Eraxis Side Effects
Generic Name: anidulafungin
Please note - some side effects for Eraxis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Eraxis - for the Consumer
Eraxis
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eraxis:
Seek medical attention right away if any of these SEVERE side effects occur when using Eraxis:Diarrhea; headache; pain, swelling, or redness at the injection site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fever, chills, or persistent sore throat; irregular heartbeat; leg redness, swelling, or pain; pale stools; seizures; severe or persistent stomach pain; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.
Eraxis Side Effects - for the Professional
Eraxis
General
Possible histamine-mediated symptoms have been reported with Eraxis, including rash, urticaria, flushing, pruritus, dyspnea, and hypotension. These events are infrequent when the rate of Eraxis infusion does not exceed 1.1 mg/minute.
Overall Eraxis Safety Experience
The safety of Eraxis for Injection was assessed in 929 individuals, including 672 patients in clinical studies and 257 individuals in Phase 1 studies. A total of 633 patients received Eraxis at daily doses of either 50 or 100 mg. A total of 481 patients received Eraxis for ≥14 days.
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. Table 8 presents treatment-related adverse events that were reported in ≥2.0% of subjects receiving Eraxis or fluconazole therapy in the comparative candidemia study.
| Eraxis 100 mg † N = 131 |
Fluconazole 400 mg † N = 125 |
|
|---|---|---|
| N (%) | N (%) | |
| Subjects with at least 1 treatment-related AE | 32 (24.4) | 33 (26.4) |
| Gastrointestinal System | ||
| Diarrhea | 4 (3.1) | 2 (1.6) |
| Investigations | ||
| ALT ↑ | 3 (2.3) | 4 (3.2) |
| AST ↑ | 1 (0.8) | 3 (2.4) |
| Alkaline phosphatase ↑ | 2 (1.5) | 5 (4.0) |
| Hepatic enzyme ↑ | 2 (1.5) | 9 (7.2) |
| Metabolic and Nutritional Systems | ||
| Hypokalemia | 4 (3.1) | 3 (2.4) |
| Vascular System | ||
| Deep vein thrombosis | 1 (0.8) | 3 (2.4) |
Esophageal Candidiasis
A single phase 3, randomized, double-blind study compared the efficacy and safety of Eraxis to that of fluconazole in patients with esophageal candidiasis. Table 9 presents treatment-related adverse events that were reported in ≥1.0% of subjects receiving Eraxis therapy. (No adverse events were reported at a frequency of 2% or greater in patients with esophageal candidiasis).
| Eraxis 50 mg † N = 300 |
Fluconazole 100 mg † N = 301 |
|
|---|---|---|
| N (%) | N (%) | |
| Subjects with at least 1 treatment-related AE | 43 (14.3) | 50 (16.6) |
| Blood and lymphatic System | ||
| Neutropenia | 3 (1.0) | -- |
| Leukopenia | 2 (0.7) | 4 (1.3) |
| Gastrointestinal System | ||
| Dyspepsia aggravated | 1 (0.3) | 3 (1.0) |
| Nausea | 3 (1.0) | 3 (1.0) |
| Vomiting NOS | 2 (0.7) | 3 (1.0) |
| General Disorders and Administration Site Conditions | ||
| Pyrexia | 2 (0.7) | 3 (1.0) |
| Investigations | ||
| Gamma-glutamyl transferase ↑ | 4 (1.3) | 4 (1.3) |
| ALT ↑ | -- | 3 (1.0) |
| AST ↑ | 1 (0.3) | 7 (2.3) |
| Nervous System | ||
| Headache | 4 (1.3) | 3 (1.0) |
| Skin and Subcutaneous Tissue | ||
| Rash | 3 (1.0) | 2 (0.7) |
| Vascular System | ||
| Phlebitis NOS ‡ | 2 (0.7) | 4 (1.3) |
The following events occurred in either < 2% of patients treated for candidemia/other Candida infections, or in < 1% of patients treated for esophageal candidiasis and were judged by investigators to be at least possibly related to Eraxis:
Blood and Lymphatic: coagulopathy, thrombocytopenia
Cardiac: atrial fibrillation, bundle branch block (right), sinus arrhythmia, ventricular extrasystoles
Eye: eye pain, vision blurred, visual disturbance
Gastrointestinal: abdominal pain upper, constipation, diarrhea NOS, dyspepsia, fecal incontinence, nausea, vomiting
General and Administration Site: infusion related reaction, peripheral edema, rigors
Hepatobiliary: abnormal liver function tests NOS, cholestasis, hepatic necrosis
Infections: candidiasis, clostridial infection, fungemia, oral candidiasis
Investigations: amylase ↑, bilirubin ↑, CPK ↑, creatinine ↑, electrocardiogram QT prolonged, electrocardiogram early transition, gamma-glutamyl transferase ↑, lipase ↑, magnesium ↓, platelet count ↑, platelet count ↓, potassium ↓, prothrombin time prolonged, urea ↑
Metabolism and Nutrition: hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypomagnesemia
Musculoskeletal and Connective Tissue: back pain
Nervous System: convulsion, dizziness, headache
Respiratory, Thoracic and Mediastinal: cough
Skin and Subcutaneous Tissue: angioneurotic edema, erythema, pruritus, pruritus generalized, sweating increased, urticaria, urticaria NOS
Vascular: flushing, hot flushes, hypertension, hypotension, thrombophlebitis superficial
TopSide Effects by Body System
General
Possible histamine-mediated symptoms have been reported, including rash, urticaria, flushing, pruritus, dyspnea, and hypotension. These events are infrequent when the rate of infusion does not exceed 1.1 mg/minute. Other general effects have included pyrexia, peripheral edema, and rigors.
Gastrointestinal
Gastrointestinal side effects have included diarrhea (3.1%) and nausea (1%). Other, less common gastrointestinal effects have included dyspepsia, vomiting, upper abdominal pain, constipation, and fecal incontinence.
Hepatic
Hepatic side effects have included elevated liver enzymes (less than 3%), cholestasis, and hepatic necrosis.
Metabolic
Metabolic side effects have included hypokalemia (3.1%), hypercalcemia, hyperglycemia, hypernatremia, hyperkalemia, and hypomagnesemia.
Nervous system
Nervous system side effects have included headache (1.3%), convulsion, and dizziness.
Hematologic
Hematologic side effects have included neutropenia (1%), leukopenia, coagulopathy, and thrombocytopenia.
Dermatologic
Dermatologic side effects have included rash (1%), erythema, increased sweating, and angioneurotic edema.
Cardiovascular
Cardiovascular side effects have rarely included deep vein thrombosis, phlebitis, atrial fibrillation, bundle branch block (right), sinus arrhythmia, ventricular extrasystoles, flushing, hot flushes, hypertension, hypotension, and thrombophlebitis.
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