Miscellaneous coagulation modifiers
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Tavalisse Dosage

Drug Detail:Tavalisse (Fostamatinib [ fos-ta-ma-ti-nib ])

Generic Name: FOSTAMATINIB 100mg

Dosage Form: tablet

Drug Class: Miscellaneous coagulation modifiers

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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.

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.

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.

Table 1: Dose Reduction Schedule
Daily Dose Administered as:
AM PM
*
Once daily TAVALISSE should be taken in the morning.
†
If further dose reduction below 100 mg/day is required, discontinue TAVALISSE.
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.

Table 2: Recommended Dose Modifications and Management for Specific Adverse Reactions
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
  • Initiate or increase dosage of antihypertensive medication for patients with increased cardiovascular risk, and adjust as needed until BP is controlled.
  • If the BP target is not met after 8 weeks, reduce TAVALISSE to next lower daily dose (refer to Table 1).
Stage 2: systolic at least 140 or diastolic at least 90 mmHg
  • Initiate or increase dosage of antihypertensive medication, and adjust as needed until BP is controlled.
  • If BP remains 140/90 mmHg or higher for more than 8 weeks, reduce TAVALISSE to next lower daily dose (refer to Table 1).
  • If BP remains 160/100 mmHg or higher for more than 4 weeks despite aggressive antihypertensive therapy, interrupt or discontinue TAVALISSE.
Hypertensive crisis: systolic over 180 and/or diastolic over 120 mmHg
  • Interrupt or discontinue TAVALISSE.
  • Initiate or increase dosage of antihypertensive medication, and adjust as needed until BP is controlled. If BP returns to less than the target BP, resume TAVALISSE at same daily dose.
  • If repeat BP is 160/100 mmHg or higher for more than 4 weeks despite aggressive antihypertensive treatment, discontinue TAVALISSE.
Hepatotoxicity
AST/ALT is 3 × ULN or higher and less than 5 × ULN If patient is symptomatic (e.g., nausea, vomiting, abdominal pain):
  • Interrupt TAVALISSE.
  • Recheck LFTs every 72 hours until ALT/AST values are no longer elevated (below 1.5 × ULN) and total BL remains less than 2 × ULN.
  • Resume TAVALISSE at next lower daily dose (refer to Table 1).
If patient is asymptomatic:
  • Recheck LFTs every 72 hours until ALT/AST are below 1.5 × ULN) and total BL remains less than 2 × ULN.
  • Consider interruption or dose reduction of TAVALISSE if ALT/AST and TBL remain in this category (AST/ALT is 3 to 5 × ULN; and total BL remains less than 2 × ULN)
  • If interrupted, resume TAVALISSE at next lower daily dose (refer to Table 1) when ALT/AST are no longer elevated (below 1.5 × ULN) and total BL remains less than 2 × ULN.
AST/ALT is 5 × ULN or higher and total BL is less than 2 × ULN
  • Interrupt TAVALISSE.
  • Recheck LFTs every 72 hours:
    • If AST and ALT decrease, recheck until ALT and AST are no longer elevated (below 1.5 × ULN) and total BL remains less than 2 × ULN; resume TAVALISSE at next lower daily dose (refer to Table 1).
    • If AST/ALT persist at 5 × ULN or higher for 2 weeks or more, discontinue TAVALISSE.
AST/ALT is 3 × ULN or higher and total BL is greater than 2 × ULN
  • Discontinue TAVALISSE.
Elevated unconjugated (indirect) BL in absence of other LFT abnormalities
  • Continue TAVALISSE with frequent monitoring since isolated increase in unconjugated (indirect) BL may be due to UGT1A1 inhibition
Diarrhea
Diarrhea
  • Manage diarrhea using supportive measures (e.g., dietary changes, hydration and/or antidiarrheal medication) early after the onset until symptom(s) have resolved.
  • If symptom(s) become severe (Grade 3 or above), temporarily interrupt TAVALISSE.
  • If diarrhea improves to mild (Grade 1), resume TAVALISSE at the next lower daily dose (refer to Table 1).
Neutropenia
Neutropenia
  • If absolute neutrophil count decreases (ANC less than 1.0 × 109/L) and remains low after 72 hours, temporarily interrupt TAVALISSE until resolved (ANC greater than 1.5 × 109/L).
  • Resume TAVALISSE at the next lower daily dose (refer to Table 1).

Dose Modification for Drug Interactions

Concomitant use with a strong CYP3A4 inhibitor increases exposure to R406 (the major active metabolite). Monitor for toxicities of TAVALISSE that may require TAVALISSE dose modifications (see Table 1) when given concurrently with a strong CYP3A4 inhibitor [see Drug Interactions (7.1)].

Discontinuation

Discontinue TAVALISSE after 12 weeks of treatment if the platelet count does not increase to a level sufficient to avoid clinically important bleeding [see Clinical Studies (14)].

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