Important Safety Information
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
.
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.
