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Indolent ISMAdvanced SMPDGFRA GIST
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Indolent ISMAdvanced SMPDGFRA GIST

SELECT A CONDITION

ISM

Indolent systemic mastocytosis (ISM)

AdvSM

Advanced systemic mastocytosis (AdvSM)

PDGFRA
GIST

Gastrointestinal stromal tumors with PDGFRA mutation (PDGFRA GIST)

Ayvakit Hero Logo GIST

FDA Approved for GIST

AYVAKIT® (avapritinib): the first tyrosine kinase inhibitor (TKI) for adults with a gastrointestinal stromal tumor (GIST) who have a PDGFRA exon 18 mutation.1
AYVAKIT selectively targets KIT and PDGFRA mutant kinases, the primary drivers of GIST.1,2

Get more information to see if AYVAKIT is right for your patients.

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EXPLORE EDUCATIONAL RESOURCES FOR YOU AND YOUR PATIENTS
Resources

What is AYVAKIT?

AYVAKIT is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.1

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend mutational testing for all patients with GIST prior to initiation of TKI therapy.3,4

Lines of TKI Treatment in GIST

Resectable GIST*

Neoadjuvant
therapy
Adjuvant
therapy

*AYVAKIT is not approved for patients with resectable GIST.

Unresectable or
Metastatic GIST

GIST Treatment
GIST Treatment

APPROVED FOR USE IN PATIENTS WITH PDGFRA EXON 18 MUTANT GIST, INCLUDING PATIENTS WITH THE PDGFRA D842V MUTATION

NCCN=National Comprehensive Cancer Network.
About AYVAKIT

Individual results may vary.

AYVAKIT Resources

The following downloadable materials are here to help provide education for you and your patients on AYVAKIT.

FOR YOU AND YOUR STAFF
 

Dosing and
Management Guide

Dosing and Management Guide
Download

Download

Product Order
Sheet

Product Order Sheet
Download

Download

FOR YOUR PATIENTS/
CAREGIVERS

Patient and
Caregiver Brochure

Patient and Caregiver Brochure
Download

Download

These materials are intended for digital use only. If you decide to print them, please be sure to print and attach a copy of the full Prescribing Information as well.

YourBlueprint® provides dedicated, personalized support to help your patients from Day 1. Blueprint Medicines offers a series of programs to support patient access, including:

  • Co-pay Support
  • Patient Assistance Program
  • Quick Start
  • Prior Authorization Support
  • Coverage Interruption

Enroll your patients at time of prescription to support the patient experience and access to programs.

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INDICATION

AYVAKIT® (avapritinib) is indicated for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

IMPORTANT SAFETY INFORMATION
INDICATION & IMPORTANT SAFETY INFORMATION

Intracranial Hemorrhage—Serious intracranial hemorrhage (ICH) may occur with AYVAKIT treatment; fatal events occurred in <1% of patients. Overall, ICH (e.g., subdural hematoma, ICH, and cerebral hemorrhage) occurred in 2.9% of 749 patients who received AYVAKIT in clinical trials. In GIST patients, ICH occurred in 3 of 267 patients (1.1%) and two (0.7%) of the events were Grade ≥3 and resulted in discontinuation. Monitor patients closely for risk factors of ICH which may include history of vascular aneurysm, ICH or cerebrovascular accident within the prior year, concomitant use of anticoagulant drugs, or thrombocytopenia. Permanently discontinue AYVAKIT if ICH of any grade occurs.

Cognitive Effects—Cognitive adverse reactions can occur in patients receiving AYVAKIT and occurred in 33% of 995 patients overall in patients who received AYVAKIT in clinical trials including: 41% of 601 GIST patients (5% were Grade ≥3). Depending on the severity, withhold AYVAKIT and then resume at same dose or at a reduced dose upon improvement, or permanently discontinue.

Photosensitivity—AYVAKIT may cause photosensitivity reactions. In all patients treated with AYVAKIT in clinical trials (n=1049), photosensitivity reactions occurred in 2.5% of patients. Advise patients to limit direct ultraviolet exposure during treatment with AYVAKIT and for one week after discontinuation of treatment.

Embryo-Fetal Toxicity—AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective contraception during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Advise women not to breastfeed during treatment with AYVAKIT and for 2 weeks following the final dose.

Adverse Reactions—The most common adverse reactions (≥20%) were edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, increased lacrimation, abdominal pain, constipation, rash, dizziness, and hair color changes.

Drug Interactions—Avoid coadministration of AYVAKIT with strong or moderate CYP3A inhibitors. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce dose of AYVAKIT. Avoid coadministration of AYVAKIT with strong or moderate CYP3A inducers.

To report suspected adverse reactions, contact Blueprint Medicines Corporation at 1-888-258-7768 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to see the full Prescribing Information for AYVAKIT.

References:

  1. AYVAKIT [prescribing information]. Cambridge, MA: Blueprint Medicines Corporation; May 2023.
  2. Evans EK et al. Sci Transl Med. 2017;9(414):eaao1690.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastrointestinal Stromal Tumors V.1.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 17, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  4. Casali PG et al. Ann Oncol. 2018;29(4):iv68-iv78.