INQOVI plus venetoclax is the only all-oral therapy to treat adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have other medical conditions that prevent the use of standard chemotherapy. View Patient Information.
You may experience side effects while taking INQOVI. Your healthcare provider will take blood tests before each cycle of INQOVI to help check the side effects such as cytopenias.
Record any side effects or important notes in your health journal, available in the INQOVI Treatment Kit or at INQOVI.com/healthjournal
The most common side effects of INQOVI include:
low white blood cell count (leukopenia)
low platelets in your blood (thrombocytopenia)
low white blood cell count (neutropenia)
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
changes in liver function tests
INQOVI may cause serious side effects, such as low blood cell counts. Low blood counts are common with INQOVI but can also be serious and can lead to infections that may be life-threatening. Your healthcare provider will check your blood counts regularly during treatment with INQOVI. If you have low blood counts, your healthcare provider may need to give you antibiotic medicines to prevent or treat infections or fever.
These are not all the possible side effects of INQOVI. Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration at 1‑800‑FDA‑1088
Tell your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with INQOVI:
fever
chills
body aches
bruising more easily than usual
INQOVI may affect fertility in men. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of INQOVI. Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration at 1‑800‑FDA‑1088
Tips for managing common side effects
Your healthcare provider may have ways to help manage certain side effects of INQOVI, such as adjusting or delaying your dosing cycle. The following information may also be helpful to you in managing some of the common side effects of INQOVI, along with your healthcare provider's care.
This information is not meant to replace your healthcare provider's advice. Always discuss any side effects with your healthcare provider.
Tiredness or weakness
Stress and anxiety may increase feelings of tiredness. You can try meditation or yoga to relax and release stress
Eat well and hydrate with about 8 cups of water or juice a day
Plan time to rest throughout the day, and consider taking short naps
Don't try to do too much. Ask for help with activities that require a lot of energy
Try to stay active with short walks or other low-effort exercise
Try to get at least 8 hours of sleep every night. Consider making a bedtime routine to relax before bed
Try keeping a diary of how you feel each day. You can share this with your healthcare provider or nurse to keep track of your energy levels
Talk to your healthcare provider. He or she may prescribe medication that can help decrease tiredness
Fever
You may have fever if you:
Feel very warm or cold
Have a headache or body aches
Have shaking chills
Have a skin rash or a new area of redness or swelling
Have a new cough or shortness of breath
Have a sore throat
Have new belly pain
Feel burning or pain while urinating
Have pus coming from an injury or other location
Feel confused or forgetful
Call your healthcare provider immediately if you have a fever or other signs of infection, such as chills, body aches, or bruising more easily than usual
To see if you have a fever, you can check your temperature by mouth. If you can't use this method, hold the thermometer under your armpit
Your healthcare provider may tell you to contact them if your temperature reaches 100.5° F (38° C) or higher
A fever can cause fluid loss and dehydration. Drink plenty of liquids, like water, juice, and soup
Get enough rest
Keep cool by using a cold compress on your forehead
Your healthcare provider may prescribe medicine to help reduce fever. Do not take fever medicine without talking to your healthcare provider
Nausea or vomiting
You may feel nauseous on the days you take INQOVI tablets or shortly after
It may help to avoid certain foods. Try eating bland, easy-to-digest foods like crackers or toast instead of greasy, fried, sweet, or spicy foods
Avoid strong smells. Go outside and get a breath of fresh air if you feel like vomiting
Eat smaller meals throughout the day instead of 3 large ones. Eat food at room temperature
Talk to your healthcare provider, who may prescribe medicine to help reduce nausea. You can take this before treatment with INQOVI
Constipation
Talk to a healthcare provider if you have not had a bowel movement in 2 days
Keep a record of your bowel movements so that you can discuss with your healthcare provider what is normal for you
Talk to your healthcare provider about high-fiber foods you can eat. Some examples are bran muffins, cooked peas and beans, and peanut butter
Stay hydrated. Drink at least 8 cups of water or other fluids per day
Drink warm fluids like tea. Fruit juice such as prune juice may also help
Be active when you can. Ask your healthcare provider about ways to exercise while taking INQOVI
Diarrhea
Talk to your healthcare provider if:
Your diarrhea lasts for more than 24 hours
You experience pain along with diarrhea
Your rectal area is sore or bleeds
Your healthcare provider may prescribe medication to help. Do not take medicine for diarrhea before talking to a doctor or nurse
Eat smaller meals throughout the day instead of 3 large ones
Ask your healthcare provider about foods high in sodium and potassium. Your body can lose these minerals when you have diarrhea and it's important to replace them
Eat low-fiber foods such as bananas, white rice, white toast, and plain or vanilla yogurt
Drink 8 to 12 cups of clear liquids each day, such as water or clear broth. Liquids containing electrolytes can be helpful
Drink liquids slowly and at room temperature
Cough
Cough can be caused by different things, such as:
Allergies
Secondhand smoke or chemicals
Infection
Acid reflux, or heartburn
Talk to your healthcare provider to determine the cause and type of cough. A cough can be acute (lasting less than 3 weeks) or persistent (more than 8 weeks)
Call your healthcare provider immediately if you cough up blood or colored mucus, or experience other symptoms with your cough
Avoid exposure to second hand smoke or chemicals that may irritate your throat. These can be found in hairspray or cleaning products
Avoid things you are allergic to. It's a good idea to vacuum and dust regularly if you have allergies
You can take a hot shower or use a humidifier to loosen mucus and moisten the throat
Stay hydrated to thin out the mucus in the throat
Talk to your healthcare provider about medicines that may help alleviate your cough, such as antihistamines or cough drops
Decreased appetite
Eat small meals throughout the day instead of 3 large ones
Set a daily schedule for meals, and eat even if you do not feel hungry
Drink liquid foods such as soup or smoothies if you do not feel like eating solid foods
Choose foods that are high in calories and/or protein
Use plastic forks or spoons if you get a metallic taste in your mouth
Being active may help you feel hungrier. Talk to your healthcare provider about exercises that can help
Talk to your healthcare provider, who may suggest that you take extra vitamins or supplements
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.
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and discuss it with your healthcare professional.