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Case study:
Ron
*

75-year-old male with a 10-YEAR history of chronic ITP

Patient Ron
Background
Age: 75
Occupation:  Veteran, retired railroad worker, part-time farmer
Date of Diagnosis: September 9, 2008
Comorbidities:
  • Type 2 diabetes, controlled with metformin
  • Hyperlipidemia, controlled with simvastatin
  • AFib with mild compensated heart failure, controlled with lisinopril, metoprolol XL, and warfarin

PATIENT REFERRED TO NEW HEMATOLOGY/ONCOLOGY SPECIALIST FOR SECOND OPINION AFTER 10 YEARS OF ITP MANAGEMENT 

RON’s treatment history

July 9, 2018: Hematology/oncology specialist reviews available medical records

TAP OR HOVER FOR ADDITIONAL DETAILS
Ron's Treatment History
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/9/08 9 x 109/L Purpura, bruising, epistaxis, fatigue Normal;
comorbidities controlled
Ron discontinued metformin upon initiation of prednisone Initiate prednisone 80 mg QD for 4 weeks, followed by a 6-week taper
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/14/08 55 x 109/L Negative for bleeding/bruising Elevated glucose Steroid-induced hyperglycemia Continue 6-week taper of prednisone; reinitiate metformin to address hyperglycemia
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/12/09 120 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
IVIG sufficiently increased platelets in preparation for arthroscopy Watch and wait; initiate second round of prednisone in July if platelet count is not sustained
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/6/09 12 x 109/L Bruising, pain, and swelling in the left knee Normal;
comorbidities controlled
Ron hospitalized with a torn ligament and slated to undergo left knee arthroscopy Administer IVIG 2 g/kg over 5 days in preparation for exploratory arthroscopy
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/6/09 9 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
Platelet counts decreased following initial peak from IVIG Initiate prednisone for 4 weeks
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/4/10 15 x 109/L Intermittent bruising, fatigue Normal;
comorbidities controlled
Loss of response upon discontinuation of prednisone Initiate dexamethasone 40 mg QD for 4 days/month for 3 months
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
2/22/10 70 x 109/L Intermittent bruising and fatigue; transient elevation of BP; fluid retention Elevated glucose Ron reported mood swings and insomnia while on dexamethasone Treated with diuretics for fluid retention from dexamethasone; continue dexamethasone 40 mg QD for 4 days in March
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/12/10 12 x 109/L Intermittent bruising, purpura Normal;
comorbidities controlled
Ron discontinued dexamethasone in March, resulting in a loss of response; Ron reluctant to receive injections and concerned about compliance but opted for romiplostim for financial reasons Initiate weekly romiplostim 2 μg/kg
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/22/11 29 x 109/L Intermittent bruising, purpura Normal;
comorbidities controlled
Ron reported issues with compliance, often missed appointments Continue weekly romiplostim 2 μg/kg
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
9/19/12 27 x 109/L Intermittent bruising, purpura Normal;
comorbidities controlled
Ron reported issues with compliance, often missed appointments Continue weekly romiplostim 2 μg/kg
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
11/18/13 21 x 109/L Intermittent bruising, purpura Normal;
comorbidities controlled
Ron decided to discontinue treatment with romiplostim Discontinue romiplostim;
watch and wait
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/7/14 30 x 109/L Intermittent  purpura Normal;
comorbidities controlled
Opted for treatment with rituximab in an effort to achieve long-term disease control Initiate rituximab 375 mg/m2
(4 weekly doses)
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
11/19/14 15 x 109/L Intermittent purpura Normal;
comorbidities controlled
No significant response to rituximab; Ron felt that the long infusion times with rituximab interfered with his life Discontinue rituximab;
initiate prednisone
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/23/15 9 x 109/L Intermittent bruising, purpura;
diagnosed with AFib
Abnormal ECG Ron was informed that he needed better control of platelet count to be treated with anticoagulant for prevention of stroke; despite aversion to injections, Ron decided to reinitiate romiplostim Initiate weekly romiplostim 2 μg/kg
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
5/14/18 Unknown Romiplostim injection-site reactions (erythema, itching, discomfort); intermittent bruising Normal;
comorbidities controlled
Missed appointments and patient-reported compliance issues led to infrequent platelet readings; Ron decided to discontinue romiplostim and received referral to hem-onc specialist Discontinue romiplostim

After learning about Ron’s compliance issues and inconsistent response to prior therapies, the hem-onc sought an oral medication in a different class of therapy

RON’S TREATMENT WITH TAVALISSE

July 24, 2018: TAVALISSE initiation

BASELINE PLATELET COUNT: 22 x 109/L
CLINICAL OBSERVATIONS:  Purpura on lower extremities, petechiae
LABORATORY FINDINGS:
  • Hemoglobin (Hb): 11.2 g/dL
  • White blood count (WBC): 4.5 x 109/L
  • Antiplatelet antibodies: positive
  • AST: 32 IU/L
  • ALT: 36 IU/L
  • Bilirubin: 0.8 mg/dL
PATIENT DISCUSSION:
  • Ron reports fear of injury and bleeding due to active lifestyle as part-time farmer
  • Ron is complaining of fatigue
  • Ron is adamantly against splenectomy
  • Physician explained the mechanism of TAVALISSE and the potential efficacy and adverse events
  • Physician counseled Ron on how to manage diarrhea, should it occur
TREATMENT PLAN: Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary

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RON’S TREATMENT WITH TAVALISSE
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
7/24/18 22 x 109/L Purpura, petechiae, bruising Low Hb, low bilirubin Ron is pleased to avoid splenectomy and initiate oral therapy Initiate TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/27/18 55 x 109/L BP: 140/92;
petechiae
Normal Platelet count has stabilized around 50 x 109/L; slight elevation in BP Maintain TAVALISSE 100 mg BID; increase lisinopril dose from 10 mg to 20 mg QD to address elevated BP
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/16/18 54 x 109/L BP within normal limits; petechiae Normal;
comorbidities controlled
Opting not to titrate up due to platelet stability and positive tolerability; continue to regularly monitor BP Maintain 100 mg BID dose and monitor
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
11/19/18 60 x 109/L Petechiae Normal;
comorbidities controlled
No reported diarrhea Maintain 100 mg BID dose and monitor
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/23/19 48 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
Petechiae have disappeared, and Ron is able to take anticoagulant without bleeding Maintain 100 mg BID dose and monitor
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
2/19/19 65 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
Slight increase in platelet count; BP well controlled Maintain 100 mg BID dose and monitor
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/20/19 54 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
Physician is satisfied that platelet count has stabilized at >50 x 109/L Maintain 100 mg BID dose and monitor
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/17/19 61 x 109/L Negative for bleeding/bruising Normal;
comorbidities controlled
Ron has reported satisfaction with this treatment due to the convenience of oral medication; platelet count stable Maintain TAVALISSE 100 mg BID and monitor labs monthly

Patient responded well to TAVALISSE within 4 weeks; he stabilized his platelet count between 55 x 109/L and 60 x 109/L on the 100 mg BID dose; he has had no bleeding and continues to use warfarin 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.

Patient data were collected from multiple healthcare providers and span 10 years—some details such as treatment dosage, time on treatment, and details of response may be missing due to their absence from the available medical records.

 

TAVA_ITP-19178 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.

 

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.