No.19- Ripretinib- (QUINLOCK)- (May 2020)

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

Palmar-Plantar Erythrodysesthesia Syndrome-                                                                      Advise patients to contact their healthcare provider immediately if they experience severe skin changes [

New Primary Cutaneous Malignancies -                                                                                Advise patients to contact their healthcare provider immediately for change in or development of new skin lesions

 Hypertension-                                                                                                                             Advise patients that hypertension may develop during treatment with QINLOCK and that blood pressure should be monitored regularly during treatment

 Cardiac Dysfunction-                                                                                                                 Advise patients that cardiac failure may develop during treatment with QINLOCK and that signs or symptoms of cardiac failure should be regularly monitored during treatment.

Advise patients to contact their healthcare provider immediately for signs or symptoms of cardiac dysfunction

 Risk of Impaired Wound Healing-                                                                                              Advise patients that QINLOCK 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 potential 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 treatment with QINLOCK 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 QINLOCK and for at least 1 week after the final dose

Manufactured for and marketed by: Deciphera Pharmaceuticals, LLC 200 Smith Street, Waltham, MA 02451