ROMVIMZA offersTwice-weekly oral dosing and
no known dietary restrictions¹

The recommended dosage of ROMVIMZA is 30 mg orally, taken twice weekly with a minimum of 72 hours between doses¹

ROMVIMZA may be taken with or without food¹
No clinically significant differences in pharmacokinetics were observed following administration of a high-fat meal¹
There are no known restrictions on consuming grapefruit or dairy products¹
70% of patients in the MOTION study were on 30 mg at 6 months²

Patients choose their Day 1 which
dictates their Day 5. Their dosing days
remain the same each week

Recommended dose modifications for adverse reactions¹

1^st dose reduction is 20 mg twice weekly
2^nd dose reduction is 14 mg twice weekly
Permanently discontinue ROMVIMZA in patients who are unable to tolerate 14 mg orally twice weekly¹

4.8%

(4 out of 83 patients) discontinued treatment due to adverse reactions¹

Adverse reactions or laboratory abnormalities led to¹:

Dose reductions in 39% (32 out of 83) of patients

Dose interruptions in 40% (33 out of 83) of patients

Recommended dosage modifications for hepatotoxicity¹

Hepatotoxicity severity	ROMVIMZA dosage modifications
AST and/or ALT increases >3–5 times ULN AND total bilirubin increases up to 2 times ULN OR 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.
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 OR Total bilirubin increases >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.
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.

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; INR=international normalized ratio; ULN=upper limit of normal.

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References: 1. Romvimza [package insert]. Waltham, MA: Deciphera Pharmaceuticals, Inc. 2. Gelderblom H, Bhadri V, Stacchiotti S, et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10445):2709-2719.

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

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.

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

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.

Please click for the full Prescribing Information.

Indications and Usage

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

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:

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.

Please click for the full Prescribing Information.

The recommended dosage of ROMVIMZA is 30 mg orally, taken twice weekly with a minimum of 72 hours between doses1

Recommended dose modifications for adverse reactions1

Adverse reactions or laboratory abnormalities led to1:

Recommended dosage modifications for hepatotoxicity1

Have additional questions?

The recommended dosage of ROMVIMZA is 30 mg orally, taken twice weekly with a minimum of 72 hours between doses¹

Recommended dose modifications for adverse reactions¹

Adverse reactions or laboratory abnormalities led to¹:

Recommended dosage modifications for hepatotoxicity¹