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Case study:
Steve
*

68-year-old male with refractory chronic ITP

Patient 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

Steve’s treatment history

April 28, 2018: Hematology/oncology specialist reviews available medical records

PLATELET COUNT: <5 x 109/L

CLINICAL OBSERVATIONS:
Petechiae on extremities; oral bleeding; right-sided epistaxis; ER doctor suspects ITP

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

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

PATIENT DISCUSSION:
ER doctor referred Steve to local hematologist/oncologist to manage treatment; hem-onc confirmed ITP diagnosis

HEM-ONC 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 

TAP OR HOVER FOR ADDITIONAL DETAILS
Steve's Treatment History
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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)
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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

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

STEVE'S TREATMENT WITH TAVALISSE

November 16, 2018: TAVALISSE initiation

BASELINE PLATELET COUNT:  42 x 109/L (following IVIG)
CLINICAL OBSERVATIONS: Negative for bleeding/bruising
LABORATORY FINDINGS: All labs normal
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:  Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary

TAP OR HOVER FOR ADDITIONAL DETAILS
Steve's treatment with Tavalisse
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/5/19 153 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
Platelets have increased Maintain 150 mg BID dosage and monitor
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
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

*Adapted from an actual patient case. 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-19177 1119

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.

 

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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.
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