Nirogacestat

Nirogacestat is used in adults to treat progressing desmoid tumors, which are a type of soft-tissue noncancerous tumor.

Nirogacestat may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take nirogacestat twice a day with or without food.

You may be given medication to prevent certain side effects.

If you vomit shortly after taking nirogacestat, do not take another dose. Take your next dose as scheduled.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood will need to be tested often.

You may need skin exams before and during treatment with nirogacestat.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines, have any medical conditions, or have allergies.

Tell your doctor if you have:

• liver disease.

Nirogacestat can harm an unborn baby if either the mother or the father is using nirogacestat.

• If you are a woman, you may need a pregnancy test to confirm that you are not pregnant. Use birth control while taking this medicine and for at least 1 week after your last dose.
• If you are a man, use birth control if your partner can become pregnant. Continue using birth control for at least 1 week after your last dose.
• Inform your doctor immediately if a pregnancy occurs. Do not use this medicine if you are pregnant.

Nirogacestat may affect fertility in both men and women. It could be more difficult to get pregnant while either parent is using this medicine.

Do not breastfeed while taking this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Nirogacestat may cause serious side effects. Call your doctor immediately if you have:

• diarrhea that does not go away after taking antidiarrheal medicines and lasts longer than a few days;
• changes in your menstrual periods, hot flashes, night sweats, or vaginal dryness;
• changing or new skin lesions;
• shortness of breath;
• signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest; 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 treatment may be changed or temporarily or permanently stopped if you have certain side effects.

Common side effects of nirogacestat may include:

• tiredness;
• rash;
• hair loss;
• headache;
• mouth sores;
• nausea, stomach pain;
• cough, shortness of breath; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Usual Adult Dose for Fibromatosis:

150 mg orally twice a day Duration of therapy: Until disease progression or unacceptable toxicityUse: For the treatment of progressing desmoid tumors in patients who require systemic therapy

Skip the missed dose and take your next dose at the usual time. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit, starfruit, and Seville oranges may interact with nirogacestat and cause side effects. Avoid consuming grapefruit, starfruit, or Seville orange products.

Avoid taking an antacid within 2 hours before or after you take nirogacestat.

Sometimes, it is not safe to use certain medicines together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect nirogacestat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.