Understanding ESR1 mutations
The ESR1 mutation is a common resistance mutation. Resistance mutations are ways that cancer develops after being treated with certain cancer therapies. There is now a treatment specifically approved for people with ESR1-mutated mBC.
of ER+/HER2- mBC cases develop an ESR1 mutation after progression
Understanding ESR1 mutations
The ESR1 mutation is a common resistance mutation. Resistance mutations are ways that cancer develops after being treated with certain cancer therapies. There is now a treatment specifically approved for people with ESR1-mutated mBC.
of ER+/HER2- mBC cases develop an ESR1 mutation after progression
How do I know if I have ESR1-mutated mBC?
A blood test ordered by a doctor can confirm if an ESR1 mutation has occurred.
- Sometimes your mBC can change over time; even if you have had a test before, it is important to talk to your doctor about repeating the test
It’s important to know if you have ESR1-mutated mBC because it will help determine if ORSERDU is right for you
Make an appointment to talk with your doctor about if or when to test for an ESR1 mutation
Getting tested for an ESR1 mutation
Steps to find out if your mBC has an ESR1 mutation:
Your doctor must confirm that your ER+/HER2- mBC has progressed after 1 or more lines of hormone therapy
A member of your healthcare team will take a blood sample
The sample will be sent to a laboratory to see if an ESR1 mutation is present
You should get results in 7 to 14 days
Call your doctor’s office if you don’t hear from them in 14 days
If your blood test detects an ESR1 mutation, your doctor may prescribe ORSERDU
Learn more about the ESR1 test
ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer.
ORSERDU resultsIMPORTANT 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
- 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
- You should use effective (contraception) birth control during treatment with ORSERDU and for 1 week after the last dose
Females who are able to become pregnant:
Males with female partners who are able to become pregnant:
- 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.
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), 345 mg tablets, 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.