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Case study:
George
*

79-year-old male with chronic ITP and peripheral vascular disease

Patient George
Background
Age: 79
Occupation:  Retired
Date of Diagnosis: 2010
Comorbidities:
  • Peripheral vascular disease; controlled with aspirin 81 mg QD and clopidogrel 75 mg QD
  • Hypertension; now controlled with metoprolol tartrate 50 mg BID and losartan/hydrochlorothiazide 50/12.5 mg QD
  • Hyperlipidemia; controlled with simvastatin 20 mg QD
  • Diabetes mellitus type 2; controlled with diet
Medical History:
  • Atrial fibrillation diagnosed 10+ years ago; had Watchman procedure in January 2019

DUE TO CONCERNS OF BLEEDING WITH ANTICOAGULATION THERAPY, CARDIOLOGIST REFERRED PATIENT TO HEMATOLOGY/ONCOLOGY (HEM-ONC) SPECIALIST

George’s treatment history

March 12, 2018: Cardiologist refers patient to hematology/oncology (hem-onc) specialist to reduce bleeding risk with anticoagulant therapy

PLATELET COUNT: 40 x 109/L

CLINICAL OBSERVATIONS: Epistaxis, petechiae, and fatigue

LABORATORY FINDINGS: WNL

PATIENT DISCUSSION:

  • Patient expresses anxiety about bleeding risk with his treatment for atrial fibrillation and peripheral vascular disease

TREATMENT PLAN:

  • Cardiologist and hem-onc confer on treatment and decide to take a “watch and wait” approach while maintaining a platelet count ≥50 x 109/L
  • Treat with steroids if platelet count drops below 50 x 109/L

TAP OR HOVER FOR ADDITIONAL DETAILS
George's Treatment History
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/12/18 40 x 109/L Epistaxis, petechiae, and fatigue WNL Patient noted concern about bleeding with anticoagulant therapy Referred to hem-onc for specialized care
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/24/18 81 x 109/L Normal WNL First visit with hem-onc; patient was asymptomatic Take a “watch and wait” approach with a goal platelet count ≥50 x 109/L
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/26/18 49 x 109/L Epistaxis and petechiae WNL No notes available Initiate prednisone 100 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/29/18 75 x 109/L Normal Glucose: 300-500 mg/dL (patient-reported) Platelet count increased, but with steroid-induced hyperglycemia Begin 9-week prednisone taper due to elevated glucose levels
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/27/18 134 x 109/L Normal Glucose: 668 mg/dL Blood glucose level remains high Prednisone decreased to 20 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/9/18 178 x 109/L Normal WNL Blood glucose has decreased to normal levels Prednisone decreased to 10 mg QD, to be discontinued on 8/30
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/9/18 262 x 109/L Normal Glucose: 262 mg/dL Platelet count remained above target; blood glucose is elevated No new treatment started as platelet counts are above goal for patient. Continue to monitor platelets
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/10/18 116 x 109/L Normal WNL Blood glucose in acceptable range; platelet count above target No treatment; continue to monitor platelets
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/8/19 22 x 109/L Epistaxis and petechiae Unreported Platelet counts have dropped below target; IVIG unavailable; prescribe lower dose of steroid to avoid recurrence of hyperglycemia Prednisone 60 mg QD x 4 days
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/11/19 25 x 109/L Unavailable Unreported Platelet count did not improve with steroid treatment Four courses of rituximab; prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/2/19 60 x 109/L Normal Glucose: 195 mg/dL; AST: 13 IU/L; ALT: 21 IU/L; bilirubin: 0.6 mg/dL Final dose of rituximab; platelet count does not appear to be responding to steroids Three-week prednisone taper begins
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/16/19 67 x 109/L Normal Glucose: 191 mg/dL; AST: 15 IU/L; ALT: 19 IU/L; bilirubin: 0.6 mg/dL Once steroid taper is complete, patient needs treatment that can help stabilize platelet counts in order to continue therapies for cardiovascular issues Prednisone decreased to 10 mg QD x 1 week, to be discontinued on 5/23

ALT=alanine aminotransferase; AST=aspartate aminotransferase; IVIG=intravenous immunoglobulin; WNL=within normal limits.

Based on George’s response to prior therapies, comorbidities, and higher risk of bleeding, the hem-onc sought an oral medication in a different class of therapy

The intent of this case study is to present the experience of a single patient, which may not represent the outcomes in the overall patient population. Response to treatment may vary from patient to patient.

GEORGE’S TREATMENT WITH TAVALISSE

May 23, 2019: TAVALISSE initiation

BASELINE PLATELET COUNT:  36 x 109/L
CLINICAL OBSERVATIONS:
  • Epistaxis, purpura on lower extremities, petechiae
LABORATORY FINDINGS:
  • BP: 133/62 mm Hg
  • WBC: 9.5 x 109/L
  • Glucose: 203 mg/dL
  • AST: 17 IU/L
  • ALT: 20 IU/L
  • Bilirubin: 0.6 mg/dL
PATIENT DISCUSSION: 
  • Physician explained the need for a treatment that could help improve platelet counts so that patient could continue proper anticoagulation therapy
  • Physician discussed several options with the patient, including splenectomy, TPO-RAs, and TAVALISSE, and reviewed potential efficacy and AEs for each treatment. Patient did not like the idea of splenectomy
  • Physician wanted to avoid therapies with a risk of bone marrow fibrosis or thromboembolism. Based on the patient’s cardiovascular issues, TPO-RAs were ruled out
TREATMENT PLAN: 
  • Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary
  • Continue aspirin and clopidogrel for coronary and peripheral artery disease

TAP OR HOVER FOR ADDITIONAL DETAILS
George's treatment with Tavalisse
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/23/19 36 x 109/L Epistaxis, purpura on lower extremities, petechiae; BP: 133/62 mm Hg Glucose: 203 mg/dL; AST: 17 IU/L; ALT: 20 IU/L; bilirubin: 0.6 mg/dL Patient made aware of treatment options; TAVALISSE prescribed. Patient understands that TAVALISSE is long-term therapy, and is eager and receptive to try it Initiate TAVALISSE 100 mg BID; complete prednisone taper
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/13/19 118 x 109/L No bleeding events; BP: 148/73 mm Hg Glucose: 139 mg/dL; AST: 23 IU/L; ALT: 26 IU/L; bilirubin: 0.6 mg/dL Platelet counts have increased; no diarrhea or abnormal LFTs; referred to cardiologist for slightly elevated BP Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/27/19 136 x 109/L BP: 144/72 mm Hg Glucose: 116 mg/dL; AST: 25 IU/L; ALT: 24 IU/L; bilirubin: 1 mg/dL Platelet count continues to increase; BP remains elevated. Dose of antihypertensive increased to manage BP, per TAVALISSE PI Continue TAVALISSE 100 mg BID; increase metoprolol from 25 mg to 50 mg BID; continue to monitor BP
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/22/19 116 x 109/L BP: 122/68 mm Hg WNL BP returns to normal level Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/19/19 165 x 109/L BP: 110/82 mm Hg Glucose: 122 mg/dL; AST: 18 IU/L; ALT: 16 IU/L; bilirubin: 0.9 mg/dL Patient demonstrates an ongoing response to TAVALISSE; BP remains normal; glucose remains controlled Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/12/19 137 x 109/L BP: 124/77 mm Hg Glucose: 130 mg/dL; AST: 25 IU/L; ALT: 21 IU/L; bilirubin: 0.9 mg/dL BP remains normal; glucose remains controlled Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/23/20 157 x 109/L BP: 113/78 mm Hg Glucose: 112 mg/dL; AST: 22 IU/L; ALT: 13 IU/L; bilirubin: 0.7 mg/dL BP remains normal; glucose remains controlled; platelet counts steadily increase Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/12/20 222 x 109/L BP: 121/74 mm Hg WNL BP remains normal; glucose remains controlled; platelet counts steadily increase Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/19/20 257 x 109/L BP: 125/79 mm Hg WNL Patient reported that he was satisfied with treatment due to the convenience of an oral medication that can be taken with or without food; platelet counts continue to increase; BP remains normal Continue TAVALISSE 100 mg BID; monitor patient every 2 months

AE=adverse event; BP=blood pressure; LFT=liver function test; TPO-RA=thrombopoietin receptor agonist; WBC=white blood cell.

Overall, the patient is very happy with his response to TAVALISSE. His platelet counts are increasing consistently, and in a stable fashion. He has not had any bleeding episodes and petechiae has resolved.

—Treating physician

*This case study contains data from an actual TAVALISSE patient. Patient name and image have been changed to protect privacy. This case study is intended for general medical education purposes only and is not a substitute for independent clinical medical judgment. The intent of this case study is to present the experience of a single patient, which may not represent the outcomes in the overall patient population. Response to treatment may vary from patient to patient.

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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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