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[Dear]
[Hello]
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[Dr. Last Name],
[First Name],
[First Name Last Name],
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[I wanted to check in with you and see how things are going.]
[I wanted to follow up on our last conversation. Thanks, again, for taking the time to speak with me.]
[I’m sorry I missed you, and I’d like to share some helpful materials.]
[I have some helpful materials I’d like to share with you.]
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I’m including some resources I hope you’ll find useful on GAVRETO® (pralsetinib)—the only once-daily 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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Patients 12 years+ with advanced or metastatic RET-mutant MTC who require systemic therapy |
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Patients 12 years+ with advanced or metastatic RET fusion+ thyroid cancer who require systemic therapy and are RAI refractory |
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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.
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Please see Important Safety Information below, and full Prescribing Information.
mNSCLC=metastatic non–small cell lung cancer; MTC=medullary thyroid cancer; RAI=radioactive iodine; RET=rearranged during transfection.
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Genentech Co-Pay Assistance Program
Genentech co-pay programs provide financial assistance to eligible commercially insured patients to help with their co-pays, co-insurance, or other out-of-pocket (OOP) costs. To find out if your patients qualify or to get more information about the Genentech Co-pay Assistance Program, call (855) MYCOPAY (692-6729) or visit copayassistancenow.com
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GAVRETO Access and 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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Oncology Prescriber Service Form
The Oncology Prescriber Service 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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GAVRETO Sampling Program
A free 30-day sample dose allows you to become familiar with GAVRETO so that you can start building experience in eligible patients. Keep in mind that GAVRETO sample doses must be used according to their approved indications. Please let me know if you would like to order a sample or call the Sample Call Center at 1-800-408-3365.
Drug samples may not be sold, purchased, traded, or offered for sale, purchase, or trade, utilized to seek reimbursement, or otherwise distributed in a manner not permitted by applicable law. Samples may only be distributed to practitioners who are licensed or authorized under applicable state law to prescribe the drug product and whose practices are relevant to the FDA-approved product labeling for GAVRETO. Distribution of the sample does not obligate use or continuing use of GAVRETO. You may not advertise or otherwise use the program as a means of promoting your services or Genentech’s products to patients. Genentech reserves the right to deny fulfillment of the sample to anyone deemed ineligible in accordance with stated program criteria. Annual sample limits per HCP and brand apply.
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I’m available in person or virtually to answer any questions you may have.
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[Rep name]
[Rep title]
Blueprint Medicines
[Rep phone number]
[Rep email address]
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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.
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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.
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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.
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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.
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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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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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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.
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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.
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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.
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GAVRETO is indicated for the treatment of:
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Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) 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-mutant medullary thyroid cancer (MTC) who require systemic therapy
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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 radioactive iodine-refractory (if radioactive iodine is appropriate)
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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.
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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 for GAVRETO.
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Reference: 1. GAVRETO Prescribing Information. Genentech, Inc. April 2021.
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