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Sharing helpful resources for GAVRETO (pralsetinib) |
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Want helpful resources for GAVRETO (pralsetinib)? |
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Helpful resources about GAVRETO (pralsetinib) |
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Sharing resources about GAVRETO (pralsetinib) |
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Some resources about GAVRETO (pralsetinib) you may find helpful |
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[From: <Rep Name> (REPNAME@blueprintmedicines.com)]
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[To: <Last Name, First Name>]
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[Dear]
[Hello]
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[Dr. Last Name],
[First Name],
[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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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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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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Please see Important Safety Information below and full Prescribing Information.
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mNSCLC=metastatic non–small cell lung cancer; RAI=radioactive iodine; RET=rearranged during transfection.
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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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GAVRETO Patient Welcome Brochure
A brochure designed to help get patients started on GAVRETO with tips about taking GAVRETO, potential side effects, and patient support. This brochure is also available in a print version.
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GAVRETO Patient Welcome Kit
This kit contains a variety of useful resources for patients starting GAVRETO—including a welcome brochure, doctor discussion guide, medication tracker, and more. Patients can sign up for a kit on GAVRETO.com/signup, or I can send you a kit to provide to your patients.
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GAVRETO Website for Healthcare Professionals
Website for healthcare professionals to learn more about GAVRETO and available resources.
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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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Prescribing Information (PDF)
GAVRETO full Prescribing Information and Patient Information.
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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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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 Interactive Patient Case Player
An interactive case player that allows you to navigate testing and treating a hypothetical RET+ mNSCLC patient. In real time, you’ll see how
your responses align with peers and guideline recommendations.
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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 would be happy to set up a
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[falsecalltruevideo chattruemeeting]
with you virtually or in person to discuss any of the above information, or to learn how I can be of assistance to your practice and patients.
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[Sincerely],
[Best],
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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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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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