Eraxis 50mg Inj, 1 Vial
It is used to treat fungal infections.
Drug Class
Antifungal
Pharmacologic Class
Echinocandin
Pregnancy Category
Category C
FDA Approved
Feb 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Anidulafungin is an antifungal medicine given by injection into a vein. It works by attacking the cell wall of certain types of fungi, which helps to kill them and treat serious fungal infections, especially those caused by Candida.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Maintain good hygiene to prevent further infections.
- Follow all instructions from your healthcare provider regarding the duration of treatment, even if you start feeling better.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg IV on Day 1, then 100 mg IV daily thereafter
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
Invasive Candidiasis/Candidemia:
200 mg IV loading dose on Day 1, then 100 mg IV daily. Administer over approximately 1 hour.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness in pediatric patients have not been established. Limited data suggest potential for use in children 1 month to <18 years for invasive candidiasis at 1.5 mg/kg loading dose then 0.75 mg/kg daily, but this is off-label and requires expert consultation.)
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No dose adjustment needed; anidulafungin is not dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Anidulafungin is an echinocandin antifungal agent that inhibits glucan synthase, an enzyme essential for the formation of (1,3)-β-D-glucan, a major component of the fungal cell wall. This inhibition leads to osmotic instability and lysis of the fungal cell.
Pharmacokinetics
Absorption:
Bioavailability:
100% (administered intravenously)
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
30-48 L
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
24-26 hours
Clearance:
1.0-1.3 L/hr
ExcretionRoute:
Primarily non-renal and non-hepatic elimination. Less than 10% of the dose is excreted unchanged in urine or feces.
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of administration)
PeakEffect:
Not applicable (concentration-dependent killing)
DurationOfAction:
Due to long half-life, once-daily dosing is effective.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling very tired or weak, decreased appetite, inability to pass urine or changes in urine production, dry mouth, dry eyes, or severe upset stomach or vomiting
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Flushing
Swelling in the arms or legs
Confusion
Depression
Mouth irritation
Additional Serious Side Effects
If you experience any of the following symptoms, contact your doctor right away:
Signs of high or low blood sugar: fruity-smelling breath, dizziness, fast breathing, fast heartbeat, confusion, sleepiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or trouble speaking or swallowing
Common Side Effects
Many people taking this medication may experience mild or no side effects. However, if you notice any of the following symptoms and they bother you or do not go away, contact your doctor:
Headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Trouble sleeping
Back pain
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling very tired or weak, decreased appetite, inability to pass urine or changes in urine production, dry mouth, dry eyes, or severe upset stomach or vomiting
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Flushing
Swelling in the arms or legs
Confusion
Depression
Mouth irritation
Additional Serious Side Effects
If you experience any of the following symptoms, contact your doctor right away:
Signs of high or low blood sugar: fruity-smelling breath, dizziness, fast breathing, fast heartbeat, confusion, sleepiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or trouble speaking or swallowing
Common Side Effects
Many people taking this medication may experience mild or no side effects. However, if you notice any of the following symptoms and they bother you or do not go away, contact your doctor:
Headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Trouble sleeping
Back pain
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: rash, itching, swelling (especially of the face, tongue, or throat), severe dizziness, trouble breathing.
- Signs of liver problems: unusual tiredness, yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain, nausea, vomiting.
- Infusion-related reactions: flushing, rash, hives, itching during or shortly after the infusion. Report these immediately to your nurse.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a condition that affects your ability to break down fructose.
For Parents or Caregivers:
If your child is under 1 month of age, as this medication is not approved for use in infants younger than 1 month.
Additional Considerations:
This medication may interact with other medications, including prescription and over-the-counter drugs, natural products, and vitamins. Provide your doctor and pharmacist with a comprehensive list of all your medications and health conditions to ensure safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a condition that affects your ability to break down fructose.
For Parents or Caregivers:
If your child is under 1 month of age, as this medication is not approved for use in infants younger than 1 month.
Additional Considerations:
This medication may interact with other medications, including prescription and over-the-counter drugs, natural products, and vitamins. Provide your doctor and pharmacist with a comprehensive list of all your medications and health conditions to ensure safe use.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.
This medication contains fructose, which can cause severe and potentially life-threatening reactions in individuals with hereditary fructose intolerance. If you have any questions or concerns about this ingredient, consult your doctor.
If you are pregnant or become pregnant while taking this medication, you should contact your doctor immediately, as it may harm the unborn baby.
If you are breastfeeding, it is crucial to discuss the potential risks to your baby with your doctor, who can help you weigh the benefits and risks of continuing treatment while nursing.
This medication contains fructose, which can cause severe and potentially life-threatening reactions in individuals with hereditary fructose intolerance. If you have any questions or concerns about this ingredient, consult your doctor.
If you are pregnant or become pregnant while taking this medication, you should contact your doctor immediately, as it may harm the unborn baby.
If you are breastfeeding, it is crucial to discuss the potential risks to your baby with your doctor, who can help you weigh the benefits and risks of continuing treatment while nursing.
Overdose Information
Overdose Symptoms:
- Limited experience with overdose. Symptoms may include those listed under adverse reactions, potentially more severe.
What to Do:
There is no specific antidote for anidulafungin overdose. Treatment should be supportive and symptomatic. Anidulafungin is not dialyzable. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: Although anidulafungin is not hepatically metabolized, baseline liver function is important for overall patient assessment and to rule out pre-existing conditions.
Timing: Prior to initiation of therapy
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney health, though no dose adjustment is needed for renal impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical signs and symptoms of fungal infection
Frequency: Daily
Target: Resolution of symptoms, negative cultures
Action Threshold: Persistent or worsening symptoms, positive cultures may indicate need for re-evaluation of therapy or alternative diagnosis.
Infusion-related reactions (e.g., rash, urticaria, flushing, pruritus)
Frequency: During and immediately after infusion
Target: Absence of reactions
Action Threshold: Occurrence of reactions may require slowing infusion rate or discontinuation.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, or if signs/symptoms of hepatic dysfunction develop
Target: Within normal limits or stable
Action Threshold: Significant elevations may warrant further investigation or discontinuation.
Symptom Monitoring
- Fever
- Chills
- Fatigue
- Rash
- Hives (urticaria)
- Flushing
- Itching (pruritus)
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Elevated liver enzymes (may be asymptomatic)
Special Patient Groups
Pregnancy
Anidulafungin is Pregnancy Category C. This means animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; use only if clearly needed.
Second Trimester:
Potential for fetal harm based on animal data; use only if clearly needed.
Third Trimester:
Potential for fetal harm based on animal data; use only if clearly needed.
Lactation
It is not known whether anidulafungin is excreted in human milk. Caution should be exercised when anidulafungin is administered to a nursing woman. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Unknown
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use in pediatric patients should be based on expert clinical judgment and consideration of potential risks versus benefits.
Geriatric Use
No dose adjustment is required for elderly patients (âĨ65 years of age). Clinical studies did not reveal differences in safety or efficacy between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Clinical Information
Clinical Pearls
- Anidulafungin is a good option for invasive candidiasis, including candidemia, due to its fungicidal activity against most Candida species.
- It has a favorable drug interaction profile because it is not metabolized by the CYP450 system, making it suitable for patients on multiple medications.
- No dose adjustments are needed for patients with renal or hepatic impairment, simplifying management in these populations.
- Administer slowly over approximately 1 hour to minimize infusion-related reactions.
Alternative Therapies
- Caspofungin (another echinocandin)
- Micafungin (another echinocandin)
- Fluconazole (azole antifungal)
- Voriconazole (azole antifungal)
- Amphotericin B (polyene antifungal)
Cost & Coverage
Average Cost:
Check current pricing, typically high for brand-name IV antifungals per vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Specialty drug, may require prior authorization)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Additionally, some medications may come with a separate patient information leaflet, which can be obtained by consulting with your pharmacist. If you have any questions or concerns about your medication, it is recommended that you discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Additionally, some medications may come with a separate patient information leaflet, which can be obtained by consulting with your pharmacist. If you have any questions or concerns about your medication, it is recommended that you discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.