ROMVIMZA

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 ...

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 ver...

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...

None. None ( 4 )

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 ...

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 ROMVIMZ...