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INDIVIDUALIZE CURRENT THERAPY BASED ON PATIENT NEED AND RESPONSE TO PRIOR THERAPY TO ACHIEVE TREATMENT GOALS

The International Consensus Report on ITP recommends individualized treatment goals

  • Maintain a target platelet count of at least >20-30 x 109/L for symptomatic patients1
  • Prevent severe bleeding episodes1
  • Cause minimal toxicity1
  • Optimize health-related quality of life1

Goal of subsequent treatment (after 1st-line treatments fail)

Reach and sustain an increased platelet count that is considered hemostatic for each patient while minimizing adverse events and allowing for the possibility of remission1

An individualized treatment strategy is needed for patients since ITP is a distinctly heterogeneous disease.

—Shih et al. Presse Med. 2014.2

ITP=immune thrombocytopenia.

ITP is a heterogeneous disease with a complex, multifactorial pathogenesis

ITP is driven by 2 factors: immune-mediated platelet destruction and limited platelet production3

  • Dysregulation of the immune system leads to production of anti-platelet antibodies

    Illustrative graphic showing how the dysregulation of the immune system leads to production of anti-platelet antibodies

  • Macrophage recognition of antibody-coated platelets results in unregulated platelet destruction

    Illustrative graphic showing how macrophage recognition of antibody-coated platelets results in unregulated platelet destruction

  • Lysis process results in an amplified production of anti-platelet antibodies

    Illustrative graphic showing how the lysis process results in an amplified production of anti-platelet antibodies

  • Platelet destruction causes decreased levels of thrombopoietin (TPO)

    Illustrative graphic showing how platelet destruction causes decreased levels of thrombopoietin (TPO)

  • Anti-platelet antibodies may also target megakaryocytes, resulting in impaired megakaryocyte function

    Illustrative graphic showing how anti-platelet antibodies may also target megakaryocytes, resulting in impaired megakaryocyte function

  • Irregular T-cell response may destroy platelets in bone marrow and impede platelet production

    Illustrative graphic showing how irregular T-cell response may destroy platelets in bone marrow and impede platelet production

TAVALISSE offers a novel approach to treating chronic ITP

Limit platelet destruction with the targeted mechanism of TAVALISSE6,7

A visual showing how TAVALISSE presents an opportunity to limit platelet destruction with a targeted mechanismA visual showing how TAVALISSE presents an opportunity to limit platelet destruction with a targeted mechanism

TAVALISSE7

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.

Corticosteroids1,3,13

  • Suppress systemic function and reduce antibody production, resulting in decreased platelet destruction
  • Standard 1st-line therapy for recently diagnosed patients
  • Over time, treatment side effects may outweigh the potential benefits
  • Most patients relapse upon discontinuation of treatment

Anti-CD201,4,11,12

  • Depletes B cells
  • Increased response when used with concomitant corticosteroids
  • A meta-analysis of 5 trials showed that rituximab was not associated with reductions in bleeding
  • In a study of response durability, only 21% maintained remission at 5 years

TPO-RAs1,4,14-16

  • Stimulate megakaryocytes in bone marrow to produce platelets
  • Associated with potential increases in bone marrow fibrosis
  • Evidence of increased thrombotic events with use of certain TPO-RA agents

TPO-RAs=thrombopoietin receptor agonists.

[TAVALISSE] has a unique mechanism of action, dissimilar to other approved ITP therapies, and produced responses in patients who had relapsed or not responded to TPO-RA agents, rituximab, and/or splenectomy.

—Bussel et al. Am J Hematol. 2018.6

WHEN YOUR PATIENT’S CURRENT ITP TREATMENT IS NO LONGER WORKING, WHAT’S NEXT?

TAVALISSE logo

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.6,7

References: 1. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817. doi:10.1182/bloodadvances.2019000812 2. Shih A, Nazi I, Kelton JG, Arnold DM. Novel treatments for immune thrombocytopenia. Presse Med. 2014;43:e87-e95. doi:10.1016/j.lpm.2014.02.006 3. Raj AB. Immune thrombocytopenia: pathogenesis and treatment approaches. J Hematol Transfus. 2017;5(1):1056-1065. 4. Newland A, Lee E, McDonald V, Bussel JB. Fostamatinib for persistent/chronic adult immune thrombocytopenia. Immunotherapy. 2018;10(1):9-25. doi:10.2217/imt-2017-0097 5. Olsson B, Ridell B, Carlsson L, Jacobsson S, Wadenvik H. Recruitment of T cells into bone marrow of ITP patients possibly due to elevated expression of VLA-4 and CX3CR1. Blood. 2008;112(4):1078-1084. doi:10.1182/blood-2008-02-139402 6. 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. 7. TAVALISSE®. Package insert. Rigel Pharmaceuticals, Inc. 8. 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 9. Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013;27(3):495-520. doi:10.1016/j.hoc.2013.03.001 10. WinRho® SDF [package insert]. Roswell, GA: Saol Therapeutics, Inc.; July 2019. 11. Stasi R, Pagano A, Stipa E, Amadori S. Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenia purpura. Blood. 2001;98(4):952-957. doi:10.1182/blood.v98.4.952 12. Rituxan® [package insert]. South San Francisco, CA: Genentech, Inc.; June 2021. 13. Mizutani H, Furubayashi T, Imai Y, et al. Mechanisms of corticosteroid action in immune thrombocytopenic purpura (ITP): experimental studies using ITP-prone mice, (NZW x BXSB) F1. Blood. 1992;79(4):942-947. 14. Doptelet® [package insert]. Durham, NC: AkaRx; July 2021. 15. Nplate® [package insert]. Thousand Oaks, CA: Amgen, Inc.; February 2022. 16. Promacta® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; October 2021.

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Indication and Important Safety Information

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 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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Indication and Important Safety Information

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.
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September is ITP Awareness month

Join Rigel in helping to raise awareness of immune thrombocytopenia (ITP) and showing support for ITP patients, care partners, and healthcare providers

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