|
WHY ARE SAMPLE DOSES BEING OFFERED?
|
|
A free sample dose allows you to become familiar with GAVRETO so that you can start building experience with GAVRETO in eligible patients†
|
|
|
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.
|
|
|
WHAT DOES A SAMPLE DOSE INCLUDE?
|
|
|
A free 30-day supply of GAVRETO, clearly labeled as a sample‡
|
|
|
Prescribing Information
|
|
|
FOLLOW 3 STEPS TO RECEIVE A SAMPLE DOSE
|
|
|
Contact me, your GAVRETO representative,
by replying to this email.
|
|
OR
|
|
Call the Sample Call Center at 866-736-2717.
|
|
|
|
|
You will be provided with a sample-dose
request form to complete and sign.
|
|
|
|
|
Your free sample doses will be delivered to your practice.
|
|
|
|
I’m including some additional information that you may find useful.
|
|
|
|
[Fragment/attachment pick list]
|
|
|
|
|
|
|
|
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.
|
|
|
|
I would be happy to set up a quick
[pick list][falsecalltruevideo chattruemeeting]
to answer any questions around the GAVRETO sampling program.
|
[pick list]
[Sincerely],
[Best],
|
|
[Rep photo]
|
[pick list]
[Rep name]
[Rep title]
Blueprint Medicines
[Rep phone number]
[Rep email address]
|
|
|
Select safety information
|
|
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 antihypertensive
therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.
|
|
Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.
|
|
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 and Patient Information for GAVRETO.
|
