No.12. Selumetinib- (KOSELUGO) - (Apr 2020)

PATIENT COUNSELING INFORMATION

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

Cardiomyopathy-                                                                                                    Advise patients and caregivers that KOSELUGO can cause a reduction in LVEF and to immediately report any signs or symptoms of cardiomyopathy to their healthcare provider 

Ocular Toxicity-                                                                                                        Advise patients and caregivers that KOSELUGO can cause ocular toxicity that can lead to blindness and to contact their healthcare provider if the patient experiences any changes in their vision 

Gastrointestinal Toxicity-                                                                                            Advise patients and caregivers that KOSELUGO can cause diarrhea and to contact their healthcare provider at the onset of diarrhea 

Skin Toxicity-                                                                                                           Advise patients and caregivers that KOSELUGO can cause serious skin toxicities and to contact their healthcare provider for severe skin changes

Increased Creatinine Phosphokinase-                                                                Advise patients and caregivers that KOSELUGO can cause increased CPK and to report any signs and symptoms of muscle pain or weakness to their healthcare provider 

Increased Vitamin E Levels and Risk of Bleeding-                                                     Advise patients and caregivers to notify their healthcare provider if they are taking a supplement containing vitamin E, a vitamin-K antagonist or an anti-platelet agent 

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 KOSELUGO and for 1 week after the last dose.

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

Lactation-                                                                                                                    Advise women not to breastfeed during treatment with KOSELUGO and for 1 week after the last dose 

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, grapefruit or grapefruit juice while taking KOSELUGO 

Dosing and Administration-                                                                                     Inform patients and caregivers on how to take KOSELUGO with food and what to do for missed or vomited doses 

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 © AstraZeneca 2020