ETCAMAH + CDK4/6 inhibitor was studied for safety in a clinical trial
Always talk to your healthcare team about any side effects that you may have.
heart-related side effects
Talking to your care team about potential side effects
QTc INTERVAL PROLONGATION
QTc interval prolongation is a type of effect on your heart rhythm that increases the time needed to reset your heart's electrical system. It may be life-threatening and may lead to death. Of patients who received ETCAMAH + CDK4/6 inhibitor, 3% experienced QTc interval prolongation. No one had to stop treatment because of this side effect.
- Dose interruptions or other dose modifications may be required to help manage this side effect
- Dose interruption was needed in less than 1% of patients
Management
Talk to your care team right away if you experience symptoms of QTc prolongation such as fainting, heart palpitations, dizziness, or seizures.
Bradycardia
Bradycardia is another type of abnormal heart rhythm where the heart beats slowly. 8% of patients who received ETCAMAH + a CDK4/6 inhibitor experienced bradycardia.
- None of these events led them to stop treatment
- No patients in the aromatase inhibitor + CDK4/6 inhibitor group reported bradycardia
Management
Talk to your care team right away if you experience an abnormally slow heart rate on ETCAMAH.
Monitoring & testing
Certain tests may be needed before or during treatment to help your doctor monitor your body’s response to ETCAMAH + a CDK4/6 inhibitor
monitoring the heart
Before and during treatment, you’ll take a routine test known as an electrocardiogram (ECG or EKG), which monitors the heart’s electrical activity over time. An ECG (or EKG) can discover if there are changes or irregularities in how your heart is processing its electric current.
In the case of someone who has a slow or irregular heartbeat or is taking medicine that lowers their heart rate, they will be monitored to check if their body’s response to ETCAMAH is safe and appropriate.
Blood tests
Your healthcare provider will also perform blood tests to check the blood levels of your electrolytes (body salts). Your healthcare provider will also treat your electrolyte levels if needed.
Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any heart and blood pressure medicines including beta-blockers.
Most common side effects
What are the most common side effects of ETCAMAH?
The most common side effects of ETCAMAH in combination with a CDK4/6 inhibitor include:
- Decreased white blood cell counts
- Decreased red blood cell counts
- Decreased platelet counts
- Vision problems such as seeing flashes of light, double or blurry vision, light sensitivity, new or increased floaters. Tell your healthcare provider if you have vision problems; you may need to see an eye care specialist
- Tiredness
These are not all the possible side effects of ETCAMAH.
Call your healthcare provider for medical advice about side effects.
22% of patients who received ETCAMAH had their regimen adjusted due to side effects.
In the same clinical trial,
~99% of people were able to stay on ETCAMAH
Certain VISION PROBLEMS
Some patients taking ETCAMAH experienced certain vision problems
In the clinical trial, vision problems occurred in 34% of patients taking ETCAMAH + CDK4/6 inhibitor and included: flashes of light, double vision or blurry vision, light sensitivity, and new or increased floaters. In addition, about 12% of patients experienced dry eye.
Photopsia can consist of brief episodes of trailing or floating lights in peripheral vision.
For patients taking ETCAMAH in clinical trials, these vision problems were mostly mild to moderate, meaning they generally had a minimal effect on daily activities, and did not cause permanent damage to their vision.
- 20% of patients experienced photopsia with ETCAMAH + CDK4/6 inhibitor
- 8% experienced this vision problem with an aromatase inhibitor + CDK4/6 inhibitor
Photopsia means trailing or floating lights in peripheral vision.Image for illustrative purposes only. Your experience may differ.
For patients taking ETCAMAH in clinical trials, these vision problems:
were mostly mild to moderate, and generally had a minimal effect on daily activities, like driving
caused no permanent damage to vision
caused no patients to stop treatment
typically lasted less than 1 minute per episode
happened 3 or fewer times per week
Everyone's experience may differ. Tell your healthcare provider if you have vision problems; you may need to see an eye care specialist.
Remember to always tell your care team about any side effects you experience, especially if side effects are severe or if they get worse.
These are not all the possible side effects of ETCAMAH. Call your healthcare provider for medical advice about side effects.
Please see full Important Safety Information below.
You may report side effects related to AstraZeneca products
.
Talk to your care team for tips and strategies about potential side effects
Have other questions about ETCAMAH?
Explore Etcamah FAQHelpful PDF Resources
Access helpful Resources
IMPORTANT SAFETY INFORMATION ABOUT ETCAMAH® (camizestrant)
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IMPORTANT SAFETY INFORMATION ABOUT ETCAMAH® (camizestrant)
What is the most important information I should know about ETCAMAH?
ETCAMAH can cause serious side effects including:
- Changes in electrical activity of your heart (QTc interval prolongation). Taking ETCAMAH in combination with ribociclib or other QTc interval prolonging drugs may cause life-threatening heart rhythm problems and may lead to death. Before starting and during treatment with ETCAMAH, your healthcare provider will do an electrocardiogram (ECG) to check the electrical activity of your heart and do blood tests to check the blood levels of your body salts (electrolytes). Your healthcare provider will treat abnormal electrolyte levels
- Slow heart rate (bradycardia). Your healthcare provider will check your heart rate frequently during the first 30 days of treatment with ETCAMAH if you have bradycardia (heart rate less than 60 beats per minute) before starting treatment and if you take medicines that lower heart rate
Get medical help right away if you get the following signs or symptoms of QTc prolongation and bradycardia including: dizziness, lightheadedness, fainting, feeling that your heart is pounding or racing (palpitations), shortness of breath, or chest pain.
Your healthcare provider may delay treatment or completely stop treatment with ETCAMAH if you have severe side effects.
Before you take ETCAMAH, tell your healthcare provider if you:
- have any liver-related problems
- have a slow heartbeat (bradycardia)
- have heart problems including irregular heartbeats and QTc prolongation
- are pregnant or plan to become pregnant. ETCAMAH can harm your unborn baby
- Females who are able to become pregnant
- Your healthcare provider will check that you are not pregnant before you start treatment with ETCAMAH
- Use effective non-hormonal birth control (contraception) during treatment with ETCAMAH and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you during this time
- Tell your healthcare provider if you become pregnant or think you may be pregnant
- Males with female partners who can become pregnant
- Use effective birth control during treatment with ETCAMAH and for 1 week after your last dose
- are breastfeeding or plan to breastfeed. It is not known if ETCAMAH passes into your breast milk. Do not breastfeed during treatment with ETCAMAH and for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with ETCAMAH
Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any heart and blood pressure medicines.
ETCAMAH may affect the way other medicines work, and other medicines may affect how ETCAMAH works. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
What are the possible side effects of ETCAMAH?
ETCAMAH can cause serious side effects, including:
- See “What is the most important information I should know about ETCAMAH?”
The most common side effects of ETCAMAH in combination with a CDK4/6 inhibitor include:
- decreased white blood cell counts
- decreased red blood cell counts
- decreased platelet counts
- vision problems such as seeing flashes of light, double or blurry vision, light sensitivity, new or increased floaters. Tell your healthcare provider if you have vision problems; you may need to see an eye care specialist
- tiredness
ETCAMAH may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of ETCAMAH.
Call your healthcare provider for medical advice about side effects.
What is ETCAMAH?
ETCAMAH is a prescription medicine used in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that:
- has worsened or spread to other parts of the body (advanced or metastatic breast cancer), and
- has an estrogen receptor-1 (ESR1) mutation detected during treatment with an aromatase inhibitor and a CDK4/6 inhibitor
Your healthcare provider will perform a test to make sure that ETCAMAH is right for you.
- ETCAMAH was FDA approved for this use based on a clinical study that measured time to cancer growth or spread (progression-free survival). ETCAMAH is still being studied to confirm these results
It is not known if ETCAMAH is safe and effective in children.
Please see full Prescribing Information, including Boxed WARNING, and Patient Information for ETCAMAH.
You may report side effects related to AstraZeneca products
.
