TAVALISSE logo

CLINICAL OUTCOMES HAVE BEEN STUDIED IN REAL TAVALISSE PATIENTS

Review these case studies to see how TAVALISSE could work for chronic ITP patients in your practice

Sarah | 53
Patient with chronic ITP, post-steroids
  • Platelets decreased with upper respiratory infection 
  • Concerned with weight gain
  • Wants to avoid traveling for treatment
George | 79
Patient with chronic ITP and peripheral vascular disease
  • At clotting risk due to cardiovascular disease
  • Fears bleeding with anticoagulation therapy
  • Has type 2 diabetes
Daniel | 63
Patient with chronic ITP and cardiovascular disease
  • Requires cardiac catheterization
  • Has multiple comorbidities
  • Leads an active lifestyle
Nicole Image
Nicole | 35
Patient with ITP and history of polysubstance abuse
  • Experiencing transient responses to treatment
  • History of intravenous (IV) drug use
  • Prefers an oral medication
Samuel | 37
Patient with ITP and a history of gastroesophageal reflux disease (GERD)
  • Has gastroesophageal reflux disease
  • Leads an active lifestyle
  • Averse to taking any medications
Steve | 68
Patient with refractory chronic ITP
  • Has refractory chronic ITP
  • Bleeding crisis required emergency treatment
  • Wants to avoid surgery 
Ron | 75
Patient with 10-year history of chronic ITP
  • 10-year history of chronic ITP
  • Treatment compliance issues
  • Shows inconsistent responses to treatment
TAVA_ITP-22119 0822

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).

Back to the top

Rigel Pharmaceuticals logo

© 2022 Rigel Pharmaceuticals, Inc. All rights reserved.  TAVA_ITP-22110 0722

TAVALISSE and RIGEL ONECARE are registered trademarks and TAVALISSE TOGETHER is a trademark of Rigel Pharmaceuticals, Inc.

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

1180 Veterans Blvd, South San Francisco, CA 94080

This site is intended for US healthcare professionals only.

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.
TAVALISSE logo

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

TAVA_ITP-20158 0920