Nolvadex

Prescription Drug Information: Nolvadex

Generic Name: Tamoxifen

Nolvadex, classified as an estrogen receptor antagonist, is used for the treatment of breast cancer. Containing the prodrug, tamoxifen, in its formulation, Nolvadex typically shows its anticancer effects at the endometrium as a mixed agonist/antagonist. Nolvadex and its generic, tamoxifen, are both used as a standard anti-estrogen therapy for the treatment of hormone receptor positive breast cancer in menopausal women. Both Nolvadex and tamoxifen are available by prescription only.

Indication/Usage: Nolvadex is primarily used for the treatment of early and advanced estrogen receptor positive (ER+) breast cancer in both pre- and post-menopausal women. It is also the most commonly used hormone treatment for male breast cancer. Nolvadex has been approved as prevention therapy in women at high risk of developing breast cancer, and have also been approved to suppress contralateral cancer. Additionally, Nolvadex has been indicated in various conditions as follows:

• McCune-Albright syndrome: Treatment of premature puberty and its consequences
• Bipolar disorder: Tamoxifen shows great results in manic bipolar disorder
• Infertility: Treatment of infertility in women with anovulatory disorders
• Gynecomastia: Tamoxifen is used to prevent estrogen related gynecomastia
• Riedel's thyroiditis treatment
• Ductal Carcinoma in Situ (DCIS)

Dose, Administration and Dosage Forms: Nolvadex and its generic both contain the same active ingredient, but they may vary in their inactive ingredients. Both are available in an orally administered tablet with 10mg and 20mg strengths. For the treatment of breast cancer, the recommended dose is 20mg once per day to 20mg twice per day. The recommended dosage for ductal carcinoma and the prevention of breast cancer in high-risk women is 20 mg per day for up to 5 years. These tablets should be stored at room temperature between 20 C to 25 C.

Mechanism of Action: Nolvadex and its generic both contain the prodrug, tamoxifen, which is metabolized in the liver by the cytochrome P450 into active content 4-hydroxytamoxifen and N-desmethyl-4-hydroxytamoxifen. These active metabolites show 30-100 times more affinity than tamoxifen towards the estrogen receptor. Research shows that breast cancer cells require estrogen for normal growth. These active metabolites competitively inhibit and prevent the estrogen from binding to the estrogen receptors. This lack of estrogen at the cellular level blocks breast cancer cell growth by decreasing DNA synthesis.

Side-effects and Safety Profile: The side-effect profiles of both Nolvadex and its generic are quite similar. Various moderately severe side-effects reported with the usage of Nolvadex and its generic include: hair thinning, tumor related pain, depression, hot flashes, headache, fever, chills, body aches, bone and joint pain, dizziness, numbness, purple or red pinpoint spots under the skin, restlessness, weakness, swelling of the hands or feet, nausea, increased thirst, loss of appetite, upper stomach pain, vaginal dryness and itching, suppressed sexual drive, impotence and difficulty in reaching orgasm, etc.

Various serious side-effects reported with Nolvadex and its generic include: sudden severe headaches, confused mental state, vision problems, blurry vision, ocular pain, speech issues, balance impairment, chest pain, wheezing and rapid breathing, rapid heart rate, abnormal vaginal bleeding or discharge, irregular menstruation, pelvic pain, bruising, nosebleed, abnormal oral and rectal bleeding, new breast lump development, clay-colored stools, darkened urine, jaundice, etc. Patients experiencing any of the above serious issues should seek immediate medical attention.

Warnings and Contraindications:

• Nolvadex and its generic both are contraindicated in patients who are allergic to tamoxifen or the various inactive ingredients.
• Nolvadex and its generic are contraindicated for those patients who need concomitant warfarin anticoagulation treatment because of a history of deep vein thrombosis (DVT) and/or pulmonary embolus.
• Both Nolvadex and its generic may cause uterine cancer, strokes, and blood clotting with serious or fatal outcomes. Patients should tell their doctor about any history of stroke, heart attack or blood clotting.
• Patients must discuss their history of smoking, high blood pressure, diabetes, and impaired walking ability with the physician before taking tamoxifen-containing drugs.
• Genital organs should be continuously monitored and examined for any early signs of uterine cancer.
• Both Nolvadex and its generic are classified as pregnancy category D drugs, meaning they may cause fetal harm and should not be prescribed to pregnant women.
• Neither Nolvadex nor its generic have been studied in lactating women; therefore, nursing mothers should take Nolvadex or tamoxifen only if the potential benefit justifies the risk to the infant.

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