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Nolvadex

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Nolvadex

NOLVADEX
(tamoxifen citrate) Tablets

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 (tamoxifen citrate) 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 (tamoxifen citrate) vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for NOLVADEX (tamoxifen citrate) vs 0.4 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for NOLVADEX (tamoxifen citrate) vs 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for NOLVADEX (tamoxifen citrate) 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 (tamoxifen citrate) to reduce their risk of developing breast cancer.

The benefits of NOLVADEX (tamoxifen citrate) outweigh its risks in women already diagnosed with breast cancer.

REFERENCES

*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.

DRUG DESCRIPTION

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

10 mg Tablets

Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.

20 mg Tablets

Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of tamoxifen.

Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol and starch.

Chemically, NOLVADEX (tamoxifen citrate) is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas are:

NOLVADEX (Tamoxifen Citrate) Structural Formula Illustration

Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.

What are the precautions when taking tamoxifen citrate (Nolvadex)?

Before taking tamoxifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have cancer limited to the milk ducts, or if you are taking this medication to prevent breast cancer, then this medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of blood clots (e.g., deep vein thrombosis, pulmonary embolism, stroke), conditions that require treatment with a "blood thinner" (such as warfarin).

If you have breast cancer and a history of blood clots/stroke, you may or may not be able to take...

Read All Potential Precautions of Nolvadex »

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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