g 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, i
