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Case study:
Daniel
*

63-year-old male with chronic ITP and cardiovascular disease

Patient Daniel
Background
Age: 63
Occupation:  Lawyer
Date of Diagnosis: May 1, 2018
Comorbidities:
  • Unprovoked deep-vein thrombosis (DVT) in 2014; now controlled
  • Hypertension, controlled with bumetanide 1 mg QD, carvedilol 3.125 mg BID, losartan 25 mg QD
  • Hyperlipidemia, controlled with atorvastatin 40 mg QD
  • Diabetes mellitus type 2, controlled with empagliflozin 10 mg QD, glimepiride 4 mg QD, insulin glargine 20 U SC QD, linagliptin 5 mg QD, metformin 1 g QD

PATIENT WITH MILD EPISTAXIS, EASY BRUISING, AND MILD FATIGUE REFERRED TO HEMATOLOGY/ONCOLOGY (HEM-ONC) SPECIALIST BY PRIMARY CARE PHYSICIAN (PCP)

Daniel’s treatment history

May-July 2018: While under the care of a hematology/oncology (hem-onc) specialist for ITP, cardiac workup reveals a need for cardiac catheterization

PLATELET COUNT: 43 x 109/L to 61 x 109/L (fluctuating)

CLINICAL OBSERVATIONS: Mild epistaxis, mild fatigue, easy bruising

LABORATORY FINDINGS:Variable

PATIENT DISCUSSION:

  • PCP diagnoses Daniel with thrombocytopenia and refers him to hem-onc for further treatment
  • Despite symptoms subsiding with initial treatment, patient is informed that he will require further treatment for immune thrombocytopenia (ITP) stemming from his need for cardiovascular surgery

TREATMENT PLAN:

  • Initiate dexamethasone 40 mg QD
  • After it is determined that patient requires surgery, platelet target set at ≥70 x 109/L

TAP OR HOVER FOR ADDITIONAL DETAILS
Daniel's treatment history
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/1/18 61 x 109/L Mild epistaxis, mild fatigue, easy bruising Not reported CBC revealed low platelet count; thrombocytopenia diagnosed Referred to hem-onc for specialized care
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/17/18 43 x 109/L Mild epistaxis, mild fatigue, easy bruising Not reported Initial visit with hem-onc Initiate dexamethasone 40 mg QD x 4 days
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/21/18 49 x 109/L Fewer bleeding incidents, reduced fatigue Not reported Dexamethasone demonstrated no meaningful response; patient reports sleep disturbance and headaches related to treatment Rituximab and IVIG considered as treatment alternatives to dexamethasone
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/4/18 59 x 109/L No clinical observations available WBC: 4.6 x 109/L Hgb: 13.1 g/dL Diagnosis of ITP confirmed by bone marrow biopsy No clinical notes available
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/2/18 Not available Negative for bleeding and bruising Not reported Daniel presents with angina; subsequent stress test abnormal Cardiac catheterization planned
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/13/18 45 x 109/L No clinical observations available WBC: 4.4 x 109/L;
Hgb: 12.9 g/dL;
AST: 39 IU/L;
ALT: 27 IU/L;
bilirubin: 1.1 mg/dL
Need to increase platelet count (to ≥70 x 109/L) for planned cardiac catheterization; treatment options discussed with patient Determine protocol to provide rapid and robust platelet count increases for patient to undergo cardiac catheterization

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CBC=complete blood count; Hgb=hemoglobin; WBC=white blood cell.

In view of Daniel’s need of an increase in platelet counts for a planned cardiac catheterization, the absence of meaningful clinical response to first-line steroids, and his active lifestyle, 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.

Daniel’s TREATMENT WITH TAVALISSE

August 1, 2018: TAVALISSE initiation

BASELINE PLATELET COUNT:  45 x 109/L
CLINICAL OBSERVATIONS:
  • Patient is clinically stable with no bleeding events
LABORATORY FINDINGS:
  • WBC: 4.4 x 109/L
  • Hgb: 12.9 g/dL
  • AST: 39 IU/L
  • ALT: 27 IU/L
  • Bilirubin: 1.1 mg/dL
  • Negative for hepatitis B/C
PATIENT DISCUSSION: 
  • Physician explained the need for rapid, robust platelet increase to ≥70 x 109/L for planned cardiac catheterization
  • Physician explained the mechanism of TAVALISSE and the potential efficacy and adverse events
  • Patient has an active lifestyle; patient and physician agree that an oral medication that can be taken with or without food would be a good fit
TREATMENT PLAN: 
  • Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary

TAP OR HOVER FOR ADDITIONAL DETAILS
Daniel's treatment with Tavalisse
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/1/18 45 x 109/L Negative for bleeding and bruising WBC: 4.4 x 109/L; Hgb: 12.9 g/dL;
AST: 39 IU/L;
ALT: 27 IU/L;
bilirubin: 1.1 mg/dL
Need to increase platelet count for planned cardiac catheterization Initiate TAVALISSE 100 mg BID with goal of achieving rapid, robust platelet increase to ≥70 x 109/L
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/15/18 94 x 109/L Negative for bleeding and bruising Not available No clinical notes available Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/21/18 73 x 109/L Negative for bleeding and bruising WBC: 3.5 x 109/L;
Hgb: 11.4 g/dL
Patient is tolerating therapy and reports no side effects; platelet counts within target range, no dose adjustment necessary Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/12/18 72 x 109/L Negative for bleeding and bruising WBC: 3.3 x 109/L;
Hgb: 10.6 g/dL;
AST: 57 IU/L;
ALT: 37 IU/L;
bilirubin: 1.2 mg/dL
No clinical notes available Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/5/18 102 x 109/L Negative for bleeding and bruising WBC: 4.9 x 109/L;
Hgb: 8.0 g/dL
Cardiac catheterization and CABG x 3 vessels; indefinite antiplatelet therapy recommended by cardiologist Continue TAVALISSE 100 mg BID; initiate aspirin 81 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/14/19 135 x 109/L Negative for bleeding and bruising WBC: 4.5 x 109/L; Hgb: 12.4 g/dL No clinical notes available Continue TAVALISSE 100 mg BID; continue aspirin 81 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
2/21/19  103 x 109/L Negative for bleeding and bruising WBC: 3.6 x 109/L; Hgb: 9.9 g/dL Patient is tolerating therapy and reports no side effects Continue TAVALISSE 100 mg BID; continue aspirin 81 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/27/19 99 x 109/L Negative for bleeding and bruising

WBC: 3.8 x 109/L;
Hgb: 10.8 g/dL;
AST: 30 IU/L;
ALT: 24 IU/L;
bilirubin: 1.1 mg/dL

No clinical notes available Continue TAVALISSE 100 mg BID; continue aspirin 81 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/24/19 94 x 109/L Negative for bleeding and bruising WBC: 3.7 x 109/L;
Hgb: 10.6 g/dL;
AST: 42 IU/L;
ALT: 37 IU/L;
bilirubin: 1.2 mg/dL
Patient has had ongoing response to TAVALISSE and will continue with therapy Continue TAVALISSE 100 mg BID; continue aspirin 81 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/3/19 91 x 109/L Negative for bleeding and bruising Not available Patient continues to tolerate therapy; patient continues to have no symptomatic bleeding, increases in BP, or diarrhea with treatment Continue TAVALISSE 100 mg BID; continue aspirin 81 mg QD

BP=blood pressure; CABG=coronary artery bypass graft.

Patient responded well to TAVALISSE; he stabilized his platelet count between 72 x 109/L and 135 x 109/L on the 100 mg BID dose; he has had no bleeding and continues to use aspirin safely.

—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.

TAVA_ITP-20115 0820

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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