Precautions for Revuforj Administration

Revuforj carries a risk of differentiation syndrome, and patients and their family members should be alert to relevant symptoms during treatment.

Precautions for Revuforj Administration

If differentiation syndrome is suspected, systemic corticosteroid therapy should be initiated immediately (e.g., adults: dexamethasone 10 mg intravenously every 12 hours; pediatric patients with a body weight of <40 kg: dexamethasone 0.25 mg/kg per dose intravenously every 12 hours) for a minimum of 3 days, with hemodynamic monitoring continued until symptom resolution. Discontinue treatment if severe signs/symptoms persist for more than 48 hours after the initiation of corticosteroid therapy, or if life-threatening symptoms develop earlier (e.g., pulmonary symptoms requiring ventilation).

Assess complete blood count, electrolytes, and liver enzymes before the start of treatment and monthly thereafter. Correct electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia) prior to and during treatment.

Perform electrocardiogram (ECG) assessments before treatment initiation, at least once weekly for the first 4 weeks, and at least once monthly thereafter. Do not initiate treatment in patients with a QTcF interval >450 milliseconds.

Revuforj Use in Special Populations

More frequent ECG monitoring is recommended for patients with congenital long QT syndrome, congestive heart failure, electrolyte abnormalities, or those taking concomitant medications known to prolong the QT interval.

If QT interval prolongation is accompanied by life-threatening arrhythmias, torsades de pointes, ventricular tachycardia, or other serious conditions, treatment should be interrupted, the dose reduced, or the drug discontinued permanently based on the severity.

Embryo-Fetal Toxicity

Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraceptive measures during treatment and for 4 months after the last dose of Revuforj.

Pregnancy

Pregnancy status must be excluded within 7 days prior to the initiation of treatment.

Lactating Women

Use is not recommended (during treatment and for 1 week after the last dose).

How to Store Revuforj?

Store Revuforj at room temperature between 68°F and 77°F (20°C and 25°C).

Keep the tablets in the original medication bottle until the time of administration.

The Revuforj bottle contains a desiccant and is fitted with a child-resistant cap.

Keep Revuforj and all medications out of the reach of children.