DECITABINE injection, powder, lyophilized, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)
Available from:
Nivagen Pharmaceuticals, Inc.
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. None. Risk Summary Based on findings from human data, animal studies, and the mechanism of action, decitabine for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)] . Limited published data on decitabine for injection use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). In animal reproduction studies, administration of decitabin
Product summary:
Decitabine for injection is a sterile, white to almost white lyophilized powder for intravenous use supplied as:                   NDC 75834-190-01, 50 mg single-dose vial individually packaged in a carton. Store vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
75834-190-01

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DECITABINE - decitabine injection, powder, lyophilized, for solution

Nivagen Pharmaceuticals, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DECITABINE FOR INJECTION safely and

effectively. See full prescribing information for DECITABINE FOR INJECTION.

DECITABINE for injection, for intravenous use

Initial U.S. Approval: 2006

INDICATIONS AND USAGE

Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic

syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British

subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory

anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2,

and high-risk International Prognostic Scoring System groups. (1)

DOSAGE AND ADMINISTRATION

Three Day Regimen: Administer decitabine for injection at a dose of 15 mg/m by continuous intravenous infusion

over 3 hours repeated every 8 hours for 3 days. Repeat cycle every 6 weeks. (2.1)

Five Day Regimen: Administer decitabine for injection at a dose of 20 mg/m by continuous intravenous infusion over 1

hour repeated daily for 5 days. Repeat cycle every 4 weeks. (2.1)

DOSAGE FORMS AND STRENGTHS

For Injection: 50 mg of decitabine as a lyophilized powder in a single-dose vial for reconstitution. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

Neutropenia and Thrombocytopenia: Perform complete blood counts and platelet counts. (5.1)

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus

and to use effective contraception (5.2, 8.1, 8.3)

ADVERSE REACTIONS

Most common adverse reactions (>50%) are neutropenia, thrombocytopenia, anemia, and pyrexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Nivagen Pharmaceuticals, Inc. at 1-877-977-0687 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

2.2 Dosage Modifications for Adverse Reactions

2.3 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

5.2 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility

14 CLINICAL STUDIES

14.1 Controlled Trial in Myelodysplastic Syndrome

14.2 Single-arm Studies in Myelodysplastic Syndrome

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes

(MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-

British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with

excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic

leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System

groups.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Sections or subsections omitted from the full prescribing information are not listed.

2.1 Recommended Dosage

Pre-Medications and Baseline Testing

Consider pre-medicating for nausea with antiemetics.

Conduct baseline laboratory testing: complete blood count (CBC) with platelets, serum hepatic

panel, and serum creatinine.

Decitabine for injection Regimen Options

Three Day Regimen

Administer decitabine for injection at a dose of 15 mg/m by continuous intravenous infusion over 3

hours repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon hematologic recovery

(ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles. A complete or

partial response may take longer than 4 cycles. Delay and reduce dose for hematologic toxicity [see

Dosage and Administration (2.2)].

Five Day Regimen

Administer decitabine for injection at a dose of 20 mg/m by continuous intravenous infusion over 1

hour daily for 5 days. Delay and reduce dose for hematologic toxicity [see Dosage and Administration

(2.2)]. Repeat cycles every 4 weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at

least 50,000/μL) for a minimum of 4 cycles. A complete or partial response may take longer than 4

cycles.

Patients with Renal or Severe Hepatic Impairment

Treatment with decitabine for injection has not been studied in patients with pre-existing renal or hepatic

impairment. For patients with pre-existing renal or hepatic impairment, consider the potential risks and

benefits before initiating treatment with decitabine for injection.

2.2 Dosage Modifications for Adverse Reactions

Hematologic Toxicity

If hematologic recovery from a previous decitabine for injection treatment cycle requires more than 6

weeks, delay the next cycle of decitabine for injection therapy and reduce decitabine for injection dose

temporarily by following this algorithm:

Recovery requiring more than 6, but less than 8 weeks: delay the decitabine for injection dosing for

up to 2 weeks and reduce the dose temporarily to 11 mg/m every 8 hours (33 mg/m /day, 99

mg/m /cycle) upon restarting therapy.

Recovery requiring more than 8, but less than 10 weeks: Perform bone marrow aspirate to assess

for disease progression. In the absence of progression, delay decitabine for injection dosing for up

to 2 more weeks and reduce the dose to 11 mg/m every 8 hours (33 mg/m /day, 99 mg/m /cycle)

upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated.

Non-hematologic Toxicity

Delay subsequent decitabine for injection treatment for any the following nonhematologic toxicities and

do not restart until toxicities resolve:

Serum creatinine greater than or equal to 2 mg/dL

Alanine transaminase (ALT), total bilirubin greater than or equal to 2 times upper limit of normal

(ULN)

Active or uncontrolled infection

2.3 Preparation and Administration

Decitabine for injection is a cytotoxic drug. Follow special handling and disposal procedures.

Aseptically reconstitute decitabine for injection with room temperature (20˚C to 25˚C) 10 mL of Sterile

Water for Injection, USP. Upon reconstitution, the final concentration of the reconstituted decitabine for

injection solution is 5 mg/mL. You must dilute the reconstituted solution with 0.9% Sodium Chloride

Injection or 5% Dextrose Injection prior to administration. Temperature of the diluent (0.9% Sodium

Chloride Injection or 5% Dextrose Injection) depends on time of administration after preparation.

For Administration Within 15 Minutes of Preparation

If decitabine for injection is intended to be administered within 15 minutes from the time of preparation,

dilute the reconstituted solution with room temperature (20˚C to 25˚C) 0.9% Sodium Chloride Injection

or 5% Dextrose Injection to a final concentration of 0.1 mg/mL to 1 mg/mL. Discard unused portion.

For Delayed Administration

If decitabine for injection is intended to be administered after 15 minutes of preparation, dilute the

reconstituted solution with cold (2˚C to 8˚C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection

to a final concentration of 0.1 mg/mL to 1 mg/mL. Store at 2˚C to 8˚C for up to 4 hours. Diluted stored

solution must be used within 4 hours from the time of preparation. Discard unused portion.

Use the diluted, refrigerated solution within 4 hours from the time of preparation or discard.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit. Do not use if there is evidence of particulate

matter or discoloration.

3 DOSAGE FORMS AND STRENGTHS

For Injection: 50 mg of decitabine as a sterile, white to almost white lyophilized powder in a single-

dose vial for reconstitution

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

Fatal and serious myelosuppression occurs in decitabine-treated patients. Myelosuppression (anemia,

neutropenia, and thrombocytopenia) is the most frequent cause of decitabine for injection dose

reduction, delay, and discontinuation. Neutropenia of any grade occurred in 90% of decitabine-treated

patients with grade 3 or 4 occurring in 87% of patients. Grade 3 or 4 febrile neutropenia occurred in

23% of patients. Thrombocytopenia of any grade occurred in 89% of patients with grade 3 or 4

occurring in 85% of patients. Anemia of any grade occurred in 82% of patients. Perform complete

blood count with platelets at baseline, prior to each cycle, and as needed to monitor response and

toxicity. Manage toxicity using dose-delay, dose-reduction, growth factors, and anti-infective therapies

as needed [see Dosage and Administration (2.2)]. Myelosuppression and worsening neutropenia may

occur more frequently in the first or second treatment cycles and may not necessarily indicate

progression of underlying MDS.

5.2 Embryo-Fetal Toxicity

Based on findings from human data, animal studies and its mechanism of action, decitabine for injection

can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and

Nonclinical Toxicology (13.1)]. In preclinical studies in mice and rats, decitabine caused adverse

developmental outcomes including embryo-fetal lethality and malformations. Advise pregnant women of

the potential risk to a fetus. Advise females of reproductive potential to use effective contraception

while receiving decitabine for injection and for 6 months following the last dose. Advise males with

female partners of reproductive potential to use effective contraception while receiving treatment with

decitabine for injection and for 3 months following the last dose [see Use in Specific Populations (8.1,

8.3)].

6 ADVERSE REACTIONS

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

Myelosuppression [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

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 safety of decitabine for injection was studied in 3 single-arm studies (N = 66, N = 98, N = 99) and

1 controlled supportive care study (N = 83 decitabine for injection, N = 81 supportive care). The data

described below reflect exposure to decitabine for injection in 83 patients in the MDS trial. In the trial,

patients received 15 mg/m intravenously every 8 hours for 3 days every 6 weeks. The median number

of decitabine for injection cycles was 3 (range 0 to 9).

Most Common Adverse Reactions: neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea,

cough, petechiae, constipation, diarrhea, and hyperglycemia.

Adverse Reactions Most Frequently (≥ 1%) Resulting in Clinical Intervention and or Dose Modification in

the Controlled Supportive Care Study in the Decitabine for Injection Arm:

Discontinuation: thrombocytopenia, neutropenia, pneumonia, Mycobacterium avium complex

infection, cardio-respiratory arrest, increased blood bilirubin, intracranial hemorrhage, abnormal

liver function tests.

Dose Delayed: neutropenia, pulmonary edema, atrial fibrillation, central line infection, febrile

neutropenia.

Dose Reduced: neutropenia, thrombocytopenia, anemia, lethargy, edema, tachycardia, depression,

pharyngitis.

Table 1 presents all adverse reactions occurring in at least 5% of patients in the decitabine for injection

group and at a rate greater than supportive care.

Table 1 Adverse Reactions Reported in ≥ 5% of Patients in the Decitabine for Injection Group

and at a Rate Greater than Supportive Care in the Controlled Trial in MDS

Decitabine for

injection

N = 83 (%)

Supportive Care

N = 81 (%)

Blood and lymphatic system disorders

Neutropenia

75 (90)

58 (72)

Thrombocytopenia

74 (89)

64 (79)

Anemia NOS

68 (82)

60 (74)

Febrile neutropenia

24 (29)

5 (6)

Leukopenia NOS

23 (28)

11 (14)

Lymphadenopathy

10 (12)

6 (7)

Thrombocythemia

4 (5)

1 (1)

Cardiac disorders

Pulmonary edema NOS

5 (6)

0 (0)

Eye disorders

Vision blurred

5 (6)

0 (0)

Gastrointestinal disorders

Nausea

35 (42)

13 (16)

Constipation

29 (35)

11 (14)

Diarrhea NOS

28 (34)

13 (16)

Vomiting NOS

21 (25)

7 (9)

Abdominal pain NOS

12 (14)

5 (6)

Oral mucosal petechiae

11 (13)

4 (5)

Stomatitis

10 (12)

5 (6)

Dyspepsia

10 (12)

1 (1)

Ascites

8 (10)

2 (2)

Gingival bleeding

7 (8)

5 (6)

Hemorrhoids

7 (8)

3 (4)

Loose stools

6 (7)

3 (4)

Tongue ulceration

6 (7)

2 (2)

Dysphagia

5 (6)

2 (2)

Oral soft tissue disorder NOS

5 (6)

1 (1)

Lip ulceration

4 (5)

3 (4)

Abdominal distension

4 (5)

1 (1)

Abdominal pain upper

4 (5)

1 (1)

Gastro-esophageal reflux disease

4 (5)

0 (0)

Glossodynia

4 (5)

0 (0)

General disorders and administrative site disorders

Pyrexia

44 (53)

23 (28)

Edema peripheral

21 (25)

13 (16)

Rigors

18 (22)

14 (17)

Edema NOS

15 (18)

5 (6)

Pain NOS

11 (13)

5 (6)

Lethargy

10 (12)

3 (4)

Tenderness NOS

9 (11)

0 (0)

Fall

7 (8)

3 (4)

Chest discomfort

6 (7)

3 (4)

Intermittent pyrexia

5 (6)

3 (4)

Malaise

4 (5)

1 (1)

Crepitations NOS

4 (5)

1 (1)

Catheter site erythema

4 (5)

1 (1)

Catheter site pain

4 (5)

0 (0)

Injection site swelling

4 (5)

0 (0)

Hepatobiliary disorders

Hyperbilirubinemia

12 (14)

4 (5)

Infections and infestations

Pneumonia NOS

18 (22)

11 (14)

Cellulitis

10 (12)

6 (7)

Candidal infection NOS

8 (10)

1 (1)

Catheter related infection

7 (8)

0 (0)

Urinary tract infection NOS

6 (7)

1 (1)

Staphylococcal infection

6 (7)

0 (0)

Oral candidiasis

5 (6)

2 (2)

Sinusitis NOS

4 (5)

2 (2)

Bacteremia

4 (5)

0 (0)

Injury, poisoning and procedural complications

Transfusion reaction

6 (7)

3 (4)

Abrasion NOS

4 (5)

1 (1)

Investigations

Cardiac murmur NOS

13 (16)

9 (11)

Blood alkaline phosphatase NOS

increased

9 (11)

7 (9)

Aspartate aminotransferase increased

8 (10)

7 (9)

Blood urea increased

8 (10)

1 (1)

Blood lactate dehydrogenase

increased

7 (8)

5 (6)

Blood albumin decreased

6 (7)

0 (0)

Blood bicarbonate increased

5 (6)

1 (1)

Blood chloride decreased

5 (6)

1 (1)

Protein total decreased

4 (5)

3 (4)

Blood bicarbonate decreased

4 (5)

1 (1)

Blood bilirubin decreased

4 (5)

1 (1)

Metabolism and nutrition disorders

Hyperglycemia NOS

27 (33)

16 (20)

Hypoalbuminemia

20 (24)

14 (17)

Hypomagnesemia

20 (24)

6 (7)

Hypokalemia

18 (22)

10 (12)

Hyponatremia

16 (19)

13 (16)

Appetite decreased NOS

13 (16)

12 (15)

Anorexia

13 (16)

8 (10)

Hyperkalemia

11 (13)

3 (4)

Dehydration

5 (6)

4 (5)

Musculoskeletal and connective tissue disorders

Arthralgia

17 (20)

8 (10)

Pain in limb

16 (19)

8 (10)

Back pain

14 (17)

5 (6)

Chest wall pain

6 (7)

1 (1)

Musculoskeletal discomfort

5 (6)

0 (0)

Myalgia

4 (5)

1 (1)

Nervous system disorders

Headache

23 (28)

11 (14)

Dizziness

15 (18)

10 (12)

Hypoesthesia

9 (11)

1 (1)

Psychiatric disorders

Insomnia

23 (28)

11 (14)

Confusional state

10 (12)

3 (4)

Anxiety

9 (11)

8 (10)

Renal and urinary disorders

Dysuria

5 (6)

3 (4)

Urinary frequency

4 (5)

1 (1)

Respiratory, thoracic and Mediastinal disorders

Cough

33 (40)

25 (31)

Pharyngitis

13 (16)

6 (7)

Crackles lung

12 (14)

1 (1)

Breath sounds decreased

8 (10)

7 (9)

Hypoxia

8 (10)

4 (5)

Rales

7 (8)

2 (2)

Postnasal drip

4 (5)

2 (2)

Skin and subcutaneous tissue disorders

Ecchymosis

18 (22)

12 (15)

Rash NOS

16 (19)

7 (9)

Erythema

12 (14)

5 (6)

Skin lesion NOS

9 (11)

3 (4)

Pruritis

9 (11)

2 (2)

Alopecia

7 (8)

1 (1)

Urticaria NOS

5 (6)

1 (1)

Swelling face

5 (6)

0 (0)

Vascular disorders

Petechiae

32 (39)

13 (16)

Pallor

19 (23)

10 (12)

Hypotension NOS

5 (6)

4 (5)

Hematoma NOS

4 (5)

3 (4)

In a single-arm MDS study (N=99), decitabine for injection was dosed at 20 mg/m intravenously,

infused over one hour daily, for 5 consecutive days of a 4-week cycle. Table 2 presents all adverse

reactions occurring in at least 5% of patients.

Table 2 Adverse Reactions Reported in ≥ 5% of Patients in a Single-arm Study*

Decitabine for injection

N = 99 (%)

Blood and lymphatic system disorders

Anemia

31 (31)

Febrile neutropenia

20 (20)

Leukopenia

6 (6)

Neutropenia

38 (38)

Pancytopenia

5 (5)

Thrombocythemia

5 (5)

Thrombocytopenia

27 (27)

Cardiac disorders

Cardiac failure congestive

5 (5)

Tachycardia

8 (8)

Ear and labyrinth disorders

Ear pain

6 (6)

Gastrointestinal disorders

Abdominal pain

14 (14)

Abdominal pain upper

6 (6)

Constipation

30 (30)

Diarrhea

28 (28)

Dyspepsia

10 (10)

Dysphagia

5 (5)

Gastro-esophageal reflux disease

5 (5)

Nausea

40 (40)

Oral pain

5 (5)

Stomatitis

11 (11)

Toothache

6 (6)

Vomiting

16 (16)

General disorders and administration site conditions

Asthenia

15 (15)

Chest pain

6 (6)

Chills

16 (16)

Fatigue

46 (46)

Mucosal inflammation

9 (9)

Edema

5 (5)

Edema peripheral

27 (27)

Pain

5 (5)

Pyrexia

36 (36)

Infections and infestations

Cellulitis

9 (9)

Oral candidiasis

6 (6)

Pneumonia

20 (20)

Sinusitis

6 (6)

Staphylococcal bacteremia

8 (8)

Tooth abscess

5 (5)

Upper respiratory tract infection

10 (10)

Urinary tract infection

7 (7)

Injury, poisoning and procedural complications

Contusion

9 (9)

Investigations

Blood bilirubin increased

6 (6)

Breath sounds abnormal

5 (5)

Weight decreased

9 (9)

Metabolism and nutrition disorders

Anorexia

23 (23)

Decreased appetite

8 (8)

Dehydration

8 (8)

Hyperglycemia

6 (6)

Hypokalemia

12 (12)

Hypomagnesemia

5 (5)

Musculoskeletal and connective tissue disorders

Arthralgia

17 (17)

Back pain

18 (18)

Bone pain

6 (6)

Muscle spasms

7 (7)

Muscular weakness

5 (5)

Musculoskeletal pain

5 (5)

Myalgia

9 (9)

Pain in extremity

18 (18)

Nervous system disorders

Dizziness

21 (21)

Headache

23 (23)

Psychiatric disorders

Anxiety

9 (9)

Confusional state

8 (8)

Depression

9 (9)

Insomnia

14 (14)

Respiratory, thoracic and mediastinal disorders

Cough

27 (27)

Dyspnea

29 (29)

Epistaxis

13 (13)

Pharyngolaryngeal pain

8 (8)

Pleural effusion

5 (5)

Sinus congestion

5 (5)

Skin and subcutaneous tissue disorders

Dry skin

8 (8)

Ecchymosis

9 (9)

Erythema

5 (5)

Night sweats

5 (5)

Petechiae

12 (12)

Pruritus

9 (9)

Rash

11 (11)

Skin lesion

5 (5)

Vascular disorders

Hypertension

6 (6)

Hypotension

11 (11)

In this single arm study, investigators reported adverse events based on clinical signs and symptoms

rather than predefined laboratory abnormalities. Thus, not all laboratory abnormalities were recorded as

adverse events.

No overall difference in safety was detected between patients > 65 years of age and younger patients in

these MDS trials. No significant differences in safety were detected between males and females.

Patients with renal or hepatic dysfunction were not studied. Insufficient numbers of non-White patients

were available to draw conclusions in these clinical trials.

Serious adverse reactions that occurred in patients receiving decitabine for injection not previously

reported in Tables 1 and 2 include:

Allergic Reaction: hypersensitivity (anaphylactic reaction)

Blood and Lymphatic System Disorders: myelosuppression, splenomegaly

Cardiac Disorders: myocardial infarction, cardio-respiratory arrest, cardiomyopathy, atrial

fibrillation, supraventricular tachycardia

Gastrointestinal Disorders: gingival pain, upper gastrointestinal hemorrhage

General Disorders and Administrative Site Conditions: chest pain, catheter site hemorrhage

Hepatobiliary Disorders: cholecystitis

Infections and Infestations: fungal infection, sepsis, bronchopulmonary aspergillosis,

peridiverticular abscess, respiratory tract infection, pseudomonal lung infection, Mycobacterium

avium complex infection

Injury, Poisoning and Procedural Complications: post procedural pain, post procedural hemorrhage

Nervous System Disorders: intracranial hemorrhage

Psychiatric Disorders: mental status changes

Renal and Urinary Disorders: renal failure, urethral hemorrhage

Respiratory, Thoracic and Mediastinal Disorders: hemoptysis, lung infiltration, pulmonary

embolism, respiratory arrest, pulmonary mass

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of decitabine for

injection. 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.

Sweet’s syndrome (acute febrile neutrophilic dermatosis)

Differentiation syndrome

Interstitial lung disease

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