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GAVRETO (pralsetinib): Important dosing information |
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Sharing important dosing information on GAVRETO (pralsetinib) |
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GAVRETO (pralsetinib): Dosing and administration information |
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Important dosing information on GAVRETO (pralsetinib) |
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Thank you for your time and consideration of GAVRETO (pralsetinib) |
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Helpful information when prescribing GAVRETO for your appropriate patients |
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[From: <Rep Name> (REPNAME@blueprintmedicines.com)]
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[Dear]
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[Dr. Last Name],
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[First Name Last Name],
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[Customize the text here with your own message to the healthcare provider in alignment with the Field Direction Memo (FDM). You may only send a 200-character message in alignment with the FDM. The message must be limited to a greeting and may not contain any implied/expressed product claims.]
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GAVRETO® (pralsetinib) offers patients a clear, once-daily dosing schedule. For an overview of the dosing requirements, including modification details, continue reading below. As a reminder, GAVRETO is a targeted RET therapy indicated for1:
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Adult patients with RET-fusion+ mNSCLC as detected by an FDA-approved test |
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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 RAI refractory (if RAI is appropriate)* |
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This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
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mNSCLC=metastatic non-small cell lung cancer; RAI=radioactive iodine; RET=rearranged during transfection
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Please see Important Safety Information below, and full Prescribing Information.
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Patients are selected for treatment with GAVRETO based on the presence of a RET gene fusion—however, please note that an FDA-approved test for the detection of RET gene fusion (thyroid cancer) is not currently available.
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Patients should take GAVRETO on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking GAVRETO). Continue treatment until disease progression or until unacceptable toxicity.
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GAVRETO is available in 100-mg capsules, giving you the opportunity to modify dosage as necessary. The recommended dosage reductions for adverse reactions are as follows:
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First reduction: 300 mg once daily |
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Second reduction: 200 mg once daily |
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Final reduction: 100 mg once daily |
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Permanently discontinue GAVRETO in patients who are unable to tolerate 100 mg taken orally once daily.
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For additional dosing information, please refer to the full Prescribing Information.
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Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO.
Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% 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.
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Please see additional Important Safety Information below and full Prescribing Information.
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I’m including some additional information that you may find useful.
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[Fragment/attachment pick list]
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GAVRETO Access & Reimbursement Guide
Includes information on product ordering, patient support, navigating the approval process, managing denials and appeals, and coverage information for diagnostic tests and related coding.
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GAVRETO RET+ mNSCLC and Advanced Thyroid Cancer Product Brochure
An overview of GAVRETO for the treatment of patients with RET+ mNSCLC or advanced thyroid cancer.
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Oncology Prescriber Service Form
This form includes patient, insurance, and prescription information and is used when Genentech Access Solutions contacts a patient’s health insurance plan to determine his or her coverage.
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I would be happy to set up a quick
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Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% 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.
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Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST)
occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days
(range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 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.
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Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with
GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.
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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.
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Risk of Impaired Wound Healing: 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.
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Embryo-Fetal Toxicity: 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 last
dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
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Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.
Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate
aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.
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Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate
CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or
moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
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Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.
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Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.
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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.
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Please click here to see the full Prescribing Information and Patient Information for GAVRETO.
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Reference: 1. GAVRETO Prescribing Information. Genentech, Inc. August 2023.
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