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ERAXIS® (anidulafungin) Adverse Reactions

6 ADVERSE REACTIONS

The following most serious adverse reactions are described elsewhere in other labeling sections:

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.

Clinical Trials Experience in Adults

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.

Candidemia/other Candida Infections

Three trials (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 (2.3%) and systemic Candida infection (1.5%) 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 Adult Patients Receiving ERAXIS or Fluconazole Therapy for Candidemia/other Candida Infections*,
Adverse ReactionERAXIS
100 mg
N=131
Fluconazole
400 mg
N=125
N (%)N (%)
*
A patient who experienced multiple reactions within a Body System 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 reaction130 (99)122 (98)
 
Gastrointestinal disorders81 (62)72 (58)
  Nausea32 (24)15 (12)
  Diarrhea24 (18)23 (18)
  Vomiting23 (18)12 (10)
  Constipation11 (8)14 (11)
  Abdominal pain8 (6)16 (13)
General disorders and administration site conditions70 (53)76 (61)
  Pyrexia23 (18)23 (18)
  Edema peripheral14 (11)16 (13)
  Chest pain7 (5)6 (5)
Respiratory, thoracic, and mediastinal disorders67 (51)55 (44)
  Dyspnea15 (12)4 (3)
  Pleural effusion13 (10)11 (9)
  Cough9 (7)7 (6)
  Respiratory distress8 (6)2 (2)
Investigations66 (50)46 (37)
  Blood alkaline phosphatase increased15 (12)14 (11)
  White blood cell increased11 (8)3 (2)
  Hepatic enzyme increased7 (5)14 (11)
  Blood creatinine increased7 (5)1 (1)
Metabolism and nutrition disorders61 (47)61 (49)
  Hypokalemia33 (25)24 (19)
  Hypomagnesemia15 (12)14 (11)
  Hypoglycemia9 (7)10 (8)
  Hyperkalemia8 (6)14 (11)
  Hyperglycemia8 (6)8 (6)
  Dehydration8 (6)2 (2)
Vascular disorders50 (38)41 (33)
  Hypotension19 (15)18 (14)
  Hypertension15 (12)5 (4)
  Deep vein thrombosis13 (10)9 (7)
Psychiatric disorders48 (37)45 (36)
  Insomnia20 (15)12 (10)
  Confusional state10 (8)10 (8)
  Depression8 (6)5 (4)
Blood and lymphatic system disorders34 (26)36 (29)
  Anemia12 (9)20 (16)
  Thrombocythemia8 (6)1 (1)
  Leukocytosis7 (5)6 (5)
Skin and subcutaneous tissue disorders30 (23)32 (26)
  Decubitus ulcer7 (5)10 (8)
Nervous system disorders27 (21)31 (25)
  Headache11 (8)10 (8)
Musculoskeletal and connective tissue disorders27 (21)25 (20)
  Back pain7 (5)13 (10)

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 related to study medication. The most common adverse reactions leading to study discontinuation were maculopapular rash (1 patient) for the ERAXIS arm. The most common adverse reactions leading to discontinuation were rash (1 patient) and increased AST (1 patient) 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 Adult Patients Receiving ERAXIS or Fluconazole Therapy for Esophageal Candidiasis*,
Adverse ReactionERAXIS
50 mg
N=300
Fluconazole
100 mg
N=301
N (%)N (%)
*
A patient who experienced multiple reactions within a Body System 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 reaction239 (80)227 (75)
 
Infections and infestations115 (38)99 (33)
  Oral candidiasis15 (5)10 (3)
Gastrointestinal disorders106 (35)113 (38)
  Diarrhea27 (9)26 (9)
  Vomiting27 (7)30 (10)
  Nausea20 (7)23 (8)
  Dyspepsia20 (7)21 (7)
Blood and lymphatic system disorders55 (18)50 (17)
  Anemia25 (8)22 (7)
Metabolism and nutrition disorders50 (17)46 (15)
  Hypokalemia14 (5)17 (6)
General disorders and administration site condition49 (16)54 (18)
  Pyrexia27 (9)28 (9)
Nervous system disorders39 (13)36 (12)
  Headache25 (8)20 (7)

Less Common Adverse Reactions in Adult Patients with Candidemia/other Candida Infections and Esophageal Candidiasis

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

Clinical Trials Experience in Pediatric Patients with Candidemia/Invasive Candidiasis

The safety of ERAXIS was investigated in 68 pediatric patients from 1 month to less than 18 years of age with candidemia/invasive candidiasis in a prospective, open-label, non-comparative pediatric trial [see Clinical Studies (14.1)]. Overall, the safety profile of ERAXIS in the pediatric patients 1 month and older was similar to that of adults.

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥5% of pediatric patients receiving ERAXIS therapy in the clinical trial are displayed by body system in Table 4.

Table 4 Adverse Reactions Occurring in ≥5% of Pediatric Patients Receiving ERAXIS Therapy for Candidemia/other Candida Infections*,
Adverse Reaction1 month to <2 years
N=19
2 to <5 years
N=19
5 to <18 years
N=30
Overall
N=68
n (%)n (%)n (%)n (%)
*
Reflects adverse reactions including those that started on or after first dose of anidulafungin through 6-week follow-up for patients who did not receive oral fluconazole, and those that started between first dose and last dose of anidulafungin for patients who received oral fluconazole.
A patient who experienced multiple reactions within a Body System 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".
Includes such terms as: abdominal pain and abdominal pain upper.
§
Includes such terms as: rash and rash generalized.
Subjects with a least one adverse reaction17 (90)14 (74)24 (80)55 (81)
 
Blood and lymphatic system disorders9 (47)3 (16)4 (13)16 (24)
  Anemia5 (26)2 (11)07 (10)
  Thrombocytopenia2 (11)1 (5)1 (3)4 (6)
Gastrointestinal disorders8 (42)8 (42)12 (40)28 (41)
  Diarrhea4 (21)2 (11)5 (17)11 (16)
  Vomiting4 (21)5 (26)2 (7)11 (16)
  Abdominal pain04 (21)2 (7)6 (9)
General disorders and administration site condition5 (26)6 (32)9 (30)20 (29)
  Pyrexia4 (21)3 (16)5 (17)12 (18)
Laboratory Investigations4 (21)4 (21)8 (27)16 (24)
  Alanine aminotransferase increased2 (11)2 (11)2 (7)6 (9)
  Aspartate aminotransferase increased2 (11)1 (5)1 (3)4 (6)
Metabolism and nutrition disorders3 (16)4 (21)6 (20)13 (19)
  Hypoglycemia1 (5)2 (11)1 (3)4 (6)
Respiratory, thoracic and mediastinal disorders5 (26)5 (26)5 (17)15 (22)
  Epistaxis1 (5)2 (11)3 (10)6 (9)
Skin and subcutaneous tissue disorders6 (32)5 (26)5 (17)16 (24)
  Rash§3 (16)1 (5)2 (7)6 (9)

Other adverse reactions were reported in 2 or more pediatric patients and in less than 5% of the 68 pediatric patients treated with ERAXIS in the clinical trial:

Blood and Lymphatic System Disorders: pancytopenia, thrombocytosis, febrile neutropenia, leukopenia, neutropenia

Eye Disorders: Periorbital edema

Gastrointestinal Disorders: gastroesophageal reflux disease, abdominal distension, nausea, stomatitis, dry mouth

General Disorders and Administrative Site Conditions: chest pain, edema peripheral

Infections and Infestations: bacteremia, device related infection, gastroenteritis, lower respiratory tract infection, upper respiratory tract infection, urinary tract infection

Laboratory Investigations: gamma-glutamyltransferase increased, transaminases increased

Metabolism and Nutrition Disorders: hypocalcemia, hypokalemia, hyponatremia, hypoproteinemia

Musculoskeletal and Connective Tissue Disorders: back pain, pain in extremity

Nervous System Disorders: headache, tremor, seizure

Psychiatric Disorders: agitation

Respiratory, Thoracic and Mediastinal Disorders: hemoptysis

Vascular Disorders: hypotension

6.2 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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