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\Hello \ \Dr. \ \##accFname##,,
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[Variable opening message]
- Do you have patients whose chronic ITP treatment isn’t delivering the results they need? If so, I wanted to outline how TAVALISSE may be able to provide a durable and stable response for these patients.
- I hope you're doing well. I wanted to reach out in case you have patients who aren’t responding well to their current treatment and you’re considering other options. TAVALISSE data demonstrated durable and stable responses and may be a good fit for these patients.
- As your representative for TAVALISSE with Rigel Pharmaceuticals, I wanted to summarize some key takeaways on how treatment with TAVALISSE differs from other treatments for chronic ITP.
- I wanted to share information on a targeted treatment option that may help your patients with chronic ITP who haven’t responded to previous treatment achieve a durable and stable response. Please review these data for TAVALISSE and let me know if you have any additional questions.
- It was great connecting with you recently. I wanted to share additional information about TAVALISSE for the treatment of your patients with chronic ITP, and how it may offer these patients a durable, stable response.
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| IS IT TIME TO SWITCH TO A DIFFERENT KIND OF TREATMENT? |
When evaluating your patients with chronic immune thrombocytopenia (ITP), these clinical markers can indicate that they are not achieving and/or maintaining an adequate response to treatment1:
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Low platelet counts |
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Fluctuating platelet counts |
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Bruising or bleeding |
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Need for frequent rescue treatment |
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Experiencing side effects |
| At the first sign that a patient's current chronic ITP treatment isn't working... |
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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.2,3
Select Important Safety Information
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.
| Please see the full Important Safety Information below. |
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| Start your APPROPRIATE patients today
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| TAVALISSE OFFERS A DIFFERENT WAY TO TREAT YOUR PATIENTS WITH CHRONIC ITP |
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70% of patients demonstrated sustained clinical benefit (≥30 x 109/L) over time4
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| MAINTAINED DURABLE AND STABLE BENEFIT |
Response, once achieved, was maintained for the majority of time on treatment4,5
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| MOST ADVERSE REACTIONS WERE MILD TO MODERATE |
No new or more frequent toxicities were observed with long‑term use6
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| ORAL DOSING WITHOUT FOOD RESTRICTIONS |
The convenience of oral dosing with or without food3
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| TARGETED APPROACH TO ACHIEVING STABLE RESPONSE |
Limits immune-mediated platelet destruction3,4
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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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Learn more about RIGEL ONECARE
See how Rigel supports patients taking TAVALISSE.
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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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[Variable closing message]
- Please let me know if you have any questions about switching your patients to TAVALISSE—I’d be happy to discuss further at your convenience.
- I appreciate you taking the time to learn more about how TAVALISSE may help your patients with chronic ITP. I look forward to connecting again soon.
- Thanks for taking the time to look over this information. If you’re interested in learning more about treatment with TAVALISSE for your patients with chronic ITP, please don’t hesitate to reach out.
- As your representative with Rigel Pharmaceuticals, I’m eager to answer any questions you may have about TAVALISSE. As you think about switching treatment options for your patients with chronic ITP, please reach out.
- Please let me know if you want to set up a follow-up meeting to discuss additional details regarding TAVALISSE, and whether switching therapies may be possible for your patients with chronic ITP.
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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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[Prepopulated representative name]
[Prepopulated representative phone number]
[Prepopulated representative email]
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| INDICATION
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.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
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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. |
Drug Interactions
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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. |
Adverse Reactions
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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. Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood. 2012;120(5):960‑969. doi:10.1182/blood‑2011-12-309153. 2. 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. 3. TAVALISSE®. Package insert. Rigel Pharmaceuticals, Inc. 4. 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. 5. 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. 6. Bussel JB, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546-553. doi:10.1002/ajh.25444. |
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