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Helpful resources for your GAVRETO (pralsetinib) patients |
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Available resources for your GAVRETO (pralsetinib) patients |
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Explore these helpful resources for your RET+ mNSCLC patients |
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Explore these helpful resources for your RET+ advanced thyroid cancer patients |
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Helpful resources for your patients inside |
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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 would like to share some helpful resources for your patients starting on or already taking GAVRETO® (pralsetinib). Digital copies can be downloaded below, but for some materials I can also provide print versions.
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As a reminder, GAVRETO is a once-daily targeted RET therapy indicated for the treatment of:
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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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Below you’ll find materials that have been designed to prepare patients and caregivers for starting and continuing treatment with GAVRETO.
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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 Patient Email Program
Patients can sign up to receive a series of emails that include topics on financial support, patient support groups, tips, and relevant resources.
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GAVRETO Patient Website
A website for patients to help them understand their RET+ cancer, how GAVRETO works, and available resources.
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NSCLC Patient Advocacy Groups
A list of support and advocacy groups for patients with NSCLC to stay informed and strengthen their support networks.
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Assistance Options for Your Eligible Patients
Genentech offers assistance for patients with different types of insurance coverage:
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Publicly insured patients can be referred to independent co-pay assistance foundations |
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Eligible patients with or without insurance coverage may receive help from the Genentech Patient Foundation |
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Commercially insured patients may be able to use a Genentech co-pay program or be referred to an independent co-pay assistance foundation |
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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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Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their Genentech medicine. Patients must be taking the Genentech medicine for an FDA-approved indication. Please visit the Co-pay Program website for the full list of Terms and Conditions. |
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Please let me know if you’d like to set up a
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[falsecalltruevideo chattruemeeting]
to discuss any of these patient resources, or if you have any questions about GAVRETO.
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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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