Source: FDA, National Drug Code (US) Revision Year: 2025
ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
The recommended dosage of ROMVIMZA is 30 mg orally taken twice weekly, with a minimum of 72 hours between doses, as directed on the blister package [see Clinical Pharmacology (12.3)]. Instruct patients to follow the schedule on the blister package and to take ROMVIMZA on the same days each week.
The recommended dose reductions for adverse reactions are provided in Table 1.
Table 1. Recommended Dose Reductions:
| Dose Reduction | Twice Weekly Dose |
|---|---|
| First | 20 mg |
| Second | 14 mg |
Permanently discontinue ROMVIMZA in patients who are unable to tolerate 14 mg orally twice weekly.
The recommended dosage modifications for hepatotoxicity are summarized in Table 2.
Table 2. Recommended Dosage Modifications for Hepatotoxicity:
| Hepatotoxicity Severity | ROMVIMZA Dosage Modifications |
|---|---|
| AST and/or ALT increases >3–5 times ULN and total bilirubin increases up to 2 times ULN | Withhold ROMVIMZA until AST and ALT resolve to baseline or ≤3 times ULN, and bilirubin resolves to baseline. Resume at the next lower dose level once Hy's law has been definitively ruled out. Permanently discontinue if adverse reaction does not resolve within 4 weeks. |
| OR | |
| Total bilirubin increases up to 2 times ULN | |
| AST and/or ALT increases >3–5 times ULN, and total bilirubin increases >2 times ULN or INR >1.5 and ALP <2 times ULN | Withhold ROMVIMZA until AST and ALT resolve to baseline or ≤3 times ULN, and bilirubin resolves to baseline. Resume at the next lower dose level once Hy's law has been definitively ruled out. Permanently discontinue if adverse reaction does not resolve within 4 weeks. |
| OR | |
| Total bilirubin increases >2 times ULN | |
| AST and/or ALT increases >5–8 times ULN, and total bilirubin ≤ULN and without clinical symptoms | Withhold ROMVIMZA until AST and ALT resolve to ≤3 times ULN or baseline. Permanently discontinue if adverse reaction does not resolve within 4 weeks. |
| AST and/or ALT increases >5-8 times ULN and total bilirubin increase >ULN, or INR >1.5, or ALP >2 times ULN | Permanently discontinue ROMVIMZA. |
| AST and/or ALT increases >8 times ULN | Permanently discontinue ROMVIMZA. |
ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase; INR = International normalized ratio; ULN = upper limit of normal
Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use of a P-gp substrate is unavoidable, administer ROMVIMZA at least 4 hours before taking the P-gp substrate unless otherwise recommended in the substrate Prescribing Information [see Drug Interactions (7.1)].
Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Store capsules in their original blister packs until ready to be taken. Do not store ROMVIMZA in another container.
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