Tamoxifen 10mg

Antineoplastic agent, selective estrogen receptor modulator (SERM)

“ALERT: US Boxed Warning

Uterine malignancies and thromboembolic events:

Serious and life-threatening events from the use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. Fatal cases of each type of event have occurred.

Incidence rates per 1,000 woman-years for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial in women at high risk for breast cancer:

• Endometrial adenocarcinoma: 2.20 for tamoxifen versus 0.71 for placebo
• Uterine sarcoma: 0.17 for tamoxifen versus 0.04 for placebo
• Stroke: 1.43 for tamoxifen versus 1.00 for placebo.
• Pulmonary embolism: 0.75 for tamoxifen versus 0.25 for placebo

Discuss the potential benefits of tamoxifen versus the potential risks of these serious events with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) considering tamoxifen to reduce the risk of developing breast cancer. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks.”

CSA NA – FDA Approved – REMS (N) – Can Ship

Tamoxifen, Nolvadex D/Soltamox is a selective estrogen receptor modulator (SERM) that has a complex mechanism of action.  Its primary action is to block the proliferative actions of estrogen on mammary epithelium.  Soltamox, Nolvadex D/Tamoxifen have also been shown to decrease DNA synthesis evident by the accumulation of cells in the G0 and G1 phases of the cell cycle implying it has a cytostatic rather than a cytocidal mechanism of action.

Tamoxifen, Nolvadex D/Soltamox is officially indicated for treatment of breast cancer in some scenarios and to reduce the risk of breast cancer in high risk patient.  It is also prescribed off-label for use in desmoid tumors, endometrial carcinoma, gynecomastia, idiopathic male infertility, induction of ovulation in breast cancer patients, severe mastalgia, and advanced or severe ovarian cancer.

Can cause bone marrow suppression 

Serious and life-threatening cancers such as uterine malignancies, endometrial adenocarcinoma and uterine sarcoma has been reported

Visual disturbances including retinal thrombosis, retinopathy, corneal changes, color perception changes and increased incidence of cataracts has been reported

Serious and life-threatening events such as stroke and pulmonary embolism has been reported

Breast Cancer, Risk Reduction
Oral: Take 20mg once daily for 5 years.

Breast Cancer, Treatment
Oral: Take 20mg once daily.

Endometrial Carcinoma, Recurrent, Metastatic, or High-Risk (Off-Label Use)
Oral: Take 20mg twice daily until disease progression or unacceptable toxicity.

Gynecomastia (Off-Label Use)
Oral: Take 20mg once daily for up to 12 months.

Idiopathic Male Infertility (Off-Label Use)
Oral: Take 20mg to 30mg once daily for 3 to 6 months.

Induction of Ovulation (Off-Label Use)
Oral: Take 60mg once daily starting on the 2nd or 3rd day of the menstrual cycle (in combination with a low dose of follicle stimulating hormone and continue until the day of hCG administration.

How Do You Take Tamoxifen, Nolvadex D/Soltamox:  Soltamox, Nolvadex D/Tamoxifen can be taken with or without food.  Take the medication exactly as prescribed by your doctor at the same time each day.  If you miss a dose, make sure to take it as soon as possible.  However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule

Do Not Use Tamoxifen, Nolvadex D/Soltamox: If you have a known hypersensitivity to Soltamox, Nolvadex D/Tamoxifen or any component of the formulation; concurrent warfarin therapy or history of deep vein thrombosis or pulmonary embolism.

>10%

Cardiovascular: Vasodilation (41%), flushing (33%), hypertension (11%), peripheral edema (11%)

Dermatologic: Skin changes (6% to 19%), skin rash (13%)

Endocrine and Metabolic: Hot flash (3% to 80%), fluid retention (32%), weight loss (23%), amenorrhea (16%)

Gastrointestinal: Nausea (5% to 26%), nausea and vomiting (12%)

Genitourinary: Vaginal discharge (12% to 55%), irregular menses (13% to 25%), vaginal hemorrhage (2% to 23%)

Hematologic: Lymphedema (11%)

Nervous System: Fatigue (≤18%), mood changes (12% to 18%), pain (3% to 16%), depression (2% to 12%)

Neuromuscular and Skeletal: Asthenia (≤18%), arthritis (14%), arthralgia (11%)

Respiratory: Pharyngitis (14%)