ROMVIMZA Vimseltinib 30 mg Capsule, 4-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other protein kinase inhibitors class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $3,511.99 | $14,047.94 / 4 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Romvimza 30 mgthis 73207-0304-41 | Deciphera | 4 capsules | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11679110 ↗ | Method of use | U-4145 | Feb 3, 2040 |
| US 11679110 ↗ | Method of use | U-4145 | Feb 3, 2040 |
| US 11679110 ↗ | Method of use | U-4145 | Feb 3, 2040 |
| US 11103507 ↗ | Method of use | U-4145 | Feb 3, 2040 |
| US 11103507 ↗ | Method of use | U-4145 | Feb 3, 2040 |
| US 12285430 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 11103507 ↗ | Method of use | U-4145 | Feb 3, 2040 |
| US 12285430 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12285430 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12485120 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12485120 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12485120 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12582655 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12582655 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 12582655 ↗ | Method of use | U-4145 | Dec 23, 2039 |
| US 9181223 ↗ | Drug substance | — | Mar 14, 2034 |
| US 12528787 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12617775 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12528787 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12686672 ↗ | Drug product | — | Apr 30, 2045 |
| US 12509443 ↗ | Drug product | — | Apr 30, 2045 |
| US 9181223 ↗ | Drug substance | — | Mar 14, 2034 |
| US 12528787 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12643883 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12447149 ↗ | Drug product | — | Dec 6, 2044 |
| US 12617775 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12509443 ↗ | Drug product | — | Apr 30, 2045 |
| US 9181223 ↗ | Drug substance | — | Mar 14, 2034 |
| US 12643883 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12447149 ↗ | Drug product | — | Dec 6, 2044 |
| US 12551483 ↗ | Drug product | — | Dec 6, 2044 |
| US 12509443 ↗ | Drug product | — | Apr 30, 2045 |
| US 12643883 ↗ | Drug substance | — | Dec 6, 2044 |
| US 12447149 ↗ | Drug product | — | Dec 6, 2044 |
| US 12686672 ↗ | Drug product | — | Apr 30, 2045 |
| US 12686672 ↗ | Drug product | — | Apr 30, 2045 |
| US 12551483 ↗ | Drug product | — | Dec 6, 2044 |
| US 12551483 ↗ | Drug product | — | Dec 6, 2044 |
| US 12617775 ↗ | Drug substance | — | Dec 6, 2044 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Feb 14, 2030 |
| NCE | New Chemical Entity (5-year) | Feb 14, 2030 |
| NCE | New Chemical Entity (5-year) | Feb 14, 2030 |
Is there a generic version of ROMVIMZA 30 MG CAPSULE?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73207-0304-40 | 1 CARTON in 1 CARTON (73207-304-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK | 2025-02-14 | Active |
| 73207-0304-41 You're viewing this | 1 CARTON in 1 CARTON (73207-304-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK | 2025-02-14 | Active |
Pack size FAQ
What quantity is in NDC 73207-0304-41?
What is the difference between NDC 73207-0304-41 and NDC 73207-0304-40?
What NDC number is used to bill for this package of ROMVIMZA Vimseltinib 30 mg Capsule?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 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. ROMVIMZA is a kinase inhibitor 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended Dosage : 30 mg orally twice weekly, with a minimum of 72 hours between doses as described in the blister package. ( 2.1 ) See full prescribing information for dosage modifications due to hepatotoxicity and drug interactions. ( 2.2 , 2.3 )
2.1Recommended 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 [see Clinical Pharmacology ( 12.3 )] . 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.
2.2Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 1 . Table 1: Recommended Dose Reductions 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 .
Table 2: Recommended Dosage Modifications for Hepatotoxicity 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. Resume at the next lower dose level.
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.
2.3Dosage 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 [see Drug Interactions ( 7.1 )] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 14 mg capsule Orange cap, white body size 4 capsule imprinted with “DCV14” in black ink. 20 mg capsule Yellow cap, white body size 2 capsule imprinted with “DCV20” in black ink. 30 mg capsule Light blue cap, white body size 1 capsule imprinted with “DCV30” in black ink. Capsules : 14 mg, 20 mg, 30 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Elevated AST and ALT can occur. Evaluate liver tests prior to initiation of treatment and during treatment. ( 2.2 , 5.1 ) Embryo-fetal toxicity: Can cause fetal harm.
Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) Allergic Reactions to FD&C Yellow No. 5 (tartrazine) and No.
6 (Sunset Yellow FCF): 14 mg capsule contains FD&C Yellow No. 6 (Sunset Yellow FCF); 20 mg capsule contains FD&C Yellow No.5 (tartrazine) and No. 6 (Sunset Yellow FCF) as color additives, which may cause allergic reactions (including bronchial asthma) in certain susceptible patients.
( 5.3 ) Increased serum creatinine without affecting renal function: Increases in serum creatinine can occur. Use alternative measures that are not based on serum creatinine to assess renal function. ( 5.4 )
5.1Hepatotoxicity Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R [see Clinical Pharmacology ( 12.1 )] . Serious and fatal liver injury have not been observed with ROMVIMZA. Across clinical trials in 253 patients treated with ROMVIMZA, 2% had Grade 3 increased AST, and 1% had Grade 3 increased ALT.
Dose interruptions occurred in 2% of patients and dose reductions occurred in 1% of patients due to AST/ALT increase. One patient discontinued therapy due to Grade 3 AST increased. 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 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 thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity [see Dosage and Administration ( 2.2 )] .
5.2Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, ROMVIMZA can cause fetal harm when administered to pregnant women. In female rats administered vimseltinib, fetal structural abnormalities occurred at exposures that were at least 3 times the recommended dose based on area under the curve (AUC). 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 [see Use in Specific Populations ( 8.1 , 8.3 )] .
5.3Allergic 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.
Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin sensitivity. ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No.6 (Sunset Yellow FCF), which may cause allergic reactions.
5.4Increased Creatinine without Affecting Renal Function In MOTION, serum creatinine increased (mean increase of 19 μmol/L) and reached a maximum mean increase by 10.4 weeks compared to baseline. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation.
The increases in serum creatinine may be due to inhibition of renal tubular secretion transporters [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC at 1-888-724-3274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions reflects exposure to ROMVIMZA in 83 patients with TGCT enrolled in the double-blind portion and in 35 patients with TGCT in the open-label portion who crossed over to ROMVIMZA in MOTION, and in 135 patients with TGCT or solid tumors in other clinical trials.
The safety of ROMVIMZA was evaluated in 83 adult patients with TGCT in MOTION [see Clinical Studies ( 14 )] . MOTION excluded patients with bilirubin, AST, or ALT >ULN. All patients received ROMVIMZA twice weekly until disease progression or unacceptable toxicity.
Among these patients, 82% were exposed for 6 months or longer and 30% were exposed for greater than one year. Serious adverse reactions occurred in 2.4% of patients who received ROMVIMZA. Serious adverse reactions in ≥1% included subcutaneous abscess (1.2%) and cellulitis (1.2%).
Permanent discontinuation due to an adverse reaction occurred in 4.8% of patients who received ROMVIMZA. Adverse reactions leading to permanent discontinuation in one patient each included periorbital edema, neuropathy, rash, and hypertension. Dose reductions due to an adverse reaction or laboratory abnormality occurred in 39% of patients who received ROMVIMZA.
Adverse reactions leading to dose reductions in ≥2% of patients receiving ROMVIMZA were rash, periorbital edema, peripheral edema, fatigue, pruritus, face edema, increased CPK, neuropathy, and hypertension. Dose interruptions due to an adverse reaction or laboratory abnormality occurred in 40% of patients who received ROMVIMZA. Adverse reactions leading to interruptions in ≥2% of patients included rash, fatigue, peripheral edema, increased CPK, periorbital edema, face edema, pruritus, neuropathy, and hypertension.
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. Table 3 and Table 4 summarize the adverse reactions and laboratory abnormalities in MOTION during the randomized phase through Week 25. Table 3: Adverse Reactions Occurring in ≥10% of Patients Receiving ROMVIMZA with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in MOTION Adverse Reaction* ROMVIMZA N=83 Placebo N=39 All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) *The severity of adverse reactions was assessed using CTCAE v5.0.
1 Includes multiple related terms Eye disorders Periorbital edema 1 60 3.6 21 0 Lacrimation increased 12 0 0 0 Dry eye 1 10 0 0 0 General disorders and administration site conditions Fatigue 1 59 1.2 38
2.6Peripheral edema 1 33 1.2 8 0 Face edema 31 1.2 8 0 Skin and subcutaneous tissue disorders Rash 1 47 3.6 5 0 Pruritus 29 2.4 8 0 Vascular disorders Hypertension 17 4.8 10
2.6Nervous system disorders Neuropathy 1 12 1.2 2.6 0 Other clinically significant adverse reactions occurring in <10% of patients treated with ROMVIMZA include blurred vision (6%). Table 4: Laboratory Abn…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS P-glycoprotein (P-gp) substrates : Avoid concomitant use with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates. ( 2.3 , 7.1 ) Breast Cancer Resistance Protein (BCRP) substrates : Avoid concomitant use with BCRP substrates. ( 7.1 ) Organic Cation Transporter 2 (OCT) substrates : Avoid concomitant use with OCT2 substrates. ( 7.1 )
7.1Effects of ROMVIMZA on Other Drugs Table 5 describes drug interactions where concomitant use with ROMVIMZA affects another drug. Table 5: Effect of ROMVIMZA on Other Drugs P-glycoprotein (P-gp) substrates Prevention or Management Avoid concomitant use with P-gp substrates while taking ROMVIMZA. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates [see Dosage and Administration ( 2.3 )] unless otherwise recommended in the substrate Prescribing Information.
Mechanism and Clinical Effect(s) This recommendation is based upon a mechanistic understanding of vimseltinib pharmacokinetics and it being a P-gp inhibitor in vitro [see Clinical Pharmacology ( 12.3 )] . Concomitant use of ROMVIMZA with P-gp substrates may increase exposure of these substrates; however, this has not been studied clinically. Breast Cancer Resistance Protein (BCRP) substrates Prevention or Management Avoid concomitant use with BCRP substrates while taking ROMVIMZA.
Refer to the Prescribing Information of the BCRP substrate for dose modifications if concomitant use cannot be avoided. Mechanism and Clinical Effect(s) This recommendation is based upon a mechanistic understanding of vimseltinib pharmacokinetics and it being a BCRP inhibitor in vitro [see Clinical Pharmacology ( 12.3 )] . Concomitant use of ROMVIMZA with BCRP substrates may increase exposure of these substrates; however, this has not been studied clinically.
Organic Cation Transporter 2 (OCT2) substrates Prevention or Management Avoid concomitant use with OCT2 substrates while taking ROMVIMZA. Refer to the Prescribing Information of the OCT2 substrate for dose modifications if concomitant use cannot be avoided. Mechanism and Clinical Effect(s) This recommendation is based upon a mechanistic understanding of vimseltinib pharmacokinetics and it being an OCT2 inhibitor in vitro [see Clinical Pharmacology ( 12.3 )] .
Concomitant use of ROMVIMZA with OCT2 substrates may increase exposure of these substrates; however, this has not been studied clinically.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on data from animal studies and its mechanism of action, ROMVIMZA can cause fetal harm when administered to a pregnant woman. There are no available data on vimseltinib use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In female rats administered vimseltinib during the period of organogenesis, fetal structural abnormalities occurred at exposures that were at least 3 times the recommended dose based on AUC ( see Data ) .
Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a rat embryo-fetal development study, pregnant female rats were dosed once daily during the period of organogenesis (gestational days 6 to 17) at doses of 2.5, 5, or 15 mg/kg/day. Structural abnormalities (skeletal variations) occurred at ≥2.5 mg/kg/day (approximately 3 times the exposure at the recommended dose based on AUC).
Additional structural abnormalities (cardiac malformations) were observed at the highest dose of 15 mg/kg/day (approximately 23 times the exposure at the recommended dose based on AUC).
8.2Lactation Risk Summary There are no data on the presence of vimseltinib or its metabolites in either human or animal milk or its effects on a breastfed child or on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ROMVIMZA and for 1 month after the last dose.
8.3Females and Males of Reproductive Potential ROMVIMZA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to the initiation of ROMVIMZA [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose [see Warnings and Precautions ( 5.2 ), Nonclinical Toxicology ( 13.1 )] .
Males Advise males that are partnered with females of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose [see Warnings and Precautions ( 5.2 ), Nonclinical Toxicology ( 13.1 )] . Infertility Females and Males Based on findings from animal studies, ROMVIMZA may impair fertility [see Nonclinical Toxicology ( 13.1 )] .
8.4Pediatric Use The safety and effectiveness of ROMVIMZA in pediatric patients have not been established. Animal Toxicity Data In a 26-week repeat-dose toxicology study, rats administered vimseltinib at ≥2.5 mg/kg/day had physeal thickening and decay of the incisors and molars. Bone and tooth toxicities occurred at exposures at least 8 times the recommended dose based on AUC.
8.5Geriatric Use Clinical studies of ROMVIMZA did not include a sufficient number of patients aged 65 years and older to determine whether they respond differently from younger patients.
8.6Hepatic Impairment No dosage adjustment is recommended for patients with mild (bilirubin ≤upper limit of normal (ULN) and AST >ULN or bilirubin >1x to 1.5x ULN and any AST) hepatic impairment. ROMVIMZA has not been studied in patients with moderate (bilirubin >1.5x to 3x ULN and any AST) or severe (bilirubin >3x ULN and any AST) hepatic impairment [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on data from animal studies and its mechanism of action, ROMVIMZA can cause fetal harm when administered to a pregnant woman. There are no available data on vimseltinib use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In female rats administered vimseltinib during the period of organogenesis, fetal structural abnormalities occurred at exposures that were at least 3 times the recommended dose based on AUC ( see Data ) .
Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a rat embryo-fetal development study, pregnant female rats were dosed once daily during the period of organogenesis (gestational days 6 to 17) at doses of 2.5, 5, or 15 mg/kg/day. Structural abnormalities (skeletal variations) occurred at ≥2.5 mg/kg/day (approximately 3 times the exposure at the recommended dose based on AUC).
Additional structural abnormalities (cardiac malformations) were observed at the highest dose of 15 mg/kg/day (approximately 23 times the exposure at the recommended dose based on AUC).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ROMVIMZA in pediatric patients have not been established. Animal Toxicity Data In a 26-week repeat-dose toxicology study, rats administered vimseltinib at ≥2.5 mg/kg/day had physeal thickening and decay of the incisors and molars. Bone and tooth toxicities occurred at exposures at least 8 times the recommended dose based on AUC.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of ROMVIMZA did not include a sufficient number of patients aged 65 years and older to determine whether they respond differently from younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.
12.2Pharmacodynamics Exposure-Response Relationship Higher vimseltinib exposure is associated with an increased risk of all grades of edema, rash, increased AST, and increased ALT. Vimseltinib exposure-response relationship for efficacy and time course of pharmacodynamic response have not been fully characterized. Cardiac Electrophysiology At the maximum recommended dose of ROMVIMZA, clinically significant QTc interval prolongation was not observed.
However, the largest mean increase in QTc interval was 8.2 ms (upper confidence internal = 12.3 ms) after administration of vimseltinib 40 mg once daily for 5 days (3.3 times the maximum recommended weekly dose). The increase in QTc interval was concentration-dependent [see Clinical Pharmacology ( 12.3 )] .
12.3Pharmacokinetics Vimseltinib pharmacokinetic parameters were determined following a single oral dose of 30 mg or at steady state following multiple doses of 30 mg twice weekly and are provided as mean (CV%) unless otherwise specified. Vimseltinib peak plasma concentration (C max ) is 283 ng/mL (36%) or 747 ng/mL (39%) after a single dose or at steady state, respectively, and area under the time concentration curve (AUC 0-inf ) is 46,900 ng•h/mL (45%) after a single dose and AUC 0-24hr is 13,400 ng•h/mL (45%) at steady state.
Vimseltinib C max and AUC increase in a dose-proportional manner. Absorption Vimseltinib median time to C max (T max ) is 1 hour (0.5 to 4 hours). Effect of Food No clinically significant differences in vimseltinib pharmacokinetics were observed following administration of a high-fat meal (800 to 1000 kcal, 50% fat), compared to fasted conditions.
Distribution Vimseltinib volume of distribution (V/F) is 90 L (16%). Vimseltinib is 96.5% bound to human plasma proteins. Elimination Vimseltinib elimination half-life (t 1/2 ) is approximately 6 days (32%) with a clearance (CL/F) of
0.5L/h (23%). Metabolism Vimseltinib is primarily metabolized by oxidation, N -demethylation, and N -dealkylation; secondary biotransformation pathways included N -demethylation, dehydrogenation, and oxidation. CYP450 enzymes are not anticipated to play a major role in the metabolism of vimseltinib.
Excretion Approximately 43% of the dose was recovered in feces (9.1% unchanged) and 38% in urine (5.1% unchanged) after a single radiolabeled dose. Specific Populations No clinically significant differences in the pharmacokinetics of vimseltinib were observed based on age (20 to 91 years), sex, race (Asian, Black or African American, White), body weight (43 to 150 kg), tumor (TGCT or other malignant solid tumors), and mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥30 mL/min calculated by CKD-EPI equation).
The effect of severe renal impairment (eGFR <30 mL/min) or moderate to severe hepatic impairment (total bilirubin >1.5 x ULN with any AST) on vimseltinib pharmacokinetics is unknown. Drug Interaction Studies Clinical Studies and Model-Informed Approaches P-glycoprotein (P-gp) inhibitors: Dabigatran (a P-gp substrate) AUC 0-inf and C max are predicted to increase 2- to 3-fold with concomitant use with vimseltinib 30 mg twice weekly. Dabigatran C max and AUC 0-inf are predicted to increase up to 1.3-fold if administered 4 hours after administration of vimseltinib 30 mg twice weekly.
Other Drugs: No clinically significant differences in vimseltinib pharmacokinetics were observed when used concomitantly with itraconazole (a P-gp inhibitor) or rabeprazole (a proton pump inhibitor). In Vitro Studies CYP 450 enzymes: Vimseltinib is not a substrate of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A. Vimseltinib is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Table 7: ROMVIMZA 14 mg, 20 mg, and 30 mg Capsules Strength Description Package Size and Type NDC Number 14 mg Size 4 hard gelatin capsule with white body and orange cap with black print “DCV14”, packed in oPA-film/ aluminum foil /PVC-film blisters with push-through aluminum foil lidding. Each carton contains one child-resistant blister pack containing 8 capsules (four-week supply) 73207-302-40 20 mg Size 2 hard gelatin capsule with white body and yellow cap with black print “DCV20”, packed in oPA-film/ aluminum foil /PVC-film blisters with push-through aluminum foil lidding.
Each carton contains one child-resistant blister pack containing 8 capsules (four-week supply) 73207-303-40 30 mg Size 1 hard gelatin capsule with white body and light blue cap with black print “DCV30”, packed in oPA-film/ aluminum foil /PVC-film blisters with push-through aluminum foil lidding. Each carton contains one child-resistant blister pack containing 8 capsules (four-week supply) 73207-304-40 Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Store capsules in their original blister packs until ready to be taken. Do not store ROMVIMZA in another container.
📋 Description ▾
11 DESCRIPTION Vimseltinib is a kinase inhibitor. The chemical name of vimseltinib dihydrate is 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one, dihydrate. Vimseltinib is a white to off-white crystalline solid.
Vimseltinib is a weak base, very slightly soluble in water. The molecular formula for vimseltinib dihydrate is C 23 H 25 N 7 O 2 • 2 H 2 O, and the molecular weight is 467.52 g/mol. The chemical structure is: ROMVIMZA (vimseltinib) capsules are supplied as printed hard gelatin capsules containing 14 mg, 20 mg, or 30 mg of vimseltinib (equivalent to 15.18 mg, 21.68 mg, or 32.52 mg of vimseltinib dihydrate, respectively).
The capsule contains the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shell contains Brilliant Blue FCF (30 mg strength), erythrosine (30 mg strength), gelatin, Sunset Yellow FCF (14 mg and 20 mg strengths), tartrazine (20 mg), and titanium dioxide. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA approved patient labeling (Medication Guide). Hepatotoxicity Advise patients there may be a potential risk of hepatotoxicity and that they will need to undergo laboratory tests to monitor liver function and to immediately report any signs or symptoms of severe liver injury to their healthcare provider [see Warnings and Precautions ( 5.1 )] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to the fetus.
Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )] . Advise females of reproductive potential to avoid pregnancy and to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )] . Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 month after the last dose of ROMVIMZA [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.3 )].
Lactation Advise females not to breastfeed during treatment with ROMVIMZA and for 1 month after the final dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise patients that ROMVIMZA may impair fertility [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] . Allergic Reactions to FD&C Yellow No.
5 (Tartrazine) and No. 6 (Sunset Yellow FCF) Advise patients that ROMVIMZA 20 mg contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons or in patients who also have aspirin hypersensitivity [see Warnings and Precautions ( 5.3 )] .
Advise patients ROMVIMZA 14 mg and ROMVIMZA 20 mg contains FD&C Yellow No. 6 (Sunset Yellow FCF) which may cause allergic-type reactions [see Warnings and Precautions ( 5.3 )] . Administration Instruct patients that doses should be taken twice weekly at least 72 hours apart [see Dosage and Administration ( 2.1 )] .
Instruct patients to swallow capsules whole (do not open, break, or chew) [see Dosage and Administration ( 2.1 )] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant products, including over-the-counter products and supplements [see Dosage and Administration ( 2.3 ), Drug Interactions ( 7.1 )] . Manufactured for and marketed by: Deciphera Pharmaceuticals, LLC 200 Smith Street, Waltham, MA 02451
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 02/2025 MEDICATION GUIDE ROMVIMZA TM (rom-vim-zah) (vimseltinib) capsules What is the most important information I should know about ROMVIMZA?
ROMVIMZA can cause serious side effects, including: Liver problems. Increased liver enzymes in your blood are common with ROMVIMZA. Your healthcare provider will do blood tests to check for liver problems: before starting treatment with ROMVIMZA, 2 times each month for the first 2 months of treatment, then 1 time every 3 months for the first year of treatment and as clinically indicated thereafter.
If you develop liver problems during treatment with ROMVIMZA, your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment depending on how severe your liver problems are. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems during treatment with ROMVIMZA including: yellowing of your skin or the white part of your eyes dark urine lack or loss of appetite right upper stomach-area (abdomen) pain or tenderness feeling overly tired nausea vomiting fever rash itching See “ What are the possible side effects of ROMVIMZA? ” for more information about side effects.
What is ROMVIMZA? ROMVIMZA is a prescription medicine used to treat adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may make the symptoms worse or cause severe problems. It is not known if ROMVIMZA is safe and effective in children.
Before taking ROMVIMZA, tell your healthcare provider about all of your medical conditions, including if you: have or had liver problems are pregnant or plan to become pregnant. ROMVIMZA can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with ROMVIMZA.
Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or you think you may be pregnant during treatment with ROMVIMZA.
Males with female partners who are able to become pregnant: Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose. Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during treatment with ROMVIMZA. are breastfeeding or plan to breastfeed. It is not known if ROMVIMZA passes into your breast milk.
Do not breastfeed during treatment with ROMVIMZA and for 1 month after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ROMVIMZA with certain other medicines may affect the way that ROMVIMZA or the other medicine works and may increase your risk of side effects.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How should I take ROMVIMZA?
Take ROMVIMZA exactly as your healthcare provider tells you to. Do not change your dose or stop taking ROMVIMZA unless your healthcare provider tells you to. Take ROMVIMZA 2 times a week with at least 72 hours between doses.
Follow the dosing directions and schedule on your blister package and take ROMVIMZA on the same days each week. Take ROMVIMZA with or without food. Swallow ROMVIMZA capsules whole.
Do not open, break, or chew the capsules. If you miss a dose of ROMVIMZA by 48 hours or less, take the missed dose as soon as possible and take the next dose on its regularly scheduled day. If you miss your dose by more than 48 hours, skip the missed dose, and take the next dose on its regularly scheduled day.
If you vomit within 30 minutes of taking a dose of ROMVIMZA, take another dose. If you vomit more t…