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 Most common adverse reactions (>30%) in adult patients with MDS by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis.
Most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Shilpa Medicare Limited 1-888-557-1212 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following adverse reactions are described in other labeling sections: Anemia, Neutropenia and Thrombocytopenia [ see Warnings and Precautions (5.2) ] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [ see Warnings and Precautions (5.3) ] Renal Toxicity [ see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [ see Warnings and Precautions (5.5) ] 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.
MDS The data described below reflect exposure to Azacitidine in 443 patients with MDS 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 (14.1) ].
In Studies 1, 2 and 3, a total of 268 patients were exposed to Azacitidine, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year).
Azacitidine 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.
5 WARNINGS AND PRECAUTIONS Risks of Substitution with Other Azacitidine Products : Do not substitute Azacitidine for oral azacitidine ( 2.1 , 5.1 ).
Anemia, Neutropenia and Thrombocytopenia : Monitor complete blood counts (CBC) frequently ( 5.2 ).
Hepatotoxicity : Patients with severe preexisting hepatic impairment are at higher risk for toxicity ( 5.3 ).
Renal Toxicity : Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys ( 5.4 ).
Tumor Lysis Syndrome : Azacitidine may cause fatal or serious tumor lysis syndrome, including in patients with MDS.
Like all medications, Azacitidine 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: