Revuforj Dosage
Generic name: revumenib citrate 25mg
Dosage form: tablet, film coated
Drug class: Miscellaneous antineoplastics
Medically reviewed by Drugs.com. Last updated on Nov 19, 2024.
Patient Selection
Select patients for the treatment of acute leukemia with REVUFORJ based on the presence of a KMT2A translocation in bone marrow cells. An FDA-approved companion diagnostic for the detection of a KMT2A translocation is not currently available.
2.2 Recommended Dosage
The recommended dosage of REVUFORJ varies by patient weight and concomitant use of strong CYP3A4 inhibitors. See Table 1 for the recommended dosage for patients 1 year and older. Do not start REVUFORJ until the WBC is reduced to less than 25 Gi/L. Continue REVUFORJ until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.
*See Table 2 for the total tablet dosage by BSA (body surface area) for patients weighing less than 40 kg. | ||
Patient Weight | Without Strong CYP3A4 Inhibitors | With Strong CYP3A4 Inhibitors |
40 kg or more | 270 mg orally twice daily | 160 mg orally twice daily |
Less than 40 kg | 160 mg/m2 orally twice daily* | 95 mg/m2 orally twice daily* |
* If needed, attain the desired dose by combining different strengths of REVUFORJ tablets. | ||
BSA (m2) | REVUFORJ Dosage for 160 mg/m2 | REVUFORJ Dosage for 95 mg/m2 |
1.4 | 220 mg twice daily | 135 mg twice daily |
1.3 | 220 mg twice daily | 135 mg twice daily |
1.2 | 185 mg twice daily | 110 mg twice daily |
1.1 | 185 mg twice daily | 110 mg twice daily |
1 | 160 mg twice daily | 100 mg twice daily |
0.9 | 135 mg twice daily | 75 mg twice daily |
0.8 | 135 mg twice daily | 75 mg twice daily |
0.7 | 110 mg twice daily | 50 mg twice daily |
0.6 | 100 mg twice daily | 50 mg twice daily |
0.5 | 75 mg twice daily | 50 mg twice daily |
0.4 | 50 mg twice daily | 25 mg twice daily |
- If the strong CYP3A4 inhibitor is discontinued, increase the REVUFORJ dose after at least 5 half-lives of the strong CYP3A4 inhibitor to the recommended dosage without strong CYP3A4 inhibitors (Table 1).
- Concurrent use of standard intrathecal chemotherapy prophylaxis is recommended for patients with risk of central nervous system relapse.
Administration:
- Administer REVUFORJ twice daily fasted or with a low-fat meal (e.g., meals with approximately 400 calories, 25% or less fat).
- Administer REVUFORJ orally around the same time each day.
- Advise patients to swallow tablets whole and to not cut or chew tablets. If patients are unable to swallow tablets, they may be crushed and dispersed in water and taken within 2 hours of preparation.
- If a dose of REVUFORJ is missed or not taken at the usual time, administer the dose as soon as possible on the same day and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours.
2.3 Dosage Modifications for Adverse Reactions
Assess blood counts, electrolytes, and liver enzymes prior to the initiation of REVUFORJ and monthly thereafter. Perform an electrocardiogram (ECG) prior to the initiation of REVUFORJ, at least once a week for the first 4 weeks, and at least monthly thereafter. Monitor for QTc interval prolongation and manage any abnormalities promptly.
Interrupt dosing or reduce dose for adverse reactions as per Table 3. Dose levels for dose reductions are listed in Table 4, Table 5, and Table 6.
*Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). **See Tables 4, 5 and 6 for the reduced dose levels. |
|
Adverse reaction | Recommended action |
Differentiation Syndrome |
|
Noninfectious leukocytosis |
|
QTc interval greater than 480 msec to 500 msec |
|
QTc interval greater than 500 msec (Grade 3*) |
|
QTc interval prolongation with signs/symptoms of life-threatening arrhythmia, Torsades de pointes, polymorphic ventricular tachycardia, signs/ symptoms of life-threatening arrhythmia (Grade 4*). |
|
Potassium 3.6-3.9 mEq/L, and/or Magnesium 1.7-1.9 mg/dL or 0.66-0.81 mmol/L |
|
Potassium ≤ 3.5 mEq/L, and/or Magnesium ≤ 1.6 mg/dL or ≤ 0.65 mmol/L |
|
Other nonhematological adverse reactions Grade ≥ 3* |
|
Grade 4* neutropenia or thrombocytopenia |
|
Grade 3* or higher allergic reactions |
|
**See Table 6 for BSA-based dosage recommendations for the reduced dosage of 95 mg/m2 twice daily. | ||
Patients Weighing 40 kg or Greater at Starting Dose 270 mg orally twice daily |
Patients Weighing Less Than 40 kg at Starting Dose 160 mg/m2 orally twice daily |
|
Reduced Dose | 160 mg orally twice daily | 95 mg/m2 orally twice daily* |
*See Table 6 for BSA-based dosage recommendations for the reduced dosage of 65 mg/m2 twice daily. | ||
Patients Weighing 40 kg or Greater at Starting Dose 160 mg orally twice daily |
Patients Weighing Less Than 40 kg at Starting Dose 95 mg/m2 orally twice daily |
|
Reduced Dose | 110 mg orally twice daily | 65 mg/m2 orally twice daily* |
* If needed, attain the desired dose by combining different strengths of REVUFORJ tablets. | ||
BSA (m2) | REVUFORJ Dosage for 95 mg/m2 | REVUFORJ Dosage for 65 mg/m2 |
1.4 | 135 mg twice daily | 100 mg twice daily |
1.3 | 135 mg twice daily | 75 mg twice daily |
1.2 | 110 mg twice daily | 75 mg twice daily |
1.1 | 110 mg twice daily | 75 mg twice daily |
1 | 100 mg twice daily | 50 mg twice daily |
0.9 | 75 mg twice daily | 50 mg twice daily |
0.8 | 75 mg twice daily | 50 mg twice daily |
0.7 | 50 mg twice daily | 50 mg twice daily |
0.6 | 50 mg twice daily | 25 mg twice daily |
0.5 | 50 mg twice daily | 25 mg twice daily |
0.4 | 25 mg twice daily | 25 mg twice daily |
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