Romvimza is a medicine called a kinase inhibitor that is used to treat tenosynovial giant cell tumor (TGCT) that may be made worse by surgery. TGCT is a condition where tumors form in joints of the body and cause swelling, pain, and loss of motion. Romvimza can help improve your pain and movement and can help shrink your tumors.
How Does Romvimza Work for TGCT?
Romvimza works by targeting certain proteins in the body called kinases, which are present on the tumor cells. These kinases, called colony-stimulating factor 1 receptors (CSF1R), release signals that bring other inflammation-causing cells to the tumor site. By blocking CSF1R, Romvimza stops the signal to recruit these inflammatory cells and helps decrease symptoms of TGCT.
How Will I Take Romvimza?
Romvimza is a capsule that you swallow. It is usually taken by mouth twice weekly 72 hours apart. You should take your dose on the same days each week. If you miss a dose by 48 hours or less or vomit within 30 minutes of taking your dose, you should take another dose as soon as possible. If you miss a dose by more than 48 hours or vomit more than 30 minutes after your dose, you should not take another dose and take the next dose on its regularly scheduled day. You should not open, break, or chew capsules.
You may need a different dose of Romvimza if you have liver problems or certain side effects. Your health care provider will tell you what dose of Romvimza is right for you.
Your health care provider may pause or discontinue your Romvimza if you are taking certain medications. You should tell your health care provider about all of the medications or supplements that you are taking.
Who Can Take Romvimza?
You can take Romvimza if you have symptoms from your TGCT and having surgery would make the symptoms worse or cause other serious problems. You can take Romvimza regardless of whether or not you have had prior surgery for your TGCT or have taken other prescription or over-the-counter medicines to treat your TGCT or the symptoms caused by TGCT.
How Was Romvimza Studied?
Romvimza was studied in people who had TGCT that would be made worse by surgery. People in this trial got either Romvimza or a placebo twice a week. The study looked at objective response rate (ORR) at week 25, which measured how effective Romvimza was by looking at the percentage of people who had either a partial response (PR) or complete response (CR) to Romvimza. A CR is when all of the tumor has disappeared and a PR is when the tumor has decreased in size by at least 30%. The study also looked at the range of motion (ROM) response rate, which measured how much the ROM was improved after treatment, and change from baseline in the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) scores and response of at least a 30% improvement in the mean Brief Pain Inventory (BPI) Worst Pain numeric rating scale (NRS). The PROMIS-PF and BPI are both patient reported measures that help to assess how well people can perform their daily living activities and how bad their pain is. There were 123 people in this study and there were twice as many people in the Romvimza group. The median age was 44 (range 20 to 78). Fifty-nine percent of people were female and 41% were male. Sixty-five percent of people were White, 4% were Asian, 3% were Black or African American, and 28% were not reported or unknown. The majority of people (74%) had prior surgery, and most of the people in this trial had TGCT that was located in their knee (67%), ankle (12%), or hip (10%).
People who got Romvimza had a significantly better response rate compared to placebo. Forty percent of people in the Romvimza group had a response, and of those people, 35% had a PR and 5% had a CR. This means that 40% of people had their tumor shrink by at least 30%. More people in the Romvimza group also saw improvements in their ROM than in the placebo group (18.4% vs. 3.8%). In addition, people taking Romvimvza had a significant improvement in PROMIS-PF (43% vs. 25%) and BPI-30 worst pain (48% vs. 23%) scores, which means they saw improvement in both their physical functioning and pain.
What Are Other Unique Considerations to Be Aware Of?
Romvimza may cause serious side effects such as problems with your liver. You should tell your health care provider if you have any signs of liver damage such as yellow skin or whites of your eyes, dark urine (pee), right upper belly pain, feeling more tired than usual, have less appetite than usual, or have nausea, vomiting, fever, rash or itching.
Romvimza may cause an allergic reaction for people who are allergic to certain types of food coloring, such as FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (Sunset Yellow FCF). One or both of these may be present in the Romvimza capsules you are taking. FD&C Yellow No. 5 can cause allergic-type reactions, such as a reaction in your lungs in certain people, especially people who are also allergic to aspirin. FD&C Yellow No. 6 can also cause allergic reactions. Contact your health care provider right away if you have any of the symptoms of an allergic reaction such as hives, rash, or breathing problems.
What Are the Possible Side Effects of Romvimza, and How Can I Prevent or Manage Them?
The most common side effects of Romvimza are swelling of tissues in the face and around the eyes (periorbital edema), swelling in hands or feet (peripheral edema), feeling tired (fatigue), rash or itchy skin (pruritus), and decreased white blood cells (neutropenia).
Edema (swelling) specifically around the face and eyes or in the hands and feet can happen while you are taking Romvimza. Edema happens when the fluid from your blood vessels leak into a tissue and cause swelling. There are some things you can do to decrease your swelling and help with your symptoms. You can avoid eating foods that are high in salt, since salt can increase your swelling. You can wear compression stockings to help with swelling in your legs and feet. You can try raising the part of your body that is swollen above your heart several times a day. Ask your health care provider about exercises that may help decrease your swelling. They may also give you medicine to help your body get rid of the extra fluid.
Feeling tired is a common side effect of Romvimza, but there are some things you can do to help increase your energy. Exercising each day, even if it is just for a short time, can help boost your energy. Eating a healthy diet of fruits, vegetables, lean protein, and whole grains while avoiding sugary foods may also help you fight fatigue.
Romvimza can cause low blood counts such as low white blood cells (neutropenia). Neutropenia can cause severe infections. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk for getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough. They may prescribe you medicine to treat your infection. You should contact your health care provider if you have these symptoms so your blood counts can be monitored.
Skin reactions such as rash and itchy skin (pruritus) are common side effects of Romvimza. If you develop a rash, you should contact your health care provider. They may recommend creams or antihistamines to help with your rash and itchiness. You may also be given a corticosteroid to treat your rash.
What Interactions Can Happen With Romvimza?
Romvimza may affect the blood levels of other medicines. This may increase side effects of these other medicines. Tell your health care provider if you are taking dabigatran (a blood thinner) or any other medicines that are considered P-glycoprotein (Pgp) substrates, breast cancer resistance protein (BCRP) substrates, or organic cation transporter 2 (OCT2) substrates.
This is not a complete list of medicines that may interact with Romvimza. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions with Romvimza or if you need a dosage adjustment.
Is There a Cost Savings Program?
There is a copay savings program available from the drugmaker that may cost you as little as $0 for your monthly copay for your Romvimza prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting www.romvimza.com/get-support or calling 833‑432‑2237.
