Important Safety Information & Indication
What are the possible side effects of REVTORPYK (gedatolisib)?
REVTORPYK may cause serious side effects, including:
Mouth sores (stomatitis). REVTORPYK can cause severe mouth sores, including mouth ulcers. Your healthcare provider will prescribe an alcohol-free, steroid-containing mouthwash to help prevent and treat mouth sores. Use as instructed by your healthcare provider. Do not eat or drink for at least 1 hour after using the steroid-containing mouthwash.
Tell your healthcare provider if you develop any of the following in your mouth: pain, swelling, redness, ulcers.
Skin reactions. REVTORPYK can cause skin reactions, including severe rash. Limit time in the sun during treatment with REVTORPYK. Tell your healthcare provider right away if you develop a new rash.
High blood sugar levels (hyperglycemia). High blood sugar can occur with REVTORPYK and may be severe. Your healthcare provider will monitor your blood sugar levels before and during treatment with REVTORPYK. It is not known if REVTORPYK is safe in people with Type 1 diabetes or Type 2 diabetes that is not controlled. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
- excessive thirst
- more frequent urination than usual or a higher amount of urine than normal
- blurred vision
- confusion
- headache
- increased appetite with weight loss
- tiredness
The most common side effects of REVTORPYK when used with fulvestrant and palbociclib include:
- decreased white blood cell counts
- decreased red blood cell counts
- mouth sores
- nausea
- decreased platelet counts
- increased sugar levels (glucose) in the blood
- tiredness
- vomiting
- rash
- constipation
- diarrhea
- increased liver function tests
- muscle and joint pain
- decreased sodium levels in the blood
- increased number of eosinophils (a type of white blood cell) in the blood
The most common side effects of REVTORPYK when used with fulvestrant include:
- mouth sores
- increased sugar level (glucose) in the blood
- increased number of eosinophils (a type of white blood cell) in the blood
- decreased red blood cell counts
- nausea
- rash
- increased liver function tests
- tiredness
- muscle and joint pain
- vomiting
- itching
- diarrhea
REVTORPYK may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.
Your healthcare provider may change your dose, temporarily stop or permanently stop treatment if you have serious side effects.
These are not all the possible side effects of REVTORPYK. Consult the Patient Information for other drugs used in combination for their side effects.
You are encouraged to report side effects of REVTORPYK to the FDA. Visit www.fda.gov/medwatch, or call 800-FDA-1088 or 877-4-CELCUITY (877-423-5284).
Before taking REVTORPYK, tell your healthcare provider about all your medical conditions, including if you:
- have diabetes
- are pregnant or plan to become pregnant; REVTORPYK can harm your unborn baby.
- Females who are able to become pregnant should use effective birth control during treatment and for at least 2 weeks after the last dose of REVTORPYK. Your healthcare provider may ask you to take a pregnancy test before you start treatment
- Males with female partners who can become pregnant should use effective birth control during treatment and for at least 2 weeks after the last dose of REVTORPYK
- are breastfeeding or plan to breastfeed. It is not known if REVTORPYK passes into your breast milk. Do not breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements.
What is REVTORPYK?
REVTORPYK is a prescription medicine used in combination with the medicine fulvestrant, with or without the medicine palbociclib, to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that:
- has spread to nearby tissues or lymph nodes (locally advanced) or that has spread to other parts of the body (metastatic), without an abnormal PIK3CA gene and
- whose cancer has come back and has spread to other parts of the body on or after at least 1 treatment with hormone (endocrine) therapy for metastatic disease
It is not known if REVTORPYK is safe and effective in children.
Please see full Prescribing Information, and read Important Facts for REVTORPYK.
Important Safety Information & Indication
What are the possible side effects of REVTORPYK (gedatolisib)?
REVTORPYK may cause serious side effects, including:
Mouth sores (stomatitis). REVTORPYK can cause severe mouth sores, including mouth ulcers. Your healthcare provider will prescribe an alcohol-free, steroid-containing mouthwash to help prevent and treat mouth sores. Use as instructed by your healthcare provider. Do not eat or drink for at least 1 hour after using the steroid-containing mouthwash.
Tell your healthcare provider if you develop any of the following in your mouth: pain, swelling, redness, ulcers.
Skin reactions. REVTORPYK can cause skin reactions, including severe rash. Limit time in the sun during treatment with REVTORPYK. Tell your healthcare provider right away if you develop a new rash.
High blood sugar levels (hyperglycemia). High blood sugar can occur with REVTORPYK and may be severe. Your healthcare provider will monitor your blood sugar levels before and during treatment with REVTORPYK. It is not known if REVTORPYK is safe in people with Type 1 diabetes or Type 2 diabetes that is not controlled. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
- excessive thirst
- more frequent urination than usual or a higher amount of urine than normal
- blurred vision
- confusion
- headache
- increased appetite with weight loss
- tiredness
The most common side effects of REVTORPYK when used with fulvestrant and palbociclib include:
- decreased white blood cell counts
- decreased red blood cell counts
- mouth sores
- nausea
- decreased platelet counts
- increased sugar levels (glucose) in the blood
- tiredness
- vomiting
- rash
- constipation
- diarrhea
- increased liver function tests
- muscle and joint pain
- decreased sodium levels in the blood
- increased number of eosinophils (a type of white blood cell) in the blood
The most common side effects of REVTORPYK when used with fulvestrant include:
- mouth sores
- increased sugar level (glucose) in the blood
- increased number of eosinophils (a type of white blood cell) in the blood
- decreased red blood cell counts
- nausea
- rash
- increased liver function tests
- tiredness
- muscle and joint pain
- vomiting
- itching
- diarrhea
REVTORPYK may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.
Your healthcare provider may change your dose, temporarily stop or permanently stop treatment if you have serious side effects.
These are not all the possible side effects of REVTORPYK. Consult the Patient Information for other drugs used in combination for their side effects.
You are encouraged to report side effects of REVTORPYK to the FDA. Visit www.fda.gov/medwatch, or call 800-FDA-1088 or 877-4-CELCUITY (877-423-5284).
Before taking REVTORPYK, tell your healthcare provider about all your medical conditions, including if you:
- have diabetes
- are pregnant or plan to become pregnant; REVTORPYK can harm your unborn baby.
- Females who are able to become pregnant should use effective birth control during treatment and for at least 2 weeks after the last dose of REVTORPYK. Your healthcare provider may ask you to take a pregnancy test before you start treatment
- Males with female partners who can become pregnant should use effective birth control during treatment and for at least 2 weeks after the last dose of REVTORPYK
- are breastfeeding or plan to breastfeed. It is not known if REVTORPYK passes into your breast milk. Do not breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements.
What is REVTORPYK?
REVTORPYK is a prescription medicine used in combination with the medicine fulvestrant, with or without the medicine palbociclib, to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that:
- has spread to nearby tissues or lymph nodes (locally advanced) or that has spread to other parts of the body (metastatic), without an abnormal PIK3CA gene and
- whose cancer has come back and has spread to other parts of the body on or after at least 1 treatment with hormone (endocrine) therapy for metastatic disease
It is not known if REVTORPYK is safe and effective in children.
Please see full Prescribing Information, and read Important Facts for REVTORPYK.