Eraxis 100mg 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 is used to treat serious fungal infections, especially those caused by Candida yeasts, by attacking their cell walls.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on the next steps to take.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on the next steps to take.
Lifestyle & Tips
- Report any new or worsening symptoms to your healthcare provider.
- Ensure you attend all scheduled appointments for infusions and monitoring.
- Maintain good hygiene to prevent further infections.
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:
Candidemia and other forms of Invasive Candidiasis:
200 mg IV loading dose on Day 1, followed by 100 mg IV daily maintenance dose.
Pediatric Dosing
Neonatal:
Not established (approved for 1 month to <18 years)
Infant:
Loading dose: 3 mg/kg (max 200 mg) on Day 1; Maintenance dose: 1.5 mg/kg (max 100 mg) daily thereafter (for 1 month to <2 years)
Child:
Loading dose: 3 mg/kg (max 200 mg) on Day 1; Maintenance dose: 1.5 mg/kg (max 100 mg) daily thereafter (for 2 to <18 years)
Adolescent:
Loading dose: 3 mg/kg (max 200 mg) on Day 1; Maintenance dose: 1.5 mg/kg (max 100 mg) daily thereafter (for 2 to <18 years)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required
Moderate:
No dose adjustment required
Severe:
No dose adjustment required
Dialysis:
No dose adjustment required; Anidulafungin is not dialyzable
Hepatic Impairment:
Mild:
No dose adjustment required
Moderate:
No dose adjustment required
Severe:
No dose adjustment required
Pharmacology
Mechanism of Action
Anidulafungin is an echinocandin antifungal. It inhibits 1,3-β-D-glucan synthase, an enzyme essential for the integrity of the fungal cell wall. This leads to osmotic instability and cell lysis, primarily against Candida species.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
30-40 L
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
24-26 hours (terminal)
Clearance:
1.0-1.3 L/hr
ExcretionRoute:
Primarily fecal (<10% unchanged in urine)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Not applicable (concentration-dependent killing)
DurationOfAction:
24 hours (due to long half-life, allowing once-daily dosing)
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 experience 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, unable to pass urine or change in the amount of urine produced, 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 eyesight
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: breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, 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, change of color, 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 experience any of the following side effects 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 experience 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, unable to pass urine or change in the amount of urine produced, 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 eyesight
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: breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, 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, change of color, 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 experience any of the following side effects 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:
- Severe rash or hives
- Difficulty breathing or wheezing
- Swelling of the face, lips, tongue, or throat
- Dizziness or lightheadedness
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Unusual tiredness or weakness
- Severe stomach pain, nausea, or vomiting
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 drugs, including prescription and over-the-counter medications, natural products, and vitamins. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of all the medications and supplements you are taking.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
Always verify that it is safe to take this medication with your other medications and health conditions.
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 drugs, including prescription and over-the-counter medications, natural products, and vitamins. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of all the medications and supplements you are taking.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
Always verify that it is safe to take this medication with your other medications and health conditions.
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.
If you have hereditary fructose intolerance, you should be aware that this medication contains fructose. In people with this condition, severe and potentially life-threatening reactions can occur when taking medications that contain fructose. If you have any questions or concerns, consult with your doctor.
Women who are pregnant or become pregnant while taking this medication should be aware that it may cause harm to the unborn baby. If you are pregnant or suspect you may be pregnant, contact your doctor immediately.
If you are breastfeeding, it is crucial to discuss the potential risks to your baby with your doctor. This will help you make an informed decision about continuing to breastfeed while taking this medication.
If you have hereditary fructose intolerance, you should be aware that this medication contains fructose. In people with this condition, severe and potentially life-threatening reactions can occur when taking medications that contain fructose. If you have any questions or concerns, consult with your doctor.
Women who are pregnant or become pregnant while taking this medication should be aware that it may cause harm to the unborn baby. If you are pregnant or suspect you may be pregnant, contact your doctor immediately.
If you are breastfeeding, it is crucial to discuss the potential risks to your baby with your doctor. This will help you make an informed decision about continuing to breastfeed while taking this medication.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. High doses (up to 1500 mg) have been administered without dose-limiting toxicity.
What to Do:
In case of suspected overdose, general supportive measures should be employed. Anidulafungin is not dialyzable. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: Although not significantly metabolized by the liver, baseline assessment is prudent for all systemic antifungals.
Timing: Prior to initiation of therapy
Renal function (SCr, BUN)
Rationale: To establish baseline, though no dose adjustment is needed for renal impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (e.g., fever resolution, negative cultures)
Frequency: Daily
Target: Improvement in signs/symptoms, eradication of infection
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or need for alternative therapy
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 (e.g., weekly) if clinically indicated or for prolonged therapy
Target: Within normal limits or stable
Action Threshold: Significant elevation may warrant further investigation or discontinuation
Symptom Monitoring
- Rash
- Hives
- Itching
- Flushing
- Shortness of breath
- Wheezing
- Dizziness
- Headache
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Fever
- Chills
- Signs of liver dysfunction (e.g., yellowing of skin/eyes, dark urine, unusual fatigue)
Special Patient Groups
Pregnancy
Category C. Anidulafungin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Potential risk, use only if clearly needed.
Second Trimester:
Potential risk, use only if clearly needed.
Third Trimester:
Potential risk, 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. Consider the benefits of breastfeeding versus the potential risks to the infant and the mother's clinical need.
Infant Risk:
Unknown; potential for adverse effects on the breastfed infant.
Pediatric Use
Approved for use in pediatric patients aged 1 month to <18 years for candidemia and other forms of invasive candidiasis. Dosing is weight-based. Safety and efficacy have been established.
Geriatric Use
No dose adjustment is required based on age. Clinical studies did not show differences in efficacy or safety between elderly and younger patients.
Clinical Information
Clinical Pearls
- Anidulafungin has a favorable drug interaction profile due to its unique non-hepatic, non-renal chemical degradation, making it a good option for patients on multiple medications or with hepatic/renal impairment.
- It is effective against most Candida species, including those resistant to azoles (e.g., C. glabrata, C. krusei).
- No loading dose is required for maintenance therapy if a patient is switched from another echinocandin.
- Infusion-related reactions are generally mild and uncommon; slowing the infusion rate can help manage them.
- Reconstitution and dilution must be done carefully according to manufacturer instructions to ensure stability and prevent precipitation.
Alternative Therapies
- Caspofungin (another echinocandin)
- Micafungin (another echinocandin)
- Fluconazole (azole antifungal)
- Voriconazole (azole antifungal)
- Amphotericin B (polyene antifungal)
Cost & Coverage
Average Cost:
Varies widely, typically high per 100mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization for many plans)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.