Romvimza Dosage
Generic name: Vimseltinib 14mg
Dosage form: capsule
Drug class: Miscellaneous antineoplastics
Medically reviewed by Drugs.com. Last updated on Feb 18, 2025.
Recommended Dosage
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. Instruct patients to follow the schedule on the blister package and to take ROMVIMZA on the same days each week.
- ROMVIMZA may be taken with or without food.
- Swallow ROMVIMZA capsules whole. Do not open, break, or chew the capsules.
- If a dose is missed by 48 hours or less, take the missed dose as soon as possible and take the next dose on its regularly scheduled day. If a dose is missed by more than 48 hours, skip the missed dose, and take the next dose on its regularly scheduled day.
- If vomiting occurs within 30 minutes of taking a dose, repeat that dose. Otherwise, take the next dose on its regularly scheduled day.
Dose Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 1.
| 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.
| Hepatotoxicity Severity | ROMVIMZA Dosage Modifications |
|---|---|
|
ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase; INR = International normalized ratio; ULN = upper limit of normal |
|
| 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. |
Dosage Modification for P-glycoprotein (P-gp) Substrates
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.
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