Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (Tamoxifen - UNII:094ZI81Y45)
Fortovia Therapeutics Inc.
TAMOXIFEN CITRATE
Tamoxifen 20 mg in 10 mL
ORAL
PRESCRIPTION DRUG
SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive metastatic breast cancer. SOLTAMOX is indicated: - for the adjuvant treatment of adult patients with early stage estrogen receptor-positive breast cancer - to reduce the occurrence of contralateral breast cancer in adult patients when used as adjuvant therapy for the treatment of breast cancer. In adult women with DCIS, following breast surgery and radiation, SOLTAMOX is indicated to reduce the risk of invasive breast cancer [see Boxed Warning and Clinical Studies (14.3)] . SOLTAMOX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer.[see Boxed Warning and Clinical Studies (14.4)] . - SOLTAMOX is contraindicated in patients with known hypersensitivity (e.g., angioedema, serious skin reactions) to tamoxifen or any other SOLTAMOX ingredient [see Adverse Reactions (6.2)] . - SOLTAMOX is contraindicated in patients who require concomitant warfarin therapy or have a history of d
SOLTAMOX oral solution is a sugar-free, clear colorless liquid, with licorice and aniseed odor and taste. It is supplied in a 150 mL bottle with a dosing cup intended for the measurement of SOLTAMOX oral solution only. Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate. NDC# 89141-123-01 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. Discard any unused portion after 3 months of first opening of the bottle.
New Drug Application
Fortovia Therapeutics Inc. ---------- MEDICATION GUIDE SOLTAMOX® (SOL-TA-MOX) (TAMOXIFEN CITRATE) ORAL SOLUTION This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2019 Before taking SOLTAMOX, you and your healthcare provider should talk about the possible benefits and risks. • The benefits and risks are different for women at high risk for breast cancer and women with breast cancer that is only inside the milk ducts (ductal carcinoma in-situ or DCIS) than for women who have been diagnosed with invasive breast cancer. • For most people who already have invasive breast cancer, the benefits of SOLTAMOX are greater than the risks. • Talk to your healthcare provider about which risks may affect you. What is the most important information I should know about SOLTAMOX? SOLTAMOX can cause serious side effects, including: • Uterine cancer. Cancer of the lining of the uterus (endometrial adenocarcinoma) or cancer of the body of the uterus (uterine sarcoma) may happen more often in women who take SOLTAMOX and can lead to death. People who take or have taken SOLTAMOX should have a gynecologic exam every year. SOLTAMOX can also cause other non-cancer effects on the uterus, including: • overgrowth of the lining of the uterus (hyperplasia) and uterine polyps • endometriosis • fibroids • irregular menstrual periods or no menstrual periods (amenorrhea) Tell your healthcare provider right away if you get any of the following symptoms during or after treatment with SOLTAMOX: • irregular menstrual periods • abnormal vaginal bleeding • a change in your vaginal discharge • pelvic pain or pressure • Blood clots in your veins or lungs. Blood clots in your veins or lungs may happen more often in people who take SOLTAMOX and can lead to death, especially in people who take SOLTAMOX during their treatment with chemotherapy. Tell your healthcare provider right away if you get any of the following symptoms of a blood clot during treatment with SOLTAMOX: • sudden chest pa Leggi il documento completo
SOLTAMOX- TAMOXIFEN CITRATE LIQUID FORTOVIA THERAPEUTICS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SOLTAMOX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOLTAMOX . SOLTAMOX (TAMOXIFEN CITRATE) ORAL SOLUTION INITIAL U.S. APPROVAL: 1977 WARNING: UTERINE MALIGNANCIES AND THROMBOEMBOLIC EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. SERIOUS, LIFE-THREATENING, AND FATAL EVENTS FROM USE OF TAMOXIFEN INCLUDE UTERINE MALIGNANCIES, STROKE, AND PULMONARY EMBOLISM. (5.1, 5.2) DISCUSS RISKS AND BENEFITS OF TAMOXIFEN WITH WOMEN AT HIGH RISK FOR BREAST CANCER AND WOMEN WITH DUCTAL CARCINOMA IN SITU (DCIS) WHEN CONSIDERING TAMOXIFEN USE TO REDUCE THE RISK OF DEVELOPING BREAST CANCER. (5.1, 5.2) FOR MOST PATIENTS ALREADY DIAGNOSED WITH BREAST CANCER, THE BENEFITS OF TAMOXIFEN OUTWEIGH ITS RISKS. (5.1, 5.2) RECENT MAJOR CHANGES Dosage and Administration (2) 09/2018 Warnings and Precautions, Embryo-Fetal Toxicity (5.3) 09/2018 INDICATIONS AND USAGE 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) DOSAGE AND ADMINISTRATION Metastatic breast cancer: 20-40 mg per day. For doses greater than 20 mg per day, administer in divided doses (morning and evening). (2) Adjuvant treatment of breast cancer, DCIS, reduction of breast cancer incidence in women at high risk: 20 mg per day (2) DOSAGE FORMS AND STRENGTHS Oral solution: Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate. (3) CONTRAINDICATIONS Known hypersensitivity to tamoxifen or any other SOLTAMOX ingredient (4) In pati Leggi il documento completo