No 1.Avapritinib (AYVAKIT)-  (Jan 2020) 

PATIENT COUNSELING INFORMATION

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

Intracranial Hemorrhage                                                                                         Advise patients to contact their healthcare provider immediately if experiencing neurological signs and symptoms that may be associated with intracranial hemorrhage 

Central Nervous System Effects                                                                                 Advise patients and caretakers to notify their healthcare provider if they experience new or worsening CNS symptoms.

Advise patients not to drive or operate hazardous machinery if they are experiencing CNS adverse reactions 

 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 AYVAKIT and for 6 weeks after the final dose

Advise males with female partners of reproductive potential to use effective contraception during treatment with AYVAKIT and for 6 weeks after the final dose

Lactation                                                                                                                 Advise women not to breastfeed during treatment with AYVAKIT and for 2 weeks following the final dose

Infertility                                                                                                                     Advise females and males of reproductive potential that AYVAKIT may impair fertility [se

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 

Administration                                                                                                      Advise patients to take AYVAKIT on an empty stomach, at least 1 hour before and at least 2 hours after a meal 

Manufactured for: Blueprint Medicines Corporation, Cambridge, MA 02139, USA