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\Hello \ \Dr. \ \##accFname##,,
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[Variable opening message]
- Are you familiar with the long-term outcomes from the clinical trial program for TAVALISSE? Included in this message are data demonstrating the durable, stable response in patients with chronic ITP.
- I wanted to share information about TAVALISSE, which has demonstrated a durable, stable response in patients with chronic ITP.
- It was great speaking with you earlier. After our conversation, I wanted to share some compelling data for TAVALISSE based on the 5-year analysis demonstrating a durable, stable response in patients with chronic ITP.
- As your representative for TAVALISSE with Rigel Pharmaceuticals, I wanted to provide you with insights into the 5-year analysis and durable, stable response data for patients with chronic ITP.
- As you evaluate current and future treatment options for your patients with chronic ITP, I wanted to share the long-term efficacy data for TAVALISSE. In the 5-year analysis, TAVALISSE demonstrated durable, stable platelet count improvements in patients with chronic ITP.
- It was great connecting with you recently. I wanted to share some interesting long-term data for TAVALISSE, which demonstrated a durable, stable response in patients with chronic ITP.
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| An analysis of the Fostamatinib in ITP (FIT) clinical program data shows TAVALISSE demonstrated durable and stable response in patients who received treatment for up to 5 years.1,*,†,‡
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Indication
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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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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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[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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Review the published post hoc analysis
Read more about the post hoc long-term thrombotic risk and efficacy analysis in Therapeutic Advances in Hematology.
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[Variable closing message]
- Thanks for taking a moment to explore the long-term data for TAVALISSE. I’m excited to continue our conversation soon.
- Thanks for reviewing this information. Feel free to reach out if you have any questions, or if you would like to review any additional information about TAVALISSE while considering treatment options for your patients with chronic ITP.
- I appreciate your time and interest in TAVALISSE for patients with chronic ITP. As your representative with Rigel Pharmaceuticals, I’m here to answer any questions you might have.
- As your TAVALISSE representative from Rigel Pharmaceuticals, I’m always here to help. Please don’t hesitate to get in touch with any questions about this data or to set up a follow-up meeting.
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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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[Optional
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. 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:e20406207211010875. doi:10.1177/20406207211010875. 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. 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. doi:10.1002/ajh.25444.
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