Nirogacestat (nye-roe-GAY-se-stat)

Treats progressing desmoid tumor.

Brand Name(s):

Ogsiveo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine or vomit after taking a dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some food and medicines can affect how nirogacestat works. Tell your doctor if you are using clarithromycin, efavirenz, erythromycin, fluconazole, itraconazole, ketoconazole, midazolam, or rifampin.
• If you are taking an antacid containing calcium or stomach medicine (including famotidine, omeprazole), take it at least 2 hours before or 2 hours after you take nirogacestat.
• Do not drink grapefruit juice or eat grapefruit, Seville oranges, or starfruit with this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may give you a pregnancy tests to make sure you are not pregnant before using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose.
• Do not breastfeed during treatment and for 1 week after the last dose.
• Tell your doctor if you have liver disease.
• This medicine may cause the following problems:
  • Ovary problems
  • Liver problems
  • Non-melanoma skin cancer
  • Electrolyte problems
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody diarrhea, fever, stomach cramps
• Chills, cough, runny or stuffy nose, sore throat, body aches
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps, uneven heartbeat
• Hot flashes, night sweats, vaginal dryness
• Persistent non-healing sore, pink growth, shiny bump, white, yellow or waxy scar-like area

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Headache
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088