Romvimza (Oral)
Vimseltinib is used in adults to treat giant cell tumor of the tendon sheath (also called tenosynovial giant cell tumor) that is not likely to improve with surgery.
Vimseltinib may also be used for purposes not listed in this medication guide.
uses
What is Romvimza (Oral) used for?
- Nodular Tenosynovitis
warnings
What is the most important information I should know about Romvimza (Oral)?
Tell your doctor if you have or have ever had:
- an allergy to aspirin or food dye (tartrazine or sunset yellow fcf); or
- liver disease.
Vimseltinib can harm an unborn baby if the mother or the father is using this medicine.
- If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 month after your last dose.
- If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 month after your last dose.
- Tell your doctor right away if a pregnancy occurs.
Vimseltinib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
Do not breastfeed while using this medicine, and for at least 1 month after your last dose.
Side Effects
What are the side effects of Romvimza (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- rash; or
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your treatments may be reduced, delayed, or permanently discontinued if you have certain side effects.
Common side effects may include:
- abnormal lab tests;
- swelling around your eyes;
- tiredness;
- rash, itching; or
- swelling in your face, hands, or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Romvimza (Oral) if I’m pregnant or breastfeeding?
Do not breastfeed while using this medicine, and for at least 1 month after your last dose.
Interactions
What drugs and food should I avoid while taking Romvimza (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Romvimza (Oral)?
Use Romvimza (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Do not change your dose or stop taking this medicine without your doctor's advice.
Vimseltinib is usually taken twice per week, with at least 72 hours between doses.
You may take vimseltinib with or without food. Follow your doctor's instructions.
Swallow the capsule whole and do not crush, chew, break, or open it.
If you vomit within 30 minutes of taking vimseltinib, take another dose. If you vomit more than 30 minutes of taking vimseltinib, do not take another dose. Take your next dose as scheduled.
You will need frequent blood tests to check your liver function before and during treatment with vimseltinib. Your next dose may be reduced, delayed, or permanently discontinued based on the results.
Your doctor will need to check your progress on a regular basis.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using vimseltinib.
Store in the original container at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if you are more than 48 hours late for the dose. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Romvimza (Oral)?
Images
DCV30
Color: blue/white
Shape: capsule
Imprint: DCV30
DCV14
Color: orange/white
Shape: capsule
Imprint: DCV14
DCV20
Color: yellow/white
Shape: capsule
Imprint: DCV20