ROMVIMZA

ROMVIMZA is an FDA-registered drug product whose active ingredient is VIMSELTINIB. It is labelled by Deciphera Pharmaceuticals, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 73207-302, application NDA219304, label effective 20260626. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing VIMSELTINIB are most often described in connection with: treatment adult, symptomatic tenosynovial, giant cell, tumor tgct, surgical resection, will potentially, cause worsening, functional limitation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 ) 2.1 Recommended 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. 2.2 Dosage 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. 2.3 Dosage 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 )] .

4 CONTRAINDICATIONS None. None ( 4 )

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. 6.1 Clinical 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 2.6 Peripheral 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 2.6 Nervous 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 Abnormalities Worsening from Baseline in ≥10% of Patients Receiving ROMVIMZA with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in MOTION Laboratory Abnormality a ROMVIMZA N=83 Placebo N=39 b All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) AST – aspartate aminotransferase, ALT – alanine aminotransferase, ALP – alkaline phosphatase a The severity of adverse reactions was assessed using CTCAE v5.0. b 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. 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 Additional clinically significant laboratory abnormality: Increased Creatine Phosphokinase (CPK)

What is ROMVIMZA used for?
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 …

Who makes ROMVIMZA?
Deciphera Pharmaceuticals, LLC is the labeler of record for ROMVIMZA.

What form does ROMVIMZA come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ROMVIMZA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has ROMVIMZA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.