Patient information: uses, side effects, how to take - Cligavyx
What is CLIGAVYX ?
CLIGAVYX is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).
CLIGAVYX may be used alone, if you have gone through menopause, and your advanced breast cancer is:
- hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy
or
- HR-positive and has progressed after endocrine therapy.
CLIGAVYX may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.
CLIGAVYX may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy.
When CLIGAVYX is used in combination with palbociclib, abemaciclib, or ribociclib, also read the Patient Information for the prescribed product.
It is not known if CLIGAVYX is safe and effective in children.
It is not known if CLIGAVYX is safe and effective in people with severe liver problems.
Who should not receive CLIGAVYX ?
Do not receive CLIGAVYX if you have had an allergic reaction to fulvestrant or any of the ingredients in CLIGAVYX. See the end of this leaflet for a list of the ingredients in CLIGAVYX.
Symptoms of an allergic reaction to CLIGAVYX may include:
- itching or hives
- swelling of your face, lips, tongue, or throat
- trouble breathing
What should I tell my healthcare provider before receiving CLIGAVYX ?
Before receiving CLIGAVYX , tell your healthcare provider about all of your medical conditions, including if you:
- have a low level of platelets in your blood or bleed easily.
- have liver problems.
are pregnant or plan to become pregnant. CLIGAVYX can harm your unborn baby.
Females who are able to become pregnant:
○ Your healthcare provider may perform a pregnancy test within 7 days before you start CLIGAVYX.
○ You should use effective birth control during treatment with CLIGAVYX and for one year after the last dose of CLIGAVYX.
○ Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with CLIGAVYX.
- are breastfeeding or plan to breastfeed. It is not known if fulvestrant passes into your breast milk. Do not breastfeed during your treatment with CLIGAVYX and for one year after the final dose of CLIGAVYX. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CLIGAVYX may affect the way other medicines work, and other medicines may affect how CLIGAVYX works.
Especially tell your healthcare provider if you take a blood thinner medicine.
How will I receive CLIGAVYX ?
- Your healthcare provider will give you Fulvestrant by injection into the muscle of each buttock.
- Your healthcare provider may change your dose of CLIGAVYX if needed.
What are the possible side effects of CLIGAVYX ?
CLIGAVYX may cause serious side effects, including:
- Injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a CLIGAVYX:
○ numbness
○ tingling
○ weakness
The most common side effects of CLIGAVYX include:
- injection site pain
- vomiting
- nausea
- loss of appetite
- muscle, joint, and bone pain
- weakness
- headache
- cough
- back pain
- shortness of breath
- tiredness
- constipation
- pain in arms, hands, legs, or feet
- increased liver enzymes
- hot flashes
- diarrhea
CLIGAVYX may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects with CLIGAVYX. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
General information about the safe and effective use of CLIGAVYX
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about CLIGAVYX that is written for health professionals.
What are the ingredients in CLIGAVYX ?
Active ingredient: fulvestrant
Inactive ingredients: benzyl alcohol, dehydrated alcohol, castor oil, medium chain triglycerides, and nitrogen.
SafetyGlide™ is a trademark of Becton Dickinson and Company.
Manufactured for:
Avyxa Pharma, LLC
New Jersey 07054, USA
Made in China
