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Nolvadex (Tamoxifen) is used for the treatment of breast cancer in women.

Drug Uses

Nolvadex is the drug used for the treatment of breast cancer that has spread to other sites in the organism.

How to use

Use Nolvadex in accordance with the directions of your doctor.

Nolvadex is for oral intake and may be received with or without food. Receive Nolvadex with water or another nonalcoholic drink. Swallow the pill as a whole. Do not break, crush or chew the pill before swallowing. Continue to receive Nolvadex even if you feel well. Avoid missing doses. Receiving Nolvadex at the same time of a day will help you to remember to receive your dose. You may ask your health care provider any questions that you may have about how to use Nolvadex.

Drug Class and Mechanism of action

Nolvadex is an antiestrogen. This drug acts by blocking the effect of estrogen on certain tumors in the human body. This action may prevent the growth of tumors that may be activated by estrogen.

Missed Dose

If you miss your regular dose of Nolvadex, receive it as soon as possible. If the current time is too close to the time for your next dose, skip the missed dose and then return to your regular dosing schedule. Do not take a double dose at once.

Storage

Nolvadex should be stored at temperatures between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed and light-resistant container. Keep away from moisture, heat and light. Do not store the drug in the bathroom. Do not receive tablets after the expiration date. This date is printed on the label. Keep the drug out of the reach of children and animals.

Forms of supply

10 mg tablets containing Tamoxifen as the citrate. The amount of Tamoxifen is equivalent to 10 mg. There is the identification NOLVADEX 600 embossed on one side of a tablet and a cameo embossed on the other side. The 10 mg tablets are supplied in bottles of 60 tablets. NDC 0310-0600-60.

20 mg tablets containing Tamoxifen as the citrate. The amount of Tamoxifen is equivalent to 20 mg. There is the identification NOLVADEX 604 embossed on one side of a tablet and a cameo embossed on the other side. The 10 mg tablets are supplied in bottles of 30 tablets. NDC 0310-0604-30.

Both 10 mg and 20 mg tablets are white, round, biconvex, uncoated.

Warnings and Precautions

Do not receive Nolvadex in the following cases:

You have the allergy to any component of Nolvadex;
You are receiving Nolvadex to reduce your risk of breast cancer and you suffered from blood clots in your legs or lungs in the past;
You are using Nolvadex to reduce your risk of breast cancer and you also receive certain anticoagulants (e.g., Warfarin);
You are receiving Anastrozole.

If any of these apply to you, contact your doctor or health care provider immediately.

Important cautions:
Do not drive, operate heavy machinery or perform other possibly unsafe tasks until you know your reaction to this drug. Nolvadex may reduce the quantity of clot-forming cells (platelets) in the blood. Avoid any potentially dangerous activities that may cause an injury or bruising. Inform your doctor if you have unusual bleeding or bruising. Inform your doctor if your stools are dark, tarry or contain blood. Nolvadex may decrease the ability of your organism to resist infection. It is recommended to avoid contacts with people who have colds or infections when you are receiving Nolvadex. Inform your doctor if you notice any signs of infection like sore throat, rash, fever or chills.

New tumors have occurred in body sites other than the uterus in some patients who were receiving Nolvadex. It is unknown yet if Nolvadex may be the cause of tumors in those cases. You may discuss any questions or your concerns with your doctor.

If you are a woman and you plan to receive Nolvadex to reduce the risk of breast cancer, you should have a breast exam, mammogram and gynecological exam. This must be done before starting and during treatment with Nolvadex.

If you are a woman and you plan to become pregnant, you should begin receiving Nolvadex during a menstrual period. If your menstrual periods are irregular, you should have a pregnancy test immediately before starting the treatment with Nolvadex. Consult with your doctor if you have any questions about how to start receiving Nolvadex.
Women who believe that they have a high possibility of becoming pregnant must use effective nonhormonal means of birth control (e.g., condoms, diaphragm) during sexual contacts while they are receiving Nolvadex. This is also necessary for 2 months after they stop receiving Nolvadex. Do not use hormonal means of birth control (e.g., birth control pills); it may not work as well while you are receiving Nolvadex. To consult about effective nonhormonal means of birth control, see your doctor. Nolvadex is NOT a contraceptive and it will not prevent you from becoming pregnant.
Lab tests may be performed while you receive Nolvadex. These tests may include: breast exams, mammograms, gynecologic exams, liver function tests, complete blood counts. These tests may be used to monitor your condition. They also may be used to check for side effects. Keep all doctor and lab appointments thoroughly. If Nolvadex is about to be used in children, it should be used with extreme caution. Safety and effectiveness of using Nolvadex in children have not been confirmed.

Warning on pregnancy and breast-feeding

Nolvadex may cause harm to the human fetus. Avoid becoming pregnant while you are receiving Nolvadex. It is also necessary to avoid becoming pregnant for 2 months after you stop receiving Nolvadex. If you suspect that you may be pregnant, contact your doctor. You will need to discuss all the benefits and risks of receiving Nolvadex during the pregnancy. It is not known if Nolvadex is found in female breast milk, therefore you ought to avoid breast-feeding while receiving this drug.

Possible Side Effects

Consult with your doctor if any of these side effects persist or become bothersome; the most common side effects are the following: pain in bones; pain in muscles; constipation; nausea; cough; hot flashes; tiredness; vaginal discharge; loss of weight.

The following side effects are severe; seek medical attention immediately if any of these side effects occur: any severe allergic reactions (hives; itching; rash; laboured breathing; tightness in the chest; unexplained hoarseness; swelling of the mouth, face, lips or tongue); abnormal menstrual periods; missed menstrual period; abnormal vaginal bleeding; abnormal bloody discharge; pain in the chest; coughing up blood; dark urine; decreased sexual desire or potency; depression; fever, chills or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; new or increased breast tumor or pain in the breast; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; skin changes; red, swollen, blistered or peeling skin; severe or persistent weakness or tiredness; shortness of breath; pain in the stomach; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; problems with vision; problems with speech; yellowing of the eyes or skin.

More Information

Nolvadex must be used only by the patient for whom it is prescribed by the doctor. Do not share this drug with other people. If your condition does not improve or if it becomes worse, see your doctor.

Metastatic Breast Cancer

NOLVADEX is effective in the treatment of breast cancer with metastases. It is used in the treatment of both men and women. NOLVADEX is an alternative to oophorectomy or ovarian irradiation used in therapy of metastatic breast cancer in premenopausal women. Available evidence indicates that patients with estrogen receptor positive tumors are more likely to get good results from NOLVADEX therapy.

Adjuvant Treatment of Breast Cancer

Prescription of NOLVADEX is indicated for the treatment of node-positive breast cancer. NOLVADEX is used for therapy in women after total or segmental mastectomy, axillary dissection and breast irradiation. In some studies of NOLVADEX, most of the benefit until now has been in the subgroup with four or more positive axillary nodes.

Prescription of NOLVADEX is indicated for the treatment of axillary node-negative breast cancer. NOLVADEX is used for therapy in women after total mastectomy or segmental mastectomy, axillary dissection, breast irradiation.

Measuring the estrogen and progesterone receptor values may be used for the prediction whether adjuvant NOLVADEX therapy is likely to be wholesome and effective.

Using adjuvant NOLVADEX therapy for breast cancer helps to reduce the occurrence of contralateral breast cancer.

Ductal Carcinoma in Situ (DCIS)

Prescription of NOLVADEX is indicated to reduce the risk of invasive breast cancer in women suffering from DCIS after breast surgery and radiation. Read the BOXED WARNING at the beginning of the label. The decision on using NOLVADEX therapy for the reduction in the incidence of breast cancer should be based upon an individual evaluation of the benefits and risks.

Current results data from clinical tests substantiate 5 years of adjuvant NOLVADEX therapy for breast cancer patients.

Reduction in the incidence of breast cancer in Women with high risk

Prescription of NOLVADEX is indicated to reduce the breast cancer incidence in women who have high risk for breast cancer. The effect was shown in the research of 5 years planned duration with a average follow-up period of 4.2 years. 25% of the participants of that research received drug for 5 years. The effects lasting for longer terms are not known. In this research, there was no impact of Tamoxifen on mortality related to breast cancer or to overall mortality. Read the BOXED WARNING at the beginning of the label.

Prescription of NOLVADEX is indicated only for women who have high risk. The term "high risk" is defined as women of 35 and more years of age with a 5-year predicted risk of breast cancer 1.67%. The risk is calculated by the Gail Model.

Examples of factor combinations predicting a 5-year risk 1.67% are the following:

Age of 35 years or older plus any of the following combination of factors:
* One first degree relative (e.g., a family member) having a history of breast cancer, 2 or more benign biopsies; or
* One first degree relative (e.g., a family member) having a history of a breast biopsy showing atypical hyperplasia; or
* At least 2 first degree relatives having a history of breast cancer, and a personal history of one or more events of breast biopsy; or
* LCIS

Age of 40 years or older plus any of the following combination of factors:
* One first degree relative (e.g., a family member) having a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 years or older, and menarche age 11 years or younger; or
* At least 2 first degree relatives having a history of breast cancer, and age at first live birth 19 years or younger; or
* One first degree relative (e.g., a family member) having a history of breast cancer, and a personal history of atypical hyperplasia shown by a breast biopsy.

Age of 45 years or older plus any of the following combination of factors:
* At least 2 first degree relatives having a history of breast cancer and age at first live birth 24 years or younger; or
* One first degree relative (e.g., a family member) having a history of breast cancer with a personal history of a benign breast biopsy, menarche age 11 years or less and age at first live birth 20 years or more.

Age of 50 years or older plus any of the following combination of factors:
* At least 2 first degree relatives (e.g., a family members) having a history of breast cancer; or
* History of one case of atypical hyperplasia shown by a breast biopsy, and age at first live birth 30 years or older and menarche age 11 years or less; or
* History of 2 or more breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 years or more.

Age of 55 years or older plus any of the following combination of factors:
* One first degree relative (e.g., a family member) having a history of breast cancer with a personal history of a benign breast biopsy, and menarche age 11 years or less; or
* History of 2 or more breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 years or older.

Age of 60 years or older combined with:
* 5-year predicted risk of breast cancer 1.67% (the method of calculation is the Gail Model).

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

After an evaluation of the risk of developing breast cancer, the decision on starting the therapy with NOLVADEX for the reduction in the incidence of breast cancer should be based upon an evaluation of the benefits and risks for each individual patient. The NSABP P-1 test showed that the treatment with NOLVADEX lowered the risk of developing breast cancer during the follow-up period of the test. However, the treatment with NOLVADEX did not eliminate the risk of breast cancer. Read the Table 3 in CLINICAL PHARMACOLOGY.

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