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68-YEAR-OLD MALE WITH REFRACTORY CHRONIC ITP

Steve*

BACKGROUND

AGE:
68
OCCUPATION:
Retired teacher
DATE OF DIAGNOSIS:
April 28, 2018
COMORBIDITIES:
  • AFib, controlled with aspirin
  • Hypertension, controlled with metoprolol and lisinopril
  • CAD, post-angioplasty

PATIENT ADMITTED TO EMERGENCY ROOM WITH BLEEDING

  • Platelet Counts
  • Treatment Summary

Steve's Platelet Counts Over Time

Swipe/click right to explore the details for each time point

  • Date
  • Date Platelet Count
  • Clinical Observations
  • Laboratory Findings
  • Physician Notes
  • Treatment Plan
4/28/18
<5 x 109/L
Petechiae, oral bleeding, epistaxis
Low RBC, low Hb, high MCV
Explained IVIG would cause rapid increase in platelet count; steroids could take 2-3 weeks to take effect
Administered IVIG 82 g; initiate prednisone 60 mg/day
5/31/18
4 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelet counts have decreased despite steroids; alternative treatment options discussed with Steve
Administered IVIG 80 g; begin rapid taper of prednisone; initiate 6 weekly rituximab infusions (375 mg/m2)
6/7/18
131 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Week 2 of rituximab (375 mg/m2); steroids have been discontinued
Continue weekly rituximab infusions (375 mg/m2) for 4 additional weeks, followed by 3 weeks of observation
6/27/18
30 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Week 5 of rituximab (375 mg/m2); platelets have decreased
Administered IVIG 80 g; continue weekly rituximab infusions (375 mg/m2) for 1 additional week, followed by 3 weeks of observation
7/31/18
22 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelets decreased over observation period; alternative treatment options discussed with Steve
Administered IVIG 80 g; initiate eltrombopag 50 mg/day
9/25/18
15 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelets decreased after transient response to IVIG
Administered IVIG 80 g; continue eltrombopag 50 mg/day
10/23/18
51 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelets decreased after transient response to IVIG
Administered IVIG 35 g; continue eltrombopag 50 mg/day; discontinue and assess treatment options if counts do not stabilize
11/16/18
42 x 109/L (following IVIG)
Negative for bleeding/bruising
Normal; comorbidities controlled
Eltrombopag discontinued; discussed alternative treatment options with Steve and prescribed TAVALISSE
Initiate TAVALISSE 100 mg BID
12/5/18
20 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelets gradually decreasing
Administered IVIG 80 g; continue TAVALISSE 100 mg BID
12/14/18
100 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelets have increased following IVIG; spoke with Steve about increasing dose to maintain platelet count increase
Increase dose to 150 mg BID and monitor
2/6/19
28 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Patient reported <Grade 1 diarrhea, resolved
Maintain 150 mg BID dosage and monitor
3/5/19
153 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Platelets have increased
Maintain 150 mg BID dosage and monitor
4/18/19
105 x 109/L
Negative for bleeding/bruising
Normal; comorbidities controlled
Steve is responding well and pleased with oral treatment
Continue TAVALISSE 150 mg BID and check labs monthly

Although Steve’s initial response to TAVALISSE was gradual, his platelet count increased and response was maintained.

AFib=atrial fibrillation; CAD=coronary artery disease; IVIG=intravenous immunoglobulin.

*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.

Steve's Treatment Summary

  • Headings:
  • Prior Treatment history

    April 28, 2018: Upon admission to the emergency room, ER team assesses bleeding

  • Headings:
  • treatment with tavalisse

    November 16, 2018: TAVALISSE initiation

  • Platelet Count:
  • <5 x 109/L

  • Platelet Count:
  • 42 x 109/L (following IVIG)

  • Clinical Observations:
    • Petechiae on extremities; oral bleeding; right-sided epistaxis; ER doctor suspects ITP
  • Clinical Observations:
    • Negative for bleeding/bruising
  • Laboratory Findings:
    • Red blood count (RBC): 3.56 million/µL
    • Hemoglobin (Hb): 12.2 g/dL
    • Hematocrit: 35.4%
    • Mean corpuscular volume (MCV): 99.4 fL/cell
    • Mean cell hemoglobin (MCH): 34.3 pg/cell
    • Mean cell hemoglobin concentration (MCHC): 34.5 g/dL
    • Red cell distribution width (RDW): 13.1%
    • White blood count: 5.93 x 109/L
    • Neutrophils: 3.45 x 109/L
    • Lymphocytes: 1.78 x 109/L
    • Monocytes: 0.49 x 109/L
    • Eosinophils: 0.16 x 109/L
  • Laboratory Findings:
    • All labs normal
  • ER Treatment:
    • Transfused with single-donor platelet pack upon admission (no improvement in platelet count)
    • Prescribed prednisone 60 mg/day and instructed to discontinue aspirin
  • ER Treatment:
  • N/A

  • Patient Discussion:
    • ER doctor referred Steve to local hematologist/oncologist (hem-onc) to manage treatment; hem-onc confirmed ITP diagnosis
  • Patient Discussion:
    • Physician explained the mechanism of TAVALISSE and the potential efficacy and adverse events
    • Physician counseled Steve on how to manage diarrhea, should it occur
    • Steve is pleased to remain on an oral medication that doesn’t require weekly visits
  • Treatment Plan:
    • Physician administered IVIG 82 g
    • Plan is to initiate prednisone 60 mg/day
    • If platelet count doesn’t stabilize, physician to treat with 6 weekly infusions of rituximab, observe, and treat with eltrombopag
    • Splenectomy is presented as a treatment option—Steve is unwilling to undergo surgery

    After multiple therapies resulting in consistent decreases in Steve’s platelet counts, the treating physician sought a different class of therapy.

  • Treatment Plan:
    • Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary

    Although Steve’s initial response to TAVALISSE was gradual, his platelet count increased and response was maintained.

    —Treating physician

AFib=atrial fibrillation; CAD=coronary artery disease; IVIG=intravenous immunoglobulin.

*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.

TAVA_ITP-21213 1121

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

TAVA_ITP-20158 0920