Orserdu is a brand-name oral tablet prescribed for breast cancer in certain situations. Orserdu contains the active drug elacestrant and is a type of hormone therapy.

Orserdu is FDA-approved to treat breast cancer in adults in certain situations. Specifically, the cancer must be advanced or metastatic and have gotten worse after treatment with at least one other hormone therapy.

You’ll find key information about Orserdu below.

  • Drug class: estrogen receptor antagonist, which is a type of hormone therapy
  • Drug form: oral tablet
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2023

Orserdu is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Orserdu can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Orserdu. These lists do not include all possible side effects.

For more information about the possible side effects of Orserdu, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Orserdu, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Orserdu. To learn about other mild side effects, talk with your doctor or pharmacist, or view Orserdu’s prescribing information.

Mild side effects of Orserdu can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Orserdu, see “Allergic reaction” below.

Serious side effects

Certain serious side effects from Orserdu are more common than others. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For details about allergic reaction and Orserdu, see “Allergic reaction” just below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Orserdu. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Orserdu, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

As with all medications, the cost of Orserdu can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons. You can visit Optum Perks* for price estimates of Orserdu. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance. If you need financial support to pay for Orserdu, or if you need help understanding your insurance coverage, help is available.

A program called Stemline ARC is available for Orserdu. For more information and to find out whether you’re eligible for support, call 833-478-3654 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version. Orserdu isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

* Optum Perks is a sister site of Medical News Today.

Here are answers to some frequently asked questions about Orserdu.

Is Orserdu a chemotherapy drug?

No, Orserdu is not a type of chemotherapy. Both Orserdu and chemotherapy can be used to treat breast cancer. However, each drug works differently to treat this condition.

Orserdu is an estrogen receptor antagonist, which is a type of hormone therapy. It works by keeping the hormone estrogen from getting to breast cancer cells. (For more information, see the “How does Orserdu work?” question just below.)

Chemotherapy drugs work by killing cells that grow rapidly. Cancer cells tend to grow more rapidly than healthy cells. However, chemotherapy can still affect healthy cells. This can lead to many of the side effects of chemotherapy.

To learn more about Orserdu and chemotherapy, talk with your doctor.

How does Orserdu work?

Orserdu is an estrogen receptor antagonist, which is a type of hormone therapy. It works by keeping the hormone estrogen from getting to breast cancer cells. Without estrogen, breast cancer cells may grow more slowly or not at all. In this way, Orserdu works to treat breast cancer.

Orserdu is the first drug approved for breast cancer that’s ER-positive* and HER2-negative* with a certain mutation (change) in the ESR1 gene. For details about these factors, see the “Orserdu uses” section below.

To learn more about how Orserdu works, talk with your doctor or pharmacist.

* “ER” is short for “estrogen receptor” and “HER2” is short for “human epidermal growth factor receptor 2.”

Will Orserdu cure breast cancer?

No, Orserdu won’t cure breast cancer. There’s currently no known cure for breast cancer.

Orserdu is approved to treat certain types of breast cancer in adults. And whether Orserdu can be taken for breast cancer depends on several factors. For more information, see the “Orserdu uses” section below.

To learn more about how Orserdu works to treat breast cancer, see the “How does Orserdu work?” question above.

The Orserdu dosage your doctor prescribes will depend on several factors. These include:

  • other medical conditions you may have
  • other medications you may take
  • the side effects you may have

The following information describes dosages that are commonly prescribed or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Orserdu comes as an oral tablet that you swallow. It’s available in two strengths: 86 milligrams (mg) and 345 mg.

Dosage for breast cancer

Orserdu is prescribed for breast cancer in certain situations. The typical dosage for this purpose is 345 mg once per day.

Your doctor may prescribe a different dosage depending on certain factors, such as whether you have moderate liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.

About taking Orserdu

Below you’ll find information about key dosage issues.

  • When to take. You should take Orserdu once per day.Taking the medication around the same time each day helps keep a steady level of the drug in your body. This helps Orserdu work effectively.
  • If you miss a dose. If it’s been fewer than 6 hours since your missed dose, take it as soon as you remember. If it’s been more than 6 hours since your missed dose, skip it. Then take your next dose again at the regular time. If you aren’t sure whether to take or skip a missed dose, talk with your doctor or pharmacist.
  • Taking Orserdu with food. You’ll take each dose of Orserdu with food. Doing so helps reduce certain side effects of the drug, such as nausea and vomiting.
  • Crushing, splitting, or chewing Orserdu. Orserdu tablets should not be crushed, split, or chewed. You swallow the tablets whole. If you have trouble swallowing this form of medication, refer to this article for tips. You can also talk with your doctor or pharmacist.
  • Length of treatment. Orserdu is meant to be a long-term treatment. If you and your doctor determine that Orserdu is safe and effective for you, you’ll likely take it long term.

Overdose

Do not take more Orserdu than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Orserdu

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

The Food and Drug Administration (FDA) approves prescription drugs such as Orserdu to treat certain conditions.

Orserdu for breast cancer

Orserdu is FDA-approved to treat breast cancer. It’s prescribed for adult males* and postmenopausal females* in certain situations.

For this use, the breast cancer must meet the following conditions:

  • It’s advanced or metastatic. The term “advanced” means the cancer has spread to at least one other part of the body near the breast. The term “metastatic” means the cancer has spread to many other areas of the body away from the breast.
  • It’s estrogen receptor (ER)-positive. The term “ER-positive” means the breast cancer cells have estrogen receptors. Your doctor will perform a biopsy to check the cancer for these receptors, also called binding sites. A biopsy procedure removes a small portion of the tumor from your breast.
  • It’s human epidermal growth factor receptor 2 (HER2)-negative. The term “HER2-negative” means the breast cancer cells do not have high levels of a protein called HER2. Your doctor will perform a biopsy to check the cancer for this protein.
  • It has a certain mutation (change) in a gene called ESR1. Your doctor will order a blood test to check the cancer for this mutation.
  • It has gotten worse after treatment with at least one other hormone therapy. Examples include anastrozole (Arimidex) and fulvestrant (Faslodex). (Orserdu is a type of hormone therapy.)

You can learn more about breast cancer by visiting our breast cancer hub.

* Sex and gender exist on spectrums. Use of the terms “male“ and “female” in this article refers to sex assigned at birth.

Orserdu and children

Orserdu is not FDA-approved for use in children. It’s not known for sure whether the drug is safe or effective for children.

Other medications are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Orserdu, talk with your doctor. They can tell you about other medications that may work well for you.

Orserdu is a type of hormone therapy. The following drugs are similar to Orserdu:

Orserdu can interact with several other medications. It isn’t known to interact with supplements or foods.

Before taking Orserdu, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications

Below is a list of medications that can interact with Orserdu. This list does not contain all drugs that may interact with Orserdu. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Orserdu • certain antifungals such as fluconazole (Diflucan) and itraconazole (Sporanox, Tolsura)
• the antibiotic drug rifampin (Rifadin, Rimactane)
• the antiviral drug efavirenz
• the heart drug digoxin (Lanoxin)
• the statin drug rosuvastatin (Crestor, Ezallor Sprinkle)

Alcohol interaction

Alcohol is not known to interact with Orserdu. It’s likely safe to consume alcohol while taking Orserdu.

If you have questions about how much alcohol is safe to drink while taking Orserdu, talk with your doctor or pharmacist.

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Orserdu and pregnancy

Orserdu should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Your doctor may suggest birth control options to use during treatment with Orserdu. They’ll likely advise you to use birth control while you’re taking Orserdu and for at least 1 week after your final dose.

Orserdu and breastfeeding

Orserdu should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Your doctor may recommend other ways to feed your child during treatment with Orserdu. They’ll likely recommend that you avoid breastfeeding while you’re taking Orserdu and for at least 1 week after your final dose.

This drug comes with several precautions.

Before taking Orserdu, discuss your health history with your doctor. Orserdu may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Orserdu, see the “Orserdu side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.