Eraxis Side Effects

Generic name: anidulafungin

Note: This document contains side effect information about anidulafungin. Some of the dosage forms listed on this page may not apply to the brand name Eraxis.

Some side effects of Eraxis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to anidulafungin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking anidulafungin (the active ingredient contained in Eraxis) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using anidulafungin and call your doctor at once if you have a serious side effect such as:

• bronchospasm (wheezing, chest tightness, trouble breathing);

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects of anidulafungin may include:

• hot flashes;

• diarrhea or constipation;

• nausea, vomiting; or

• pain, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to anidulafungin: intravenous powder for injection

General

The most common side effects reported during studies in patients with candidemia and other Candida infections were hypokalemia, nausea, diarrhea, vomiting, pyrexia, and insomnia. Anidulafungin was discontinued in 11.5% of patients due to side effects. The most common side effects leading to discontinuation of anidulafungin (the active ingredient contained in Eraxis) were multi-organ failure and systemic Candida infection.

The most common side effects reported during a study in patients with esophageal candidiasis were diarrhea, pyrexia, anemia, headache, vomiting, nausea, and dyspepsia. Anidulafungin was discontinued in 9% of patients due to side effects. The most common side effect leading to discontinuation of anidulafungin was maculopapular rash.

Metabolic

Metabolic side effects have included hypokalemia (up to 25%), hypomagnesemia (12%), increased blood alkaline phosphatase (12%), hypoglycemia (7%), hyperglycemia (6%), hyperkalemia (6%), dehydration (6%), increased amylase (less than 2%), increased creatine phosphokinase (less than 2%), increased lipase (less than 2%), decreased potassium (less than 2%), decreased magnesium, hypercalcemia, and hypernatremia.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 24%), diarrhea (up to 18%), vomiting (up to 18%), constipation (8%), dyspepsia (7%), abdominal pain (6%), oral candidiasis (5%), upper abdominal pain, and fecal incontinence.

Other

To reduce occurrence of infusion-related side effects, the rate of infusion should not exceed 1.1 mg/minute.

Other side effects have included pyrexia (up to 18%), bacteremia (18%), peripheral edema (up to 11%), sepsis (7%), chest pain (5%), flushing (less than 2%), hot flushes (less than 2%), infusion-related reaction (less than 2%), rigors (less than 2%), clostridial infection (less than 2%), fungemia, candidiasis, multi-organ failure, and systemic Candida infection. Infusion-related side effects, possibly histamine-mediated, have included rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension.

Cardiovascular

Cardiovascular side effects have included hypotension (15%), hypertension (12%), deep vein thrombosis (10%), phlebitis, and electrocardiogram early transition. Atrial fibrillation, bundle branch block (right), sinus arrhythmia, superficial thrombophlebitis, electrocardiogram QT prolonged, and ventricular extrasystoles have been reported in less than 2% of patients.

Psychiatric

Psychiatric side effects have included insomnia (15%), confusional state (8%), and depression (6%).

Genitourinary

Genitourinary side effects have included urinary tract infection (15%).

Respiratory

Respiratory side effects have included dyspnea (12%), pleural effusion (10%), cough (up to 7%), pneumonia (6%), and respiratory distress (6%). Bronchospasm has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (up to 9%), increased white blood cell (8%), thrombocythemia (6%), leukocytosis (5%), coagulopathy (less than 2%), thrombocytopenia (less than 2%), prothrombin time prolonged (less than 2%), neutropenia, leukopenia, and increased and decreased platelet count.

Nervous system

Nervous system side effects have included headache (8%), convulsion (less than 2%), and dizziness (less than 2%).

Hepatic

Hepatic side effects have included increased hepatic enzymes (5%), ALT, and AST. Increased gamma-glutamyltransferase, increased bilirubin, abnormal liver function tests, cholestasis, and hepatic necrosis have been reported in less than 2% of patients. Significant hepatic dysfunction, hepatitis, and hepatic failure have been reported.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic shock and anaphylactic reaction during postmarketing experience.

Dermatologic

Dermatologic side effects have included decubitus ulcer (5%), rash, generalized pruritus, and maculopapular rash. Erythema, pruritus, increased sweating, urticaria, and angioneurotic edema have been reported in less than 2% of patients.

Renal

Renal side effects have included increased blood creatinine (5%) and urea (less than 2%).

Musculoskeletal

Musculoskeletal side effects have included back pain (5%).

Ocular

Ocular side effects have included eye pain, blurred vision, and visual disturbance in less than 2% of patients.

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