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
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*
*AYVAKIT is not approved for patients with resectable GIST
Unresectable or Metastatic GIST
APPROVED FOR USE IN PATIENTS WITH PDGFRA EXON 18 MUTANT GIST, INCLUDING PATIENTS WITH THE PDGFRA D842V MUTATION
APPROVED FOR USE IN PATIENTS WITH PDGFRA EXON 18 MUTANT GIST, INCLUDING PATIENTS WITH THE PDGFRA D842V MUTATION
AYVAKIT Resources
The following downloadable materials are here to help provide education for you and your patients on AYVAKIT.
PATIENT AND CAREGIVER BROCHURE
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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INDICATION
INDICATION & IMPORTANT SAFETY INFORMATION
AYVAKIT® (avapritinib) is 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.
IMPORTANT SAFETY INFORMATION
Intracranial Hemorrhage—Serious intracranial hemorrhage (ICH) may occur with AYVAKIT treatment; fatal events occurred in <1% of patients. Overall, ICH (eg, subdural hematoma, ICH, and cerebral hemorrhage) occurred in 2.9% of 749 patients who received AYVAKIT. 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 of ICH including those with thrombocytopenia, vascular aneurysm or a history of ICH or cerebrovascular accident within the prior year. Permanently discontinue AYVAKIT if ICH of any grade occurs.
Cognitive Effects—Cognitive adverse reactions can occur in patients receiving AYVAKIT. Cognitive adverse reactions occurred in 39% of 749 patients and in 41% of 601 GIST patients (5% were Grade ≥3). Memory impairment occurred in 21% of patients; <1% of these events were Grade 3. Cognitive disorder occurred in 12% of patients; 1.2% of these events were Grade 3. Confusional state occurred in 6% of patients; <1% of these events were Grade 3. Amnesia occurred in 3% of patients; <1% of these events were Grade 3. Somnolence and speech disorder occurred in 2% of patients; none of these events were Grade 3. Other events occurred in less than 2% of patients. 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=803), 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 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 2 weeks after 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 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.
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.
INDICATION
AYVAKIT® (avapritinib) is 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:
- AYVAKIT [prescribing information]. Cambridge, MA: Blueprint Medicines Corporation; March 2023.
- Evans EK, Guardino AK, Kim JL, et al. A precision therapy against cancers driven by KIT/PDGRFA mutations. Sci Transl Med. 2017;9(414):eaao1690.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastrointestinal Stromal Tumors (GISTs) V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed October 21, 2022. 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.
- 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.
INDICATION
AYVAKIT® (avapritinib) is 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.
