Inqovi

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/8/2021
Inqovi Side Effects Center

What Is Inqovi?

Inqovi (decitabine and cedazuridine) is a combination of a nucleoside metabolic inhibitor and a cytidine deaminase inhibitor used to treat adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French¬-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

What Are Side Effects of Inqovi?

Side effects of Inqovi include:

Dosage for Inqovi

The recommended dosage of Inqovi is 1 tablet (35 mg decitabine and 100 mg cedazuridine) taken orally once daily on Days 1 through 5 of each 28-day cycle.

Inqovi In Children

The safety and effectiveness of Inqovi have not been established in pediatric patients.

Use sodium nitrite with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk.

What Drugs, Substances, or Supplements Interact with Inqovi?

Inqovi may interact with other medicines.

  • drugs that are metabolized by the cytidine deaminase (CDA) enzyme.

Tell your doctor all medications and supplements you use.

Inqovi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Inqovi; it may harm a fetus. The pregnancy status in females of reproductive potential should be verified prior to initiating Inqovi. Females of reproductive potential are advised to use effective contraception during treatment with Inqovi and for 6 months after the last dose. Males with female partners of reproductive potential are advised to use effective contraception during treatment with Inqovi and for 3 months after the last dose. It is unknown if Inqovi passes into breast milk. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended while using Inqovi and for at least 2 weeks after the last dose.

Additional Information

Our Inqovi (decitabine and cedazuridine) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Inqovi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • signs of a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • fever, low blood cell counts;
  • bruising or bleeding;
  • abnormal liver function tests;
  • headache, dizziness, feeling tired;
  • swelling in your arms or legs;
  • muscle or joint pain;
  • painful mouth sores;
  • shortness of breath, lung infection;
  • nausea, loss of appetite;
  • diarrhea, constipation;
  • rash; or
  • cold symptoms such as stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Inqovi (Decitabine and Cedazuridine Tablets)

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Inqovi Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely variable conditions, adverse event rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice.

Myelodysplastic Syndrome And Chronic Myelomonocytic Leukemia

The safety of INQOVI was evaluated in a pooled safety population that includes patients enrolled in Study ASTX727-01-B and Study ASTX727-02 [see Clinical Studies].

Patients were randomized to receive INQOVI (35 mg decitabine and 100 mg cedazuridine) orally once daily on Days 1 through 5 in Cycle 1 and decitabine 20 mg/m² intravenously on Days 1 through 5 in Cycle 2, or the reverse sequence, and then INQOVI (35 mg decitabine and 100 mg cedazuridine) orally once daily on Days 1 through 5 of each 28-day cycle in Cycles 3 and beyond. Patients were allowed to have one prior cycle of decitabine or azacitidine and there was no limit for body weight or surface area. Among the patients who received INQOVI, 61% of patients were exposed for 6 months or longer and 24% were exposed to INQOVI for greater than 1 year.

Serious adverse reactions occurred in 68% of patients who received INQOVI. Serious adverse reactions in > 5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions occurred in 6% of patients. These included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.

Permanent discontinuation due to an adverse reaction occurred in 5% of patients who received INQOVI. The most frequent adverse reactions resulting in permanent discontinuation were febrile neutropenia (1%) and pneumonia (1%).

Dose interruptions due to an adverse reaction occurred in 41% of patients who receiived INQOVI. Adverse reactions requiring dosage interruptions in > 5% of patients who received INQOVI included neutropenia (18%), febrile neutropenia (8%), thrombocytopenia (6%), and anemia (5%).

Dose reductions due to an adverse reaction occurred in 19% of patients who received INQOVI. Adverse reactions requiring dosage reductions in > 2% of patients who received INQOVI included neutropenia (12%), anemia (3%), and thrombocytopenia (3%).

The most common adverse reactions (≥ 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (≥ 50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.

Table 2 summarizes the adverse reactions in the pooled safety population.

Table 2: Adverse Reactions (≥ 10%) in Patients Who Received INQOVI in Pooled Safety Population

Adverse Reactions INQOVI Cycle 1
N=107
Intravenous Decitabine Cycle 1
N=106
INQOVI All Cycles
N=208
All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
General disorders and administration site conditions
Fatigue1 29 2 25 0 55 5
Hemorrhage2 24 2 17 0 43 3
Edema3 10 0 11 0 30 0.5
Pyrexia 7 0 7 0 19 1
Gastrointestinal disorders
Constipation4 20 0 23 0 44 0
Mucositis5 18 1 24 2 41 4
Nausea 25 0 16 0 40 0.5
Diarrhea6 16 0 11 0 37 1
Transaminase increased7 12 1 3 0 21 3
Abdominal pain8 9 0 7 0 19 1
Vomiting 5 0 5 0 15 0
Musculoskeletal and connective tissue disorders
Myalgia9 9 2 16 1 42 3
Arthralgia10 9 1 13 1 40 3
Respiratory, thoracic, and mediastinal disorders
Dyspnea11 17 3 9 3 38 6
Cough12 7 0 8 0 28 0
Blood & lymphatic system disorders
Febrile neutropenia 10 10 13 13 33 32
Skin and subcutaneous tissue disorders
Rash13 12 1 11 1 33 0.5
Nervous system disorders
Dizziness14 16 1 11 0 33 2
Headache15 22 0 13 0 30 0
Neuropathy16 4 0 8 0 13 0
Metabolism and nutritional disorders
Decreased appetite 10 1 6 0 24 2
Infections and infestations
Upper respiratory tract infection17 6 0 3 0 23 1
Pneumonia18 7 7 7 5 21 15
Sepsis19 6 6 2 1 14 11
Cellulitis20 4 1 3 2 12 5
Investigations
Renal impairment21 9 0 8 1 18 0
Weight decreased 5 0 3 0 10 1
Injury, poisoning, and procedural complications
Fall 4 0 1 0 12 1
Psychiatric disorders
Insomnia 6 0 2 0 12 0.5
Vascular disorders
Hypotension22 4 0 6 1 11 2
Cardiac Disorders
Arrhythmia23 3 0 2 0 11 1
†Includes adverse reactions that occurred during all cycles, including during treatment with
1 cycle of intravenous decitabine. 1 Includes fatigue, asthenia, and lethargy
2 Includes contusion, epistaxis, petechiae, hematuria, conjunctival hemorrhage, mouth hemorrhage, purpura, angina bullosa hemorrhagica, gingival bleeding, hematoma, hemoptysis, eye contusion, hemorrhagic diathesis, increased tendency to bruise, vaginal hemorrhage, abdominal wall hematoma, blood blister, bone contusion, catheter site bruise, ecchymosis, genital hemorrhage, intra abdominal hematoma, oral mucosa hematoma, periorbital hemorrhage, procedural hemorrhage, pulmonary alveolar hemorrhage, retinal hemorrhage, scleral hemorrhage, thrombotic thrombocytopenic purpura, tongue hemorrhage, and vessel puncture site hemorrhage
3 Includes edema peripheral, peripheral swelling, swelling face, fluid overload, localized edema, face edema, edema, eye swelling, eyelid edema, fluid retention, periorbital swelling, scrotal edema, scrotal swelling, and swelling
4 Includes constipation and feces hard
5 Includes oropharyngeal pain, stomatitis, mouth ulceration, proctalgia, oral pain, gingivitis, oral disorder, gingival pain, colitis, glossodynia, mouth swelling, pharyngitis, proctitis, duodenitis, enteritis, gingival discomfort, gingival swelling, lip disorder, lip ulceration, mucosal ulceration, nasal ulcer, noninfective gingivitis, oral mucosal blistering, oral mucosal erythema, pharyngeal erythema, pharyngeal ulceration, tongue ulceration, and vulvitis
6 Includes diarrhea and feces soft
7 Includes alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma glutamyltransferase increased, liver function test increased, and transaminases increased
8 Includes abdominal pain, abdominal pain upper, abdominal pain lower, epigastric discomfort, and abdominal discomfort
9 Includes myalgia, pain in extremity, muscle spasms, pain, musculoskeletal pain, non-cardiac chest pain, muscular weakness, musculoskeletal chest pain, flank pain, musculoskeletal stiffness, muscle strain, and musculoskeletal discomfort
10 Includes arthralgia, back pain, neck pain, joint stiffness, pain in jaw, joint swelling, bursitis, joint range of motion decreased, and joint injury
11 Includes dyspnea, dyspnea exertional, hypoxia, wheezing, chronic obstructive pulmonary disease, and tachypnoea
12 Includes cough and productive cough
13 Includes maculo-papular rash, rash, erythema, skin lesion, folliculitis, dermatitis, dermatitis acneiform, eczema, erythema multiforme, rash erythematous, seborrheic keratosis, skin ulcer, dermatitis allergic, dermatitis contact, eczema nummular, genital erythema, rash papular, rash pruritic, rash pustular, seborrheic dermatitis, skin exfoliation, skin irritation, stasis dermatitis, and ulcerative keratitis
14 Includes dizziness, vertigo, postural dizziness, and positional vertigo
15 Includes headache, sinus pain, and sinus headache
16 Includes hypoesthesia, paresthesia, neuropathy peripheral, gait disturbance, peripheral sensory neuropathy, ataxia, balance disorder, brachial plexopathy, carpal tunnel syndrome, and radicular pain
17 Includes upper respiratory tract infection, nasopharyngitis, sinusitis, and viral upper respiratory tract infection
18 Includes pneumonia, pneumonitis, atypical pneumonia, and lung infection
19 Includes sepsis, bacteremia, septic shock, endocarditis, pseudomonal bacteremia, and staphylococcal bacteremia
20 Includes cellulitis, catheter site cellulitis, and infected bite
21 Includes blood creatinine increased, acute kidney injury, blood urea increased, blood creatine increased, and renal failure
22 Includes hypotension, blood pressure decreased, and cardiogenic shock
23 Includes sinus tachycardia, atrial fibrillation, bradycardia, tachycardia, atrial flutter, sinus bradycardia, and conduction disorder

Clinically relevant adverse reactions in < 10% of patients who received INQOVI included:

  • Acute febrile neutrophilic dermatosis (Sweet's syndrome) (1%)
  • Tumor lysis syndrome (0.5%)

Table 3: Select Laboratory Abnormalities (> 20%) Worsening from Baseline in Patients Who Received INQOVI in Pooled Safety Population

Lab Abnormality* INQOVI Cycle 1† Intravenous Decitabine Cycle 1† INQOVI All Cycles†
All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Hematology
Leukocytes decreased 79 65 77 59 87 81
Platelet count decreased 79 65 77 67 82 76
Neutrophil count decreased 70 65 62 59 73 71
Hemoglobin decreased 58 41 59 36 71 55
Chemistry
Glucose increased 19 0 11 0 54 7
Albumin decreased 22 1 20 0 45 2
Alkaline phosphatase increased 22 1 12 0 42 0.5
Glucose decreased 14 0 17 0 40 1
Alanine aminotransferase increased 13 1 7 0 37 2
Sodium decreased 9 2 8 0 30 4
Calcium decreased 16 0 12 0 30 2
Aspartate aminotransferase increased 6 1 2 0 30 2
Creatinine increased 7 0 8 0 29 0.5
* Includes any lab abnormalities that worsened by one or more grades. Grade 3-4 includes any lab abnormalities that worsened to Grade 3 or Grade 4.
† The denominator used to calculate the rate varied from 103 to 107 for INQOVI Cycle 1, from 102 to 106 for Intravenous Decitabine Cycle and from 203 to 208 for INQOVI All Cycles based on the number of patients with a baseline value and at least one post-treatment value.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of intravenous decitabine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Differentiation syndrome

Respiratory, Thoracic and Mediastinal Disorders: Interstitial lung disease

DRUG INTERACTIONS

Effects Of INQOVI On Other Drugs

Drugs Metabolized by Cytidine Deaminase

Cedazuridine is an inhibitor of the cytidine deaminase (CDA) enzyme. Coadministration of INQOVI with drugs that are metabolized by CDA may result in increased systemic exposure with potential for increased toxicity of these drugs [see CLINICAL PHARMACOLOGY]. Avoid coadministration of INQOVI with drugs that are metabolized by CDA.

Read the entire FDA prescribing information for Inqovi (Decitabine and Cedazuridine Tablets)

© Inqovi Patient Information is supplied by Cerner Multum, Inc. and Inqovi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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