FDA Approved for GIST

AYVAKIT™ (avapritinib): the first tyrosine kinase inhibitor (TKI) for people 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

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What is AYVAKIT?

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

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
1L
2L
3L
4L+
table_tki-treatment-bracket
Approved for use in patients with PDGFRA exon 18 mutant GIST, including patients with the PDGFRA D842V mutation
 

AYVAKIT Resources

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

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 is a patient support program that was designed with your patients’ care in mind. YourBlueprint assists patients throughout many aspects of treatment by providing:

  • Benefits investigation
  • Prior authorization support
  • Financial assistance options
  • Helpful resources

Click below for information on how to enroll your patient in YourBlueprint today.

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IMPORTANT SAFETY INFORMATION

There are no contraindications for AYVAKIT.

Intracranial hemorrhage (e.g., subdural hematoma, intracranial hemorrhage, and cerebral hemorrhage) occurred in 1% of 267 patients (0.7% Grade 3 or 4) with GIST and overall in 3% of 335 patients (1.2% Grade 3 or 4) who received AYVAKIT. Overall, 0.9% of patients receiving AYVAKIT required permanent discontinuation for an intracranial hemorrhage. Withhold AYVAKIT and then resume at a reduced dose upon resolution, or permanently discontinue AYVAKIT based on severity.

In 335 patients receiving AYVAKIT, CNS adverse reactions occurred overall in 58% of patients including cognitive impairment (41%; 3.6% Grade 3 or 4), dizziness (20%; 0.6% Grade 3 or 4), sleep disorders (15%; 0.3% Grade 3 or 4), mood disorders (13%; 1.5% Grade 3 or 4), speech disorders (6%; none Grade 3 or 4), and hallucinations (2.1%; none Grade 3 or 4). Overall, 3.9% of patients required permanent discontinuation of AYVAKIT for a CNS adverse reaction. Depending on severity, withhold AYVAKIT and then resume at the same dose or at a reduced dose upon improvement, or permanently discontinue AYVAKIT.

AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential and pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective method of 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 two weeks after the final dose. Advise females and males of reproductive potential that AYVAKIT may impair fertility.

In 204 patients with unresectable or metastatic GIST, the most common adverse reactions (20%) were edema, nausea, fatigue/asthenia, anemia, cognitive impairment, vomiting, diarrhea, decreased appetite, abdominal pain, increased lacrimation, constipation, rash and dizziness.

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

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

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

INDICATION

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

References:

  1. AYVAKIT Prescribing Information. Blueprint Medicines Corporation, Cambridge, MA. January 2020.
  2. Evans EK, Guardino AK, Kim JL, et al. A precision therapy against cancers driven by KIT/PDGRFA mutations. Sci Transl Med. 2017;9(414).
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.4.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed [September 12, 2019]. 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, Abecassis N, Bauer S, et al. Gastrointestinal stromal tumours: ESMO-EURACAN clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(4):iv68-iv78.

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