Recommended Topic Related To:

Eraxis

"Some cryogenic wart removers—which remove warts from the skin by freezing them off—have caught fire during use at home, harming consumers or setting fire to items around the house.

Since 2009, the Food and Drug Administratio"...

Eraxis

Eraxis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Eraxis (anidulafungin) treats candida (yeast) infections in the blood, or in the stomach or esophagus. It is an antifungal antibiotic. Common side effects include flushing, dizziness, diarrhea, or headache.

The recommended dose of Eraxis to treat candidemia and other candida infections is a single 200 mg loading dose on Day 1, followed by 100 mg daily dose thereafter. The recommended dose to treat esophageal candidiasis is a single 100 mg loading dose on Day 1, followed by 50 mg daily dose thereafter. Other drugs may interact with Eraxis. Tell your doctor all medications and supplements you use. During pregnancy, Eraxis should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Eraxis (anidulafungin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Eraxis in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Eraxis (Anidulafungin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Eraxis Overview - Patient Information: Side Effects

SIDE EFFECTS: Flushing, dizziness, diarrhea, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling/pain at injection site, shortness of breath, dark urine, severe stomach/abdominal pain, yellowing eyes/skin, persistent nausea/vomiting, muscle weakness/spasm, vision changes, pain/redness/swelling of arms or legs, new signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, fast/slow/irregular heartbeat, seizures, increased urination/thirst, mental/mood changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Eraxis (Anidulafungin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Eraxis FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions reported with ERAXIS are:

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.

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
N (%)
Fluconazole 400 mg
N=125
N (%)
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)
*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.

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
N (%)
Fluconazole 100 mg
N=301
N (%)
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)
*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.

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, gammaglutamyl 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

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 [seeWARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Eraxis (Anidulafungin) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.