DECITABINE: 2,983 Adverse Event Reports & Safety Profile
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Drug Class: Nucleic Acid Synthesis Inhibitors [MoA] · Route: INTRAVENOUS · Manufacturer: Qilu Pharmaceutical Co., Ltd. · FDA Application: 021790 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 2003 · Latest Report: 20250908
What Are the Most Common DECITABINE Side Effects?
All DECITABINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Febrile neutropenia | 336 | 11.3% | 92 | 223 |
| Off label use | 292 | 9.8% | 75 | 98 |
| Drug ineffective | 253 | 8.5% | 63 | 60 |
| Pneumonia | 243 | 8.2% | 120 | 98 |
| Myelosuppression | 233 | 7.8% | 30 | 93 |
| Product use in unapproved indication | 195 | 6.5% | 59 | 17 |
| Neutropenia | 193 | 6.5% | 64 | 69 |
| Sepsis | 175 | 5.9% | 99 | 81 |
| Acute myeloid leukaemia | 172 | 5.8% | 92 | 52 |
| Thrombocytopenia | 170 | 5.7% | 31 | 50 |
| Disease progression | 156 | 5.2% | 55 | 33 |
| Death | 140 | 4.7% | 139 | 25 |
| Pyrexia | 137 | 4.6% | 22 | 104 |
| Infection | 126 | 4.2% | 55 | 23 |
| Nausea | 118 | 4.0% | 18 | 36 |
| Anaemia | 113 | 3.8% | 20 | 51 |
| Bone marrow failure | 111 | 3.7% | 18 | 11 |
| Pancytopenia | 88 | 3.0% | 21 | 60 |
| Therapy non-responder | 84 | 2.8% | 22 | 7 |
| Respiratory failure | 81 | 2.7% | 64 | 33 |
Who Reports DECITABINE Side Effects? Age & Gender Data
Gender: 43.2% female, 56.8% male. Average age: 56.2 years. Most reports from: US. View detailed demographics →
Is DECITABINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 1 |
| 2010 | 3 | 1 | 1 |
| 2011 | 8 | 3 | 6 |
| 2012 | 17 | 6 | 15 |
| 2013 | 32 | 10 | 18 |
| 2014 | 83 | 30 | 66 |
| 2015 | 69 | 21 | 48 |
| 2016 | 70 | 18 | 56 |
| 2017 | 98 | 20 | 69 |
| 2018 | 97 | 19 | 68 |
| 2019 | 75 | 19 | 54 |
| 2020 | 112 | 30 | 73 |
| 2021 | 113 | 42 | 79 |
| 2022 | 56 | 17 | 35 |
| 2023 | 60 | 15 | 34 |
| 2024 | 86 | 2 | 43 |
| 2025 | 32 | 1 | 25 |
What Is DECITABINE Used For?
DECITABINE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Nucleic Acid Synthesis Inhibitors [MoA]
Official FDA Label for DECITABINE
Official prescribing information from the FDA-approved drug label.
Drug Description
Decitabine is a nucleoside metabolic inhibitor. Decitabine for Injection contains decitabine (5-aza-2’-deoxycitidine), an analogue of the natural nucleoside 2’-deoxycytidine. Decitabine is a fine, white to almost white powder with the molecular formula of C 8 H 12 N 4 O 4 and a molecular weight of 228.21 gm/mol. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1 H )-one and it has the following structural formula: Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for Injection, for intravenous use is a sterile, white to almost white lyophilized powder supplied in a clear colorless glass single-dose vial.
Each
20 mL, vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment. decitabine-spl-structure
FDA Approved Uses (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. 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 & Administration
AND ADMINISTRATION Three Day Regimen : Administer Decitabine for Injection at a dose of 15 mg/m 2 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 2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. Repeat cycle every 4 weeks. ( 2.1 )
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 2 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/mcL and platelets at least 50,000/mcL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles. Delay and reduce dose for hematologic toxicity <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.2 )]</span> .
Five Day Regimen Administer
Decitabine for Injection at a dose of 20 mg/m 2 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/mcL and platelets at least 50,000/mcL) 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 Decitabine for Injection dosing for up to 2 weeks and reduce the dose temporarily to 11 mg/m 2 every 8 hours (33 mg/m 2 /day, 99 mg/m 2 /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 2 every 8 hours (33 mg/m 2 /day, 99 mg/m 2 /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. 1 Aseptically reconstitute Decitabine for Injection with room temperature (20° 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 per 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° to 25°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg per mL to 1 mg per 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° to 8°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg per mL to 1 mg per mL. Store at 2° 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.
Contraindications
None. None. ( 4 ）
Known Adverse Reactions
REACTIONS Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies 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 2 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 Commonly Occurring 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 Phase 3 Trials in the Decitabine for Injection Arm: Discontinuation: thrombocytopenia, neutropenia, pneumonia, Mycobacterium avium complex infection, cardiorespiratory 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 Phase 3 MDS Trial 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) Decitabine for Injection N = 83 (%)
Supportive
Care N = 81 (%) Abdominal distension 4 (5) 1 (1) Abdominal pain upper 4 (5) 1 (1) Gastro-esophageal relux 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)
Pruritus
9 (11) 2 (2) Decitabine for Injection N = 83 (%)
Supportive
Care N = 81 (%)
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 2 intravenous, 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* * 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. 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 relux 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%) Decitabine for Injection N = 99 (%) 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%) No overall difference in safety was detected between patients > 65 years of age and younger patients in these myelodysplasia trials. No significant gender differences in safety or efficacy were detected. 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 regardless of causality, not previously reported in Tables 1 and 2 include: 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.
Allergic
Reaction: Hypersensitivity (anaphylactic reaction) to decitabine for injection has been reported in a Phase 2 trial.
6.2 Post-marketing Experience The following adverse reactions have been identified during post - approval 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. Cases of Sweet's Syndrome (acute febrile neutrophilic dermatosis) have been reported.
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 )
5.1 Myelosuppression Fatal and serious myelosuppression occurs in decitabine for injection-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 for injection treated patients with grade 3 or 4 occurring in 87% of patients. Thrombocytopenia of any grade occurred in 89% of patients with grade 3 or 4 occurring in 85% of patients.
Grade
3 or 4 febrile neutropenia occurred in 23% 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 Decitabine for injection can cause fetal harm when administered to a pregnant woman. Based on its mechanism of action, decitabine for injection alters DNA synthesis and is expected to result in adverse reproductive effects <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.1 )]</span> . In preclinical studies in mice and rats, decitabine was teratogenic, fetotoxic, and embryotoxic. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Advise women of childbearing potential to avoid becoming pregnant while taking decitabine for injection and for 6 months following the last dose. Advise men with female partners of childbearing potential to avoid fathering a child while receiving treatment with decitabine for injection, and for 3 months following the last dose. Counsel patients of childbearing potential to use effective contraception during this time <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.1 , 8.3 )]</span>.
Drug Interactions
INTERACTIONS Drug interaction studies with decitabine have not been conducted. In vitro studies in human liver microsomes suggest that decitabine is unlikely to inhibit or induce cytochrome P450 enzymes. In vitro metabolism studies have suggested that decitabine is not a substrate for human liver cytochrome P450 enzymes. As plasma protein binding of decitabine is negligible (< 1%), interactions due to displacement of more highly protein bound drugs from plasma proteins are not expected.