No.18- Selpercatinib- (RETEVMO)- (May 2020)

 PATIENT COUNSELING INFORMATION

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

Hepatotoxicity-                                                                                                             Advise patients that hepatotoxicity can occur and to immediately contact their healthcare provider for signs or symptoms of hepatotoxicity

Hypertension-                                                                                                        Advise patients that they will require regular blood pressure monitoring and to contact their healthcare provider if they experience symptoms of increased blood pressure or elevated readings.

QT Prolongation-                                                                                                    Advise patients that RETEVMO can cause QTc interval prolongation and to inform their healthcare provider if they have any QTc interval prolongation symptoms, such as syncope 

Hemorrhagic Events-                                                                                                   Advise patients that RETEVMO may increase the risk for bleeding and to contact their healthcare provider if they experience any signs or symptoms of bleeding 

Hypersensitivity Reactions-                                                                                       Advise patients to monitor for signs and symptoms of hypersensitivity reactions, particularly during the first month of treatment 

Risk of Impaired Wound Healing-                                                                         Advise patients that RETEVMO may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure [

Embryo-Fetal Toxicity -                                                                                           Advise pregnant women and females of reproductive potential of the possible risk to a fetus.

Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy 

Use in Specific Populations-                                                                                         Advise females of reproductive potential to use effective contraception during the treatment with RETEVMO and for at least 1 week after the final dose 

Advise males with female partners of reproductive potential to use effective contraception during treatment with RETEVMO and for at least 1 week after the final dose 

Lactation-                                                                                                                Advise women not to breastfeed during treatment with RETEVMO and for 1 week following the final dose 

Infertility-                                                                                                                Advise males and females of reproductive potential that RETEVMO may impair fertility 

Drug Interactions-                                                                                                  Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products.

Inform patients to avoid St. John’s wort, proton pump inhibitors, H2 receptor antagonists, and antacids while taking RETEVMO.

If PPIs are required, instruct patients to take RETEVMO with food.

If H2 receptor antagonists are required, instruct patients to take RETEVMO 2 hours before or 10 hours after the H2 receptor antagonist.

If locally-acting antacids are required, instruct patients to take RETEVMO 2 hours before or 2 hours after the locally-acting antacid 

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