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Overview: Orserdu is used to treat certain types of breast cancer. It blocks growth of breast tissue that needs estrogen to grow. The most common side effects are muscle and bone pain, nausea, and increases in your cholesterol and triglyceride levels.

Uses

What is Orserdu used for?

Orserdu (elacestrant) is commonly used to treat certain types of breast cancer in people who have gone through menopause or in men.

Your Guide to Orserdu for Breast Cancer – What You Need to Know

Orserdu may also be used for other conditions as determined by your healthcare provider.

How does Orserdu work (mechanism of action)?

Orserdu blocks estrogen activity in breast  tissue. It binds to estrogen receptors blocking growth of breast tissue that needs estrogen to grow.

How is Orserdu supplied (dosage forms)?

Brands and other names

  • Orserdu

Dosage forms and strengths

  • 86 mg oral tablets
  • 345 mg oral tablets

How should I store Orserdu?

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

Side Effects

What are the most common side effects of Orserdu?

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

  • Muscle or bone pain
  • Nausea, vomiting, diarrhea, constipation, upset stomach or indigestion
  • Increased cholesterol and triglyceride levels (see below)
  • Increased liver function tests (a measure of how well your liver is working)
  • Feeling weak or tired
  • Reduced hemoglobin levels
  • Reduced sodium blood levels
  • Increased serum creatinine (a measure of how well kidneys are working)
  • Decreased appetite
  • Headache
  • Stomach pain
  • Hot flashes

There may be other side effects of Orserdu that are not listed here. Contact your healthcare 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. 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 Orserdu?

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

Severe Allergic Reactions. Orserdu may cause allergic reactions, which can be serious. Stop taking Orserdu 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, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Increased Cholesterol and Triglyceride Levels. Orserdu may cause you to have very high fat levels in your blood. Keep all healthcare appointments, including lab appointments to have your blood checked.

Warnings & Precautions

Who should not use Orserdu?

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

  • Orserdu
  • Elacestrant
  • Any of the ingredients in the specific product dispensed

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

Liver Problems. Orserdu should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.

What should I know about Orserdu before using it?

Do not take Orserdu unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

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

Keep Orserdu out of the reach of children.

Take Orserdu once each day at about the same time. Take it with food to decrease the chance you will have an upset stomach. 

Do not crush, split, chew, or cut Orserdu tablets, they should be swallowed whole. Do not take tablets that are crumbly, broken, or have a crack in them. 

What should I tell my healthcare provider before using Orserdu?

Tell your healthcare 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 determine if Orserdu is right for you.

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

Other Medicines and Supplements. Orserdu may interact with other medicines and supplements. Before taking Orserdu, tell your healthcare 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. You should use effective birth control while taking Orserdu. Your healthcare provider may check to make sure you are not pregnant before you start taking Orserdu. Orserdu may cause harm to an unborn baby. Tell your healthcare provider if you are, think you are, or plan to become pregnant. 

Breastfeeding. It is not known if Orserdu passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Orserdu.

How can I get more information about Orserdu?

For more information about Orserdu, you can visit the manufacturer’s website at https://www.orserdu.com/ or call them at 877-332-7961.

Interactions

Does Orserdu interact with foods or drinks?

There are no known interactions between Orserdu and foods or drinks.

It is unknown if drinking alcohol will affect Orserdu. However, the risk of hot flashes may be increased if you drink alcohol while taking Orserdu because alcohol can trigger hot flashes.

Does Orserdu interact with other medicines (drug interactions)?

Always tell your healthcare 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 Orserdu.

  • Itraconazole (Sporanox, Tolsura) or fluconazole (Diflucan), which is a medicine used for fungal infections
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Efavirenz, which is a medicine commonly used to treat HIV
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Rosuvastatin (Crestor), which is a medicine to lower cholesterol

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

This may not be a complete list of medicines that can interact with Orserdu. Always check with your healthcare 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 Orserdu?

If you or someone else has used too much Orserdu, 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 Orserdu?

If you miss a dose and it has been less than six hours since you normally take your dose, take it as soon as you remember. If it has been more than six hours since you normally take your dose, skip the missed dose. Take your next dose when you normally take it. Do not take double or extra doses. 

If you vomit after taking Orserdu, do not take another dose that day. Take your next dose the following day when you normally take it.