ROMVIMZA:A manageable safety profile¹

ROMVIMZA was associated with elevated liver enzymes¹

No cases of serious and fatal liver injury have been observed¹
Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R, pexidartinib^1,2
Monitor liver tests, including AST, ALT, total bilirubin, direct bilirubin, ALP, and gamma-glutamyl transferase (GGT), 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 thereafter¹

Across clinical trials in 253 patients treated with ROMVIMZA¹

Grade ≥3
increased AST2%

Grade ≥3
increased ALT1%

Grade ≥3
increased bilirubin0%

Cases of serious or fatal liver injury0

Dose interruptions occurred in 2% and dose reductions occurred in 1% of patients due to AST/ALT increase. One patient discontinued therapy due to Grade 3 AST increased¹
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including increased ALP¹
Isolated liver enzyme elevations and mixed or cholestatic hepatotoxicity are clinically distinct adverse events^3,4

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No REMS program* required¹

No cases of hair hypopigmentation were observed in the MOTION study⁵

95% of ARs were Grade 1 or 2⁶

Adverse reactions and lab abnormalities (in ≥10%) at 6 months in the MOTION study^1†

Adverse reaction^1‡
	ROMVIMZA (n=83)		Placebo (n=39)
	All Grades (%)	Grades 3 or 4 (%)	All Grades (%)	Grades 3 or 4 (%)
Eye disorders
Periorbital edema^§	60	3.6	21	0
Lacrimation increased	12	0	0	0
Dry eye^§	10	0	0	0
General disorders and administration site conditions
Fatigue^§	59	1.2	38	2.6
Peripheral edema^§	33	1.2	8	0
Face edema	31	1.2	8	0
Skin and subcutaneous tissue disorders
Rash^§	47	3.6	5	0
Pruritus	29	2.4	8	0
Vascular disorders
Hypertension	17	4.8	10	2.6
Nervous system disorders
Neuropathy^§	12	1.2	2.6	0
Lab abnormality^1‡‖
	ROMVIMZA (n=83)		Placebo (n=39)
	All Grades (%)	Grades 3 or 4 (%)	All Grades (%)	Grades 3 or 4 (%)
Chemistry
AST increased	92	0	11	0
Cholesterol increased	43	0	16	0
ALT increased	24	0	16	0
Creatinine increased	17	0	2.6	0
ALP increased	14	0	8	0
Magnesium increased	13	1.2	2.6	0
Calcium decreased	13	0	2.6	0
Hematology
Neutrophils decreased	31	1.2	2.6	0
Leukocytes decreased	29	0	8	0

At ≥2 years of follow-up of MOTION, ROMVIMZA continued to have a manageable safety profile with no new safety signals observed^7¶
Other clinically significant reactions occurring in <10% of patients treated with ROMVIMZA include blurred vision (6%)¹
Elevated AST and ALT can occur with ROMVIMZA¹
If a patient develops elevated AST and/or ALT during treatment on ROMVIMZA, consider temporarily stopping treatment, dose reduction, or permanently stopping treatment depending on how severe liver problems are¹
Additional clinically significant laboratory abnormality: Increased Creatine Phosphokinase (CPK)¹

^*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.

^†Adverse reactions occurring and laboratory abnormalities worsening from baseline in ≥10% patients receiving ROMVIMZA and with a 5% difference between ROMVIMZA and placebo arms through week 25 in the MOTION study.

^‡The severity of adverse reactions was assessed using CTCAE Version 5.0.¹

^§Includes multiple related terms.¹

^‖The denominator used to calculate the rate was 83 for ROMVIMZA and 38 for placebo based on the number of patients with a baseline value and at least one post-treatment value.¹

^¶Median (range) treatment duration was 23.6 months (2–36) for patients randomized to ROMVIMZA and 19.1 months (1–30) for those who crossed over to ROMVIMZA.⁷

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AR=adverse reaction; AST=aspartate aminotransferase; CSF1R=colony- stimulating factor 1 receptor; CTCAE=Common Terminology Criteria for Adverse Events; FDA=Food and Drug Administration; REMS=Risk Evaluation and Mitigation Strategy; ROM=range of motion; TGCT=tenosynovial giant cell tumor; ULN=upper limit of normal.

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References: 1. ROMVIMZA [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC. 2. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2025. 3. Lewis JH, Khaldoyanidi SK, Britten CD, Wei AH, Subklewe M. Clinical Significance of Transient Asymptomatic Elevations in Aminotransferase (TAEAT) in Oncology. Am J Clin Oncol. 2022;45(8):352-365. 4. Newsome PN, Cramb R, Davison SM, et al. Guidelines on the management of abnormal liver blood tests. Gut. 2018;67(1):6-19. 5. Gelderblom H, Bhadri VA, Stacchiotti S, et al. Updated efficacy and safety of vimseltinib in patients with tenosynovial giant cell tumor (TGCT): one-year follow-up from the MOTION phase 3 trial. Presented at the European Society for Medical Oncology (ESMO) Congress 2024, Sept 13-17, Barcelona, Spain. 6. Data on file. Deciphera Pharmaceuticals, LLC; 2026. 7. Bauer S, Bhadri V, Gelderblom H, et al. Long-term efficacy and safety of vimseltinib in patients with tenosynovial giant cell tumor: 2-year results from the MOTION phase 3 trial. Poster presented at the European Society for Medical Oncology (ESMO) Congress 2025, October 17-21, Berlin, Germany.

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.

ROMVIMZA was associated with elevated liver enzymes1

95% of ARs were Grade 1 or 26

Adverse reactions and lab abnormalities (in ≥10%) at 6 months in the MOTION study1†

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ROMVIMZA was associated with elevated liver enzymes¹

95% of ARs were Grade 1 or 2⁶

Adverse reactions and lab abnormalities (in ≥10%) at 6 months in the MOTION study^1†

Help your patients get started on ROMVIMZA