What is OGSIVEO?
OGSIVEO is the first and only FDA-approved treatment for adults with progressing desmoid tumors who require a medicine by mouth or injection (systemic therapy). It is not known if OGSIVEO is safe and effective in children.
OGSIVEO is an oral medication that you can take at home.
Before taking OGSIVEO
Tell your healthcare provider about all of your medical conditions, including if you:
- Have liver problems
- Are pregnant or plan to become pregnant. OGSIVEO can harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with OGSIVEO
Females who are able to become pregnant:
- Your healthcare provider will give you a pregnancy test before you start treatment with OGSIVEO
- You should use effective birth control (contraception) during treatment with OGSIVEO and for 1 week after the last dose. Talk to your healthcare provider about birth control methods that may be right for you
- Stop taking OGSIVEO and tell your healthcare provider right away if you become pregnant
Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with OGSIVEO and for 1 week after the last dose
- Are breastfeeding or plan to breastfeed. It is not known if OGSIVEO passes into your breast milk.
Do not breastfeed during treatment with OGSIVEO and for 1 week 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.
You should avoid taking proton pump inhibitors (PPIs) and H2 blockers during treatment with OGSIVEO. Ask your healthcare provider if you are not sure if you take one of these medicines.
Recognizing & Managing Side Effects
Let your doctor or care team know what you experience.
There may be supportive medicines or therapies they can recommend for certain side effects to help during treatment.
OGSIVEO can cause serious side effects, including:
DiarrheaDiarrhea is common during treatment with OGSIVEO, and may sometimes be severe. Your healthcare provider may tell you to drink more fluids or may tell you to take antidiarrheal medicines. Tell your healthcare provider right away if you have diarrhea that lasts longer than a few days and does not get better after taking antidiarrheal medicines.
Ovarian problems Females who are able to become pregnant may have ovarian problems and changes in their menstrual cycle during treatment with OGSIVEO. OGSIVEO may affect fertility which may affect your ability to have a child. Tell your healthcare provider if you have any changes in your menstrual cycle or any hot flashes, night sweats, or vaginal dryness during treatment with OGSIVEO.
Liver problems
OGSIVEO can cause an increase in liver enzymes. Your healthcare provider will do blood tests to check your liver function before you start and during your treatment with OGSIVEO.
New non-melanoma skin cancers
Your healthcare provider will do skin exams before and during treatment with OGSIVEO if you are at risk for skin cancer. Tell your healthcare provider if you have any new or changing skin lesions.
Electrolyte (salt) problems
Your healthcare provider will do blood tests to check your phosphate and potassium levels during treatment with OGSIVEO and may give you medicines to treat low phosphate or low potassium if needed. Tell your healthcare provider if you develop any muscle pain or weakness.
Tell your healthcare provider right away if you have any side effect that bothers you or that does not go away. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OGSIVEO.
The most common side effects of OGSIVEO are:
- Rash
- Nausea
- Tiredness
- Mouth sores
- Headache
- Stomach (abdominal) pain
- Cough
- Hair loss
- Upper respiratory infection
- Shortness of breath
OGSIVEO can affect fertility in females and males, which may affect your ability to have a child.
Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of OGSIVEO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of OGSIVEO
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
- Do not use OGSIVEO for a condition for which it is not prescribed
- Do not give OGSIVEO to other people even if they have the same symptoms you have. It may harm them
You can ask your healthcare provider or pharmacist for information about OGSIVEO that is written for
healthcare professionals.
How to take OGSIVEO
A convenient twice-daily schedule with OGSIVEO
Can be taken in the convenience of your home
Can be taken with or without food.
Avoid eating or drinking grapefruit products, Seville oranges, and starfruit during treatment with OGSIVEO.
Recommended dosage:
three 50 mg tablets, 2 times a day – a total of 6 tablets
Remember:
- Take OGSIVEO exactly as your healthcare provider tells you to take it
- Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OGSIVEO if you develop side effects
- Swallow OGSIVEO tablets whole. Do not break, crush, or chew tablets
- If you take an antacid medicine, take OGSIVEO 2 hours before or 2 hours after taking the antacid
- You should avoid taking proton pump inhibitors (PPIs) and H2 blockers during treatment with OGSIVEO. Ask your healthcare provider if you are not sure if you take one of these medicines
- If you vomit after taking a dose or miss a dose of OGSIVEO, take your next dose at your regular time. Do not take 2 doses of OGSIVEO to make up the dose
Questions about OGSIVEO
What should I avoid while taking OGSIVEO?
- Avoid eating or drinking grapefruit products, Seville oranges, and starfruit during treatment with OGSIVEO
- You should avoid taking proton pump inhibitors (PPIs) and H2 blockers during treatment with OGSIVEO. Ask your healthcare provider if you are not sure if you take one of these medicines
- If you take an antacid medicine, take OGSIVEO 2 hours before or 2 hours after taking the antacid
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How long will I take OGSIVEO?
You should take OGSIVEO as long as your doctor advises you to stay on treatment.
If I have side effects, do I need to stop taking OGSIVEO?
Tell your healthcare provider right away if you have any side effect that bothers you or that does not go away. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OGSIVEO if you develop side effects.
How do I store OGSIVEO?
- Store OGSIVEO tablets at room temperature between 68°F to 77°F (20°C to 25°C)
- Keep OGSIVEO and all medicines out of reach of children
What are the ingredients in OGSIVEO?
Active Ingredient: nirogacestat
Inactive Ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate type A.
Film Coat Ingredients: FD&C yellow #6/sunset yellow FCF aluminum lake, glycerol monocaprylocaprate type 1/mono/diglycerides, iron oxide yellow, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol – partially hydrolyzed, talc, and titanium dioxide.
Start the Conversation With Your Doctor
This guide lists questions and considerations to discuss with your doctor to learn if OGSIVEO may be right for you.
Access the OGSIVEO Patient Brochure
Learn important information about taking OGSIVEO. This helpful brochure can be shared with your care partner or family members, too.
Questions about insurance coverage or financial support?
If you have been prescribed OGSIVEO, ask your doctor to help you enroll in the SpringWorks CareConnections™ Patient Support Program, so you can have access to support. Call SpringWorks CareConnections at 844-CARES-55 (844-227-3755) Monday – Friday 8 am – 10 pm ET. Visit www.springworkstxcares.com