|
[pick list]
[Dear]
[Hello]
[pick list]
[Dr. Last Name],
[First Name],
[First Name Last Name],
|
|
[Customize the text here with your own message to the healthcare provider in alignment with FDM. You may only send a 200-character message in alignment with FDM.]
|
|
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.
|
|
As a reminder, GAVRETO is a once-daily targeted RET therapy indicated for the treatment of:
|
•
|
Adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test
|
|
•
|
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who require systemic therapy
|
|
•
|
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)
|
|
|
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. |
|
Below you’ll find materials that have been designed to prepare patients and caregivers for starting and continuing treatment with GAVRETO.
|
|
|
[Fragment/attachment pick list]
|
[GAVRETO Patient Welcome Brochure]
|
|
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.
|
|
|
[GAVRETO Patient Welcome Kit]
|
|
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.
|
|
|
[GAVRETO Patient Email Program]
|
|
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.
|
|
|
[GAVRETO Patient Website]
|
|
GAVRETO Patient Website
A website for patients to help them understand their RET+ cancer, how GAVRETO works, and available resources.
|
|
|
[NSCLC Patient Advocacy Groups]
|
|
NSCLC Patient Advocacy Groups
A list of support and advocacy groups for patients with NSCLC to stay informed and strengthen their support networks.
|
|
|
[Thyroid Cancer Patient Advocacy Groups]
|
|
|
|
[Biomarker Testing in mNSCLC Fact Sheet for Patients]
|
|
|
|
[Biomarker Testing in Advanced Thyroid Cancer Fact Sheet for Patients]
|
|
|
|
[RET+ mNSCLC Fact Sheet for Patients]
|
|
|
|
[RET+ Advanced Thyroid Cancer Fact Sheet for Patients]
|
|
|
|
|
|
Assistance Options for Your Eligible Patients
Genentech offers assistance for patients with different types of insurance coverage:
| • |
Publicly insured patients can be referred to independent co-pay assistance foundations |
| • |
Eligible patients with or without insurance coverage may receive help from the Genentech Patient Foundation |
| • |
Commercially insured patients may be able to use a Genentech co-pay program or be referred to an independent co-pay assistance foundation |
|
|
|
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.
|
|
|
|
|
Please let me know if you’d like to set up a
[pick list]
[falsecalltruevideo chattruemeeting]
to discuss any of these patient resources, or if you have any questions about GAVRETO.
|
[pick list]
[Sincerely],
[Best],
|
|
[Rep photo]
|
[pick list]
[Rep name]
[Rep title]
Blueprint Medicines
[Rep phone number]
[Rep email address]
|
|
|
Important Safety Information
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
Please click here to see the full Prescribing Information for GAVRETO.
|
