Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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 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.
5 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.
Like all medications, Decitabine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: