ROMVIMZA 30 mg/1
Vimseltinib · CAPSULE · Deciphera Pharmaceuticals, LLC
ROMVIMZA is a capsule containing vimseltinib at 30 mg/1, taken oral. Manufactured by Deciphera Pharmaceuticals, LLC.
Key Facts
- Brand Name
- ROMVIMZA
- Generic Name
- Vimseltinib
- NDC Code (Product)
73207-304- Manufacturer
- Deciphera Pharmaceuticals, LLC
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA219304
- Drug Class
- Kinase Inhibitor [EPC]
- Marketing Start
- 02/14/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 ) 2.1 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 Dose Modifications for Adverse Reactions The recommended dose reductions for adver…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 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. Concomitant use of vimseltinib with P-gp substrates may increase exposure of these substrates. ( 2.3 , 7.1 ) Breast Cancer Resistance Protein (BCRP) substrates : Avoid concomitant use of ROMVIMZA with BCRP substrates. Concomitant use of vimseltinib with BCRP substrates may increase exposure of these substrates. ( 7.1 ) Organic Cation Transporter 2 (OCT) substrates : Avoid concomitant use of ROMVIMZA with OCT2 substrates. Concomitant use of vimseltinib with OCT2 substrates may increase exposure of these substrates. ( 7.1 ) 7.1 Effects 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 i…
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. 6.1 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 cli…
Frequently Asked Questions
What is ROMVIMZA used for?
ROMVIMZA contains Vimseltinib. It is a capsule taken oral. Consult your doctor for specific uses.
Is ROMVIMZA a controlled substance?
ROMVIMZA is not classified as a controlled substance by the DEA.
What is the generic name for ROMVIMZA?
The generic name for ROMVIMZA is Vimseltinib. There are no other listed brand versions of Vimseltinib.
What is the NDC code for ROMVIMZA 30 mg/1?
The NDC (National Drug Code) for ROMVIMZA 30 mg/1 is 73207-304, listed by Deciphera Pharmaceuticals, LLC.
Other ROMVIMZA Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)