Applies to cedazuridine / decitabine: oral tablet.

Serious side effects

Along with its needed effects, cedazuridine/decitabine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cedazuridine / decitabine:

More common

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• blurred vision
• body aches or pain
• burning, numbness, painful, or tingling sensations
• chest pain
• chills
• confusion
• cough
• coughing up blood
• cracked lips
• decreased frequency or amount of urine
• diarrhea
• difficult or labored breathing
• difficulty in swallowing
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• ear congestion
• fainting
• fast, slow, or irregular heartbeat
• fever
• headache
• increased menstrual flow or vaginal bleeding
• increased thirst
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• loss of appetite
• loss of voice
• lower back or side pain
• nausea
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• rapid, shallow breathing
• runny or stuffy nose
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• sweating
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Less common

• Fever sores on the skin
• blue lips, fingernails, or skin

Rare

• Joint pain, stiffness, or swelling
• stomach pain

Other side effects

Some side effects of cedazuridine / decitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• decreased appetite
• difficulty in moving
• falls
• muscle pain, cramps, or stiffness
• skin rash
• trouble sleeping
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to cedazuridine / decitabine: oral tablet.

Hematologic

Very common (10% or more): Thrombocytopenia (82%) Grade 3 or 4 occurring in 76%, leukocytes decreased (87%), platelet count decreased (82%), neutropenia (73%) with Grade 3 or 4 occurring in 71%. anemia (71%) with Grade 3 or 4 occurring in 55%, hemorrhage (e.g., 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, abdominal hematoma, oral mucosa hematoma, periorbital hemorrhage, procedural hemorrhage, pulmonary alveolar hemorrhage, retinal hemorrhage, scleral hemorrhage, thrombotic thrombocytopenic purpura, tongue hemorrhage, vessel puncture site hemorrhage) (43%), febrile neutropenia (33%)^[Ref]

Immunologic

Very common (10% or more): Sepsis (e.g., sepsis, bacteremia, septic shock, endocarditis, pseudomonal bacteremia, staphylococcal bacteremia) (14%), cellulitis (e.g., cellulitis, catheter site cellulitis, infected bite) (12%)^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (e.g., myalgia, pain in extremity, muscle spasms, pain, musculoskeletal pain, non-cardiac chest pain, muscular weakness,

musculoskeletal chest pain, flank pain, musculoskeletal stiffness, muscle strain, musculoskeletal discomfort (42%), arthralgia (e.g., arthralgia, back pain, neck pain, joint stiffness, pain in jaw, joint swelling, bursitis, joint range of motion decreased, joint injury (40%)^[Ref]

Metabolic

Very common (10% or more): Glucose increased (54%), sodium decreased (30%), calcium decreased (30%), anorexia (24%), weight loss (10%)

Uncommon (0.1% to 1%): Tumor lysis syndrome^[Ref]

Psychiatric

Very common (10% or more): Insomnia (12%)^[Ref]

Hepatic

Very common (10% or more): Transaminase increased (e.g., alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, liver function test increased, transaminases increased) (21%), abdominal pain (e.g., abdominal pain upper, abdominal pain lower, epigastric discomfort, abdominal discomfort) (19%), vomiting (15%)^[Ref]

Respiratory

Very common (10% or more): Dyspnea (e.g., dyspnea, dyspnea exertional, hypoxia, wheezing, chronic obstructive pulmonary disease, tachypnea (38%) cough (e.g., cough, productive cough) (28%), upper respiratory tract infection (e.g., upper respiratory tract infection, nasopharyngitis, sinusitis, viral upper respiratory tract infection) (23%), pneumonia (e.g., pneumonia, pneumonitis, atypical pneumonia, lung infection) (21%)

Postmarketing reports: Interstitial lung disease (decitabine)^[Ref]

Other

Very common (10% or more): Fatigue/asthenia/lethargy (55%), edema (e.g., 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) (30%), pyrexia (19%), fall (12%)^[Ref]

General

Myelosuppression (e.g., thrombocytopenia, neutropenia, anemia, febrile neutropenia) is the most frequent cause of dose reduction or interruption, occurring in 36% of patients. Permanent discontinuation due to myelosuppression (febrile neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.^[Ref]

Nervous system

Very common (10% or more): Dizziness (e.g., dizziness, vertigo, postural dizziness, positional vertigo) (33%), headache (e.g., headache, sinus pain, sinus headache) (30%), neuropathy (e.g., hypoesthesia, paresthesia, neuropathy peripheral, gait disturbance, peripheral sensory neuropathy, ataxia, balance disorder, brachial plexopathy, carpal tunnel syndrome, radicular pain) (13%)^[Ref]

Renal

Very common (10% or more): Renal impairment (e.g., blood creatinine increased, acute kidney injury, blood urea increased, blood creatine increased, renal failure) (18%)^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (e.g., hypotension, blood pressure decreased, cardiogenic shock) (11%), arrhythmia (e.g., sinus tachycardia, atrial fibrillation, bradycardia, tachycardia, atrial flutter, sinus bradycardia, conduction disorder) (11%)^[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., maculopapular 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, ulcerative keratitis (33%)

Common (1% to 10%): Acute febrile neutrophilic dermatosis (Sweet's syndrome)

Postmarketing reports: Differentiation syndrome (decitabine)^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (44%), mucositis (e.g., 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, vulvitis) (41%), nausea (40%), diarrhea (37%)^[Ref]