The term "myelodysplastic syndromes (MDS)" refers to a group of conditions, which are sometimes called bone marrow failure disorders, that can lead to abnormalities in the blood. MDS occurs when bone marrow produces fewer healthy blood cells that work properly.
MDS is a rare type of blood cancer.
Up to 20,000 new cases of MDS are reported in the United States every year
Between 60,000 and 170,000 people in the United States are estimated to have MDS
MDS is not contagious. In very rare cases (up to 10%), MDS can be linked to inherited conditions (meaning they run in your family). Talk to your healthcare provider about inheritable disorders related to MDS.
What are the risk factors of MDS?
The cause of MDS is unknown in more than 80% of diagnosed patients. You may be at greater risk of MDS if you:
Are older than 60 years (86% of patients with MDS are over 60)
Are male (men are more than twice as likely to develop MDS as women)
Have spent a lot of time around chemicals such as benzene (which can be found in tobacco smoke) or other toxic chemicals
Have received chemotherapy or radiation therapy for other cancers
INQOVI is an oral combination pill made of decitabine and cedazuridine. Decitabine has been used to treat MDS for many years, but was previously only available as an intravenous (IV) infusion. Cedazuridine is an ingredient that allows INQOVI to be taken by mouth.
In clinical trials, INQOVI was shown to be effective in some patients with myelodysplastic syndromes (MDS), including CMML.
CMML=chronic myelomonocytic leukemia
How can INQOVI help?
In a trial of 133 people,
21%
had a complete response
Of the 57 people who needed blood transfusions* before starting the trial,
53%
no longer required blood transfusions after treatment with INQOVI*
*In this trial, blood transfusions could mean either red blood cell or platelet transfusions. Patients who did not need blood transfusions were able to go without a transfusion for 56 days.
Who should take INQOVI?
INQOVI is for adult patients (18+ years of age). INQOVI was primarily studied in patients with intermediate- or high-risk types of myelodysplastic syndromes (MDS), including CMML. Your healthcare provider will determine if INQOVI can treat your type of MDS. It is not known if INQOVI is safe or effective in children.
The revised International Prognostic Scoring System is used to help predict the course of MDS in your body and your risk level for progressing to AML. Risk level (low, intermediate, high) is determined by your hemoglobin, blood cell counts, and genetic tests. You can talk to your healthcare provider about your risk level.
Be sure to talk to your healthcare provider before taking INQOVI if you
have kidney or liver problems
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
AML=acute myeloid leukemia
Ready to speak with your doctor about INQOVI?
If you have been diagnosed with MDS, navigating your treatment journey can be overwhelming. It's important to talk with your healthcare team about any questions you may have about MDS and INQOVI as a treatment option so you can feel more informed when making treatment decisions.
Review our guide for getting this important conversation started with your doctor.
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.
Call 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
Before taking INQOVI, tell your healthcare provider about all of your medical conditions, including if you:
have kidney problems
have liver problems
are pregnant or plan to become pregnant. INQOVI can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with INQOVI.
Females who are able to become pregnant:
Your healthcare provider will check to see if you are pregnant before you start treatment with INQOVI.
You should use effective birth control during treatment with INQOVI and for at least 6 months after your 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. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
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 and changes in liver function tests.
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.
Please read the full
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