Vidaza Side Effects

Generic Name: azacitidine

Please note - some side effects for Vidaza may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Vidaza - for the Consumer

Vidaza

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vidaza:

Anxiety; constipation; cough; diarrhea; dizziness; dry skin; headache; indigestion; joint pain; loss of appetite; mild muscle pain; nausea; pain, swelling, or redness at the injection site; stomach tenderness; tiredness or weakness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Vidaza:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding at the injection site; blood in the urine; chest pain; confusion; dark urine; decreased or painful urination; fainting; fever, chills, or persistent sore throat; irregular heartbeat; mouth or tongue swelling or soreness; muscle pain, weakness, or cramping; numbness of an arm or leg; one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; stomach or leg pain; swelling of the hands, arms, ankles, feet, or legs; unusual bruising or bleeding; unusual or severe tiredness or weakness; vision changes; weight loss; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Vidaza Side Effects - for the Professional

Vidaza

Overview

Adverse Reactions Described in Other Labeling Sections: anemia, neutropenia, thrombocytopenia, elevated serum creatinine, renal failure, renal tubular acidosis, hypokalemia, hepatic coma [see Warnings and Precautions (5.1, 5.2, 5.3)].

Most Commonly Occurring Adverse Reactions (SC or IV Route): nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis. The most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia.

Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC or IV 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 (SC administration), Studies 2 and 3 were single arm studies (one with SC administration and one with IV administration), and Study 4 was an international randomized trial (SC administration) [see Clinical Studies (14)].

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 IV 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 (SC) 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 SC Vidaza Treated Patients; Studies 1 and 2)

	Number (%) of Patients
System Organ Class Preferred Terma	All Vidazab (N=220)	Observationc (N=92)
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.
Blood and lymphatic system disorders
Anemia	153 (69.5)	59 (64.1)
Anemia aggravated	12 (5.5)	5 (5.4)
Febrile neutropenia	36 (16.4)	4 (4.3)
Leukopenia	106 (48.2)	27 (29.3)
Neutropenia	71 (32.3)	10 (10.9)
Thrombocytopenia	144 (65.5)	42 (45.7)
Gastrointestinal disorders
Abdominal tenderness	26 (11.8)	1 (1.1)
Constipation	74 (33.6)	6 (6.5)
Diarrhea	80 (36.4)	13 (14.1)
Gingival bleeding	21 (9.5)	4 (4.3)
Loose stools	12 (5.5)	0
Mouth hemorrhage	11 (5.0)	1 (1.1)
Nausea	155 (70.5)	16 (17.4)
Stomatitis	17 (7.7)	0
Vomiting	119 (54.1)	5 (5.4)
General disorders and administration site conditions
Chest pain	36 (16.4)	5 (5.4)
Injection site bruising	31 (14.1)	0
Injection site erythema	77 (35.0)	0
Injection site granuloma	11 (5.0)	0
Injection site pain	50 (22.7)	0
Injection site pigmentation changes	11 (5.0)	0
Injection site pruritus	15 (6.8)	0
Injection site reaction	30 (13.6)	0
Injection site swelling	11 (5.0)	0
Lethargy	17 (7.7)	2 (2.2)
Malaise	24 (10.9)	1 (1.1)
Pyrexia	114 (51.8)	28 (30.4)
Infections and infestations
Nasopharyngitis	32 (14.5)	3 (3.3)
Pneumonia	24 (10.9)	5 (5.4)
Upper respiratory tract infection	28 (12.7)	4 (4.3)
Injury, poisoning, and procedural complications
Post procedural hemorrhage	13 (5.9)	1 (1.1)
Metabolism and nutrition disorders
Anorexia	45 (20.5)	6 (6.5)
Musculoskeletal and connective tissue disorders
Arthralgia	49 (22.3)	3 (3.3)
Chest wall pain	11 (5.0)	0
Myalgia	35 (15.9)	2 (2.2)
Nervous system disorders
Dizziness	41 (18.6)	5 (5.4)
Headache	48 (21.8)	10 (10.9)
Psychiatric disorders
Anxiety	29 (13.2)	3 (3.3)
Insomnia	24 (10.9)	4 (4.3)
Respiratory, thoracic and mediastinal disorders
Dyspnea	64 (29.1)	11 (12.0)
Skin and subcutaneous tissue disorders
Dry skin	11 (5.0)	1 (1.1)
Ecchymosis	67 (30.5)	14 (15.2)
Erythema	37 (16.8)	4 (4.3)
Rash	31 (14.1)	9 (9.8)
Skin nodule	11 (5.0)	1 (1.1)
Urticaria	13 (5.9)	1 (1.1)
Vascular disorders
Hematoma	19 (8.6)	0
Hypotension	15 (6.8)	2 (2.2)
Petechiae	52 (23.6)	8 (8.7)

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)

	Number (%) of Patients
	Any Grade		Grade 3/4
System Organ Class Preferred Terma	Vidaza (N=175)	Best Supportive Care Only (N=102)	Vidaza (N=175)	Best Supportive Care Only (N=102)
a Multiple reports of the same preferred term from a patient were only counted once within each treatment.
Blood and lymphatic system disorders
Anemia	90 (51.4)	45 (44.1)	24 (13.7)	9 (8.8)
Febrile neutropenia	24 (13.7)	10 (9.8)	22 (12.6)	7 (6.9)
Leukopenia	32 (18.3)	2 (2.0)	26 (14.9)	1 (1.0)
Neutropenia	115 (65.7)	29 (28.4)	107 (61.1)	22 (21.6)
Thrombocytopenia	122 (69.7)	35 (34.3)	102 (58.3)	29 (28.4)
Gastrointestinal disorders
Abdominal pain	22 (12.6)	7 (6.9)	7 (4.0)	0
Constipation	88 (50.3)	8 (7.8)	2 (1.1)	0
Dyspepsia	10 (5.7)	2 (2.0)	0	0
Nausea	84 (48.0)	12 (11.8)	3 (1.7)	0
Vomiting	47 (26.9)	7 (6.9)	0	0
General disorders and administration site conditions
Fatigue	42 (24.0)	12 (11.8)	6 (3.4)	2 (2.0)
Injection site bruising	9 (5.1)	0	0	0
Injection site erythema	75 (42.9)	0	0	0
Injection site hematoma	11 (6.3)	0	0	0
Injection site induration	9 (5.1)	0	0	0
Injection site pain	33 (18.9)	0	0	0
Injection site rash	10 (5.7)	0	0	0
Injection site reaction	51 (29.1)	0	1 (0.6)	0
Pyrexia	53 (30.3)	18 (17.6)	8 (4.6)	1 (1.0)
Infections and infestations
Rhinitis	10 (5.7)	1 (1.0)	0	0
Upper respiratory tract infection	16 (9.1)	4 (3.9)	3 (1.7)	0
Urinary tract infection	15 (8.6)	3 (2.9)	3 (1.7)	0
Investigations
Weight decreased	14 (8.0)	0	1 (0.6)	0
Metabolism and nutrition disorders
Hypokalemia	11 (6.3)	3 (2.9)	3 (1.7)	3 (2.9)
Nervous system disorders
Lethargy	13 (7.4)	2 (2.0)	0	1 (1.0)
Psychiatric disorders
Anxiety	9 (5.1)	1 (1.0)	0	0
Insomnia	15 (8.6)	3 (2.9)	0	0
Renal and urinary disorders
Hematuria	11 (6.3)	2 (2.0)	4 (2.3)	1 (1.0)
Respiratory, thoracic and mediastinal disorders
Dyspnea	26 (14.9)	5 (4.9)	6 (3.4)	2 (2.0)
Dyspnea exertional	9 (5.1)	1 (1.0)	0	0
Pharyngolaryngeal pain	11 (6.3)	3 (2.9)	0	0
Skin and subcutaneous tissue disorders
Erythema	13 (7.4)	3 (2.9)	0	0
Petechiae	20 (11.4)	4 (3.9)	2 (1.1)	0
Pruritus	21 (12.0)	2 (2.0)	0	0
Rash	18 (10.3)	1 (1.0)	0	0
Vascular disorders
Hypertension	15 (8.6)	4 (3.9)	2 (1.1)	2 (2.0)

In Studies 1, 2 and 4 with SC 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 SC 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 IV and SC studies. Adverse reactions that appeared to be specifically associated with the IV 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 SC or IV 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, cardio-respiratory 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

Reports of interstitial lung disease have been received in the post-marketing setting.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects including nausea (70.5%), vomiting (54.1%), diarrhea (36.4%), constipation (33.6%), anorexia (20.5%), pharyngitis (20.0%), appetite decreased (12.7%), gingival bleeding (9.5%), oral mucosal petechiae (7.7%), stomatitis (7.7%), dyspepsia (6.8), hemorrhoids (6.8%), loose stools (5.5%), dysphagia (5.0%), mouth hemorrhage (5.0%), tongue ulceration (5.0%), diverticulitis, gastrointestinal hemorrhage, melena, and perirectal abscess have been reported.

Hematologic

Hematologic side effects including anemia (69.5%), thrombocytopenia (65.5%), leukopenia (48.2%), neutropenia (32.3%), febrile neutropenia (16.4%), hypokalemia (12.7%), post procedural hemorrhage (5.9%), aggravated anemia (5.5%), agranulocytosis, bone marrow depression, bone marrow failure, pancytopenia, and splenomegaly have been reported.

General

General side effects including pyrexia (51.8%), fatigue (35.9%), weakness (29.1%), rigors (25.5%), pain in limb (20%), back pain (18.6%), contusion (18.6%), dizziness (18.6%), erythema (16.8%), chest pain (16.4%), epistaxis (16.4%), myalgia (15.9%), decreased weight (15.9%), abdominal pain (15.5%), aggravated fatigue (12.7%), abdominal tenderness (11.8%), insomnia (10.9%), malaise (10.9%), pain (10.9%), upper abdominal pain (10.5%), night sweats (8.6%), lethargy (7.7%), peripheral swelling (7.3%), transfusion reaction (6.8%), abdominal distension (5.9%), syncope (5.9%), chest wall pain (5.0%), hypoesthesia (5.0%), post procedural pain (5.0%), general physical health deterioration, and systemic inflammatory response syndrome have been reported.

Local

Local side effects including injection site erythema (35%), injection site pain (22.7%), injection site bruising (14.1%), injection site reaction (13.6%), injection site pruritus (6.8%), injection site granuloma (5.0%), injection site pigmentation changes (5.0%), injection site swelling (5.0%), and catheter site hemorrhage have been reported.

Dermatologic

Dermatologic side effects including ecchymosis (30.5%), petechiae (23.6%), skin lesions (14.5%), rash (14.1%), pruritus (12.3%), increased sweating (10.5%), urticaria (5.9%), dry skin (5.0%), skin nodule (5.0%), pyoderma gangrenosum, pruritic rash, and skin induration have been reported.

Respiratory

Respiratory side effects including cough (29.5%), dyspnea (29.1%), nasopharyngitis (14.5%), exertional dyspnea (14.1%), productive cough (11.4%), pneumonia (10.9%), lung crackles (10.5%), rhinorrhea (10.0%), rales (8.6%), wheezing (8.6%), decreased breath sounds (7.7%), pleural effusion (6.4%), postnasal drip (5.9%), rhonchi (5.9%), nasal congestion (5.5%), atelectasis (5.0%), exacerbated dyspnea (5.0%), sinusitis (5.0%), hemoptysis, lung infiltration, pneumonitis, and respiratory distress have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (22.3%), muscle cramps (5.9%), aggravated bone pain, muscle weakness, and neck pain have been reported.

Nervous system

Nervous system side effects including headache (21.8%), convulsions, and intracranial hemorrhage have been reported.

Cardiovascular

Cardiovascular side effects including peripheral edema (18.6%), cardiac murmur (10.0%), tachycardia (8.6%), hypotension (6.8%), atrial fibrillation, cardiac failure, congestive cardiac failure, orthostatic hypotension, cardiorespiratory arrest, cerebral hemorrhage, and congestive cardiomyopathy have been reported.

Other

Other side effects including pallor (15.5%), pitting edema (14.5%), lymphadenopathy (9.5%), hematoma (8.6%), cellulitis (8.2%), and cholecystectomy have been reported.

Infections and infestations including herpes simplex (9.1%), limb abscess, bacterial infection, blastomycosis, injection site infection, Klebsiella sepsis, streptococcal pharyngitis, Klebsiella pneumonia, sepsis, Staphylococcal bacteremia, Staphylococcal infection, neutropenic sepsis, septic shock, and toxoplasmosis have been reported.

Genitourinary

Genitourinary side effects including urinary tract infection (7.7%), hematuria, and loin pain have been reported.

Renal

Renal side effects including renal failure have been reported.

Hepatic

Hepatic side effects including cholecystitis have been reported.

Immunologic

Immunologic side effects including anaphylactic shock and hypersensitivity have been reported.

Metabolic

Metabolic side effects including dehydration have been reported.

Oncologic

Oncologic side effects including leukemia cutis have been reported.

Psychiatric

Psychiatric side effects including confusion have been reported.

Ocular

Ocular side effects including eye hemorrhage have been reported.

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