No.15- Sacituzumab-Govitecan -hziy-(TRODELVY)- (April 2020)

 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Neutropenia-                                                                                                           Advise patients of the risk of neutropenia. Instruct patients to immediately contact their healthcare provider if they experience fever, chills, or other signs of infection

Diarrhea-                                                                                                                       Advise patients of the risk of diarrhea.                                                                    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 

Hypersensitivity-                                                                                                    Inform patients of the risk of serious infusion reactions and anaphylaxis.             Instruct patients to immediately contact their healthcare provider if they experience facial, lip, tongue, or throat swelling, urticaria, difficulty breathing, lightheadedness, dizziness, chills, rigors, wheezing, pruritus, flushing, rash, hypotension or fever, that occur during or within 24 hours following the infusion 

Nausea/Vomiting-                                                                                                  Advise patients of the risk of nausea and vomiting.                                             Premedication according to established guidelines with a two or three drug regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) is also recommended.

Additional antiemetics, sedatives, and other supportive measures may also be employed as clinically indicated.

All patients should receive take-home medications for preventing and treating delayed nausea and vomiting, with clear instructions.

Instruct patients to immediately contact their healthcare provider if they experience uncontrolled nausea or vomiting

Embryo-Fetal Toxicity-                                                                                          Advise female patients to contact their healthcare provider if they are pregnant or become pregnant.

Inform female patients of the risk to a fetus and potential loss of the pregnancy 

Contraception -                                                                                                     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 

Lactation-                                                                                                              Advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY [see Use in Specific Populations (8.2)].

Infertility-                                                                                                               Advise females of reproductive potential that TRODELVY may impair fertility 

Manufactured by: Immunomedics, Inc. 300 The American Road Morris Plains, NJ 07950, USA U.S. License No. 1737