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The fostamatinib in ITP (FIT) program was designed to evaluate short- and long-term treatment effects

The FIT-1, FIT-2, and FIT-3 phase 3 clinical trials assessed TAVALISSE efficacy, safety, and durability1,2,*

 

Trial design
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  • All patients with platelets <50 x 10⁹/L, regardless of treatment arm, were eligible to enter FIT-3 (open-label extension) at or after week 121
  • In clinical trials, stable concurrent ITP therapy was allowed, and rescue therapy was permitted if needed. Visits where rescue medication was used were excluded from the efficacy analysis3,‡

*Duration of response analysis endpoint: the number of days from achieving a platelet count ≥50 x 10⁹/L to reaching a platelet count <30 x 10⁹/L at two consecutive visits. Patients were classified as losing response if platelet counts dropped below 30 x 10⁹/L for two consecutive visits 28 days apart, or if rescue medication was used.2

Overall response: the initial 12 weeks were selected since most nonresponding patients from both arms discontinued FIT-1 and FIT-2 and entered the open-label extension study at or very soon after week 12.

Stable concurrent ITP therapies permitted in clinical trials: glucocorticoids (<20 mg prednisone equivalent per day), azathioprine, or danazol.

THE FIT PROGRAM INCLUDED ADULT PATIENTS WITH CHRONIC ITP WHO HAD RECEIVED ≥1 PRIOR THERAPY

FIT program patients were representative of the general adult chronic ITP population, including exposure to prior therapies

 

Select baseline patient characteristics in FIT-1 and FIT-23,4

Median time since diagnosis 8.5 years
Median age 54 years
Gender 61% female; 39% male
Median platelet count 16 x 109/L
Platelet counts <15 x 109/L 45%
Splenectomy (time since splenectomy) 35% (all >6 months, except for 1 patient)

Prior treatment exposure among patients in FIT-1 and FIT-21,3,4

Median number of prior therapies 4
Corticosteroids 94%
Immunoglobulins 53%
TPO-RAs 48%
Immunosuppressants 44%
Rituximab 32%

TAVALISSE dosing3

  • Starting dose of TAVALISSE: One 100 mg tablet BID   
  • Based on platelet count and tolerability, the dose could be increased to one 150 mg tablet BID at or after week 4 
  • Patients who had a platelet count ≥50 x 109/L at the time of rollover to the FIT-3 open-label extension study maintained their existing dose of TAVALISSE 

References: 1. 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. 2. 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. 3. TAVALISSE® [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; April 2018. 4. Data on file, Rigel Pharmaceuticals, Inc. April 2018.

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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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