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Vanflyta Dosage

Drug Detail:Vanflyta (Quizartinib)

Generic Name: Medically reviewed

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients for the treatment of AML with VANFLYTA based on the presence of FLT3-ITD mutation positivity [see Clinical Studies (14)]. Information on FDA-approved tests for the detection of FLT3-ITD mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

  • A treatment course consists of up to 2 cycles of VANFLYTA in combination with induction cytarabine and anthracycline, up to 4 cycles of VANFLYTA in combination with high-dose cytarabine consolidation, and up to 36 cycles of VANFLYTA as maintenance therapy [see Clinical Studies (14)] or until disease progression or unacceptable toxicity. VANFLYTA maintenance therapy should be initiated following consolidation chemotherapy upon blood count recovery of absolute neutrophil count >500/mm3 and platelet count >50,000/mm3.
  • See Table 1 for the recommended dosage of VANFLYTA by phase of therapy.
Table 1: VANFLYTA Dosage Regimen
VANFLYTA Initiation Induction* Consolidation† Maintenance
Starting on Day 8
(for 7 + 3 regimen)‡		 Starting on Day 6 Starting on Day 1
*
Patients can receive up to 2 cycles of induction.
†
Patients can receive up to 4 cycles of consolidation.
‡
For 5 + 2 regimen as the second induction cycle, VANFLYTA will be given on Days 6 to 19.
Dose 35.4 mg orally once daily 35.4 mg orally once daily
  • Administer 26.5 mg orally once daily Days 1 through 14 of the first cycle if QTcF is less than or equal to 450 ms.
  • Increase the dose to 53 mg once daily on Day 15 of the first cycle if QTcF is less than or equal to 450 ms. Maintain the 26.5 mg once daily dose if QTcF greater than 500 ms was observed during induction or consolidation.
Duration
(28-day cycles)		 Two weeks in each cycle (Days 8 to 21)‡ Two weeks in each cycle (Days 6 to 19)
  • Once daily with no break between cycles for up to 36 cycles

For patients who proceed to hematopoietic stem cell transplantation (HSCT), VANFLYTA should be stopped 7 days before the start of a conditioning regimen.

Administer VANFLYTA orally with or without food at approximately the same time each day. Swallow tablets whole. Do not cut, crush, or chew the tablets. If a dose of VANFLYTA is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of VANFLYTA is missed or not taken at the usual time, administer the dose as soon as possible on the same day and return to the usual schedule the following day. The patient should not take two doses on the same day.

Monitoring and Dosage Modifications for Adverse Reactions

Initiate VANFLYTA only if QTcF is less than or equal to 450 ms [see Warnings and Precautions (5.1)].

During induction and consolidation, perform ECGs prior to initiation and then once weekly during VANFLYTA treatment or more frequently as clinically indicated [see Warnings and Precautions (5.1)].

During maintenance, perform ECGs prior to initiation, once weekly for at least the first month following dose initiation and escalation, and thereafter as clinically indicated. Escalate the dose only if QTcF is less than or equal to 450 ms [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].

Correct electrolyte abnormalities (hypokalemia and hypomagnesemia), and if possible, avoid concomitant administration of drugs that prolong the QT interval [see Warnings and Precautions (5.1)].

For recommended dosage modifications due to adverse reactions, see Table 2. For dosage adjustments due to adverse reactions, see Table 3.

Table 2: Recommended Dosage Modifications for Adverse Reactions [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Adverse Reaction Recommended Action
Grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03).
*
Recommend bone marrow evaluation.
QTcF between 450 ms and 480 ms (Grade 1)
  • Continue VANFLYTA dose.
QTcF between 481 ms and 500 ms (Grade 2)
  • Reduce the dose of VANFLYTA (see Table 3) without interruption.
  • Resume VANFLYTA at the previous dose in the next cycle if QTcF has decreased to less than 450 ms. Monitor the patient closely for QT prolongation during the first cycle at the increased dose.
QTcF greater than 500 ms (Grade 3)
  • Interrupt VANFLYTA.
  • Resume VANFLYTA at a reduced dose (see Table 3) when QTcF returns to less than 450 ms.
  • Maintain the 26.5 mg once daily dose during maintenance if QTcF greater than 500 ms was observed during induction or consolidation.
Recurrent QTcF greater than 500 ms (Grade 3)
  • Permanently discontinue VANFLYTA if QTcF greater than 500 ms recurs despite appropriate dose reduction and correction/elimination of other risk factors (e.g., serum electrolyte abnormalities, concomitant QT prolonging medications).
Torsades de pointes, polymorphic ventricular tachycardia, signs/symptoms of life-threatening arrhythmia (Grade 4)
  • Permanently discontinue VANFLYTA.
Grade 3 or 4 non-hematologic adverse reactions
  • Interrupt VANFLYTA.
  • Resume treatment at the previous dose if adverse reaction improves to Grade 1 or less.
  • Resume treatment at a reduced dose (see Table 3) if adverse reaction improves to Grade 2.
  • Discontinue if Grade 3 or 4 adverse reaction persists beyond 28 days.
Grade 3 or 4 hypokalemia (<3 mmol/L) or hypomagnesemia (<0.4 mmol/L or <0.9 mg/dL)
  • Interrupt VANFLYTA.
  • Correct hypokalemia and hypomagnesemia according to institutional guidelines.
  • VANFLYTA may be restarted at the previous dose when the adverse reaction improves to Grade 2 or less without symptoms.
Grade 4 neutropenia or thrombocytopenia after achieving remission*
  • Reduce VANFLYTA dose (see Table 3).
Table 3: Recommended Dosage Adjustments for Adverse Reactions for VANFLYTA
Current Dosage Modified Dosage
53 mg once daily 35.4 mg once daily
35.4 mg once daily 26.5 mg once daily
26.5 mg once daily Interrupt
17.7 mg once daily Interrupt

Dosage Modifications for Strong CYP3A Inhibitors

Reduce the dosage of VANFLYTA when used concomitantly with strong CYP3A inhibitors as shown in Table 4. If the current dosage is 17.7 mg once daily, interrupt VANFLYTA treatment for the duration of strong CYP3A inhibitor use. After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the VANFLYTA dose that was taken before initiating the strong inhibitor [see Drug Interactions (7)].

Table 4: Dosage Adjustments for Concomitant Use with Strong CYP3A Inhibitors
Current Dosage Modified Dosage
53 mg once daily 26.5 mg once daily
35.4 mg once daily 17.7 mg once daily
26.5 mg once daily 17.7 mg once daily
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