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Nolvadex (Tamoxifen Citrate) - Summary

 
 



BOXED WARNING

For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with NOLVADEX in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY-Clinical Studies − Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for NOLVADEX vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for NOLVADEX vs 0.04 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for NOLVADEX vs 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for NOLVADEX versus 0.25 for placebo**.

Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering NOLVADEX to reduce their risk of developing breast cancer.

The benefits of NOLVADEX outweigh its risks in women already diagnosed with breast cancer.

*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.

**See Table 3 under CLINICAL PHARMACOLOGY-Clinical Studies

 

NOLVADEX SUMMARY

NOLVADEX
(Tamoxifen Citrate)
TABLETS

NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX Tablets are available as.

NOLVADEX® is indicated for the following:

Metastatic Breast Cancer:

NOLVADEX is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, NOLVADEX is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from NOLVADEX therapy.

Adjuvant Treatment of Breast Cancer:

NOLVADEX is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some NOLVADEX adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.

NOLVADEX is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.

The estrogen and progesterone receptor values may help to predict whether adjuvant NOLVADEX therapy is likely to be beneficial.

NOLVADEX reduces the occurrence of contralateral breast cancer in patients receiving adjuvant NOLVADEX therapy for breast cancer.

Ductal Carcinoma in Situ (DCIS):

In women with DCIS, following breast surgery and radiation, NOLVADEX is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with NOLVADEX for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of NOLVADEX therapy.

Current data from clinical trials support five years of adjuvant NOLVADEX therapy for patients with breast cancer.

Reduction in Breast Cancer Incidence in High Risk Women:

NOLVADEX is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label).

NOLVADEX is indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.

Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are:

Age 35 or older and any of the following combination of factors:

•One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or

•At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or

•LCIS

Age 40 or older and any of the following combination of factors:

•One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or

•At least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or

•One first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia.

Age 45 or older and any of the following combination of factors:

•At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or

•One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more.

Age 50 or older and any of the following combination of factors:

•At least 2 first degree relatives with a history of breast cancer; or

•History of one breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or

•History of at least two breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more.

Age 55 or older and any of the following combination of factors:

•One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or

•History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older.

Age 60 or older and:

•5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.

For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-544-2007.

There are insufficient data available regarding the effect of NOLVADEX on breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of NOLVADEX in these patients.

After an assessment of the risk of developing breast cancer, the decision regarding therapy with NOLVADEX for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of NOLVADEX therapy. In the NSABP P-1 trial, NOLVADEX treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (See Table 3 in CLINICAL PHARMACOLOGY).


See all Nolvadex indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nolvadex (Tamoxifen)

Young Women Refuse Tamoxifen Because of Fertility Concerns
Source: Medscape Medical News Headlines [2015.08.28]
Concerns about fertility can influence adherence to endocrine therapy in young women with breast cancer, a new study suggests.
Medscape Medical News

Some Breast Cancer Patients Balk at Tamoxifen (CME/CE)
Source: MedPage Today Endocrinology [2015.08.26]
(MedPage Today) -- Desire for pregnancy leads a third to refuse, discontinue

Use of tamoxifen by young women is influenced by fertility concerns
Source: Breast Cancer News From Medical News Today [2015.08.25]
The risk of breast cancer recurrence and mortality is decreased by endocrine therapy (ET) such as tamoxifen, but younger patients may decline it or discontinue treatment early if they are concerned...

Tamoxifen for breast cancer prevention of little benefit
Source: The Doctors Lounge - Oncology
Only women at very high risk for breast cancer experience a benefit according to a study published in the journal Cancer.

Aromatase inhibitors 'significantly reduce breast cancer deaths'
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.07.26]
A study finds a class of hormonal drugs - aromatase inhibitors - are more effective than tamoxifen for reducing mortality among women with ER-positive breast cancer.

more news >>

Published Studies Related to Nolvadex (Tamoxifen)

A four week randomised control trial of adjunctive medroxyprogesterone and tamoxifen in women with mania. [2014]
Emerging research has suggested that hormone treatments such as selective oestrogen receptor modulators (SERMs) or progestins may be useful in the treatment of mania. The current pilot study compared the use of the SERM tamoxifen and the progestin medroxyprogesterone acetate (MPA), as an adjunct to mood stabiliser medications, for the treatment of mania symptoms in 51 women in a 28-day double blind, placebo controlled study...

National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial: advancing the science of recruitment and breast cancer risk assessment in minority communities. [2013]
understanding of breast cancer risk assessment in minority communities... CONCLUSIONS: Recruitment strategies used in STAR for racial and ethnic minorities

Weight change associated with anastrozole and tamoxifen treatment in postmenopausal women with or at high risk of developing breast cancer. [2012]
Weight gain is commonly reported by breast cancer patients on tamoxifen or aromatase inhibitors. Since weight gain may impact on outcome and compliance we have prospectively assessed the effects of these agents on weight change in three randomised trials for the treatment or prevention of breast cancer...

CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast cancer patients. [2012]
for patient benefit from tamoxifen therapy... CONCLUSION: The results do not support the hypothesis that CYP2D6 genotype

Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. [2012]
goserelin for early breast cancer in the neoadjuvant setting... INTERPRETATION: Given its favourable risk-benefit profile, the combination of

more studies >>

Clinical Trials Related to Nolvadex (Tamoxifen)

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid [Active, not recruiting]
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

Tamoxifen in Patients With Oesophageal Cancer [Not yet recruiting]
Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive 5 years once diagnosed. It is more common in men than women, and men appear to have a worse prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer however, is less well defined. Work conducted by the investigators, as well as another research group in Australia showed that antioestrogens including tamoxifen, reduce oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators propose a study to determine the effect of tamoxifen in patients with oesophageal cancer who aren't undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for 4 weeks after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a flexible camera that is passed into the mouth through the gullet into the stomach). The biopsy will be compared with the biopsy taken at the time of diagnosis to determine if tamoxifen has had any effect on cancer cell growth. If this study shows that tamoxifen does slow cancer cell growth it could lead to a larger study of patients with oesophageal cancer taking tamoxifen for a longer time period to determine if there is any clinical benefit.

Tamoxifen Treatment in Patients With Motor Neuron Disease [Recruiting]
The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND) patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS, and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate TDP-43 accumulation and inclusion body formation in ALS.

A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors [Suspended]
Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor. Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway. LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2).

Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients [Recruiting]
This study will help to understand the interaction between the hormonal therapy Tamoxifen, estrogen receptors and certain genes in the cancer cell. This information may eventually help select the appropriate therapy for future patients with similar cancer.

more trials >>

Reports of Suspected Nolvadex (Tamoxifen) Side Effects

Retinal Detachment (3)Urticaria (3)Fall (3)Joint Stiffness (3)Chronic Lymphocytic Leukaemia (3)Musculoskeletal Stiffness (3)Tendonitis (3)Stress (3)Alopecia (3)Wrong Technique in Drug Usage Process (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Nolvadex has an overall score of 6.25. The effectiveness score is 8 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Nolvadex review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Breast Cancer
Dosage & duration:   1 TAB 20mg taken everyday for the period of must take 5 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The objective of Tamoxifen is to work against the effects of estrogen on cancer cells. As a treatment for breast cancer, the drug is supposed to slow or stop the growth of cancer cells that are present in the body. I am praying that this is fulfilling its purpose but only in 3rd month of taking it so who knows.
Side effects:   Main side effect : vaginal discharge, slight weight gain (water retention I hope) and heartburn.
Comments:   I have to take Tamoxifen for 5 years.

 

Nolvadex review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   breast cancer
Dosage & duration:   20mg taken daily for the period of 3 months so far, but for next 5 years
Other conditions:   none
Other drugs taken:   herceptin
  
Reported Results
Benefits:   prevention of recurrence of estrogen positive tumours
Side effects:   severe menopause symptoms - hot flashes, cold sweats causing disturbed sleep and insomnia. symptoms seen to be worse after herceptin and the most distressing is the inability to get warm. I have also developed a discharge that is not pleasant but not too terrible and a change in the smell of my body odour. My skin also seems thinner.
Comments:   take 1 pill daily

 

Nolvadex review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   breast cancer
Dosage & duration:   20mg taken daily for the period of 3 months so far, but for next 5 years
Other conditions:   none
Other drugs taken:   herceptin
  
Reported Results
Benefits:   prevention of recurrence of estrogen positive tumours
Side effects:   severe menopause symptoms - hot flashes, cold sweats causing disturbed sleep and insomnia. symptoms seen to be worse after herceptin and the most distressing is the inability to get warm. I have also developed a discharge that is not pleasant but not too terrible and a change in the smell of my body odour. My skin also seems thinner.
Comments:   take 1 pill daily

See all Nolvadex reviews / ratings >>

Page last updated: 2015-08-28

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