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[Variable salutation: false Hello true Hi true Dear true Good morning true Good afternoon] [Variable title: false Dr. true Nurse true Mr. true Mrs. true Ms.] [Variable/optional name: false First Name true Last Name true First Name Last Name],
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[Variable opening message]
- As you consider options for chronic ITP treatment, I’d like to share information regarding the sample program for TAVALISSE 100 mg or 150 mg tablets with you today.
- Thank you for your time earlier. Following up on our conversation, I have information on how to order TAVALISSE samples for your adult patients with chronic ITP.
- As your representative for TAVALISSE with Rigel Pharmaceuticals, I’m reaching out to provide details on requesting samples for your adult patients with chronic ITP.
- I hope you’ve been doing well. I wanted to bring your attention that TAVALISSE samples are available to order for your adult patients with chronic ITP.
- I’m excited to share a new way to gain clinical experience with TAVALISSE through the TAVALISSE sample program.
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| When treatment for chronic ITP isn't working |
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| WHAT'S NEXT? |
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Gain clinical experience with TAVALISSE by ordering through the sample program
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Offer your adult patients with chronic immune thrombocytopenia (ITP) the potential for a durable and stable response.1-3
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TAVALISSE is the first spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.1,4
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SELECT IMPORTANT SAFETY INFORMATION
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Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
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Please see the full Important Safety Information below.
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The starting dose of TAVALISSE is 100 mg BID, taken with or without food. If platelet count has not increased to at least 50 x 109/L after one month, increase TAVALISSE dose to 150 mg twice daily. Use the lowest dose of TAVALISSE to achieve and maintain a platelet count of at least 50 x 109/L as necessary to reduce the risk of bleeding.1
Patient response to TAVALISSE may vary. |
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| SUPPORT FOR YOUR PATIENTS |
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[Variable fragment: CTA]
Download the Enrollment Form
Enroll patients in RIGEL ONECARE® for patient support services, including benefits verification, prior authorizations, temporary and long-term free drug supply, and adherence support. All Rigel programs are subject to eligibility requirements. Restrictions may apply.
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Download the Dosing and Administration Guide
Learn about the convenience of oral dosing without food restrictions, dosing modifications, and management of certain adverse reactions.
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Download the Patient Brochure
This brochure provides information on chronic ITP, how TAVALISSE is different from other therapies, and how TAVALISSE can help patients reach their treatment goals.
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Learn about patients’ responses to dosing
See how you can adjust your patient's dosing so that they can achieve target platelet count.
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[Variable closing message]
- Do you have any questions about TAVALISSE or ordering samples? I’d be happy to discuss further at your convenience.
- Let me know if there’s additional information you’d like as you consider TAVALISSE and ordering through the sample program.
- I appreciate your time and interest in TAVALISSE. As your representative with Rigel Pharmaceuticals, I’m here to answer any questions you might have.
- As your TAVALISSE representative with Rigel Pharmaceuticals, I’m here to support you—please reach out with any questions or to schedule a follow-up meeting.
- I hope this was helpful as you evaluate treatment options for chronic ITP. If you’re interested in learning more about how TAVALISSE can offer your patients a durable and stable response, I’d be happy to continue the conversation.
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[Variable sign-off: false Sincerely true Kind regards true Best true Talk soon true Thank you true Thanks again]
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| TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. |
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Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required. |
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Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation. |
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Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE. |
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Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation. |
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TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose. |
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Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose. |
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It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406. |
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Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug. |
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Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug. |
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Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%). |
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Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia. |
Please see TAVALISSEhcp.com for full Prescribing Information.
To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). |
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| References: 1. TAVALISSE®. Package insert. Rigel Pharmaceuticals, Inc. 2. Cooper N, Altomare I, Thomas MR, et al. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021;12:1-12. doi:10.1177/20406207211010875. 3. Boccia R, Cooper N, Ghanima W, et al. Fostamatinib is an effective second-line therapy in patients with immune thrombocytopenia. Br J Haematol. 2020;190(6):933-938. doi:10.1111/bjh.16959. 4. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930. |
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