TAVALISSE
TAVALISSE- fostamatinib tablet
Rigel Pharmaceuticals, Inc.
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Initiate TAVALISSE at a dose of 100 mg taken orally twice daily. After a month, if platelet count has not increased to at least 50 × 109 /L, increase TAVALISSE dose to 150 mg twice daily.
Use the lowest dose of TAVALISSE to achieve and maintain a platelet count at least 50 × 109 /L as necessary to reduce the risk of bleeding.
TAVALISSE may be taken with or without food. In the case of a missed dose of TAVALISSE, instruct patients to take their next dose at its regularly scheduled time.
2.2 Monitoring
After obtaining baseline assessments:
- Monitor CBCs, including platelet counts, monthly until a stable platelet count (at least 50 × 109 /L) is achieved. Thereafter, continue to monitor CBCs, including neutrophils, regularly.
- Monitor liver function tests (LFTs) (e.g., ALT, AST, and bilirubin) monthly.
- Monitor blood pressure every 2 weeks until establishment of a stable dose, then monthly thereafter.
2.3 Dose Modification for Adverse Reactions
TAVALISSE dose modification is recommended based on individual safety and tolerability. Management of some adverse reactions may require dose-interruption, reduction, or discontinuation.
A dose reduction schedule is provided in Table 1, based on daily dose. For example, if a patient is on the maximum dose at the time of an adverse reaction, the first dose reduction would be from 300 mg/day to 200 mg/day.
Daily Dose | Administered as: | |
---|---|---|
AM | PM | |
300 mg/day | 150 mg | 150 mg |
200 mg/day | 100 mg | 100 mg |
150 mg/day | 150 mg * | — |
100 mg/day † | 100 mg * | — |
The recommended dose modifications for adverse reactions are provided in Table 2.
Adverse Reaction | Recommended Action |
---|---|
ALT = alanine aminotransferase; AST = aspartate aminotransferase; BP = blood pressure; BL = bilirubin; ULN = upper limit of normal; LFT = liver function tests (AST, ALT, total BL with fractionation if elevated, alkaline phosphatase); AST/ALT = AST or ALT | |
Hypertension | |
Stage 1: systolic between 130-139 or diastolic between 80-89 mmHg |
|
Stage 2: systolic at least 140 or diastolic at least 90 mmHg |
|
Hypertensive crisis: systolic over 180 and/or diastolic over 120 mmHg |
|
Hepatotoxicity | |
AST/ALT is 3 × ULN or higher and less than 5 × ULN | If patient is symptomatic (e.g., nausea, vomiting, abdominal pain):
|
If patient is asymptomatic:
| |
AST/ALT is 5 × ULN or higher and total BL is less than 2 × ULN |
|
AST/ALT is 3 × ULN or higher and total BL is greater than 2 × ULN |
|
Elevated unconjugated (indirect) BL in absence of other LFT abnormalities |
|
Diarrhea | |
Diarrhea |
|
Neutropenia | |
Neutropenia |
|
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