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Case study:
Nicole
*

35-year-old female
with ITP

Patient Nicole
Background
Age: 35
Occupation:  Unemployed
Date of Diagnosis: June 20, 2018
Comorbidities:
  • Depression, controlled with fluoxetine 20 mg QD
  • Anxiety, controlled with lorazepam 2 mg TID
  • Bipolar disorder, controlled with aripiprazole 10 mg QD
MEDICAL HISTORY:
  • Diagnosed with hepatitis C, treated with ledipasvir/sofosbuvir (PCR negative)
  • History of thrombocytopenia during pregnancy (2015)
  • History of polysubstance abuse (clean for 3 years)

PATIENT REFERRED TO HEMATOLOGY/ONCOLOGY SPECIALIST BY PRIMARY CARE PHYSICIAN SUSPECTING ITP DUE TO SEVERE BRUISING ON EXTREMITIES

Nicole’s treatment history

June 20, 2018: Patient referred to hematology/oncology specialist (hem-onc) by primary care physician suspecting ITP due to severe bruising on extremities

PLATELET COUNT: 4 x 109/L

CLINICAL OBSERVATIONS: Severe bruising on arms and legs

LABORATORY FINDINGS: Normal

PATIENT DISCUSSION:

  • Nicole shared that she has a history of intravenous (IV) drug use and that she hasn’t used drugs in 3 years; she would like to avoid injections or infusions for this reason
  • Nicole recalls experiencing transient thrombocytopenia during pregnancy (2015)

HEM-ONC TREATMENT PLAN:

  • Initiate prednisone 60 mg QD; Nicole’s low platelet count and symptoms require treatment to rapidly increase platelet counts

TAP OR HOVER FOR ADDITIONAL DETAILS
Nicole's Treatment History
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/20/18 4 x 109/L Severe bruising on extremities Normal Low platelet count; primary care physician suspected ITP and referred Nicole to hem‑onc Nicole diagnosed with ITP
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/21/18 10 x 109/L Severe bruising on extremities Normal Platelet count is still low Initiate prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/30/18 25 x 109/L Minimal bruising remains Normal Slight increase in platelet count Administered IVIG; continue prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/7/18 81 x 109/L Negative for bleeding/bruising Normal Substantial increase in platelet count; monitor durability of response Continue prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/24/18 15 x 109/L Negative for bleeding/bruising Normal Transient response to IVIG; administer IVIG again and monitor Administered IVIG; continue prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/3/18 71 x 109/L Negative for bleeding/bruising Normal Platelet count increase due to IVIG; monitor durability of response Continue prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/17/18 35 x 109/L Negative for bleeding/bruising Normal Transient response to IVIG; administer IVIG again and monitor Administered IVIG; continue prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/10/18 62 x 109/L Negative for bleeding/bruising Normal Nicole’s platelet count has increased but responses to IVIG are transient Continue prednisone 60 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
11/6/18 55 x 109/L Negative for bleeding/bruising Normal Slight decrease in platelet count; current treatment regimen has not stabilized platelet count, warranting an exploration of alternate therapeutic approaches Continue prednisone 60 mg QD

ALT=alanine aminotransferase; AST=aspartate aminotransferase; BP=blood pressure; IVIG=IV immunoglobulin; LFT=liver function test.

After Nicole experienced transient responses to  IVIG while on prednisone, her 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.

NICOLE'S TREATMENT WITH TAVALISSE

December 5, 2018: TAVALISSE initiation

BASELINE PLATELET COUNT:  52 x 109/L
CLINICAL OBSERVATIONS:
  • Negative for bleeding/bruising
  • BP: 123/73
LABORATORY FINDINGS:
  • Bilirubin: 0.8 mg/dL
  • AST: 21 IU/L
  • ALT: 18 IU/L
PATIENT DISCUSSION: 
  • While discussing treatment options, Nicole expressed preference for an oral medication due to history of IV drug use and a desire for less frequent office visits
  • TAVALISSE was selected because it is an oral medication in a different class of therapy
  • Hem-onc counseled Nicole on the potential efficacy and adverse events of TAVALISSE and explained how the mechanism of TAVALISSE inhibits platelet destruction
  • Hem-onc counseled Nicole on how to manage diarrhea, should it occur
TREATMENT PLAN: 
  • Initiate TAVALISSE 100 mg BID and titrate dose as needed; taper prednisone over 3 weeks, then discontinue

TAP OR HOVER FOR ADDITIONAL DETAILS
Nicole's treatment with Tavalisse
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/5/18 52 x 109/L Slightly elevated BP; negative for bleeding/bruising AST: 21 IU/L
ALT: 18 IU/L
Nicole is pleased to start an oral medication that may reduce need for IVIG Initiate TAVALISSE 100 mg BID; begin 3-week prednisone taper
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/18/18 Unknown BP: 125/79; negative for bleeding/bruising Bilirubin:
0.6 mg/dL
Nicole to continue prednisone taper, titrating down from 20 mg to 10 mg Continue TAVALISSE 100 mg BID; continue prednisone taper
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/24/18 Unknown Negative for bleeding/bruising Normal Prednisone taper complete Prednisone discontinued; continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/5/19 132 x 109/L BP: 119/82; negative for bleeding/bruising AST: 22 IU/L
ALT: 25 IU/L
Significant increase in platelet count Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/15/19 175 x 109/L Negative for bleeding/bruising AST: 19 IU/L
ALT: 18 IU/L
Nicole reports moderate diarrhea, but claims she’s been able to control it with loperamide Continue TAVALISSE 100 mg BID; continue loperamide for diarrhea management
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
2/4/19 200 x 109/L BP: 121/72; negative for bleeding/bruising Normal Nicole reports that diarrhea recurred despite loperamide use TAVALISSE dose decreased to 100 mg QD; continue loperamide for diarrhea management
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
2/20/19 150 x 109/L Negative for bleeding/bruising AST: 23 IU/L
ALT: 19 IU/L
Nicole reports that urgency and frequency of diarrhea have persisted and are impacting daily life; discussed withholding TAVALISSE until diarrhea is under control Withhold TAVALISSE for 2 weeks, then resume at 100 mg QD; discontinue loperamide upon cessation of diarrhea
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/5/19 58 x 109/L Negative for bleeding/bruising Normal Decrease in platelet count; no reports of diarrhea Reinitiate TAVALISSE 100 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/25/19 76 x 109/L Negative for bleeding/bruising Bilirubin:
0.7 mg/dL
Platelet count steadily increasing; no reports of diarrhea Continue TAVALISSE 100 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/21/19 240 x 109/L BP: 118/77; negative for bleeding/bruising AST: 19 IU/L
ALT: 25 IU/L
Increase in platelet count; no reports of diarrhea Continue TAVALISSE 100 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/19/19 151 x 109/L BP: 120/80; negative for bleeding/bruising Normal No further reports of diarrhea; LFTs and BP have remained within normal range throughout treatment; Nicole is pleased that her platelet counts have stabilized and she hasn’t experienced any bruising or bleeding Maintain TAVALISSE 100 mg QD dose and monitor labs monthly

Nicole responded well to TAVALISSE—her platelet count stabilized above 150 x 109/L on the 100 mg QD dose and she hasn’t experienced any bleeding.

 

*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-20044 0420

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

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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