ROMVIMZA has a proven and
manageable safety profile
ROMVIMZA has a proven and
manageable safety profile
The majority (95%) of side effects reported with ROMVIMZA were mild or moderate
In the MOTION study, the side effects in ≥10% of patients were:
| Adverse Reaction* | ROMVIMZA N=83 | Placebo N=39 | ||
| All Grades (%) | Grades 3 or 4 (%) | All Grades (%) | Grades 3 or 4 (%) | |
| Eye disorders | ||||
| Periorbital edema † | 60 | 3.6 | 21 | 0 |
| Lacrimation increased | 12 | 0 | 0 | 0 |
| Dry eye† | 10 | 0 | 0 | 0 |
| General disorders and administration site conditions | ||||
| Fatigue† | 59 | 1.2 | 38 | 2.6 |
| Peripheral edema† | 33 | 1.2 | 8 | 0 |
| Face edema | 31 | 1.2 | 8 | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash† | 47 | 3.6 | 5 | 0 |
| Pruritus | 29 | 2.4 | 8 | 0 |
| Vascular disorders | ||||
| Hypertension | 17 | 4.8 | 10 | 2.6 |
| Nervous system disorders | ||||
| Neuropathy† | 12 | 1.2 | 2.6 | 0 |
*The severity of adverse drug reactions was assessed using CTCAE Version 5.0.
†Includes multiple related terms.
The majority of lab abnormalities were mild-to-moderate
No patients stopped because of lab abnormalities in MOTION
| Laboratory Abnormality‡ | ||||
| Vimseltinib N=83 | Placebo N=39 | |||
| All Grades (%) | Grades 3 or 4 (%) | All Grades (%) | Grades 3 or 4 (%) | |
| Increased AST | 92 | 0 | 11 | 0 |
| Increased cholesterol | 43 | 0 | 16 | 0 |
| Decreased neutrophils | 31 | 1 | 3 | 0 |
| Decreased leukocytes | 29 | 0 | 8 | 0 |
| Increased ALT | 24 | 0 | 16 | 0 |
The severity of adverse drug reactions was assessed using CTCAE Version 5.0.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events.
Increased liver enzymes in your blood are common with ROMVIMZA- If you develop liver problems during treatment with ROMVIMZA, your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment depending on how severe your liver problems are
Tenosynovial giant cell tumor (TGCT) treatment with a manageable safety profile
- No cases of drug-induced liver damage were reported by patients taking ROMVIMZA in the MOTION study
- ROMVIMZA can cause serious side effects, including liver problems. Increased liver enzymes in your blood are common with ROMVIMZA. Your healthcare provider will do blood tests to check for liver problems before starting treatment with ROMVIMZA and during treatment.
- No hair color changes were seen in patients taking ROMVIMZA in the MOTION study
- Use with any birth control-even hormonal. Use effective birth control during treatment with ROMVIMZA and for 1 month after the last dose.
ROMVIMZA does not require a REMS program§
§ Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
Most patients were able to start and stay on ROMVIMZA in the MOTION study
In the primary analysis:
- 4.8% of patients stopped using ROMVIMZA because of side effects (4 out of 83 people)
- 39% of patients who took ROMVIMZA lowered their dose, but were able to stay on treatment
- 40% of patients had a dose interruption because of an adverse reaction or lab abnormality, but were able to stay on treatment
After 2 years of follow-up data, no new safety concerns were identified in the MOTION study
Ask about ROMVIMZA
Our doctor discussion guide can help guide the conversation
between you and your care team.
