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\Hello \ \Dr. \ \##accFname##,
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[Variable opening message]
- With the many treatment options for chronic ITP, I’d like to share more about a different approach with TAVALISSE, including the convenience of the oral dosing without food restrictions.
- It was great speaking with you earlier. As a follow-up to our conversation, I wanted to share dosing details for TAVALISSE—an oral medication with no food restrictions.
- As your TAVALISSE representative with Rigel Pharmaceuticals, I wanted to share an overview of the dosing schedule as you consider treatment options for your patients with chronic ITP.
- If you are interested in starting your patients with chronic ITP on TAVALISSE, I thought it would be beneficial for you to review the dosing schedule for this oral treatment option.
- I hope you are doing well. I wanted to share key information about optimizing TAVALISSE dosing while assessing clinical benefit for your patients with chronic ITP.
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| Starting treatment with TAVALISSE |
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At the first sign that a patient's current chronic ITP treatment isn't working, give your patients the opportunity for a durable and stable response with TAVALISSE. Get the convenience of oral dosing without food restrictions.1-4
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TAVALISSE is the first spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.1,2
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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 additional Important Safety Information below.
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| Get access to complete dosing and administration information
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12-week evaluation period recommended per product labeling.1
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Clinical benefit: platelet count increase to a level sufficient to avoid clinically important bleeding.1
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Patient response to TAVALISSE may vary. 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
| Allow at least 12 weeks of treatment to determine if the patient is responding to TAVALISSE. Once a clinical benefit is observed, continue treatment with the therapeutic dose.1
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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 the TAVALISSE dosing schedule. I would be happy to go over any additional details whenever it’s convenient for you.
- I appreciate you taking the time to learn more about TAVALISSE and the dosing schedule as you consider treatment options for your patients with chronic ITP. I look forward to our next conversation.
- I appreciate you taking the time to explore TAVALISSE as a treatment option for patients with chronic ITP. I hope the information was valuable, and I’m happy to answer any questions you may have.
- As your Rigel Pharmaceuticals representative for TAVALISSE, I'm here to support you with any information you need. Feel free to reach out with any questions or to arrange a follow-up discussion.
- I hope you found the dosing information about TAVALISSE beneficial as you consider the next treatment options for your patients with chronic ITP. Please feel free to reach out if you need more information or have any questions.
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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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representative photo]
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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.
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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.
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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.
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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. 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. 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. 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.
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