes in the NOLVADEX (tamoxifen citrate) group were considered occlusive and 7 were considered to be of unknown etiology. Fourteen of the 24 strokes on the placebo arm were reported to be occlusive and 4 of unknown etiology. Among these strokes 3 strokes in the placebo group and 4 strokes in the NOLVADEX (tamoxifen citrate) group were fatal. Eighty-eight percent of the strokes occurred in women at least 50 years of age at the time of randomization. Among women receiving NOLVADEX (tamoxifen citrate) , the events occurred between 1 and 63 months (average=30 months) from the start of treatment.

Effects on the liver: Liver cancer

In the Swedish trial using adjuvant NOLVADEX (tamoxifen citrate) 40 mg/day for 2-5 years, 3 cases of liver cancer have been reported in the NOLVADEX (tamoxifen citrate) -treated group vs. 1 case in the observation group (See PRECAUTIONS- Carcinogenesis). In other clinical trials evaluating NOLVADEX (tamoxifen citrate) , no cases of liver cancer have been reported to date.

One case of liver cancer was reported in NSABP P-1 in a participant randomized to NOLVADEX (tamoxifen citrate) .

Effects on the liver: Non-malignant effects

NOLVADEX (tamoxifen citrate) has been associated with changes in liver enzyme levels, and on rare occasions, a spectrum of more severe liver abnormalities including fatty liver, cholestasis, hepatitis and hepatic necrosis. A few of these serious cases included fatalities. In most reported cases the relationship to NOLVADEX (tamoxifen citrate) is uncertain. However, some positive rechallenges and dechallenges have been reported.

In the NSABP P-1 trial, few grade 3-4 changes in liver function (SGOT, SGPT, bilirubin, alkaline phosphatase) were observed (10 on placebo and 6 on NOLVADEX (tamoxifen citrate) ). Serum lipids were not systematically collected.

Other cancers

A number of second primary tumors, occurring at sites other than the endometrium, have been reported following the treatment of breast cancer with NOLVADEX (tamoxifen citrate) in clinical trials. Data from the NSABP B-14 and P-1 studies show no increase in other (non-uterine) cancers among patients receiving NOLVADEX (tamoxifen citrate) . Whether an increased risk for other (non-uterine) cancers is associated with NOLVADEX (tamoxifen citrate) is still uncertain and continues to be evaluated.

Effects on the Eye

Ocular disturbances, including corneal changes, decrement in color vision perception, retinal vein thrombosis, and retinopathy have been reported in patients receiving NOLVADEX (tamoxifen citrate) . An increased incidence of cataracts and the need for cataract surgery have been reported in patients receiving NOLVADEX (tamoxifen citrate) .

In the NSABP P-1 trial, an increased risk of borderline significance of developing cataracts among those women without cataracts at baseline (540-NOLVADEX (tamoxifen citrate) ; 483-placebo; RR=1.13, 95% CI: 1.00-1.28) was observed. Among these same women, NOLVADEX (tamoxifen citrate) was associated with an increased risk of having cataract surgery (101-NOLVADEX (tamoxifen citrate) ; 63-placebo; RR=1.62, 95% CI 1.18-2.22) (See Table 3 in CLINICAL PHARMACOLOGY). Among all women on the trial (with or without cataracts at baseline), NOLVADEX (tamoxifen citrate) was associated with an increased risk of having cataract surgery (201-NOLVADEX (tamoxifen citrate) ; 129-placebo; RR=1.58, 95% CI 1.26-1.97). Eye examinations were not required during the study. No other conclusions regarding non-cataract ophthalmic events can be made.

Pregnancy Category D

NOLVADEX (tamoxifen citrate) may cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant while taking NOLVADEX (tamoxifen citrate) or within 2 months of discontinuing NOLVADEX (tamoxifen citrate) and should use barrier or nonhormonal contraceptive measures if sexually active. Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. Effects on reproductive functions are expected from the antiestrogenic properties of the drug. In reproductive studies in rats at dose levels equal to or below the human dose, nonteratogenic developmental skeletal changes were seen and were found reversible. In addition, in fertility studies in rats and in teratology studies in rabbits using doses at or below those used in humans, a lower incidence of embryo implantation and a higher incidence of fetal death or retarded in utero growth were observed, with slower learning behavior in some rat pups when compared to historical controls. Several pregnant marmosets were dosed with 10 mg/kg/day (about 2-fold the daily maximum recommended human dose on a mg/m² basis) during organogenesis or in the last half of pregnancy. No deformations were seen and, although the dose was high enough to terminate pregnancy in some animals, those that did maintain pregnancy showed no evidence of teratogenic malformations.

In rodent models of fetal reproductive tract development, tamoxifen (at doses 0.002 to 2.4-fold the daily maximum recommended human dose on a mg/m² basis) caused changes in both sexes that are similar to those caused by estradiol, ethynylestradiol and diethylstilbestrol. Although the clinical relevance of these changes is unknown, some of these changes, especially vaginal adenosis, are similar to those seen in young women who were exposed to diethylstilbestrol in utero and who have a 1 in 1000 risk of developing clear-cell adenocarcinoma of the vagina or cervix. To date, in utero exposure to tamoxifen has not been shown to cause vaginal adenosis, or clear-cell adenocarcinoma of the vagina or cervix, in young women. However, only a small number of young women have been exposed to tamoxifen in utero, and a smaller number have been followed long enough (to age 15-20) to determine whether vaginal or cervical neoplasia could occur as a result of this exposure.

There are no adequate and well-controlled trials of tamoxifen in pregnant women. There have been a small number of reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women. If this drug is used during pregnancy, or the patient becomes pregnant while taking this drug, or within approximately two months after discontinuing therapy, the patient should be apprised of the potential risks to the fetus including the potential long-term risk of a DES-like syndrome.

Reduction in Breast Cancer Incidence in High Risk Women - Pregnancy Category D

For sexually active women of child-bearing potential, NOLVADEX (tamoxifen citrate) therapy should be initiated during menstruation. In women with menstrual irregularity, a negative B-HCG immediately prior to the initiation of therapy is sufficient (See PRECAUTIONS-INFORMATION FOR PATIENTS - Reduction in Breast Cancer Incidence in High Risk Women).

PRECAUTIONS

General

Decreases in platelet counts, usually to 50,000-100,000/mm³, infrequently lower, have been occasionally reported in patients taking NOLVADEX (tamoxifen citrate) for breast cancer. In patients with significant thrombocytopenia, rare hemorrhagic episodes have occurred, but it is uncertain if these episodes are due to NOLVADEX (tamoxifen citrate) therapy. Leukopenia has been observed, sometimes in association with anemia and/or thrombocytopenia. There have been rare reports of neutropenia and pancytopenia in patients receiving NOLVADEX (tamoxifen citrate) ; this can sometimes be severe.

In the NSABP P-1 trial, 6 women on NOLVADEX (tamoxifen citrate) and 2 on placebo experienced grade 3-4 drops in platelet counts ( ≤ 50,000/mm³).

Information for Patients

Patients should be instructed to read the Medication Guide supplied as required by law when NOLVADEX is dispensed. The complete text of the Medication Guide is reprinted at the end of this document.

Reduction in Invasive Breast Cancer and DCIS in Women with DCIS

Women with DCIS treated with lumpectomy and radiation therapy who are considering NOLVADEX (tamoxifen citrate) to reduce the incidence of a second breast cancer event should assess the risks and benefits of therapy, since treatment with NOLVADEX (tamoxifen citrate) decreased the incidence of invasive breast cancer, but has not been shown to affect survival (See Table 1 in CLINICAL PHARMACOLOGY).

Reduction in Breast Cancer Incidence in High Risk Women

Women who are at high risk for breast cancer can consider taking NOLVADEX (tamoxifen citrate) therapy to reduce the incidence of breast cancer. Whether the benefits of treatment are considered to outweigh the risks depends on a woman's personal health history and on how she weighs the benefits and risks. NOLVADEX (tamoxifen citrate) therapy to reduce the incidence of breast cancer may therefore not be appropriate for all women at high risk for breast cancer. Women who are considering NOLVADEX (tamoxifen citrate) therapy should consult their health care professional for an assessment of the potential benefits and risks prior to starting therapy for reduction in breast cancer incidence (See Table 3 in CLINICAL PHARMACOLOGY). Women should understand that NOLVADEX (tamoxifen citrate) reduces the incidence of breast cancer, but may not eliminate risk. NOLVADEX (tamoxifen citrate) decreased the incidence of small estrogen receptor positive tumors, but did not alter the incidence of estrogen receptor negative tumors or larger tumors. In women with breast cancer who are at high risk of developing a second breast cancer, treatment with about 5 years of NOLVADEX (tamoxifen citrate) reduced the annual incidence rate of a second breast cancer by approximately 50%.

Women who are pregnant or who plan to become pregnant should not take NOLVADEX (tamoxifen citrate) to reduce her risk of breast cancer. Effective nonhormonal contraception must be used by all premenopausal women taking NOLVADEX (tamoxifen citrate) and for approximately two months after discontinuing therapy if they are sexually active. Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. For sexually active women of child-bearing potential, NOLVADEX (tamoxifen citrate) therapy should be initiated during menstruation. In women with menstrual irregularity, a negative B-HCG immediately prior to the initiation of therapy is sufficient (See WARNINGS-Pregnancy Category D).

Two European trials of tamoxifen to reduce the risk of breast cancer were conducted and showed no difference in the number of breast cancer cases between the tamoxifen and placebo arms. These studies had trial designs that differed from that of NSABP P-1, were smaller than NSABP P-1, and enrolled women at a lower risk for breast cancer than those in P-1.

Monitoring During NOLVADEX (tamoxifen citrate) Therapy

Women taking or having previously taken NOLVADEX (tamoxifen citrate) should be instructed to seek prompt medical attention for new breast lumps, vaginal bleeding, gynecologic symptoms (menstrual irregularities, changes in vaginal discharge, or pelvic pain or pressure), symptoms of leg swelling or tenderness, unexplained shortness of breath, or changes in vision. Women should inform all care providers, regardless of the reason for evaluation, that they take NOLVADEX (tamoxifen citrate) .

Women taking NOLVADEX (tamoxifen citrate) to reduce the incidence of breast cancer should have a breast examination, a mammogram, and a gynecologic examination prior to the initiation of therapy. These studies should be repeated at regular intervals while on therapy, in keeping with good medical practice. Women taking NOLVADEX (tamoxifen citrate) as adjuvant breast cancer therapy should follow the same monitoring procedures as for women taking NOLVADEX (tamoxifen citrate) for the reduction in the incidence of breast cancer. Women taking NOLVADEX (tamoxifen citrate) as treatment for metastatic breast cancer should review this monitoring plan with their care provider and select the appropriate modalities and schedule of evaluation.

Laboratory Tests

Periodic complete blood counts, including platelet counts, and periodic liver function tests should be obtained.

During the ATAC trial, more patients receiving anastrozole were reported to have an elevated serum cholesterol compared to patients receiving NOLVADEX (tamoxifen citrate) (9% versus 3.5%, respectively).

Carcinogenesis

A conventional carcinogenesis study in rats at doses of 5, 20, and 35 mg/kg/day (about one, three and seven-fold the daily maximum recommended human dose on a mg/m²basis) administered by oral gavage for up to 2 years) revealed a significant increase in hepatocellular carcinoma at all doses. The incidence of these tumors was significantly greater among rats administered 20 or 35 mg/kg/day (69%) compared to those administered 5 mg/kg/day (14%). In a separate study, rats were administered tamoxifen at 45 mg/kg/day (about nine-fold the daily maximum recommended human dose on a mg/m² basis); hepatocellular neoplasia was exhibited at 3 to 6 months.

Granulosa cell ovarian tumors and interstitial cell testicular tumors were observed in two separate mouse studies. The mice were administered the trans and racemic forms of tamoxifen for 13 to 15 months at doses of 5, 20 and 50 mg/kg/day (about one-half, two and five-fold the daily recommended human dose on a mg/m² basis).

Mutagenesis

No genotoxic potential was found in a conventional battery of in vivo and in vitro tests with pro- and eukaryotic test systems with drug metabolizing systems. However, increased levels of DNA adducts were observed by 32P post-labeling in DNA from rat liver and cultured human lymphocytes. Tamoxifen also has been found to increase levels of micronucleus formation in vitro in human lymphoblastoid cell line (MCL-5). Based on these findings, tamoxifen is genotoxic in rodent and human MCL-5 cells.

Impairment of Fertility

Tamoxifen produced impairment of fertility and conception in female rats at doses of 0.04 mg/kg/day (about 0.01-fold the daily maximum recommended human dose on a mg/m² basis) when dosed for two weeks prior to mating through day 7 of pregnancy. At this dose, fertility and reproductive indices were markedly reduced with total fetal mortality. Fetal mortality was also increased at doses of 0.16 mg/kg/day (about 0.03-fold the daily maximum recommended human dose on a mg/m² basis) when female rats were dosed from days 7-17 of pregnancy. Tamoxifen produced abortion, premature delivery and fetal death in rabbits administered doses equal to or greater than 0.125 mg/kg/day (about 0.05-fold the daily maximum recommended human dose on a mg/m² basis). There were no teratogenic changes in either rats or rabbits.

Pregnancy Category D

See WARNINGS.

Nursing Mothers

Tamoxifen has been reported to inhibit lactation. Two placebo-controlled studies in over 150 women have shown that tamoxifen significantly inhibits early postpartum milk production. In both studies tamoxifen was administered within 24 hours of delivery for between 5 and 18 days. The effect of tamoxifen on established milk production is not known.

There are no data that address whether tamoxifen is excreted into human milk. If excreted, there are no data regarding the effects of tamoxifen in breast milk on the breastfed infant or breastfed animals. However, direct neonatal exposure of tamoxifen to mice and rats (not via breast milk) produced 1) reproductive tract lesions in female rodents (similar to those seen in humans after intrauterine exposure to diethylstilbestrol) and 2) functional defects of the reproductive tract in male rodents such as testicular atrophy and arrest of spermatogenesis.

It is not known if NOLVADEX (tamoxifen citrate) is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from NOLVADEX (tamoxifen citrate) , women taking NOLVADEX (tamoxifen citrate) should not breast feed.

Reduction in Breast Cancer Incidence in High Risk Women with DCIS

It is not known if NOLVADEX (tamoxifen citrate) is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from NOLVADEX (tamoxifen citrate) , women taking NOLVADEX (tamoxifen citrate) should not breast feed.

Pediatric Use

The safety and efficacy of NOLVADEX (tamoxifen citrate) for girls aged two to 10 years with McCune-Albright Syndrome and precocious puberty have not been studied beyond one year of treatment. The long-term effects of NOLVADEX (tamoxifen citrate) therapy for girls have not been established. In adults treated with NOLVADEX (tamoxifen citrate) , an increase in incidence of uterine malignancies, stroke and pulmonary embolism has been noted (see BOXED WARNING, and CLINICAL PHARMACOLOGY-Clinical Studies-McCune-Albright Syndrome subsection).

Geriatric Use

In the NSABP P-1 trial, the percentage of women at least 65 years of age was 16%. Women at least 70 years of age accounted for 6% of the participants. A reduction in breast cancer incidence was seen among participants in each of the subsets: A total of 28 and 10 invasive breast cancers were seen among participants 65 and older in the placebo and NOLVADEX (tamoxifen citrate) groups, respectively. Across all other outcomes, the results in this subset reflect the results observed in the subset of women at least 50 years of age. No overall differences in tolerability were observed between older and younger patients (See CLINICAL PHARMACOLOGY - Clinical Studies - Reduction in Breast Cancer Incidence in High Risk Women section).

In the NSABP B-24 trial, the percentage of women at least 65 years of age was 23%. Women at least 70 years of age accounted for 10% of participants. A total of 14 and 12 invasive breast cancers were seen among participants 65 and older in the placebo and NOLVADEX (tamoxifen citrate) groups, respectively. This subset is too small to reach any conclusions on efficacy. Across all other endpoints, the results in this subset were comparable to those of younger women enrolled in this trial. No overall differences in tolerability were observed between older and younger patients.

Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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