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ERAXIS®Adverse Reactions (anidulafungin)

6 ADVERSE REACTIONS

The most serious adverse reactions reported with ERAXIS are:

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 ERAXIS for Injection was assessed in 929 individuals, including 257 healthy subjects and 672 patients in clinical trials of candidemia, other forms of Candida infections, and esophageal candidiasis. A total of 633 patients received ERAXIS at daily doses of either 50 mg or 100 mg. A total of 481 patients received ERAXIS for ≥14 days.

6.2 Candidemia/other Candida Infections

Three studies (one comparative vs. fluconazole, two non-comparative) assessed the efficacy and safety of ERAXIS (100 mg) in patients with candidemia and other Candida infections.

The data described below reflect exposure to ERAXIS and fluconazole in 127 and 118 patients, respectively, with candidemia and other forms of invasive candidiasis, in the randomized, comparative trial of the efficacy and safety of ERAXIS to that of fluconazole. In ERAXIS-treated patients, the age range was 16–89 years, the gender distribution was 51% male and 49% female, and the race distribution was 72% White, 18% Black/African American, 9% other races. Patients were randomized to receive once daily IV ERAXIS (200 mg loading dose followed by 100 mg maintenance dose) or IV fluconazole (800 mg loading dose followed by 400 mg maintenance dose). Treatment was administered for at least 14 and not more than 42 days.

The number of patients with adverse reactions leading to discontinuation of study medication was 11.5% in the ERAXIS arm and 21.6% in the fluconazole arm. The most common adverse reactions leading to study drug discontinuation were multi-organ failure and systemic Candida infection in the ERAXIS arm.

Table 2 presents adverse reactions that were reported in ≥5% of subjects receiving ERAXIS or fluconazole therapy in this trial.

Table 2: Adverse Reactions Reported in ≥5% of Subjects Receiving ERAXIS or Fluconazole Therapy for Candidemia/other Candida Infections*,
ERAXIS
100 mg
N=131
Fluconazole
400 mg
N=125
N (%) N (%)
*
A patient who experienced multiple reactions with a System Organ Class (SOC) or preferred term was counted one time for that class, one time for the preferred term and one time for "subjects with at least one adverse reaction"
This trial was not designed to support comparative claims for ERAXIS for the adverse reactions reported in this table.
Subjects with a least one adverse reaction 130 (99) 122 (98)
 
Infections and infestations 82 (63) 80 (64)
  Bacteremia 23 (18) 23 (18)
  Urinary tract infection 19 (15) 22 (18)
  Sepsis 9 (7) 11 (9)
  Pneumonia 8 (6) 19 (15)
Gastrointestinal disorders 81 (62) 72 (58)
  Nausea 32 (24) 15 (12)
  Diarrhea 24 (18) 23 (18)
  Vomiting 23 (18) 12 (10)
  Constipation 11 (8) 14 (11)
  Abdominal pain 8 (6) 16 (13)
General disorders and administration site conditions 70 (53) 76 (61)
  Pyrexia 23 (18) 23 (18)
  Edema peripheral 14 (11) 16 (13)
  Chest pain 7 (5) 6 (5)
Respiratory, thoracic, and mediastinal disorders 67 (51) 55 (44)
  Dyspnea 15 (12) 4 (3)
  Pleural effusion 13 (10) 11 (9)
  Cough 9 (7) 7 (6)
  Respiratory distress 8 (6) 2 (2)
Investigations 66 (50) 46 (37)
  Blood alkaline phosphatase increased 15 (12) 14 (11)
  White blood cell increased 11 (8) 3 (2)
  Hepatic enzyme increased 7 (5) 14 (11)
  Blood creatinine increased 7 (5) 1 (1)
Metabolism and nutrition disorders 61 (47) 61 (49)
  Hypokalemia 33 (25) 24 (19)
  Hypomagnesemia 15 (12) 14 (11)
  Hypoglycemia 9 (7) 10 (8)
  Hyperkalemia 8 (6) 14 (11)
  Hyperglycemia 8 (6) 8 (6)
  Dehydration 8 (6) 2 (2)
Vascular disorders 50 (38) 41 (33)
  Hypotension 19 (15) 18 (14)
  Hypertension 15 (12) 5 (4)
  Deep vein thrombosis 13 (10) 9 (7)
Psychiatric disorders 48 (37) 45 (36)
  Insomnia 20 (15) 12 (10)
  Confusional state 10 (8) 10 (8)
  Depression 8 (6) 5 (4)
Blood and lymphatic system disorders 34 (26) 36 (29)
  Anemia 12 (9) 20 (16)
  Thrombocythemia 8 (6) 1 (1)
  Leukocytosis 7 (5) 6 (5)
Skin and subcutaneous tissue disorders 30 (23) 32 (26)
  Decubitus ulcer 7 (5) 10 (8)
Nervous system disorders 27 (21) 31 (25)
  Headache 11 (8) 10 (8)
Musculoskeletal and connective tissue disorders 27 (21) 25 (20)
  Back pain 7 (5) 13 (10)

6.3 Esophageal Candidiasis

The data described below reflect exposure to ERAXIS and fluconazole in 300 and 301 patients, respectively, with esophageal candidiasis in a randomized trial comparing the efficacy and safety of ERAXIS to that of oral fluconazole. In ERAXIS-treated patients, the age range was 18–68 years, the gender distribution was 42% male and 58% female and the race distribution was 15% White, 49% Black/African American, 15% Asian, 0.3 % Hispanic, 21% other races. Patients were randomized to receive IV ERAXIS (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day 1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14–21 days).

Twenty eight (9%) patients in the ERAXIS arm and 36 (12%) patients in the fluconazole arm had adverse reactions leading to discontinuation of study medication. The most common adverse reactions leading to study drug discontinuation were maculopapular rash for the ERAXIS arm. The most common adverse reactions leading to discontinuation were rash and increased AST for the fluconazole arm.

Table 3 presents adverse reactions that were reported in ≥5% of subjects receiving ERAXIS therapy.

Table 3 Adverse Reactions Reported in ≥5% of Subjects Receiving ERAXIS or Fluconazole Therapy for Esophageal Candidiasis*,
ERAXIS
50 mg
N=300
Fluconazole
100 mg
N=301
N (%) N (%)
*
A patient who experienced multiple reactions with a System Organ Class (SOC) or preferred term was counted one time for that class, one time for the preferred term and one time for "subjects with at least one adverse reaction"
This trial was not designed to support comparative claims for ERAXIS for the adverse reactions reported in this table.
Subjects with a least one adverse reactions 239 (80) 227 (75)
 
Infections and infestations 115 (38) 99 (33)
  Oral candidiasis 15 (5) 10 (3)
Gastrointestinal disorders 106 (35) 113 (38)
  Diarrhea 27 (9) 26 (9)
  Vomiting 27 (7) 30 (10)
  Nausea 20 (7) 23 (8)
  Dyspepsia 20 (7) 21 (7)
Blood and lymphatic system disorders 55 (18) 50 (17)
  Anemia 25 (8) 22 (7)
Metabolism and nutrition disorders 50 (17) 46 (15)
  Hypokalemia 14 (5) 17 (6)
General disorders and administration site condition 49 (16) 54 (18)
  Pyrexia 27 (9) 28 (9)
Nervous system disorders 39 (13) 36 (12)
  Headache 25 (8) 20 (7)

6.4 Less Common Adverse Reactions

The following selected adverse reactions occurred in <2% of patients:

Blood and Lymphatic: coagulopathy, thrombocytopenia

Cardiac: atrial fibrillation, bundle branch block (right), sinus arrhythmia, ventricular extrasystoles

Eye: eye pain, vision blurred, visual disturbance

General and Administration Site: infusion related reaction, peripheral edema, rigors

Hepatobiliary: abnormal liver function tests, cholestasis, hepatic necrosis

Infections: clostridial infection

Investigations: amylase increased, bilirubin increased, CPK increased, electrocardiogram QT prolonged, gamma-glutamyl transferase increased, lipase increased, potassium decreased, prothrombin time prolonged, urea increased

Nervous System: convulsion, dizziness

Respiratory, Thoracic and Mediastinal: cough

Skin and Subcutaneous Tissue: angioneurotic edema, erythema, pruritus, sweating increased, urticaria

Vascular: flushing, hot flushes, thrombophlebitis superficial

6.5 Post-marketing Experience

The following adverse reactions have been identified during post approval use of anidulafungin. 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.

Immune: Anaphylactic shock, anaphylactic reaction, bronchospasm [see Warnings and Precautions (5.2)].

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