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Overview: Ogsiveo is used to stop the growth of desmoid tumors. Common side effects include diarrhea, rash, mouth sores, headache, stomach upset, cough, shortness of breath, and hair loss. Contact your health care provider right away if you have severe diarrhea, diarrhea that does not go away after three days, changes in your menstrual cycle, hot flashes, night sweats, vaginal dryness, yellowing of your eyes or skin, other skin changes, weakness, or muscle pain.

Uses

What is Ogsiveo used for?

Ogsiveo (nirogacestat) is commonly used to treat growing desmoid tumors in certain people.

Desmoid tumors  are benign (not cancerous) and are found in the tissue that makes up your tendons and ligaments.

Ogsiveo may also be used for other conditions as determined by your health care provider.

How does Ogsiveo work (mechanism of action)?

Cells within a desmoid tumor can grow out of control. Tumor cells can keep growing if they get certain signals. Ogsiveo blocks a substance called gamma secretase. This substance activates certain signals for cell growth. By blocking gamma secretase, Ogsiveo may slow or stop the growth of a desmoid tumor.

How is Ogsiveo supplied (dosage forms)?

Brands and other names

  • Ogsiveo

Dosage forms and strengths

  • 50 mg, 100 mg, and 150 mg oral tablets

How should I store Ogsiveo?

Ogsiveo should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

If your medicine comes in a blister pack, do not remove tablets from blister packs until ready to take.

Side Effects

What are the most common side effects of Ogsiveo?

The most common side effects of Ogsiveo are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea (see below)
  • Problems with the ovaries
  • Rash
  • Nausea
  • Tiredness
  • Mouth sores
  • Headache
  • Stomach pain
  • Cough
  • Hair loss
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Shortness of breath
  • Low potassium or phosphate levels (see below)
  • High liver enzymes

There may be other side effects of Ogsiveo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ogsiveo?

While less common, the most serious side effects of Ogsiveo are described below, along with what to do if they happen.

Severe Allergic Reactions. Ogsiveo may cause allergic reactions, which can be serious. Stop taking Ogsiveo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Diarrhea. Diarrhea is common with Ogsiveo and can be serious. If your health care provider tells you to drink more fluids or take medicine to prevent or treat diarrhea, follow their instructions exactly. Call your health care provider right away if you have any of the following.

  • Severe diarrhea
  • Diarrhea that does not go away or lasts longer than a few days
  • Diarrhea with weakness, dizziness, or fever
  • Diarrhea that does not get better with medicine used to prevent or treat diarrhea

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Ogsiveo. Liver damage can be found by an increase in liver enzymes in your blood. Ogsiveo commonly causes high liver enzymes. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

New Skin Cancer. Ogsiveo may increase the risk of a new skin cancer that is not melanoma. Your health care provider may check your skin before starting Ogsiveo and during treatment. Tell your health care provider right away if you see any changes in your skin after starting Ogsiveo.

Low Potassium or Phosphate Levels. Ogsiveo may cause changes to the levels of certain minerals in your body, called an electrolyte imbalance. For example, it may cause low phosphate levels (hypophosphatemia) and low potassium levels (hypokalemia). These changes can be serious. You may need supplementation to get these electrolytes back to normal. Keep appointments for blood work, so that your health care provider can check your electrolyte levels, especially if you take certain other medicines. Call your health care provider if you have any of the following symptoms of electrolyte changes.

  • Weakness
  • Unusual tiredness
  • Muscle cramps, pain, or twitching
  • Constipation
  • Dizziness

Warnings & Precautions

Who should not use Ogsiveo?

Allergies to Ingredients. People who are allergic to any of the following should not take Ogsiveo.

  • Nirogacestat
  • Ogsiveo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ogsiveo.

What should I know about Ogsiveo before using it?

Do not take Ogsiveo unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Ogsiveo with other people, even if they have the same condition as you. It may harm them.

Keep Ogsiveo out of the reach of children.

Do not chew, cut, or crush Ogsiveo. Swallow Ogsiveo whole.

If you have side effects while taking Ogsiveo, your health care provider may change your Ogsiveo dose or tell you to stop taking Ogsiveo, either temporarily or permanently. Follow your health care provider’s instructions.

Ogsiveo can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Ogsiveo affects you.

Ogsiveo can cause ovarian problems and changes in menstrual cycles in people who can get pregnant. These problems may continue after you stop taking Ogsiveo. Tell your health care provider right away if you have changes in your menstrual cycle, hot flashes, night sweats, or vaginal dryness.

Ogsiveo may make it hard for you to get pregnant or get your partner pregnant. If you may want children one day, talk to your health care provider.

If you can get pregnant, use effective birth control while taking Ogsiveo and for one week after your last dose. If you can get your partner pregnant, use effective birth control like condoms with spermicide while taking Ogsiveo and for one week after your last dose. Talk to your health care provider about your birth control options. See the Pregnancy section for more details.

What should I tell my health care provider before using Ogsiveo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Ogsiveo is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Ogsiveo may interact with other medicines and supplements. Before taking Ogsiveo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Ogsiveo can harm an unborn baby. Your health care provider will likely do a test to make sure you are not pregnant before starting Ogsiveo. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed during treatment with Ogsiveo and for one week after your last dose. It is not known if Ogsiveo passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Ogsiveo?

For more information about Ogsiveo, you can visit the drugmaker’s website at www.ogsiveo.com.

Interactions

Does Ogsiveo interact with foods or drinks?

Do not eat grapefruit, Seville oranges, and starfruit or drink their juice while you are taking Ogsiveo. Grapefruit, Seville oranges, and starfruit can all increase Ogsiveo blood levels in your body and increase your risk of having side effects.

There are no known interactions between Ogsiveo and alcohol.

Does Ogsiveo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

 In particular, make sure that you discuss if you are using any of the following before taking Ogsiveo.

  • An antacid, a H2 blocker, or a proton pump inhibitor (PPI), which is a medicine used to treat heartburn
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura) or ketoconazole, which is a medicine used for fungal infections
  • Clarithromycin or erythromycin, which is an antibiotic used to treat various infections
  • Rifampin (Rifadin), which is a medicine used to treat an infection called tuberculosis
  • Efavirenz, which is a medicine used to treat HIV
  • Midazolam, which is a medicine used to treat seizures

Many other medicines may alter the blood levels of Ogsiveo, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ogsiveo. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ogsiveo?

If you or someone else has used too much Ogsiveo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ogsiveo?

If you miss a dose of Ogsiveo, skip the missed dose and only take the next dose at your regular time. If you vomit after taking a dose of Ogsiveo, take your next dose at your regular time. Do not take double or extra doses.