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Case study:
Samuel
*

37-year-old male with ITP and a history of Gerd

Patient Samuel
Background
Age: 37
Occupation:  Taxi driver
Date of Diagnosis: December 2019
Comorbidities:
  • Gastroesophageal reflux disease (GERD) diagnosed in 2016; partially controlled with diet and antacids as needed

PATIENT WITH FATIGUE, ANXIETY, BONE PAIN, AND BRUISING was DIAGNOSED WITH ITP BY PRIMARY CARE PHYSICIAN (PCP) AND REFERRED TO HEMATOLOGY/ONCOLOGY (HEM-ONC) SPECIALIST

Samuel’s treatment history

December 2, 2019: PCP referred patient to hem-onc after ITP diagnosis

PLATELET COUNT: 10 x 109/L

CLINICAL OBSERVATIONS: Fatigue, anxiety, bone pain, bruising

LABORATORY FINDINGS:

  • Hb: 14.9 g/dL
  • WBC: 3.0 x 109/L
  • AST: 23 IU/L
  • ALT: 23 IU/L
  • Bilirubin: 1.1 mg/dL
  • BP: 118/74 mm Hg

 

PATIENT DISCUSSION:

  • PCP diagnosed Samuel with ITP and referred him to hem-onc for further treatment
  • Patient stated he had intermittent epistaxis in the past; hem-onc explained that this could be caused by ITP and that treatment to prevent bleeding is necessary
  • Patient leads an active lifestyle and expressed aversion to taking additional medication

TREATMENT PLAN:

  • Treat with prednisone to increase platelet count

TAP OR HOVER FOR ADDITIONAL DETAILS
Samuel's treatment history
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
12/2/19 10 x 109/L Fatigue, anxiety, bone pain, and bruising; BP: 118/74 mm Hg WNL Patient presented with fatigue, anxiety, bone pain, and bruising; initial diagnosis of ITP No treatment started; referred to hem-onc for specialized care
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/3/20 16 x 109/L Fatigue, anxiety, bone pain, and bruising; BP: 119/78 mm Hg Bone marrow biopsy: normal hematopoiesis; additional findings consistent with autoimmune destruction First visit with hem-onc; patient reported past intermittent epistaxis; bone marrow biopsy performed; treatment recommended to prevent future bleeding Started prednisone 80 mg QD
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
1/17/20 71 x 109/L No fatigue, bone pain, or bleeding; BP: 118/75 mm Hg WNL Patient reported severe GERD; recommended omeprazole 20 mg QD, but patient declined because he did not like taking “extra medications”; GERD symptoms resolved when prednisone tapered Prednisone taper started, to be discontinued on 2/20

ALT=alanine aminotransferase; AST=aspartate aminotransferase; BP=blood pressure; Hb=hemoglobin; WBC=white blood cell; WNL=within normal limits.

Based on Samuel’s history of GERD, active lifestyle, and inability to visit the office weekly, the hem-onc sought an oral medication with a targeted mechanism that could sustain stable platelet counts while limiting the need for steroid use

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.

Samuel’s TREATMENT WITH TAVALISSE

February 21, 2020: TAVALISSE initiation

BASELINE PLATELET COUNT:  19 x 109/L
CLINICAL OBSERVATIONS:
  • Fatigue, bruising on the lower extremities, bone pain
LABORATORY FINDINGS:
  • Hb: 14.3 g/dL
  • WBC: 4.1 x 109/L
  • AST: 29 IU/L
  • ALT: 32 IU/L
  • Bilirubin: 0.8 mg/dL
  • BP: 117/73 mm Hg
PATIENT DISCUSSION: 
  • Patient is opposed to taking medications and requested vitamins; physician explained that his choices were injections or oral medications
  • Patient wanted to avoid injections and stated that it is difficult for him to come to the office frequently because of his job and active lifestyle
  • Physician discussed the mechanisms of TAVALISSE and TPO-RAs; patient liked TAVALISSE because “it reduces the destruction of platelets” and has no food restrictions1
  • Physician explained the potential efficacy and adverse events of TAVALISSE; patient stated he was willing to take medication daily as long as it helps
TREATMENT PLAN: 
  • Initiate TAVALISSE 100 mg BID and increase to 150 mg BID after week 4 if necessary

TAP OR HOVER FOR ADDITIONAL DETAILS
Samuel's treatment with Tavalisse
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
2/21/20 19 x 109/L Fatigue, bone pain, and bruising on the lower extremities; BP: 117/73 mm Hg AST: 29 IU/L;
ALT: 32 IU/L
Discussed treatment options and potential side effects with patient; patient presents potential adherence risk; TAVALISSE prescribed Started TAVALISSE 100 mg BID; titrate if necessary to achieve platelet count goal of ≥50 x 109/L; follow up in 1 month
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
3/20/20 39 x 109/L No fatigue, bone pain, or bruising on lower extremities; BP: 121/72 mm Hg AST: 23 IU/L
ALT: 24 IU/L
Target of ≥50 x 109/L has not been reached, however, patient is asymptomatic and has not experienced adverse events; continue to monitor platelet count for response without altering treatment regimen and risking nonadherence Continue TAVALISSE 100 mg BID; follow up in 1 month
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
4/24/20 56 x 109/L Asymptomatic; BP: 115/74 mm Hg AST: 24 IU/L;
ALT: 26 IU/L
Patient reached ≥50 x 109/L platelet count target Continue TAVALISSE 100 mg BID; continue regular follow-ups
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
6/28/20 87 x 109/L Asymptomatic; BP: 121/71 mm Hg AST: 19 IU/L;
ALT: 21 IU/L
Patient continues to ask if he can discontinue medication due to increase in platelet counts; patient encouraged to continue on therapy as prescribed Continue TAVALISSE 100 mg BID; continue follow-ups to reduce risk of nonadherence
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
8/24/20 91 x 109/L Asymptomatic; BP: 114/74 mm Hg Not available Patient expresses that he is pleased with TAVALISSE and that he continues to take it without issue Continue TAVALISSE 100 mg BID
Date Platelet count Clinical Observations Laboratory Findings Physician Notes Treatment Plan
10/23/20 94 x 109/L Not reported Not available Platelet counts continue to increase Continue TAVALISSE 100 mg BID

ALT=alanine aminotransferase; AST=aspartate aminotransferase; BP=blood pressure; Hb=hemoglobin; TPO-RA=thrombopoietin receptor agonist; WBC=white blood cell.

The patient is pleased with his stable and consistent increase in platelet counts while on TAVALISSE. He is happy that he does not have to follow up more than once a month and that he can take it with or without food.

—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.

Reference: 1. TAVALISSE® [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; November 2020.

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

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