Active Ingredient: Mirdametinib
Mirdametinib as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Oral, 2 milligrams mirdametinib per square meter of body surface, 2 times daily, 42 doses in total, over the duration of 28 days.
Regimen B, in case that patient body surface area is ≥ 0.40 m² and patient body surface area is ≤ 0.69 m²
Oral, 1 milligrams mirdametinib, 2 times daily, 42 doses in total, over the duration of 28 days.
Regimen C, in case that patient body surface area is ≥ 0.70 m² and patient body surface area is ≤ 1.04 m²
Oral, 2 milligrams mirdametinib, 2 times daily, 42 doses in total, over the duration of 28 days.
Regimen D, in case that patient body surface area is ≥ 1.05 m² and patient body surface area is ≤ 1.49 m²
Oral, 3 milligrams mirdametinib, 2 times daily, 42 doses in total, over the duration of 28 days.
Regimen E, in case that patient body surface area is ≥ 1.50 m²
Oral, 4 milligrams mirdametinib, 2 times daily, 42 doses in total, over the duration of 28 days.
The recommended dose of mirdametinib is 2 mg/m² of body surface area (BSA), twice daily (approximately every 12 hours) for the first 21 days of each 28‑day cycle. The maximum dose is 4 mg twice daily (see Table 1).
For paediatric patients 2 to <6 years of age and for patients who are unable to swallow capsules whole, mirdametinib is also available as a 1 mg dispersible tablet formulation that can be dispersed in water. The recommended dose for patients with a BSA less than 0.40 m² has not been established.
Table 1. Recommended dose based on body surface area:
| Body surface area (BSA) | Recommended dose |
|---|---|
| 0.40 to 0.69 m² | 1 mg twice daily |
| 0.70 to 1.04 m² | 2 mg twice daily |
| 1.05 to 1.49 m² | 3 mg twice daily |
| ≥1.50 m² | 4 mg twice daily |
Treatment with mirdametinib should continue until PN progression or the development of unacceptable toxicity.
If a dose of mirdametinib is missed, an additional dose is not to be taken. The patient should continue with the next scheduled dose.
If vomiting occurs after mirdametinib is administered, an additional dose is not to be taken. The patient should continue with the next scheduled dose. Manage events of vomiting as clinically indicated, including use of anti‑emetics
Interruption and/or dose reduction or permanent discontinuation of mirdametinib may be required based on individual safety and tolerability. Recommended dose reductions are given in Table 2. Permanently discontinue treatment in patients unable to tolerate mirdametinib after one dose reduction.
Table 2. Recommended dose reductions:
| Body surface area (BSA) | Reduced dose | |
|---|---|---|
| Morning | Evening | |
| 0.40 to 0.69 m² | 1 mg once daily | |
| 0.70 to 1.04 m² | 2 mg | 1 mg |
| 1.05 to 1.49 m² | 2 mg | 2 mg |
| ≥1.50 m² | 3 mg | 3 mg |
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