Pronunciation:

nye-roe-GAY-se-stat

Brand Names:

• Ogsiveo

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Nirogacestat is used to treat progressing desmoid tumors in patients who require systemic treatment.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nirogacestat in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nirogacestat in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abemaciclib
• Acalabrutinib
• Alfentanil
• Amprenavir
• Apalutamide
• Aprepitant
• Astemizole
• Atazanavir
• Axitinib
• Boceprevir
• Bosentan
• Bosutinib
• Brigatinib
• Carbamazepine
• Cenobamate
• Ceritinib
• Cimetidine
• Ciprofloxacin
• Cisapride
• Clarithromycin
• Clindamycin
• Clobazam
• Clofazimine
• Cobicistat
• Cobimetinib
• Colchicine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Darunavir
• Dasatinib
• Dexlansoprazole
• Dihydroergotamine
• Diltiazem
• Dipyrone
• Docetaxel
• Dofetilide
• Dronedarone
• Duvelisib
• Ebrotidine
• Efavirenz
• Elagolix
• Entrectinib
• Enzalutamide
• Ergotamine
• Erythromycin
• Esomeprazole
• Etravirine
• Everolimus
• Famotidine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivosidenib
• Ketoconazole
• Lansoprazole
• Letermovir
• Levomethadyl
• Lomitapide
• Lonafarnib
• Lorlatinib
• Lumacaftor
• Midostaurin
• Mifepristone
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Neratinib
• Netupitant
• Nilotinib
• Nizatidine
• Olaparib
• Omeprazole
• Oxycodone
• Paclitaxel
• Pantoprazole
• Paritaprevir
• Pazopanib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Posaconazole
• Primidone
• Proguanil
• Quinidine
• Quinine
• Rabeprazole
• Ranitidine
• Ranitidine Bismuth Citrate
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Roxatidine
• Ruxolitinib
• Saquinavir
• Schisandra sphenanthera
• Sirolimus
• Sonidegib
• St John's Wort
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telithromycin
• Telotristat Ethyl
• Temsirolimus
• Thioridazine
• Tolvaptan
• Trimipramine
• Troleandomycin
• Tucatinib
• Verapamil
• Voriconazole
• Voxelotor
• Zanubrutinib

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Bitter Orange
• Grapefruit Juice
• Starfruit

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using 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.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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

You may take this medicine with or without food.

If you are taking an antacid containing calcium or stomach medicine (eg, 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For the treatment of progressing desmoid tumor:
    • Adults—150 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking your dose, skip that dose and take the next dose at your regular schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause diarrhea, and in some cases it can be severe. Your doctor may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor. Call your doctor right away if you have stomach pain, or mucus or blood in your stool.

This medicine may cause ovarian problems. Check with your doctor if you have changes in menstrual cycle, hot flashes, night sweats, or vaginal dryness.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Check with your doctor right away if you have stomach pain, pale stools or dark urine, loss of appetite, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause non-melanoma skin cancer. Check with your doctor right away if you have persistent non-healing sore, pink growth, reddish patch or irritated area, shiny bump, or white, yellow or waxy scar-like area.

This medicine may cause electrolyte problems, including hypophosphatemia (low phosphate in the blood) and hypokalemia (low potassium in the blood). Check with your doctor right away if you have bone pain, decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trouble breathing, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloody nose

body aches or pain

burning, itching, and pain in hairy areas, pus at root of the hair

chills

cough

diarrhea

ear congestion

fever

general feeling of discomfort or illness

headache

hot flashes

joint pain

loss of appetite

muscle aches and pains

night sweats

persistent non-healing sore

pink growth

reddish patch or irritated area

shiny bump

shivering

sneezing

sore throat

stuffy or runny nose

sweating

trouble breathing

trouble sleeping

unusual tiredness or weakness

vaginal dryness

vomiting

white, yellow or waxy scar-like area

Incidence not known

Bone pain

dark urine

decreased urine

dry mouth

increased thirst

irregular heartbeat

mood changes

nausea

numbness or tingling in the hands, feet, or lips

seizures

stomach pain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Loss or thinning of the hair

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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