Important Safety Information | Full Prescribing Information | Visit Website

[pick list]
[Dear]
[Hello]

[pick list]
[Dr. Last Name]
[First Name]
[First Name Last Name]
,

[pick list]
[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).]
[I wanted to follow up on our last conversation. Thanks again for taking the time to speak with me. Below is some helpful information around dosing and administration for GAVRETO™ (pralsetinib).]
[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 for adults with RET fusion+ mNSCLC and for patients 12 years+ with advanced or metastatic RET-mutant MTC who require systemic therapy, or advanced or metastatic RET fusion+ thyroid cancer who require systemic therapy and are RAI refractory.

These indications are approved under accelerated approval. Please see Important Safety Information below, and click here to see the full Prescribing Information for GAVRETO.

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.

Select Safety Information

Please see additional safety information below.

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.

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 for GAVRETO.

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.

[email fragments]

[GAVRETO Product Brochure]

GAVRETO Product Brochure
An overview of GAVRETO for the treatment of patients with RET fusion+ mNSCLC, advanced or metastatic RET-mutant MTC, and advanced or metastatic RET fusion+ thyroid cancer.

I would be happy to set up a quick [pick list] [ falsecall truevideo chat truemeeting ] to answer any questions and provide helpful resources for you and your patients.

[pick list]
[Sincerely]
[Best]
,

[Rep photo]

[Rep Name]
[Rep Title]
Blueprint Medicines
[Rep Phone Number]
[Rep E-mail]

MTC=medullary thyroid cancer; NSCLC=non–small cell lung cancer;

RAI=radioactive iodine; RET=rearranged during transfection.

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.

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)

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 click here to see the full Prescribing Information for GAVRETO.

Reference: 1. GAVRETO™ (pralsetinib). Prescribing Information. Blueprint Medicines Corporation; Cambridge, MA. December 2020.

Information for Vermont Prescribers

This e-mail is intended for U.S. healthcare professionals only.

This promotional e-mail is brought to you by Blueprint Medicines and Genentech USA, Inc.

This e-mail is intended for the recipient identified above. If you have received this e-mail in error, please notify the sender immediately and delete the e-mail from your system.

To unsubscribe from this type of informational e-mail as delivered by your Blueprint Medicines representative, please click here. Regular communications between you and your Blueprint Medicines representative regarding standard business and meeting coordination activities may continue.

GAVRETO, Blueprint Medicines and associated logos are
trademarks of Blueprint Medicines Corporation.
The Genentech logo is a registered trademark of Genentech, Inc.

Blueprint Medicines Corporation
45 Sidney Street, Cambridge, MA 02139

Genentech USA, Inc.
1 DNA Way, South San Francisco, CA 94080-4990

12/2020 USBP-PRP-20.077.1