Tamoxifen 20 mg Tablet

SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at high risk ( 1.4 ) 1.1 Metastatic Breast Cancer SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive metastatic breast cancer. …

• Metastatic breast cancer: 20-40 mg per day
• For doses greater than 20 mg per day, administer in divided doses (morning and evening)
• Adjuvant treatment of breast cancer, DCIS, reduction of breast cancer incidence in women at high risk: 20 mg per day Metastatic Breast Cancer For patients with breast cancer, the recommended daily dose of SOLTAMOX is 20 to 40 mg
• Doses greater than 20 mg per day should be given in divided doses (morning and evening)
• Adjuvant Treatment of Breast Cancer For use in the adjuvant setting, the recommended dose of SOLTAMOX is 20 mg daily for 5-10 years [see Clinical Studies ]
• Doses greater than 20 mg daily yield no additional clinical benefit
• Ductal Carcinoma in Situ For patients with DCIS, the recommended dose of SOLTAMOX is 20 mg daily for 5 years
• Reduction in Breast Cancer Incidence in Women at High Risk In the risk reduction setting, the recommended dose of SOLTAMOX is 20 mg daily for 5 years

SOLTAMOX oral solution: Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate. Oral solution: Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate. ( 3 )

• The safety and effectiveness of SOLTAMOX
• In pediatric patients have not been established
• Tamoxifen Use in McCune-Albright Syndrome The safety and effectiveness of SOLTAMOX
• For the treatment of girls with McCune-Albright syndrome, including long-term effects, have not been established
• A single, uncontrolled multicenter trial of tamoxifen 20 mg once a day was conducted in a heterogeneous group of girls with McCune-Albright syndrome and precocious puberty manifested by physical signs of pubertal development, episodes of vaginal bleeding, and/or advanced bone age (bone age of at least 12 months …

Ductal Carcinoma in Situ In the NSABP B-24 trial, the percentage of women at least 65 years of age was 23%. Women at least 70 years of age accounted for 10% of participants. A total of 14 and 12 invasive breast cancers were seen among participants 65 and older in the placebo and tamoxifen groups, respectively. This subset is too small to reach any conclusions on efficacy. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Uterine Malignancies Inform women that SOLTAMOX increases the risk of uterine malignancies (endometrial carcinoma and uterine sarcoma), including fatal cases
• Advise women to promptly inform a healthcare provider if they experience any abnormal gynecological symptoms (e.g., menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure.) Advise women receiving or who have previously received tamoxifen to undergo annual gynecological examinations [see Boxed Warning and Warnings and Precautions ] . …

• SOLTAMOX is contraindicated in patients with known hypersensitivity (e.g., angioedema, serious skin reactions) to tamoxifen or any other SOLTAMOX ingredient [see Adverse Reactions ]
• SOLTAMOX is contraindicated in patients who require concomitant warfarin therapy or have a history of deep vein thrombosis or pulmonary embolus if the indication for treatment is either reduction of breast cancer incidence in high-risk patients or risk reduction of invasive breast cancer after treatment of DC …

Anastrozole and letrozole: Should not be used in combination with tamoxifen. ( 7.1 ) Warfarin: Do not use in patients taking tamoxifen for DCIS and for reduction in breast cancer incidence in women at high risk. ( 4 ) Closely monitor coagulation indices for increased anticoagulant effect when used with tamoxifen for metastatic breast cancer or as adjuvant therapy. ( 7.2 ) 7.1 Aromatase Inhibitors Anastrozole The combination of anastrozole and tamoxifen did not demonstrate any benefit when compared to tamoxifen alone and should be avoided in all patients [see Clinical Studies (14.2) ] . …

Uterine malignancies: Promptly evaluate abnormal vaginal bleeding in a woman with current or past tamoxifen use. ( 5.1 ) Thromboembolic events: Risk increases with coadministered chemotherapy. For treatment of breast cancer, consider risks and benefits in patients with a history of thromboembolic events. ( 5.2 ) Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) Effects on the liver: Liver cancer and liver abnormalities, some fatal, have occurred. Perform periodic liver function testing. …

The following serious adverse reactions are discussed below and elsewhere in the labeling: Uterine malignancies [see Boxed Warning , Warnings and Precautions (5.1) , and Clinical Studies (14.4) ] Thromboembolic events [see Boxed Warning , Warnings and Precautions (5.2) , and Clinical Studies (14.4) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.3) , and Use in Specific Populations (8.1 , 8.3) ] Liver cancer [see Warnings and Precautions (5.4) ] Most common adverse reactions: hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention ( 6.1 ). …

8.1 Pregnancy Risk Summary SOLTAMOX can cause fetal harm when administered to a pregnant woman . There are no adequate and well- controlled studies of tamoxifen in pregnant women. There are limited postmarketing reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women taking tamoxifen. …

No specific treatment for SOLTAMOX overdosage is recommended, other than symptomatic treatment. In a study of advanced metastatic cancer patients to determine the maximum tolerated dose of tamoxifen that could reverse multidrug resistance, the following adverse events were observed: acute neurotoxicity manifested by tremor, hyperreflexia, unsteady gait, and dizziness. These symptoms occurred within 3 to 5 days of beginning tamoxifen and cleared within 2 to 5 days after stopping therapy. No permanent neurologic toxicity was noted. …

Store at room temperatures 20° to 25°C (68° - 77°F); excursions permitted between 15° to 30°C (59° - 86°F) [see USP Controlled Room Temperature]. DO NOT freeze or refrigerate. Store in original packaging in order to protect from light. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.