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WHY ARE SAMPLE DOSES BEING OFFERED?
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A free sample dose allows you to become familiar with GAVRETO so that you can start building experience with GAVRETO in eligible patients*
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Keep in mind that GAVRETO sample doses must be used according to their approved indications. See Important Safety Information below and see full Indication above.
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WHAT DOES A SAMPLE DOSE INCLUDE?
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A free 30-day supply of GAVRETO, clearly labeled as a sample†
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Prescribing Information
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FOLLOW 3 STEPS TO RECEIVE A SAMPLE DOSE
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Contact me, your GAVRETO representative
by replying to this email.
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Or
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Call the Sample Call Center
at 1-800-408-3365.
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You will be provided with a sample-dose
request form to complete and sign.
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Your free sample doses will be delivered to your practice.
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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 RET+ mNSCLC and Advanced Thyroid Cancer Product Brochure]
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[GAVRETO RET+ mNSCLC Product Brochure]
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[GAVRETO Website for Healthcare Professionals]
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[GAVRETO Dosing and Administration Guide]
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[GAVRETO Access & Reimbursement Guide]
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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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I would be happy to set up a quick
[pick list]
[
falsecall
truevideo chat
truemeeting
]
to answer any questions around the GAVRETO sampling program.
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[pick list]
[Sincerely],
[Best],
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[Rep photo]
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[pick list]
[Rep name]
[Rep title]
Blueprint Medicines
[Rep phone number]
[Rep email address]
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Select safety information
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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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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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