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Case study:
Sarah
*

53-year-old female with chronic Itp, post-steroids

Patient Sarah
Background
Age: 53
Occupation:  Baker
Date of Diagnosis: 2004
Comorbidities:
  • Metabolic syndrome
  • Obesity
  • Hypertension, controlled with nebivolol
  • Hypothyroidism, controlled with levothyroxine

PATIENT REFERRED TO NEW HEMATOLOGIST/ONCOLOGIST FROM THE PRIMARY CARE PHYSICIAN WHO WAS MANAGING HER ITP

She was adamant about discontinuing this therapy because, with her history of metabolic syndrome, she had been trying to lose weight and had lost 20 lb in the 3 months prior to starting steroids.

—Treating physician

Sarah’s treatment history

April 10, 2018: Sarah visits new hematologist/oncologist (hem-onc) upon referral from primary care physician due to upper respiratory infection and concern over decrease in platelet count

PLATELET COUNT: 30 x 109/L

CLINICAL OBSERVATIONS: Negative for bruising/bleeding

PREVIOUS TREATMENT SUMMARY:

  • Treated with intermittent IVIG and steroids by transplant hematologist until 2013
  • Platelet counts stabilized in 2013 and Sarah was transferred to primary care physician
  • Primary care physician monitored Sarah until 2018, when she was referred to new hem-onc while experiencing an upper respiratory infection; primary care physician was concerned about a decrease in platelet count

Recent ITP TREATMENT SUMMARY:

  • Treated with 3 doses of IV methylprednisolone over 3 days, followed by 2 months of prednisone 50 mg QD
  • Despite sufficient platelet response, Sarah experienced substantial weight gain (40 lb in 2 months), which made her reluctant to continue treatment

PATIENT DISCUSSION:

  • Sarah is unwilling to continue steroids due to weight gain and wants to try a different treatment
  • Hem-onc is also concerned about the potential adverse reactions of long-term steroid use and agrees to explore options
  • Treatment options are presented and discussed with Sarah
  • Sarah is averse to injections and infusions that would require her to travel a long distance to her hem-onc’s office

Due to Sarah’s rapid weight gain, the treating physician sought a targeted treatment that could sustain healthy platelet counts while limiting the need for steroid use

Sarah’S TREATMENT WITH TAVALISSE

June 12, 2018: TAVALISSE initiation

BASELINE PLATELET COUNT: 105 x 109/L
CLINICAL OBSERVATIONS: 

Sarah has gained 14 lb since last visit (40 lb total since initiating prednisone in April)

  • BP: 118/75
LABORATORY FINDINGS:
  • ALT: 17 IU/L
  • AST: 13 IU/L
  • Bilirubin: 0.7 mg/dL
PATIENT DISCUSSION:
  • Sarah and her hem-onc opted for treatment with TAVALISSE because it’s an oral treatment without food restrictions
  • Hem-onc counseled Sarah on the potential efficacy and adverse events of TAVALISSE and explained how the mechanism of TAVALISSE inhibits platelet destruction
TREATMENT PLAN:
  • Begin prednisone taper by reducing dose to 25 mg QD
  • Initiate TAVALISSE at 100 mg BID and increase to 150 mg BID after week 4 if necessary

TAP OR HOVER FOR ADDITIONAL DETAILS
Sarah's Treatment History
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/12/18 105 x 109/L Sarah has gained 14 lb since last visit (40 lb total since initiating prednisone) ALT: 17 IU/L
AST: 13 IU/L
Sarah pleased to initiate prednisone taper Initiate TAVALISSE 100 mg BID; decrease prednisone to 25 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/26/18 183 x 109/L Negative for bruising/bleeding Normal; comorbidities controlled Notable increase in platelet count Continue TAVALISSE 100 mg BID; decrease prednisone to 10 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/12/18 124 x 109/L Negative for bruising/bleeding; slight increase in BP ALT: 23 IU/L
AST: 21 IU/L
Discussed increasing antihypertensive medication to manage BP per TAVALISSE Prescribing Information Continue TAVALISSE 100 mg BID; decrease prednisone to 5 mg QD; increase nebivolol dose from 10 mg QD to 20 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/9/18 132 x 109/L Negative for bruising/bleeding Normal; comorbidities controlled Sarah is responding to treatment Continue TAVALISSE 100 mg BID; discontinue prednisone
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/6/18 108 x 109/L Negative for bruising/bleeding WBC: 6.3 x 109/L
RBC: 4.53 million/µL
Platelet count is still above target levels; Sarah has not reported diarrhea Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/5/18 73 x 109/L Negative for bruising/bleeding ALT: 27 IU/L
AST: 23 IU/L
Slight decrease in platelet count Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/10/19 71 x 109/L Negative for bruising/bleeding ALT: 20 IU/L
AST: 22 IU/L
Platelet count stabilized Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/30/19 129 x 109/L Negative for bruising/bleeding WBC: 5.6 x 109/L
RBC: 3.83 million/µL
Substantial increase in platelet count Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/29/19 86 x 109/L Negative for bruising/bleeding; BP: 147/77 Normal Discussed adding lisinopril to Sarah’s existing antihypertensive regimen (nebivolol) Continue TAVALISSE 100 mg BID; initiate lisinopril 20 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/25/19 67 x 109/L Negative for bruising/bleeding Slight TSH increase Platelet count is still stable; Sarah is pleased with oral treatment that doesn’t require weekly visits Increase levothyroxine to 150 µg QD to account for increased TSH; continue TAVALISSE 100 mg BID and follow up every 3-4 months

After steroid taper concludes, Sarah's platelet count stabilizes above 60 x 109/L while on TAVALISSE and she continues to be asymptomatic (negative for bruising/bleeding)

 

*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.

Medical records prior to 2018 are unavailable.

TAVA_ITP-20043 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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