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Resources that will help you with your treatment

You may find the following materials helpful while on treatment with ORSERDU. They contain information that will help you get the most out of your experience with ORSERDU.

Download the brochure

Talk with your healthcare team about your experience

You play an important role in your care. Take part in your treatment decisions. Speak openly and honestly with your healthcare team so they understand your goals and preferences. Knowing what to expect and speaking up will help you get the most out of your treatment experience with ORSERDU.

Here are some questions to help get you started:

  • Is there anything more I should know about ESR1 mutations?
  • How long can I expect to take ORSERDU?
  • What kind of results can I expect from ORSERDU?
  • How will I know if ORSERDU is the right treatment for me?
  • How should I track my treatment experience?
  • How often will I need to come into the clinic for any type of monitoring or testing?
  • When should I contact my doctor or nurse?
  • What should I know or do before my next office visit?

Additional tips:

  • If possible, take a family member or friend to your appointments for support
  • Come prepared to your appointments: take notes and ask questions
  • Ask your healthcare team members to repeat or write down information
  • Before your next appointment, write down any changes to your overall health, treatment side effects you are experiencing, and/or changes in your
    daily routine

Take ORSERDU every day as directed. If you experience any side effects, let your doctor or healthcare team know. They can help you manage certain side effects or provide other advice to help ensure that you receive appropriate treatment.

Before you start taking ORSERDU, talk with your healthcare team about any questions or concerns you may have.

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ESR1, estrogen receptor 1.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

ORSERDU may cause serious side effects, including:

  • Increased fat (lipid) levels in your blood (hypercholesterolemia and hypertriglyceridemia). Your healthcare provider will do blood tests to check your lipid levels before and during your treatment with ORSERDU

Before taking ORSERDU, tell your healthcare provider about all your medical conditions, including if you:

  • Have liver problems
  • Are pregnant or plan to become pregnant. ORSERDU can harm your unborn baby
    • Females who are able to become pregnant:

    • Your healthcare provider may do a pregnancy test before you start treatment with ORSERDU
    • You should use effective (contraception) birth control during treatment with ORSERDU and for 1 week after the last dose
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ORSERDU
    • Males with female partners who are able to become pregnant:

    • You should use effective (contraception) birth control during treatment with ORSERDU and for 1 week after the last dose
  • Are breastfeeding or plan to breastfeed. It is not known if ORSERDU passes into your breast milk. Do not breastfeed during treatment with ORSERDU and for 1 week after the last dose

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ORSERDU and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

The most common side effects of ORSERDU include:

  • Muscle and joint (musculoskeletal) pain
  • Nausea
  • Increased cholesterol and triglyceride levels in your blood
  • Increased liver function tests
  • Tiredness
  • Decreased red blood cell counts
  • Vomiting
  • Decreased salt (sodium) levels in your blood
  • Increased kidney function test
  • Decreased appetite
  • Diarrhea
  • Headache
  • Constipation
  • Stomach-area (abdominal) pain
  • Hot flush
  • Indigestion or heartburn

Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with ORSERDU, if you develop certain side effects.

ORSERDU may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

ORSERDU is available as 345 mg and 86 mg tablets.

These are not all the possible side effects of ORSERDU. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

INDICATION

ORSERDU (elacestrant) is a prescription medicine to treat women who have gone through menopause and adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after endocrine therapy.

Your healthcare provider will perform a test to make sure that ORSERDU is right for you.

It is not known if ORSERDU is safe and effective in children.

Please see full Prescribing Information, including Patient Information, for ORSERDU.