Vimseltinib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Vimseltinib is a kinase inhibitor that is FDA approved for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.. Common adverse reactions include laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
FDA-labeled Indications
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.
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.
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.
'Dose Modifications for Adverse Reactions' The recommended dose reductions for adverse reactions are provided in the table on the right.
'Doasage Modifications 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vimseltinib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Vimseltinib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Vimseltinib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Vimseltinib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Vimseltinib in pediatric patients.
Contraindications
None.
Warnings
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.
- 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.
Embryo-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.
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.
- 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.
Increased 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.
- During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.
Adverse Reactions
Clinical Trials Experience
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.
- 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.
Postmarketing Experience
There is limited information regarding Vimseltinib Postmarketing Experience in the drug label.
Drug Interactions
P-glycoprotein (P-gp)substrates
- 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 unless otherwise recommended in the substrate Prescribing Information.
- This recommendation is based upon a mechanistic understanding of vimseltinib pharmacokinetics and it being a P-gp inhibitor in vitro. 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
- 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.
- This recommendation is based upon a mechanistic understanding of vimseltinib pharmacokinetics and it being a BCRP inhibitor in vitro. 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
- 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.
- This recommendation is based upon a mechanistic understanding of vimseltinib pharmacokinetics and it being an OCT2 inhibitor in vitro. Concomitant use of ROMVIMZA with OCT2 substrates may increase exposure of these substrates; however, this has not been studied clinically.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): 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.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.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vimseltinib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Vimseltinib during labor and delivery.
Nursing Mothers
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.
Pediatric Use
The safety and effectiveness of ROMVIMZA in pediatric patients have not been established.
Geriatic 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.
Gender
There is no FDA guidance on the use of Vimseltinib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Vimseltinib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Vimseltinib in patients with renal impairment.
Hepatic Impairment
No dose adjustment is recommended for patients with mild (bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (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.
Females of Reproductive Potential and Males
ROMVIMZA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations.
- 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.
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.
- Infertility
Females and Males Based on findings from animal studies, ROMVIMZA may impair fertility.
Immunocompromised Patients
There is no FDA guidance one the use of Vimseltinib in patients who are immunocompromised.
Administration and Monitoring
Administration
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.
Monitoring
There is limited information regarding Vimseltinib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Vimseltinib and IV administrations.
Overdosage
There is limited information regarding Vimseltinib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Vimseltinib Pharmacology in the drug label.
Mechanism 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.
Structure
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 C23H25N7O2 • 2 H2O, and the molecular weight is 467.52 g/mol. The chemical structure is:
Pharmacodynamics
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 Elecrophysiology
- 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.
Pharmacokinetics
- 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 (Cmax) 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 (AUC0-inf) is 46,900 ng•h/mL (45%) after a single dose and AUC0-24hr is 13,400 ng•h/mL (45%) at steady state.
- Vimseltinib pharmacokinetics are dose-proportional.
- Vimseltinib median time to Cmax (Tmax) is 1 hour (0.5 to 4 hours).
- 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.
- Vimseltinib volume of distribution (V/F) is 90 L (16%). Vimseltinib is 96.5% bound to human plasma proteins.
- Vimseltinib elimination half-life (t1/2) is approximately 6 days (32%) with a clearance (CL/F) of 0.5 L/h (23%).
- 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.
- Approximately 43% of the dose was recovered in feces (9.1% unchanged) and 38% in urine (5.1% unchanged) after a single radiolabeled dose.
- 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.
- Clinical Studies and Model-Informed Approaches
P-glycoprotein (P-gp) inhibitors: Dabigatran (a P-gp substrate) AUC0-inf and Cmax are predicted to increase 2- to 3-fold with concomitant use with vimseltinib 30 mg twice weekly.
Dabigatran Cmax and AUC0-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, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
Vimseltinib is not an inducer of CYP1A2, CYP2B6, or CYP3A4.
- Transporter systems: Vimseltinib is a P-gp substrate but is not a substrate of BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, and MATE2-K.
Vimseltinib inhibits P-gp, BCRP, BSEP, OATP1B1, OATP1B3, OCT2, BSEP, MATE1, and MATE2-K. Vimseltinib does not inhibit OAT1 and OAT3. Vimseltinib may increase serum creatinine by decreasing renal tubular secretion of creatinine; this may occur due to inhibition of renal transporters OCT2 and MATE1 and may not affect renal function.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
- In a 6-month transgenic mouse carcinogenicity study at doses up to 12.5 mg/kg/day, vimseltinib was negative for carcinogenic findings.
- In a 2-year rat carcinogenicity study, female rats were orally administered vimseltinib at doses of 0.15, 0.45, or 1.5 mg/kg/day.
- There was no evidence of vimseltinib-related neoplasms in female rats. Male rats were orally administered vimseltinib at doses of 0.1, 0.3, or 1.0 mg/kg/day.
- There was a statistically significant increase in the combined incidence of benign and malignant pheochromocytomas in the adrenal gland of male rats administered 1.0 mg/kg/day (approximately 1.4 times the exposure at the recommended dose based on AUC).
- The relevance of this finding to human carcinogenic risk is not known. In male rats receiving 1.0 mg/kg/day, two out of sixty rats were identified as having sarcomas in the synovium of the femorotibial joint. The sarcoma finding was not statistically significant and its relevance to human carcinogenic risk is not known.
- Vimseltinib was not mutagenic in the bacterial reverse mutation assay (Ames). In an in vitro micronucleus assay, vimseltinib increased micronuclei after a 24 -hour incubation in the absence of metabolic activation.
- In vivo, vimseltinib administered to rats at doses up to 200 mg/kg/day did not increase bone marrow micronucleated polychromatic erythrocytes, nor did vimseltinib increase liver DNA strand breaks.
- In a fertility and early embryonic development study, male rats were administered 1, 2.5, or 5 mg/kg/day of vimseltinib starting 10 weeks before cohabitation, during cohabitation with untreated females, and at least 2 weeks post-cohabitation. Lower epididymal and testes weights were observed at 5 mg/kg/day (approximately 12 times the exposure at the recommended dose based on AUC).
- There were no treatment-related effects on mating, fertility, or sperm parameters at any dose tested. Female rats were administered 2.5, 5, or 10 mg/kg/day of vimseltinib 2 weeks prior to cohabitation with untreated males and during cohabitation until gestational day 7.
- Although there were no treatment-related effects on mating or estrous cycles, vimseltinib administered daily resulted in post-implantation loss at 10 mg/kg/day in female rats (approximately 20 times the exposure at the recommended dose based on AUC).
- In a 26-week repeat-dose general toxicology study, recovery male rats that were administered 2.5 or 5 mg/kg/day had moderate to marked reductions in sperm and marked testicular atrophy (1 of 5 and 2 of 5 animals, respectively) corresponding to approximately 6 and 12 times the exposure at the recommended dose based on AUC, respectively.
- In a 39-week repeat-dose general toxicology study, minimal to moderate epididymal mineralization occurred in male dogs administered ≥4 mg/kg/day corresponding to exposures lower than the exposure at the recommended dose based on AUC.
Clinical Studies
- The efficacy of ROMVIMZA was evaluated in MOTION (NCT05059262), a phase 3, double-blind, multicenter, randomized (2:1), placebo-controlled study in patients with TGCT for whom surgical resection may cause worsening functional limitation or severe morbidity. Eligible patients had a confirmed diagnosis of TGCT with measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) with at least one lesion having a minimum size of 2 cm.
- Patients were randomized to placebo or ROMVIMZA 30 mg twice weekly for 24 weeks. Randomization was stratified by tumor location (lower limb versus all other) and region (United States [US] versus non-US). At Week 25, patients who completed the double-blind, randomized part of the trial were eligible to advance to an ongoing, open-label extension study in which all patients received ROMVIMZA.
- The major efficacy outcome measure was overall response rate (ORR) as assessed by blinded independent radiological review (IRR) per RECIST v1.1 at Week 25.
- Additional efficacy outcomes measured at Week 25 included ORR as assessed using tumor volume score (TVS), mean change from baseline in active range of motion of the affected joint at Week 25 measured by goniometry assessments, change from baseline in the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) 15-item score (upper and lower extremity items), and response of at least a 30% improvement in the mean Brief Pain Inventory (BPI) Worst Pain numeric rating scale (NRS) score without a 30% or greater increase in narcotic analgesic use.
- A total of 123 patients were randomized: 83 to ROMVIMZA and 40 to placebo during the double-blind period of the study. The median age was 44 years (range 20 to 78 years); 59% of patients were female; 65% were White, 4% were Asian, 3% were Black or African American, and 28% were not reported or unknown; 69% were not Hispanic or Latino, 3% were Hispanic or Latino, and 28% were not reported or unknown; 74% of patients had prior surgery; 69% of patients had diffuse TGCT; and 23% of patients were previously treated with systemic therapy. Disease locations were knee (67%), ankle (12%), hip (10%), other (5%), foot (3.3%), and wrist (2.4%).
How Supplied
- 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.
Storage
There is limited information regarding Vimseltinib Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Vimseltinib |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Vimseltinib |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.
- 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. 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. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 month after the last dose of ROMVIMZA.
- Lactation
Advise females not to breastfeed during treatment with ROMVIMZA and for 1 month after the final dose.
- 'Infertility
Advise patients that ROMVIMZA may impair fertility.
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. Advise patients ROMVIMZA 14 mg and ROMVIMZA 20 mg contains FD&C Yellow No. 6 (Sunset Yellow FCF) which may cause allergic-type reactions.
- Administration
Instruct patients that doses should be taken twice weekly at least 72 hours apart. Instruct patients to swallow capsules whole (do not open, break, or chew)
- Drug Interactions
Advise patients to inform their healthcare providers of all concomitant products, including over-the-counter products and supplements.
Precautions with Alcohol
Alcohol-Vimseltinib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Vimseltinib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Vimseltinib Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.