INQOVI plus venetoclax for AML

Understanding treatment with INQOVI plus venetoclax for AML

Who is right for INQOVI treatment?

INQOVI is a prescription medicine used in combination with venetoclax to treat adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years of age or older or have other medical conditions that prevent the use of standard chemotherapy.

How can INQOVI plus venetoclax help those living with AML?

A clinical study showed that INQOVI plus venetoclax is an all-oral option for the treatment of AML.

Who was in the clinical study?

The study included 101 adults with newly diagnosed AML who were either:

Aged 75 years or older, or
Unable to undergo standard chemotherapy due to health conditions, such as:
- Serious heart or lung problems
- Liver or kidney issues
- Difficulty performing daily activities because of their overall health

Goals of the study

The study focused on how INQOVI plus venetoclax affected people with AML and whether the medications were safe when taken together.

Proven results from pills for those with AML

In the clinical trial, INQOVI plus venetoclax was shown to be effective in some patients with AML.

	Study results
How the 101 participants responded to treatment	42 (41.6%) had test results showing no evidence of AML	Among the 42 responders, test results showed no evidence of AML after 2.0 months*
How many participants did not need blood cell transfusions after treatment	Of the 44 participants who needed transfusions at the start of the study, 16 (36.4%) did not anymore^†

*This is the middle number in a range.

^†No red blood cell or platelet transfusions for at least 56 consecutive days during active treatment with INQOVI plus venetoclax.

Taking INQOVI

Learn about taking and tracking INQOVI for AML and MDS, including CMML.

Explore dosing information

Possible Side Effects

See a list of the most common side effects associated with INQOVI treatment and tips on managing them.

Learn more about side effects

INDICATIONS AND IMPORTANT SAFETY INFORMATION

WHAT IS INQOVI?

WHAT IS INQOVI?

INQOVI is a prescription medicine used:

to treat adults with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). Your healthcare provider will determine if INQOVI can treat your type of MDS
in combination with venetoclax to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy

It is not known if INQOVI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

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.