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[I wanted to check in with you and see how things are going. Below is some helpful information around dosing and administration for GAVRETO® (pralsetinib).]
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[I have some helpful information around dosing and administration for GAVRETO® (pralsetinib) I’d like to share with you.]

GAVRETO is the only once-daily targeted RET therapy indicated for¹:

>	Adult patients with RET fusion+ mNSCLC as detected by an FDA approved test
>	Patients 12 years+ with advanced or metastatic RET-mutant MTC who require systemic therapy
>	Patients 12 years+ with advanced or metastatic RET fusion+ thyroid cancer who require systemic therapy and are RAI refractory

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.

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.

The recommended starting dose for GAVRETO is
400 mg taken once daily.

Patients should take GAVRETO on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking GAVRETO).

•	Continue treatment until disease progression or until unacceptable toxicity.
•	Select patients for treatment with GAVRETO based on the presence of a RET gene fusion or RET gene mutation.
•	An FDA-approved test for the detection of RET gene fusion (thyroid cancer) and RET gene mutations is not currently available.

SELECT 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.

Please see additional Important Safety Information below, and full
Prescribing Information.

Recommended dosage reductions for adverse reactions

Permanently discontinue GAVRETO in patients who are unable to tolerate 100 mg taken orally once daily.

For additional dosing information, please refer to the full Prescribing Information.

GAVRETO is available in 100-mg capsules, giving you the opportunity to modify dosage based on individual patient needs.

I’m including some additional information that you may find useful.

[Fragment/attachment pick list]

[GAVRETO Access & Reimbursement Guide]

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.

[GAVRETO RET+ mNSCLC Product Brochure]

GAVRETO RET+ mNSCLC Product Brochure
An overview of GAVRETO for the treatment of patients with RET+ mNSCLC.

[GAVRETO RET+ mNSCLC and Advanced Thyroid Cancer Product Brochure]

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.

[Oncology Prescriber Service Form]

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.

[Billing and Coding Information for GAVRETO]

Billing and Coding Information for GAVRETO
Includes billing and coding information for GAVRETO.

[GAVRETO Dosing & Administration Guide]

GAVRETO Dosing & Administration Guide
How to dose and administer GAVRETO.

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Blueprint Medicines
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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.

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 5.4% 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.

GAVRETO is indicated for the treatment of:

•	Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
•	Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (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)

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.

Reference: 1. GAVRETO Prescribing Information. Genentech, Inc. April 2021.

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