OGSIVEO

Generic Name/API: nirogacestat

Manufacturer: SpringWorks Therapeutics, Inc.

Dosage Forms & Strength & Pack Size:
Tablets are round, orange, film-coated, and debossed with “50” on one face. Each tablet contains
50 mg nirogacestat. 180’s Tablets.

Storage:
Store at 20°C-25°C (68°F-77°F). Excursions permitted between 15°C-30°C (59°F-86°F). See
USP Controlled Room Temperature.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
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.

Important Safety Information

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.
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 during treatment and for 1 week after the last dose. Talk to your healthcare provider about 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 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.

How should I take OGSIVEO?

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.
Take OGSIVEO 2 times a day with or without food.
Swallow OGSIVEO tablets whole. Do not break, crush, or chew.
If you take an antacid medicine, take OGSIVEO 2 hours before or 2 hours after the antacid.
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.
What should I avoid while taking OGSIVEO?

Avoid eating or drinking grapefruit products, Seville oranges, and starfruit during treatment with OGSIVEO.

What are the possible side effects of OGSIVEO?

OGSIVEO can cause serious side effects, including:

Diarrhea. Diarrhea is common with OGSIVEO and may sometimes be severe. Your healthcare provider may tell you to drink more fluids or 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. 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 hot flashes, night sweats, or vaginal dryness during treatment.
Liver problems. OGSIVEO can increase liver enzymes. Your healthcare provider will do blood tests to check your liver function before you start and during 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 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

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