Select therapeutic use:

Colorectal and other GI cancers:

Indications for: AYVAKIT

In 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.

Adult Dosage:

Give on an empty stomach (at least 1hr before and 2hrs after a meal). 300mg once daily; continue until disease progression or unacceptable toxicity. Avoid concomitant use with strong or moderate CYP3A inhibitors; if use with moderate CYP3A inhibitor is unavoidable, initiate dosing at 100mg once daily. Dose modifications: see full labeling.

Children Dosage:

Not established.

AYVAKIT Warnings/Precautions:

Risk of intracranial hemorrhage; monitor closely including those with thrombocytopenia, vascular aneurysm, or history of intracranial hemorrhage or cerebrovascular accident within the prior year. Permanently discontinue if intracranial hemorrhage of any grade occurs. In AdvSM: interrupt or reduce dose if platelet counts <50×109/L; platelet support may be needed. Risk of CNS effects (eg, cognitive impairment, dizziness, sleep disorders, others); if occurs, withhold dose and then resume at reduced (or at same) dose upon resolution, or permanently discontinue based on severity. Severe renal impairment (CrCl 15–29mL/min) or ESRD (CrCl <15mL/min). Severe hepatic impairment. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

AYVAKIT Classification:

Tyrosine kinase inhibitor.

AYVAKIT Interactions:

See Adults. Potentiated by strong or moderate CYP3A inhibitors (eg, itraconazole, fluconazole). Antagonized by strong or moderate CYP3A inducers (eg, rifampin, efavirenz); avoid.

Adverse Reactions:

Edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, increased lacrimation, abdominal pain, rash, constipation, dizziness, hair color changes; anemia, subdural hematoma, pleural effusion, ascites, pneumonia, sepsis.

Generic Drug Availability:

NO

How Supplied:

Tabs—30

Pricing for AYVAKIT

300mg tablet (Qty: 30)
Appx. price $34249
GoodRx

Miscellaneous immune disorders:

Indications for: AYVAKIT

In adults with advanced systemic mastocytosis (AdvSM), including those with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL).

Limitations of Use:

Not for use in patients with AdvSM with platelet counts <50x109/L.

Adult Dosage:

Give on an empty stomach (at least 1hr before and 2hrs after a meal). 200mg once daily; continue until disease progression or unacceptable toxicity. Avoid concomitant use with strong or moderate CYP3A inhibitors; if use with moderate CYP3A inhibitor is unavoidable, initiate dosing at 50mg once daily. Dose modifications: see full labeling.

Children Dosage:

Not established.

AYVAKIT Warnings/Precautions:

Risk of intracranial hemorrhage; monitor closely including those with thrombocytopenia, vascular aneurysm, or history of intracranial hemorrhage or cerebrovascular accident within the prior year. Permanently discontinue if intracranial hemorrhage of any grade occurs. In AdvSM: interrupt or reduce dose if platelet counts <50×109/L; platelet support may be needed. Risk of CNS effects (eg, cognitive impairment, dizziness, sleep disorders, others); if occurs, withhold dose and then resume at reduced (or at same) dose upon resolution, or permanently discontinue based on severity. Severe renal impairment (CrCl 15–29mL/min) or ESRD (CrCl <15mL/min). Severe hepatic impairment. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

AYVAKIT Classification:

Tyrosine kinase inhibitor.

AYVAKIT Interactions:

See Adults. Potentiated by strong or moderate CYP3A inhibitors (eg, itraconazole, fluconazole). Antagonized by strong or moderate CYP3A inducers (eg, rifampin, efavirenz); avoid.

Adverse Reactions:

Edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, increased lacrimation, abdominal pain, rash, constipation, dizziness, hair color changes; anemia, subdural hematoma, pleural effusion, ascites, pneumonia, sepsis.

Generic Drug Availability:

NO

How Supplied:

Tabs—30

Pricing for AYVAKIT

300mg tablet (Qty: 30)
Appx. price $34249
GoodRx