WARNINGS AND PRECAUTIONS
Hepatotoxicity:
- Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
- Elevated AST and ALT can occur with ROMVIMZA.
- Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
- Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.
Embryo-Fetal Toxicity:
- ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
- Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.
Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):
- ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
- Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.
Increased Creatinine without Affecting Renal Function:
- Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.
Adverse Reactions:
The most common (≥20%) adverse reactions, including laboratory abnormalities that occurred in patients receiving ROMVIMZA were increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.
Drug Interactions:
- P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
- Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
- Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
- Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.
Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.
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Robust tumor response: 40% ORR by RECIST with ROMVIMZA vs 0% with placebo1
