MTC=medullary thyroid cancer; NSCLC=non–small cell lung cancer; RET=rearranged during transfection.
GAVRETO is available in a single-dosage strength that allows for dose reductions within an existing bottle
Permanently discontinue GAVRETO in patients who are unable to tolerate 100 mg taken orally once daily.
|Adverse Reaction||Severity*||Dosage Modiﬁcation|
|ILD/Pneumonitis||Grade 1 or 2||Withhold GAVRETO until resolution. Resume by reducing the dose (see dose reduction table).
Permanently discontinue GAVRETO for recurrent ILD/pneumonitis.
|Grade 3 or 4||Permanently discontinue for conﬁrmed ILD/pneumonitis.|
|Hypertension||Grade 3||Withhold GAVRETO for Grade 3 hypertension that persists despite optimal antihypertensive therapy. Resume at a reduced dose when hypertension is controlled.|
|Grade 4||Discontinue GAVRETO.|
|Hepatotoxicity||Grade 3 or Grade 4||Withhold GAVRETO and monitor AST/ALT once weekly until resolution to Grade 1 or baseline. Resume at reduced dose. If hepatotoxicity recurs at Grade 3 or higher, discontinue GAVRETO.|
|Hemorrhagic Events||Grade 3 or Grade 4||Withhold GAVRETO until recovery to baseline or Grade 0 or 1.
Discontinue GAVRETO for severe or life-threatening hemorrhagic events.
|Other Adverse Reactions||Grade 3 or 4||Withhold GAVRETO until improvement to ≤ Grade 2.
Resume at reduced dose.
Permanently discontinue for recurrent Grade 4 adverse reactions.
*Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03.
ILD=interstitial lung disease.
Strong CY3PA inducers or combined P-gp and strong CY3PA inhibitors are the only known drug-to-drug interactions that require dosage or administration modifications for GAVRETO.
|Current GAVRETO Dosage||Recommended GAVRETO Dosage|
|400 mg orally once daily||200 mg orally once daily|
|300 mg orally once daily||200 mg orally once daily|
|200 mg orally once daily||100 mg orally once daily|
Avoid coadministration of GAVRETO with known combined P-gp and strong CYP3A inhibitors. If coadministration with a combined P-gp and strong CYP3A inhibitor cannot be avoided, reduce the current dose of GAVRETO as recommended in the table directly above. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume GAVRETO at the dose taken prior to initiating the combined P-gp and strong CYP3A inhibitor.
Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration with a strong CYP3A inducer cannot be avoided, increase the starting dose of GAVRETO to double the current GAVRETO dosage starting on Day 7 of coadministration of GAVRETO with the strong CYP3A inducer. After the inducer has been discontinued for at least 14 days, resume GAVRETO at the dose taken prior to initiating the strong CYP3A inducer.
Take the GAVRETO dosing and administration guide with you.
Learn more about GAVRETO patient financial and practice resources.
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