IMPORTANT SAFETY INFORMATION
INQOVI may cause serious side effects, including:
Low blood cell counts. Low blood counts (white blood cells, platelets, and red blood cells) are common with INQOVI but can also be serious and lead to infections that may be life-threatening. If your blood cell counts are too low, your healthcare provider may need to delay treatment with INQOVI, lower your dose of INQOVI, or in some cases, give you a medicine to help treat low blood cell counts. Your healthcare provider may need to give you antibiotic medicines to prevent or treat infections or fever while your blood cell counts are low. Your healthcare provider will check your blood cell counts before you start treatment and regularly during treatment with INQOVI.
Tell your healthcare provider right away if you get any of the following signs and symptoms during treatment with INQOVI:
- fever
- chills
- body aches
- tiredness
- bruising more easily than usual
Before taking INQOVI, tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems
-
are pregnant or plan to become pregnant. INQOVI can harm your unborn baby
Females who are able to become pregnant:
- Your healthcare provider will check to see if you are pregnant before you start treatment with INQOVI
- Use effective birth control during treatment with INQOVI and for 6 months after the last dose of INQOVI
Males with female partners who are able to become pregnant should use effective birth control during treatment with INQOVI and for 3 months after the last dose. Talk to your healthcare provider if you have questions about birth control options that are right for you.
- are breastfeeding or plan to breastfeed. It is not known if INQOVI passes into breast milk. Do not breastfeed during treatment with INQOVI and for 2 weeks after your last dose of INQOVI
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INQOVI may affect the way certain other medicines work and may cause side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
If taking INQOVI in combination with venetoclax for AML, please refer to the venetoclax Medication Guide for additional information.
The most common side effects of INQOVI in adults with MDS or CMML include: low white blood cell count (leukopenia, neutropenia), low platelets in your blood (thrombocytopenia), low red blood cell count (anemia), tiredness, constipation, bleeding, muscle pain, pain or sores in your mouth or throat, joint pain, nausea, shortness of breath, diarrhea, rash, dizziness, fever with low white blood cell count (febrile neutropenia), swelling of arms or legs, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and changes in liver function tests.
The most common side effects of INQOVI in adults with AML in combination with venetoclax include: low white blood cell counts (leukopenia, lymphocytopenia, neutropenia), low platelets in your blood (thrombocytopenia), fever with low white blood cell count (febrile neutropenia), bleeding, low red blood cell count (anemia), infection, diarrhea, tiredness, pain or sores in your mouth or throat, constipation, joint pain, decreased appetite, swelling of arms or legs, nausea, shortness of breath, sepsis, pneumonia, rash, changes in liver function tests, muscle pain, abnormal heart rhythm, stomach-area (abdomen) pain, dizziness or feeling lightheaded, and decreased kidney function.
INQOVI may affect fertility in men. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of INQOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If you are taking INQOVI in combination with venetoclax for AML, please refer to the venetoclax Medication Guide for additional information.
Please read the full Patient Information and discuss with your healthcare provider.
