What foods should I avoid when taking ROMVIMZA?

There are no known dietary restrictions when taking ROMVIMZA.

How should I store ROMVIMZA?

Store ROMVIMZA capsules at room temperature between 20ºC to 25ºC (68ºF to 77ºF). Store ROMVIMZA capsules in the original blister pack until you are ready to take them. Do not store ROMVIMZA capsules in another container. The blister packs are child resistant. Keep ROMVIMZA and all medicines out of the reach of children.

What if I vomit or miss a dose?

If you miss a dose of ROMVIMZA by 48 hours or less, take the missed dose as soon as possible and take the next dose on its regularly scheduled day. If you miss your dose by more than 48 hours, skip the missed dose, and take the next dose on its regularly scheduled day. If you vomit within 30 minutes of taking a dose of ROMVIMZA, take another dose. If you vomit more than 30 minutes after taking your dose, do not take another dose and take the next dose on its regularly scheduled day.

Are there any allergic reactions to be aware of with ROMVIMZA?

ROMVIMZA 20 mg capsules contain the inactive ingredients FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (Sunset Yellow FCF). ROMVIMZA 14 mg capsules contain the inactive ingredient FD&C Yellow No. 6 (Sunset Yellow FCF). FD&C Yellow No. 5 (tartrazine) can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin. FD&C Yellow No. 6 (Sunset Yellow FCF) can also cause allergic reactions. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with ROMVIMZA.

How to take ROMVIMZA

ROMVIMZA is the only FDA-approved TGCT treatment with no known dietary restrictions

You can take ROMVIMZA with or without food

No planning meals around ROMVIMZA since there are no known dietary restrictions**There are no known restrictions on consuming grapefruit or dairy products.

Follow the dosing directions and schedule on your blister package and take ROMVIMZA on the same days each week

Convenient, 2x weekly dosing

Take ROMVIMZA twice weekly, at least 72 hours apart. You do not take it every day

Important dosing information

Take ROMVIMZA exactly as prescribed. Even if you are feeling better, do not discontinue treatment without first consulting your healthcare provider.

The recommended starting dose of ROMVIMZA is 30 mg, taken twice weekly

Do not remove ROMVIMZA capsules from their original packaging until you're going to take them
Swallow ROMVIMZA capsules whole. Do not open, break, or chew the capsules
Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment depending on how severe your side effects are
Do not change your dose or stop taking ROMVIMZA unless your healthcare provider tells you to
If you take more than the prescribed dose of ROMVIMZA, call your healthcare provider

What to know before taking ROMVIMZA

Tell your healthcare provider about all of your medical conditions, including if you:

Have or had liver problems
Are pregnant or plan to become pregnant. ROMVIMZA can harm your unborn baby
Are breastfeeding or plan to breastfeed. It is not known if ROMVIMZA passes into breast milk. Do not breastfeed during treatment with ROMVIMZA and for 1 month after the last dose

Have questions about taking ROMVIMZA? We have answers

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Receive important updates, information, and support designed to help you in your unique TGCT journey.

Important Safety Information

What is the most important information I should know about ROMVIMZA?

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,
2 times each month for the first 2 months of treatment,
then 1 time every 3 months for the first year of treatment and as clinically indicated thereafter.

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.

Tell your healthcare provider right away if you develop any signs or symptoms of liver problems during treatment with ROMVIMZA including yellowing of your skin or the white part of your eyes, dark urine, lack or loss of appetite, right upper stomach‑area (abdomen) pain or tenderness, feeling overly tired, nausea, vomiting, fever, rash, and itching.

Before taking ROMVIMZA, tell your healthcare provider about all of your medical conditions, including if you:

have or had liver problems.
are pregnant or plan to become pregnant. ROMVIMZA can harm your unborn baby.

Females who are able to become pregnant:

Your healthcare provider will do a pregnancy test before you start treatment with ROMVIMZA.
Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant or you think you may be pregnant during treatment with ROMVIMZA.

Males with female partners who are able to become pregnant:

Use effective birth control (contraception) during treatment with ROMVIMZA and for 1 month after the last dose.
Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during treatment with ROMVIMZA.

are breastfeeding or plan to breastfeed. It is not known if ROMVIMZA passes into your breast milk. Do not breastfeed during treatment with ROMVIMZA and for 1 month after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking ROMVIMZA with certain other medicines may affect the way that ROMVIMZA or the other medicine works and may increase your risk of side effects.

What are the possible side effects of ROMVIMZA?

ROMVIMZA can cause serious side effects.

Allergic reactions to FD&C Yellow No. 5 and FD&C Yellow No. 6. ROMVIMZA 20 mg capsules contain the inactive ingredients FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (Sunset Yellow FCF). ROMVIMZA 14 mg capsules contain the inactive ingredient FD&C Yellow No. 6 (Sunset Yellow FCF). FD&C Yellow No. 5 (tartrazine) can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin. FD&C Yellow No. 6 (Sunset Yellow FCF) can also cause allergic reactions. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with ROMVIMZA.

The most common side effects of ROMVIMZA include:

swelling around your eyes
tiredness
rash
increased cholesterol levels in your blood

swelling of your hands or feet
swelling of your face
decreased white blood cells
itchy skin

ROMVIMZA may cause fertility problems, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of ROMVIMZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is ROMVIMZA?

ROMVIMZA is a prescription medicine used to treat adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may make the symptoms worse or cause severe problems.

It is not known if ROMVIMZA is safe and effective in children.

Please click for the full Prescribing Information, including Medication Guide.