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75-YEAR-OLD MALE WITH A 10-YEAR HISTORY OF CHRONIC ITP

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 (HEM-ONC) FOR SECOND OPINION AFTER 10 YEARS OF ITP MANAGEMENT

  • Platelet Counts
  • Treatment Summary

Ron's Platelet Counts Over Time

Swipe/click right to explore the details for each time point

  • Date
  • 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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
11/19/18
60 x 109/L
Petechiae
Normal; comorbidities controlled
No reported diarrhea
Maintain 100 mg BID dose and monitor
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
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
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
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.

AFib=atrial fibrillation; ALT=alanine aminotransferase; AST=aspartate aminotransferase; Hb=hemoglobin; IVIG=intravenous immunoglobulin; WBC=white blood cell.

*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.

Ron’s Treatment Summary

  • Headings:
  • Prior Treatment history

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

  • Headings:
  • treatment with tavalisse

    July 24, 2018: TAVALISSE initiation

  • Platelet Count:
  • 9 x 109/L

  • Platelet Count:
  • 22 x 109/L

  • Clinical Observations:
    • Purpura, bruising, epistaxis, fatigue
  • Clinical Observations:
    • Purpura on lower extremities, petechiae
  • Laboratory Findings:
    • Normal; comorbidities controlled
  • Laboratory Findings:
    • Hb: 11.2 g/dL
    • WBC: 4.5 x 109/L
    • Antiplatelet antibodies: positive
    • AST: 32 IU/L
    • ALT: 36 IU/L
    • Bilirubin: 0.8 mg/dL
  • Patient Discussion:
  • N/A

  • 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:
    • Begin treatment with prednisone; discontinue metformin

    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.

  • Treatment Plan:
    • Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary

    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

AFib=atrial fibrillation; ALT=alanine aminotransferase; AST=aspartate aminotransferase; Hb=hemoglobin; IVIG=intravenous immunoglobulin; WBC=white blood cell.

*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-21212 1121

Indication and Important Safety Information

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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This site is intended for US healthcare professionals only.

Indication and Important Safety Information

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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September is ITP Awareness month

Join Rigel in helping to raise awareness of immune thrombocytopenia (ITP) and showing support for ITP patients, care partners, and healthcare providers

TAVA_ITP-20158 0920