ROMVIMZA offersConvenient, twice-a-week, oral dosing
with no known dietary restrictions¹

The recommended dosage of ROMVIMZA is

30 mg orally, taken twice weekly at least 72 hours apart, with or without food.¹

30 mg

Not actual size

20 mg

Not actual size

14 mg

Not actual size

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

With ROMVIMZA, there's no¹:

Known dietary restrictions (including grapefruit and dairy products) and can be taken with a high-fat meal
REMS program requirement*

For females and males of reproductive potential¹:

Use effective contraception during treatment and for one month after their last dose due to risks of embryo-fetal toxicity

ROMVIMZA can be used alongside all contraceptive methods, including hormonal birth control, allowing patients to continue with their preferred birth control method

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

With ROMVIMZA, there's no¹:

Known dietary restrictions (including grapefruit and dairy products) and can be taken with a high-fat meal
REMS program requirement*

For females and males of reproductive potential¹:

Use effective contraception during treatment and for one month after their last dose due to risks of embryo-fetal toxicity
ROMVIMZA can be used alongside all contraceptive methods, including hormonal birth control, allowing patients to continue with their preferred birth control method

Dose modifications were common and can help patients stay on ROMVIMZA^1‑3

For adverse reactions^1-3

Dose interruptions or dose reductions may be required based on a patient's safety and tolerability. Consider dose reductions as part of AR management to help maintain treatment continuity.

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 weekly

ARs or laboratory abnormalities led to¹:

Discontinuation in 4.8% (4 out of 83) of patients

Dose reductions in 39% (32 out of 83) of patients
Dose interruptions in 40% (33 out of 83) of patients

For hepatotoxicity¹

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.

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. Resume at the next lower dose. 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.

*REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AR=adverse reaction; AST=aspartate aminotransferase; FDA=Food and Drug Administration; INR=international normalized ratio; REMS=Risk Evaluation and Mitigation Strategy; ULN=upper limit of normal.

Inform your patients of the MyROMVIMZA app: a tool that can help them with medication trackers, appointment reminders, and more.

Get information about ROMVIMZA

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References: 1. ROMVIMZA [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC. 2. Stacchiotti S, Durr HR, Schaefer IM, et al. Best clinical management of tenosynovial giant cell tumour (TGCT): a consensus paper from a community of experts. Cancer Treat Rev. 2023;112:102491. 3. Stacchiotti S, Durr HR, Schaefer IM, et al. Best clinical management of tenosynovial giant cell tumour (TGCT): a consensus paper from a community of experts. Cancer Treat Rev. 2023;112:102491(suppl):1-8.

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

With ROMVIMZA, there's no1:

For females and males of reproductive potential1:

With ROMVIMZA, there's no1:

For females and males of reproductive potential1:

Dose modifications were common and can help patients stay on ROMVIMZA1‑3

For adverse reactions1-3

ARs or laboratory abnormalities led to1:

For hepatotoxicity1

Get information about ROMVIMZA

With ROMVIMZA, there's no¹:

For females and males of reproductive potential¹:

With ROMVIMZA, there's no¹:

For females and males of reproductive potential¹:

Dose modifications were common and can help patients stay on ROMVIMZA^1‑3

For adverse reactions^1-3

ARs or laboratory abnormalities led to¹:

For hepatotoxicity¹