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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)

Night light exposure could make breast cancer tumors tamoxifen resistant
Source: Pharma Industry / Biotech Industry News From Medical News Today [2014.07.25]
A study in rats reveals that tamoxifen - a drug typically used to treat breast cancer that has spread - is less effective when subjects are exposed to dim light at night.

Faslodex and tamoxifen combo reverse tamoxifen-resistant breast cancer
Source: Lupus News From Medical News Today [2014.06.17]
The inexpensive anti-malarial drug hydroxychloroquine (HCQ) reverses resistance to tamoxifen, a widely used breast cancer drug, in mice.

New Guidelines Recommend Longer Tamoxifen Treatment
Source: MedicineNet tamoxifen Specialty [2014.05.28]
Title: New Guidelines Recommend Longer Tamoxifen Treatment
Category: Health News
Created: 5/27/2014 4:35:00 PM
Last Editorial Review: 5/28/2014 12:00:00 AM

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.

more news >>

Published Studies Related to Nolvadex (Tamoxifen)

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

Longer-term outcomes of letrozole versus placebo after 5 years of tamoxifen in the NCIC CTG MA.17 trial: analyses adjusting for treatment crossover. [2012]
crossed over to letrozole after being unblinded... CONCLUSION: Exploratory analyses based on longer follow-up and adjusting for

Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial. [2011.11]
OBJECTIVE: To reevaluate the efficacy of induction of ovulation with CC versus TMX in a group of anovulatory subfertile women with PCOS in a randomized controlled trial... CONCLUSIONS: Clomiphene citrate is more successful than tamoxifen as a first line therapy for ovulation induction in women with PCOS. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

more studies >>

Clinical Trials Related to Nolvadex (Tamoxifen)

Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study [Completed]
This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.

ITA - Clinical Study Comparing ARIMIDEXâ„¢ With NOLVADEXâ„¢ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years [Active, not recruiting]
The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

Casodex - Nolvadex Combination [Completed]
This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.

Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. [Active, not recruiting]
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer

PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM) [Recruiting]
All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of tamoxifen treatment. However CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as co-medication may influence the treatment outcome of tamoxifen.

The investigators propose a prospective study in women taking tamoxifen at a dose of 20mg QD. In each woman, information will be collected on endoxifen levels, CYP2D6 status, adherence and use of co-medication. In women who are phenotypically poor metabolizers of tamoxifen, a dose increase to 40mg QD will be applied and the effect of this intervention on tamoxifen pharmacokinetics will be evaluated after 4 weeks.

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: 2014-07-25

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