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TAVALISSE delivered rapid, robust, and durable improvements in platelet counts

Robust improvements in platelet counts

Response rates achieved in the 24-week evaluation period (double-blind, placebo-controlled studies)

Graph showing response rates of the TAVALISSE treatment group compared to placebo group

*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.

Rapid improvements in platelet counts

TAVALISSE response summary—day 1 to 24 weeks11 

Stable response 

Table showing the median platelet counts by study visit

Overall response 

Graph of the median platelet counts by study visit

Time to first response was a post hoc analysis.

  • First platelet count measurement at week 2 and every 2 weeks thereafter
  • A total of 102 patients exited the placebo-controlled trials early (at or after week 12) and entered the open-label extension study7

FIT-3 interim analysis: Durable benefit beyond 2 years11,§

Graph depicting duration of response to TAVALISSE

A total of 61 of 123 patients discontinued from the open-label extension study early.

§Interim analysis, April 2017.

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. Patients who discontinued prior to meeting the criteria for loss of response were censored on the last platelet count measurement date.

Bleeding events and use of rescue medication in FIT-1 and FIT-2

Rate of bleeding episodes—TAVALISSE patients had a lower incidence of bleeding episodes than placebo patients7,11

  • In the placebo-controlled trials, the incidence of bleeding in patients who received TAVALISSE (regardless of responder status) was 29%, compared with 37% in patients who received placebo

Graph comparing the incidence of bleeding among FIT trial participants

Rescue medication use—TAVALISSE patients required less rescue medication than placebo patients7,11

  • In the placebo-controlled trials, 30% of patients who received TAVALISSE (regardless of responder status) required rescue medication, compared with 45% of patients who received placebo

Graph depicting the percentage of patients who required rescue medication during FIT trials

TAVALISSE demonstrated efficacy across patient subgroups compared to placebo

Treatment benefit favored TAVALISSE in the phase 3 clinical studies (FIT-1 + FIT-2)11

Graph showing TAVALISSE efficacy across patient subgroups

#Post hoc subgroup.

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.