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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 durability*

Trial design

STUDY ENDPOINTS

  • Overall response: a post hoc endpoint, defined as a platelet count ≥50 x 10⁹/L within the first 3 months/12 weeks without rescue medication in the preceding 4 weeks; 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 1211
  • Stable platelet response: a primary efficacy endpoint; achievement of a platelet count ≥50 x 10⁹/L on ≥4 of the 6 visits during weeks 14-24 without need for rescue treatment7
  • 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 127

*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.11

Interim analysis, April 2017.

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-27,11

Table showing baseline patient characteristics in FIT trials

Prior treatment exposure among patients in FIT-1 and FIT-27,11

Table showing prior treatment exposure among patients in FIT trials

TAVALISSE dosing7

  • 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 taking TAVALISSE who were rolled over to the open-label extension trial maintained their existing dose 

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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TAVALISSE and RIGEL ONECARE are trademarks of Rigel Pharmaceuticals, Inc. 

RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc.

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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

  • 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.