Active Ingredient: Vimseltinib
Vimseltinib is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 30 milligrams vimseltinib, 2 times weekly.
The recommended dose of vimseltinib is 30 mg taken twice weekly at least 72 hours apart as long as benefit is observed or until unacceptable toxicity.
If the patient misses a dose of vimseltinib by less than 48 hours, the patient should be instructed to take the missed dose as soon as possible and return to the usual dosing schedule. If the patient misses a dose of vimseltinib by more than 48 hours, the patient should be instructed not to take the missed dose and return to the usual dosing schedule.
Dose interruptions or dose reductions may be required based on individual safety and tolerability. If patients are unable to tolerate a 30 mg dose of vimseltinib, treatment with vimseltinib should be temporarily withheld. When the clinical condition of the patient improves, a reduced dose of vimseltinib should be given as described in the following table.
Recommended dose reduction:
| Dose reduction | Twice weekly dose |
|---|---|
| First | 20 mg |
| Second | 14 mg |
Vimseltinib should be discontinued in patients unable to tolerate a 14 mg dose.
Dose reductions to 14 mg twice weekly for patients of ≥115 kg body weight have not been used and efficacy has not been established.
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