Nirogacestat

Generic name: nirogacestat [ NYE-roe-GAY-se-stat ]
Brand name: Ogsiveo
Dosage form: oral tablet (50 mg)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com on Jan 30, 2024. Written by Cerner Multum.

What is nirogacestat?

Nirogacestat is used in adults to treat a type of fibrous (connective) tissue tumors called desmoid-type fibromatosis (desmoid tumor).

Nirogacestat may also be used for purposes not listed in this medication guide.

Nirogacestat side effects

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

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

• diarrhea that does not go away after taking antidiarrheal medicines and lasting 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 discontinued 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.

Related/similar drugs

Ogsiveo

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

Tell your doctor if you have:

• liver disease.

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

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 week after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.

• Tell your doctor right away if a pregnancy occurs. Do not use this medicine if you are pregnant.

Nirogacestat may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

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

How should I take nirogacestat?

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.

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

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

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.

Nirogacestat dosing information

Usual Adult Dose for Fibromatosis:

150 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For the treatment of progressing desmoid tumors in patients who require systemic therapy

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

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

What should I avoid while taking nirogacestat?

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.

What other drugs will affect nirogacestat?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, 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 use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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