t 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 x 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.
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].
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].
HOW SUPPLIED
Storage And Handling
TAVALISSE 100 mg tablets are round, biconvex, orange, film-coated tablets debossed with “100” on one side and “R” on the reverse side.
TAVALISSE 150 mg tablets are oval, biconvex, orange, film-coated tablets debossed with “150” on one side and “R” on the reverse side.
100 mg tablets: Available in bottle of 60 with 2 desiccant canisters NDC 71332-001-01
150 mg tablets: Available in bottle of 60 with 2 desiccant canisters NDC 71332-002-01
Store at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not remove desiccants.
Dosage Forms And Strengths
TAVALISSE is available as:
•100 mg tablet: orange, film-coated, round, biconvex tablets debossed with “100” on one side and “R” on the reverse side.
•150 mg tablet: orange, film-coated, oval, biconvex tablets debossed with “150” on one side and “R” on the reverse side.
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