Usual Adult Dose for Acute Myeloid Leukemia

120 mg orally once a day until disease progression or unacceptable toxicity

Comments:

• Response may be delayed. In the absence of disease progression or unacceptable toxicity, patients should be treated for a minimum of 6 months to allow time for a clinical response.
• Select patients for the treatment of AML with this drug based on the presence of FLT3 mutations in the blood or bone marrow.

Use: For the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

DOSAGE MODIFICATIONS FOR TOXICITY:
DIFFERENTIATION SYNDROME:

• If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring until symptom resolution and for a minimum of 3 days.
• Interrupt therapy if severe symptoms persist for more than 48 hours after initiation of corticosteroids.
• Resume therapy when symptoms improve to Grade 2 or lower.

POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME:

• Discontinue therapy.

QTc INTERVAL GREATER THAN 500 MSEC:

• Interrupt therapy; resume therapy at 80 mg orally once a day when QTc interval returns to within 30 msec of baseline or less than or equal to 480 msec.

QTc INTERVAL INCREASED BY MORE THAN 30 MSEC ON ECG ON DAY 8 OF CYCLE 1:

• Confirm with ECG on Day 9; if confirmed, consider dose reduction to 80 mg orally once a day.

PANCREATITIS: Interrupt therapy until pancreatitis is resolved; resume therapy at 80 mg orally once a day.
OTHER GRADE 3 OR HIGHER TOXICITY CONSIDERED RELATED TO TREATMENT:

• Interrupt therapy until toxicity resolves to Grade 1; resume therapy at 80 mg orally once a day.

Precautions

US BOXED WARNINGS:

• Patients treated with this drug have experienced symptoms of differentiation syndrome, which can be fatal if not treated.
• Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction.
• If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until resolution.
• If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not break or crush tablets.
• This drug may be taken with or without food.
• Administer this drug at approximately the same time each day.
• If a dose is missed or not taken at the usual time, administer it as soon as possible on the same day, and at least 12 hours prior to the next scheduled dose; return to normal schedule the following day.
• Do not administer 2 doses within 12 hours.

Storage requirements:

• Store this drug at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
• Keep in original container.

Monitoring:

• Assess blood counts and blood chemistries, including creatine phosphokinase, prior to the initiation of therapy, at least once weekly for the first month, once every other week for the second month, and once monthly for the duration of therapy.
• Perform electrocardiogram (ECG) prior to initiation of therapy, on days 8 and 15 of cycle 1, and prior to the start of the next 2 cycles.

Patient advice:

• Read the patient information labeling each time you fill this drug.
• Female patients of reproductive potential should use effective contraceptive methods while receiving therapy and for 6 months after completion.
• Notify your healthcare provider immediately in the event of a pregnancy or if pregnancy is suspected during therapy.
• Males with female partners of reproductive potential should use effective contraception during therapy and for at least 4 months after the last dose.
• Do not breastfeed during therapy and for at least 2 months after.
• Immediately report a seizure, feeling faint, loss of consciousness, or altered mental status to your healthcare provider.

Frequently asked questions

• What type of leukemia is Xospata (gilteritinib) used to treat?