For Patients

GAVRETO Dosing

The only once-daily RET inhibitor1

Recommended starting dose: 400 mg once daily

GAVRETO offers patients a clear, once-daily dosing schedule

  • Continue treatment until disease progression or until unacceptable toxicity 
  • If a dose of GAVRETO is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for GAVRETO the next day
  • Advise patients not to take an additional dose if vomiting occurs after taking GAVRETO but to continue with the next dose as scheduled
  • Select patients for treatment with GAVRETO based on the presence of a RET gene fusion (NSCLC or thyroid cancer) or RET gene mutation (MTC)
  • An FDA-approved test for the detection of RET gene fusion (thyroid cancer) and RET gene mutations is not currently available

MTC=medullary thyroid cancer; NSCLC=non–small cell lung cancer; RET=rearranged during transfection.

Recommended dosage reductions and modifications for adverse reactions

GAVRETO is available in a single-dosage strength that allows for dose reductions within an existing bottle

Capsules are not actual size.

Permanently discontinue GAVRETO in patients who are unable to tolerate 100 mg taken orally once daily.

Recommended Dose Reductions for GAVRETO for Adverse Reactions

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.

Recommended Dosage Modifications for GAVRETO for Coadministration with Combined P-gp and Strong CYP3A Inhibitors

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.

P-gp=P-glycoprotein.

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Important Safety Information & Indications

INDICATIONS

GAVRETO® (pralsetinib) is indicated for the treatment of:

  • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 10% of patients who received GAVRETO, including 2.7% with Grade 3/4, and 0.5% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.

Hypertension occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.

Hepatotoxicity: Serious hepatic adverse reactions occurred in 2.1% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 69% of patients, including Grade 3/4 in 5% and increased alanine aminotransferase (ALT) occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.

Grade ≥ 3 hemorrhagic events occurred in 2.5% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.

Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.

Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the final dose. Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the final dose.

Common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, decreased platelets and increased alkaline phosphatase.

Avoid coadministration of GAVRETO with strong CYP3A inhibitors or combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

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

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