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Vidaza

Last reviewed on RxList: 3/27/2020
Vidaza Side Effects Center

What Is Vidaza?

Vidaza (azacitidine for injection) is a cancer medication used to treat certain types of bone marrow cancers and blood cell disorders.

What Are Side Effects of Vidaza?

Common side effects of Vidaza include:

Tell your doctor if you have serious side effects of Vidaza including:

  • easy bleeding or bruising,
  • chest pain,
  • muscle cramps,
  • irregular heartbeat,
  • swollen ankles or feet,
  • mental/mood changes (e.g., anxiety, depression),
  • changes in the amount of urine,
  • dark urine, or
  • yellowing eyes or skin.

Dosage for Vidaza

The recommended starting dose of Vidaza for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m² subcutaneously or intravenously, daily for 7 days. Cycles should be repeated every 4 weeks.

What Drugs, Substances, or Supplements Interact with Vidaza?

Other drugs may interact with Vidaza. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Vidaza During Pregnancy and Breastfeeding

Vidaza is not recommended for use during pregnancy. Men using this medication should avoid causing pregnancy during treatment. It is recommended that men and women use 2 forms of birth control (e.g., condoms and birth control pills) while using this medication and for some time afterward. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Vidaza (azacitidine for injection) 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.

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Vidaza 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:

  • severe ongoing nausea, vomiting, or diarrhea;
  • redness, swelling, warmth, oozing, or other signs of skin infection;
  • stabbing chest pain, wheezing, cough with yellow or green mucus, feeling short of breath;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • kidney problems--pain in your lower back, blood in your urine, little or no urination, swelling in your feet or ankles;
  • liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, muscle weakness or limp feeling; or
  • signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • fever, chills, bruising, or other signs of low blood cell counts;
  • nausea, vomiting, constipation, diarrhea;
  • weakness; or
  • redness or other irritation where the injection was given.

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 Vidaza (Azacitidine)

Vidaza Professional Information

SIDE EFFECTS

The following adverse reactions are described in other labeling sections:

  • Anemia, Neutropenia and Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Embryo-Fetal Risk [see WARNINGS AND PRECAUTIONS]

Most Commonly Occurring Adverse Reactions (Subcutaneous Or Intravenous Route)

nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis. The most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia.

Adverse Reactions Most Frequently (>2%) Resulting In Clinical Intervention (Subcutaneous Or Intravenous Route)

Discontinuation: leukopenia, thrombocytopenia, neutropenia.
Dose Held: leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia.
Dose Reduced: leukopenia, neutropenia, thrombocytopenia.

Adverse Reactions In Clinical Trials

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

The data described below reflect exposure to VIDAZA in 443 MDS patients from 4 clinical studies. Study 1 was a supportive-care controlled trial (subcutaneous administration), Studies 2 and 3 were single arm studies (one with subcutaneous administration and one with intravenous administration), and Study 4 was an international randomized trial (subcutaneous administration) [see Clinical Studies].

In Studies 1, 2 and 3, a total of 268 patients were exposed to VIDAZA, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year). VIDAZA was studied primarily in supportive-care controlled and uncontrolled trials (n=150 and n=118, respectively). The population in the subcutaneous studies (n=220) was 23 to 92 years old (mean 66.4 years), 68% male, and 94% white, and had MDS or AML. The population in the intravenous study (n=48) was 35 to 81 years old (mean 63.1 years), 65% male, and 100% white. Most patients received average daily doses between 50 and 100 mg/m2.

In Study 4, a total of 175 patients with higher-risk MDS (primarily RAEB and RAEB-T subtypes) were exposed to VIDAZA. Of these patients, 119 were exposed for 6 or more cycles, and 63 for at least 12 cycles. The mean age of this population was 68.1 years (ranging from 42 to 83 years), 74% were male, and 99% were white. Most patients received daily VIDAZA doses of 75 mg/m2.

Table 1 presents adverse reactions occurring in at least 5% of patients treated with VIDAZA (subcutaneous) in Studies 1 and 2. It is important to note that duration of exposure was longer for the VIDAZA-treated group than for the observation group: patients received VIDAZA for a mean of 11.4 months while mean time in the observation arm was 6.1 months.

Table 1: Most Frequently Observed Adverse Reactions (≥ 5.0% in All Subcutaneous VIDAZA Treated Patients; Studies 1 and 2)

Number (%) of Patients
System Organ Class
  Preferred Terma
All VIDAZAb
(N=220)
Observationc
(N=92)
Blood and lymphatic system disorders
  Anemia153 (70)59 (64)
  Anemia aggravated12 (6)5 (5)
  Febrile neutropenia36 (16)4 (4)
  Leukopenia106 (48)27 (29)
  Neutropenia71 (32)10 (11)
  Thrombocytopenia144 (66)42 (46)
Gastrointestinal disorders
  Abdominal tenderness26 (12)1 (1)
  Constipation74 (34)6 (7)
  Diarrhea80 (36)13 (14)
  Gingival bleeding21 (10)4 (4)
  Loose stools12 (6)0
  Mouth hemorrhage11 (5)1 (1)
  Nausea155 (71)16 (17)
  Stomatitis17 (8)0
  Vomiting119 (54)5 (5)
General disorders and administration site conditions
  Chest pain36 (16)5 (5)
  Injection site bruising31 (14)0
  Injection site erythema77 (35)0
  Injection site granuloma11 (5)0
  Injection site pain50 (23)0
  Injection site pigmentation changes11 (5)0
  Injection site pruritus15 (7)0
  Injection site reaction30 (14)0
  Injection site swelling11 (5)0
  Lethargy17 (8)2 (2)
  Malaise24 (11)1 (1)
  Pyrexia114 (52)28 (30)
Infections and infestations
  Nasopharyngitis32 (15)3 (3)
  Pneumonia24 (11)5 (5)
  Upper respiratory tract infection28 (13)4 (4)
Injury, poisoning, and procedural complications
  Post procedural hemorrhage13 (6)1 (1)
Metabolism and nutrition disorders
  Anorexia45 (21)6 (7)
Musculoskeletal and connective tissue disorders
  Arthralgia49 (22)3 (3)
  Chest wall pain11 (5)0
  Myalgia35 (16)2 (2)
Nervous system disorders
  Dizziness41 (19)5 (5)
  Headache48 (22)10 (11)
Psychiatric disorders
  Anxiety29 (13)3 (3)
  Insomnia24 (11)4 (4)
Respiratory, thoracic and mediastinal disorders
  Dyspnea64 (29)11 (12)
Skin and subcutaneous tissue disorders
  Dry skin11 (5)1 (1)
  Ecchymosis67 (31)14 (15)
  Erythema37 (17)4 (4)
  Rash31 (14)9 (10)
  Skin nodule11 (5)1 (1)
  Urticaria13 (6)1 (1)
Vascular disorders
  Hematoma19 (9)0
  Hypotension15 (7)2 (2)
  Petechiae52 (24)8 (9)
a Multiple terms of the same preferred terms for a patient are only counted once within each treatment group.
b Includes adverse reactions from all patients exposed to VIDAZA, including patients after crossing over from observations.
c Includes adverse reactions from observation period only; excludes any adverse events after crossover to VIDAZA.

Table 2 presents adverse reactions occurring in at least 5% of patients treated with VIDAZA in Study 4. Similar to Studies 1 and 2 described above, duration of exposure to treatment with VIDAZA was longer (mean 12.2 months) compared with best supportive care (mean 7.5 months).

Table 2: Most Frequently Observed Adverse Reactions (≥ 5.0% in the VIDAZA Treated Patients and the Percentage with NCI CTC Grade 3/4 Reactions; Study 4)

System Organ Class
  Preferred Terma
Number (%) of Patients
Any GradeGrade 3/4
VIDAZA
(N=175)
Best Supportive Care Only
(N=102)
VIDAZA
(N=175)
Best Supportive Care Only
(N=102)
Blood and lymphatic system disorders
  Anemia90 (51)45 (44)24 (14)9 (9)
  Febrile neutropenia24 (14)10 (10)22 (13)7 (7)
  Leukopenia32 (18)2 (2)26 (15)1 (1)
  Neutropenia115 (66)29 (28)107 (61)22 (22)
  Thrombocytopenia122 (70)35 (34)102 (58)29 (28)
Gastrointestinal disorders
  Abdominal pain22 (13)7 (7)7 (4)0
  Constipation88 (50)8 (8)2 (1)0
  Dyspepsia10 (6)2 (2)00
  Nausea84 (48)12 (12)3 (2)0
  Vomiting47 (27)7 (7)00
General disorders and administration site conditions
  Fatigue42 (24)12 (12)6 (3)2 (2)
  Injection site bruising9 (5)000
  Injection site erythema75 (43)000
  Injection site hematoma11 (6)000
  Injection site induration9 (5)000
  Injection site pain33 (19)000
  Injection site rash10 (6)000
  Injection site reaction51 (29)01 (1)0
  Pyrexia53 (30)18 (18)8 (5)1 (1)
Infections and infestations
  Rhinitis10 (6)1 (1)00
  Upper respiratory tract infection16 (9)4 (4)3 (2)0
  Urinary tract infection15 (9)3 (3)3 (2)0
  Investigations
  Weight decreased14 (8)01 (1)0
Metabolism and nutrition disorders
  Hypokalemia11 (6)3 (3)3 (2)3 (3)
Nervous system disorders
  Lethargy13 (7)2 (2)01 (1)
Psychiatric disorders
  Anxiety9 (5)1 (1)00
  Insomnia15 (9)3 (3)00
Renal and urinary disorders
  Hematuria11 (6)2 (2)4 (2)1 (1)
Respiratory, thoracic and mediastinal disorders
  Dyspnea26 (15)5 (5)6 (3)2 (2)
  Dyspnea exertional9 (5)1 (1)00
  Pharyngolaryngeal pain11 (6)3 (3)00
Skin and subcutaneous tissue disorders
  Erythema13 (7)3 (3)00
  Petechiae20 (11)4 (4)2 (1)0
  Pruritus21 (12)2 (2)00
  Rash18 (10)1 (1)00
Vascular disorders
  Hypertension15 (9)4 (4)2 (1)2 (2)
a Multiple reports of the same preferred term from a patient were only counted once within each treatment.

In Studies 1, 2 and 4 with subcutaneous administration of VIDAZA, adverse reactions of neutropenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, constipation, and injection site erythema/reaction tended to increase in incidence with higher doses of VIDAZA. Adverse reactions that tended to be more pronounced during the first 1 to 2 cycles of subcutaneous treatment compared with later cycles included thrombocytopenia, neutropenia, anemia, nausea, vomiting, injection site erythema/pain/bruising/reaction, constipation, petechiae, dizziness, anxiety, hypokalemia, and insomnia. There did not appear to be any adverse reactions that increased in frequency over the course of treatment.

Overall, adverse reactions were qualitatively similar between the intravenous and subcutaneous studies. Adverse reactions that appeared to be specifically associated with the intravenous route of administration included infusion site reactions (e.g. erythema or pain) and catheter site reactions (e.g. infection, erythema, or hemorrhage).

In clinical studies of either subcutaneous or intravenous VIDAZA, the following serious adverse reactions occurring at a rate of <5% (and not described in Tables 1 or 2) were reported:

Blood and lymphatic system disorders: agranulocytosis, bone marrow failure, pancytopenia splenomegaly.

Cardiac disorders: atrial fibrillation, cardiac failure, cardiac failure congestive, cardiorespiratory arrest, congestive cardiomyopathy.

Eye disorders: eye hemorrhage

Gastrointestinal disorders: diverticulitis, gastrointestinal hemorrhage, melena, perirectal abscess.

General disorders and administration site conditions: catheter site hemorrhage, general physical health deterioration, systemic inflammatory response syndrome.

Hepatobiliary disorders: cholecystitis.

Immune system disorders: anaphylactic shock, hypersensitivity.

Infections and infestations: abscess limb, bacterial infection, cellulitis, blastomycosis, injection site infection, Klebsiella sepsis, neutropenic sepsis, pharyngitis streptococcal, pneumonia Klebsiella, sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, toxoplasmosis.

Metabolism and nutrition disorders: dehydration.

Musculoskeletal and connective tissue disorders: bone pain aggravated, muscle weakness, neck pain.

Neoplasms benign, malignant and unspecified: leukemia cutis.

Nervous system disorders: cerebral hemorrhage, convulsions, intracranial hemorrhage.

Renal and urinary disorders: loin pain, renal failure.

Respiratory, thoracic and mediastinal disorders: hemoptysis, lung infiltration, pneumonitis, respiratory distress.

Skin and subcutaneous tissue disorders: pyoderma gangrenosum, rash pruritic, skin induration.

Surgical and medical procedures: cholecystectomy.

Vascular disorders: orthostatic hypotension.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of VIDAZA. 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.

  • Interstitial lung disease
  • Tumor lysis syndrome
  • Injection site necrosis
  • Sweet’s syndrome (acute febrile neutrophilic dermatosis)
  • Necrotizing fasciitis (including fatal cases)
  • Differentiation syndrome

Read the entire FDA prescribing information for Vidaza (Azacitidine)

Related Resources for Vidaza

Read the Vidaza User Reviews »

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

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