View efficacy data across different lines of therapy  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌
From: <Representative email>
To: <Recipient email>
Subject: 
<Variable subject lines>
• Efficacy by line of therapy for TAVALISSE® (fostamatinib disodium hexahydrate) tablets
• Chronic ITP: improvement in responses across lines of therapy
• Data by line of therapy for chronic ITP treatment
• For chronic ITP: durable improvement in platelet counts
Preheader:  View efficacy data across different lines of therapy

 

 
[Variable salutation: false Hello true Hi true Dear true Good morning true Good afternoon] [customTest(max length:20 characters)] [Variable title: false Dr. true Nurse true Mr. true Mrs. true Ms. true ] [customTest(max length:20 characters)] [Variable/optional name: false First Name true Last Name true First Name Last Name],
[Variable opening message]
  • I know you have many options for chronic ITP treatment. I’d like to share some information regarding the improvements in platelet counts across different lines of therapy.
  • Thank you for your time earlier. Following up on our conversation, I wanted to share some compelling data for TAVALISSE by line of therapy.
  • As your representative for TAVALISSE with Rigel Pharmaceuticals, I wanted to provide you with insights into the efficacy across different lines of therapy for your patients with chronic ITP.
  • I hope you’ve been doing well. I wanted to bring your attention to the efficacy of TAVALISSE and the improvement in platelet counts across lines of therapy.
  • I wanted to reach out to make sure you were aware of the additional data for TAVALISSE by different lines of therapy.
Early treatment with spleen tyrosine kinase (SYK) inhibition may limit platelet destruction in patients with chronic immune thrombocytopenia (ITP).1
 
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.
 
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 additional Important Safety Information below.
 
The Fostamatinib in ITP (FIT) Program was designed to evaluate the short- and long-term treatment effects of TAVALISSE in 2 double-blind, placebo-controlled studies of 150 adults with chronic ITP who had received prior therapy, followed by an open-label extension study.2,3
 
Primary endpoint—stable response: 17% vs Placebo 2%1,2,4*
- Median post-baseline platelet count: 97 x 109/L
- Platelet counts ≥50 x 109/L during weeks 14-24 (at least 4 of 6 consecutive visits)
 
Post hoc endpoint—overall response: 43% vs Placebo 14%2,4†
- Median post-baseline platelet count: 49 x 109/L
- At least one platelet count ≥50 x 109/L during weeks 0-12
 
A post hoc analysis of the FIT Program was published in the British Journal of Haematology, evaluating patient response to treatment by line of therapy. The authors of this analysis “hypothesize that early treatment of ITP with SYK inhibition may interrupt disease progression by blocking phagocytosis of antibody-coated platelets and thus subsequent events.”4
 
* Stable platelet response: achievement of a platelet count ≥50 x 109/L on ≥4 of the 6 visits during weeks 14-24 without need for rescue treatment.
† Overall response: achievement of a platelet count ≥50 x 109/L at least once during the first 3 months/12 weeks without need for rescue treatment.
 
ROBUST IMPROVEMENTS IN PLATELET COUNTS WERE OBSERVED WITH TAVALISSE AFTER STEROID AND/OR TPO-RA USE4
 
‡ Data cutoff date: December 2019.4
§ Platelet response was assessed by the proportion of patients achieving platelet counts of ≥50 x 109/L and of ≥30 x 109/L at any visit (without rescue therapy within 4 weeks).4
|| Percentage of patients achieving platelet counts of ≥30 x 109/L calculated using data on file.5
 

 

Rigel onecare

 

Find support for every step of treatment, including how to access TAVALISSE, copay assistance, patient support services, and downloadable resources for you and your patients.

 

To enroll your patients or learn more about available patient support programs

 
[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.
Download the Dosing and Administration Guide
Learn about the convenience of oral dosing without food restrictions, dosing modifications, and management of certain adverse reactions.
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.
[Variable closing message]
  • Do you have any questions about the efficacy by line of therapy for TAVALISSE? I’d be happy to discuss further at your convenience.
  • Thank you for taking the time to explore TAVALISSE and its potential as a treatment for your patients with chronic ITP. I look forward to our next discussion.
  • I appreciate you taking the time to review this data. Let me know if there’s any additional information you would like as you continue to evaluate treatment options for your patients with chronic ITP.
  • I appreciate your time and interest in TAVALISSE for patients with chronic ITP, and I hope you found this information valuable. 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 it was helpful to see the response data by line of therapy for TAVALISSE. If I can provide any further information, please let me know.
[Variable sign-off: false Sincerely true Kind regards true Best true Talk soon true Thank you true Thanks again],
[Optional
representative photo]
[Prepopulated representative name]
[Prepopulated representative phone number]
[Prepopulated representative email]
 
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
 
• 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.
• 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.
• 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.
• 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.
• 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
 
• 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.
• It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
• Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
• 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
 
• 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%).
• 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)‌.
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. doi:10.1002/ajh.25125. 3. 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. 4. Boccia R, Cooper N, Ghanima W, et al. Fostamatinb is an effective second-line therapy in patients with immune thrombocytopenia. Br J Haematol. 2020;190(6):933-938. doi:10.1111/bjh.16959. 5. Data on file, Rigel Pharmaceuticals, Inc. April 2018.
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