Inform female patients of the risk to a fetus and potential loss of the pregnancy Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of Trodelvy Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of Trodelvy Advise women not to breastfeed during treatment and for 1 month after the last dose of Trodelvy Advise females of reproductive potential that Trodelvy may impair fertility The Patient Information has been approved by the U.S. Food and Drug Administration.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In a repeat-dose toxicity study in cynomolgus monkeys, intravenous administration of sacituzumab govitecan-hziy on Day 1 and Day 4 resulted in endometrial atrophy, uterine hemorrhage, increased follicular atresia of the ovary, and atrophy of vaginal epithelial cells at doses ≥ 60 mg/kg (≥ 6 times the human recommended dose of 10 mg/kg based on body weight).The efficacy of Trodelvy was evaluated in study IMMU-132-01 (NCT01631552), a multicenter, single-arm, trial that enrolled 108 patients with metastatic triple-negative breast cancer (mTNBC) who had received at least two prior treatments for metastatic disease. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamideIf severe diarrhea occurs, withhold Trodelvy until resolved toDo NOT substitute Trodelvy for or use with other drugs containing irinotecan or its active metabolite SN-38.General disorders and administration site conditionsAdvise the patient to read the FDA-approved patient labeling (What is the most important information I should know about Trodelvy?Trodelvy can cause serious side effects, including:Call your healthcare provider right away if you develop any of the following signs of infection during treatment with TrodelvyDo not receive Trodelvy if you have had a severe allergic reaction to Trodelvy.Before receiving Trodelvy, tell your healthcare provider about all of your medical conditions, including if you:General information about the safe and effective use of Trodelvy.We comply with the HONcode standard for trustworthy health information -

The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 1% (3/408). Adverse reactions leading to discontinuation were anaphylaxis, anorexia/fatigue, headache (each <1%, 1 patient for each event). The efficacy of TRODELVY was evaluated in study IMMU-132-01 (NCT01631552), a multicenter, single-arm, trial that enrolled 108 patients with metastatic triple-negative breast cancer (mTNBC) who had received at least two prior treatments for metastatic disease. Do not administer TRODELVY at doses greater than 10 mg/kg. First infusion: Administer infusion over 3 hours. The majority of patients were female (99%), and White (76%). TRODELVY is a type of drug called an antibody-drug conjugate, or ADC for short. The clearance of the sacituzumab govitecan-hziy was 0.002 L/h/kg. ADCs contain 3 parts: an antibody, a linker, and an anti-cancer drug. Sex subgroup was not analyzed because all but one patient were females.TRODELVY may cause serious side effects including low white cell blood count (neutropenia), severe diarrhea, life-threatening allergic reactions, nausea and vomiting.The most common side effects of TRODELVY are nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, hair loss, constipation, rash, decreased appetite, and abdominal pain.General disorders and administration site conditionsAnalysis of side effects by race and age subgroups is presented below.

Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Discontinue loperamide 12 hours after diarrhea resolves. The mean half-life of sacituzumab govitecan-hziy and free SN-38 was 16 and 18 hours, respectively. Do not administer TRODELVY at doses greater than 10 mg/kg. Instruct patients to immediately contact their healthcare provider if they experience fever, chills, or other signs of infection Advise patients of the risk of diarrhea. The most frequent serious adverse reactions (reported in >1%) of the patients receiving Trodelvy were febrile neutropenia (6%) vomiting (5%), nausea (3%), dyspnea (3%), diarrhea (4%), anemia (2%), pleural effusion, neutropenia, pneumonia, dehydration (each 2%).Trodelvy was permanently discontinued for adverse reactions in 2% of patients. Reconstitution. 1 INTRODUCTION . There are no available data in pregnant women to inform the drug-associated risk. Do not administer Trodelvy at doses greater than 10 mg/kg.Administer Trodelvy as an intravenous infusion only. Patients received TRODELVY 10 mg/kg intravenously on Days 1 and 8 of a 21-day treatment cycle. Instruct patients to immediately contact their healthcare provider if they experience diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours Inform patients of the risk of serious infusion reactions and anaphylaxis.


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