Loading…
Romvimza is a brand name for Vimseltinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a healthcare professional experienced in the diagnosis and treatment of conditions for which ROMVIMZA is indicated. Posology Recommended dose The recommended dose of ROMVIMZA is 30 mg taken twice weekly at least 72 hours apart as long as benefit is observed or until unacceptable toxicity.
If the patient misses a dose of ROMVIMZA by less than 48 hours, the patient should be instructed to take the missed dose as soon as possible and return to the usual dosing schedule. If the patient misses a dose of ROMVIMZA by more than 48 hours, the patient should be instructed not to take the missed dose and return to the usual dosing schedule.
Dose reduction Dose interruptions or dose reductions may be required based on individual safety and tolerability. If patients are unable to tolerate a 30 mg dose of ROMVIMZA, treatment with ROMVIMZA should be temporarily withheld. When the clinical condition of the patient improves, a reduced dose of ROMVIMZA should be given as described in Table 1.
Table 1:
Recommended dose reduction Dose reduction Twice weekly dose First 20 mg Second 14 mg ROMVIMZA should be discontinued in patients unable to tolerate a 14 mg dose of vimseltinib. 2). No clinical data are available in patients with severe renal impairment.
2). Hepatic impairment No dose adjustment is recommended in patients with mild hepatic impairment (Child-Pugh A). Dose reductions to 14 mg twice weekly for patients with mild hepatic impairment have not been used and efficacy has not been established.
No clinical data are available in patients with moderate and severe hepatic impairment. 2). 2). Body weight Dose reductions to 14 mg twice weekly for patients of ≥ 115 kg body weight have not been used and efficacy has not been established.
3). 1). No clinical data are available. Method of administration ROMVIMZA is to be taken orally, with or without food. Prescribers should instruct patients to swallow the hard capsules whole and not to open, break or chew them. Patients should not ingest the hard capsules if they are broken, cracked, or otherwise not intact as the potential effects of these alterations have not been evaluated.
Summary of the safety profile The safety of ROMVIMZA is based on pooled data from 184 patients with TGCT who received ROMVIMZA at a dose of 30 mg twice weekly in 2 clinical studies. The MOTION study, a phase 3, 7 double-blind, multicentre, randomised (2:1), placebo-controlled study, included 122 adult patients who received vimseltinib (n = 83) or placebo (n = 39) in the double-blind period; 35 patients crossed over from placebo and received vimseltinib in the open-label period.
The phase 1/2 study DCC-3014-01-001 included a total of 66 patients with TGCT who received vimseltinib at a dose of 30 mg twice weekly. The median duration of treatment in the pooled safety population was 13 months. The median age of patients who received vimseltinib was 44 years (range from 20 to 78 years) and the population was 60% female and 72% White.
The most frequently observed adverse reactions were increased aspartate aminotransferase (AST) (92%), periorbital oedema (63%), increased cholesterol (53%), rash (51%), increased creatinine (43%), decreased neutrophils (36%), fatigue (30%), face oedema (28%), increased alanine aminotransferase (ALT) (27%), pruritus (27%), peripheral oedema (22%) and hypertension (21%).
5%). 5%). Permanent discontinuation due to an adverse reaction occurred in 7% of patients. The most frequently observed adverse reactions leading to permanent discontinuation were rash (3%), periorbital oedema (2%), neuropathy (1%) and pruritus (1%).
Dose reductions or interruptions due to an adverse reaction occurred in 59% of patients. The most frequently observed adverse reactions leading to dose reductions or interruptions were rash (21%), periorbital oedema (18%), increased creatine phosphokinase (CPK) (17%), pruritus (10%), face oedema (7%), generalised oedema (7%), fatigue (6%) and peripheral oedema (5%).
Tabulated list of adverse reactions The adverse reactions are listed below by system organ class and frequency categories, defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Long-term safety The long-term safety of ROMVIMZA has not been established. ROMVIMZA has a novel mechanism of action by inhibition of the colony stimulating factor 1 receptor (CSF1R). The long-term implications of the resulting macrophage depletion, particularly in organs such as the liver, skin, central nervous system and bone marrow are currently uncertain.
Arterial hypertension Treatment with ROMVIMZA in clinical studies was frequently associated with an increase in blood pressure. Increase in creatinine Treatment with ROMVIMZA in clinical studies was frequently associated with an increase in creatinine.
The underlying reason is currently unknown. 3). Women should be advised to avoid pregnancy while taking vimseltinib. Pregnant women should be informed of the potential risk to the foetus. Women of childbearing potential must use effective contraception during treatment with vimseltinib and for 30 days after the final dose.
Effects of vimseltinib on hormonal contraceptives have not been studied. A barrier method contraception should be added if systemic contraceptives are used. Pruritus Pruritus has been reported in patients receiving vimseltinib. 8). Pruritus has also been reported after single doses of vimseltinib in healthy participants.
2). 5 Serum enzyme elevations Vimseltinib has been associated with serum enzyme elevations, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and creatine phosphokinase (CPK). Although currently these elevations did not result in any cases of liver injury or rhabdomyolysis in clinical studies, this is not excluded since experience in this rare clinical condition is very limited.
Thus, ROMVIMZA treatment should be avoided in patients with pre-existing serum transaminase elevations, total bilirubin or direct bilirubin elevations, or active liver or biliary tract disease. Patients should be monitored for liver function prior to the start of ROMVIMZA, once a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter.
1. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Table 2:
Adverse reactions observed in MOTION and DCC-3014-01-001 studies System organ class Frequency category Adverse reaction Nervous system disorders Very common Neuropathy1 Eye disorders Very common Periorbital oedema2, lacrimation increased Common Dry eye, vision blurred Vascular disorders Very common Hypertension Skin and subcutaneous tissue disorders Very common Rash3, pruritus, dry skin General disorders and administration site conditions Very common Peripheral oedema, fatigue, face oedema, generalised oedema Investigations4 Very common Blood creatine phosphokinase increased5, aspartate aminotransferase increased, blood cholesterol increased, blood creatinine increased, neutrophil 8 System organ class Frequency category Adverse reaction count decreased, alanine aminotransferase increased, alkaline phosphatase increased 1 Neuropathy comprises peripheral neuropathy, paraesthesia, hypoaesthesia, peripheral sensory neuropathy.
2 Periorbital oedema comprises eye oedema, eyelid oedema, swelling of eyelid, periorbital oedema, periorbital swelling. 3 Rash comprises rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, dermatitis acneiform, erythema.
4 Terms based on laboratory parameters. 5 Frequency category for blood creatine phosphokinase increased is based on laboratory data from DCC-3014-01-001 only. Description of selected adverse reactions Creatine phosphokinase (CPK) Consistent with the mechanism of action, increased CPK was reported during the MOTION study in vimseltinib-treated patients.
The frequency of increased CPK cannot be determined from the MOTION study because CPK was not assessed at baseline. In the phase 1/2 study conducted in 66 patients receiving vimseltinib 30 mg twice weekly, increased CPK was observed in all patients.
Other special populations Elderly No overall differences in safety were observed between patients ≥ 65 years of age and patients < 65 years of age. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Excipients with known effect Lactose ROMVIMZA contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sunset yellow FCF (E 110) ROMVIMZA 14 mg and 20 mg hard capsules contain sunset yellow FCF (E 110), which may cause allergic reactions.
Tartrazine (E 102) ROMVIMZA 20 mg hard capsules contain tartrazine (E 102), which may cause allergic reactions.