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ERAXIS anidulafungin 100 mg/30mL Injection, Powder, Lyophilized, For Solution, 30 mL — NDC 0049-0116-28 (Billing 00049-0116-28)

by Roerig · 30 mL in 1 VIAL, SINGLE-USE

This is a package of 30 mL of ERAXIS anidulafungin 100 mg/30mL Injection, Powder, Lyophilized, For Solution from Roerig, marketed since Feb 2006 and currently FDA-listed. It is this product's only package size.

NDC 00049-0116-28
🏷️ FDA NDC (as labeled) 0049-0116-28 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0049-0116-28
Product NDC 0049-0116
11-digit billing NDC 00049011628
NCPDP billing unit EA — each (per item)
RxCUI 1804743, 1804746, 1804748, 1804750
UNII 9HLM53094I
Application # NDA021632
SPL Set ID a88d9010-55fb-4a02-baff-042cd27688ea
Established class (EPC) Echinocandin Antifungal
Chemical class Lipopeptides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-02-17
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ANIDULAFUNGIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 11500010002130
GPI class Eraxis
GCN Seq No 062989
GCN 98749
HICL code 033502
Ingredient (HICL) Anidulafungin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3A
Therapeutic class — specific (HIC3) Antifungal Antibiotics
AHFS code 08:14.16.00
AHFS class Echinocandin Antifungals
FDB label name ERAXIS 100 MG VIAL
FDB brand name Eraxis
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062989
  • GCN: 98749
  • GPI-14 (Medi-Span): 11500010002130
  • HICL (First Databank): 033502
  • AHFS class code: 08:14.16.00
  • RxCUI (RxNorm): 1804743
Why two NDCs? The FDA registers this code as 0049-0116-28 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00049-0116-28. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Echinocandin Antifungal class.

Pharmacologic class Echinocandin Antifungal
Drug family (ATC) Other antimycotics for systemic use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ERAXIS 100 MG VIAL Ingredient Anidulafungin
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $147.50 $4,424.95 / 30 ml
Medicare drug plans payPart D · Q2 2026 $190.63 $5,719.00 / 30 ml
Medicare Part B allowsASP · J0348 $0.486 / J0348 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0049-0116-28
11-digit billing NDC00049-0116-28
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0348
DescriptorInjection, anidulafungin, 1 mg
Billing units / pkg100 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$3,814 · 39 claims · $97.79 per claim (all NDCs under J0348)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00049-0116-28 You're viewing this Main listing 30 mL in 1 VIAL, SINGLE-USE 2006-02-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eraxis 100 mg/30mLthis 00049-0116-28 Roerig 30 ml — — FDA listed —
Eraxis 100 mg/30mL 00049-2242-01 Roerig 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2006
On the market since
Feb 2006
📍
2026
Currently FDA-listed
20 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerRoerig
Application holderVICURON HOLDINGS LLC
FDA applicationNDA021632 (NDA)
Labeler code00049
First marketedFeb 2006
Product typeHuman Prescription Drug
Portfolio33 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 ) • Esophageal candidiasis in adults ( 1.2 ) Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established.

( 1.3 , 5.3 , 8.4 ) • ERAXIS is associated with high relapse rates in esophageal candidiasis. ( 1.3 , 14.2 )

1.1Candidemia and Other Forms of Candida Infections (Intra-abdominal Abscess and Peritonitis) ERAXIS is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis in adults and pediatric patients 1 month of age and older [see Clinical Studies (14.1) and Microbiology (12.4) ] .

1.2Esophageal Candidiasis ERAXIS is indicated for the treatment of esophageal candidiasis in adults [see Indications and Usage (1.3) , Clinical Studies (14.2) ] .

1.3Limitations of Use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida , and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established [see Warning and Precautions (5.3) , Use in Specific Populations (8.4) ] . • ERAXIS is associated with high relapse rates in esophageal candidiasis [see Clinical Studies (14.2) ] .

1.4Usage Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adults Pediatric Patients 1 Month of Age and Older Candidemia and other forms of Candida infections 200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture ( 2.1 ) 3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture ( 2.2 ) Esophageal candidiasis 100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms ( 2.1 ) Not Approved Rate of Infusion for Adults and Pediatric Patients The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions] ( 2.3 , 2.4 )

2.1Recommended Dosage in Adults Candidemia and other Candida infections (intra-abdominal abscess and peritonitis) The recommended dose is a single 200 mg loading dose of ERAXIS on Day 1, followed by a 100 mg once daily maintenance dose thereafter. Duration of treatment should be based on the patient's clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.

Esophageal Candidiasis The recommended dose is a single 100 mg loading dose of ERAXIS on Day 1, followed by a 50 mg once daily maintenance dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. Duration of treatment should be based on the patient's clinical response.

Because of the risk of relapse of esophageal candidiasis in patients with HIV infection, suppressive antifungal therapy may be considered after a course of treatment.

2.2Recommended Dosage in Pediatric Patients (1 Month of Age and Older) Candidemia and other Candida infections (intra-abdominal abscess and peritonitis) The recommended dose is a single loading dose of 3 mg/kg (not to exceed 200 mg) of ERAXIS on Day 1, followed by a once daily maintenance dose of 1.5 mg/kg (not to exceed 100 mg) of ERAXIS thereafter. Overall antifungal treatment should continue for at least 14 days after the last positive culture.

2.3Preparation for Administration ERAXIS for Injection must be reconstituted with sterile Water for Injection and subsequently diluted only with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline), prior to administration. The compatibility of reconstituted ERAXIS with intravenous substances, additives, or medications other than 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) has not been established. Do NOT dilute with other solutions or co-infuse with other medications or electrolytes .

The infusion solution must not be frozen. Reconstitution of the 50 mg/vial Aseptically reconstitute each 50 mg vial with 15 mL of sterile Water for Injection to provide a concentration of 3.33 mg/mL. Reconstitution of the 100 mg/vial Aseptically reconstitute each 100 mg vial with 30 mL of sterile Water for Injection to provide a concentration of 3.33 mg/mL.

Storage of the Reconstituted Solution ERAXIS reconstituted solution can be stored at 25°C (77°F) for up to 24 hours prior to dilution into the infusion solution. Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C (77°F). From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25°C.

2.4Dilution and Administration of the Infusion Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is identified, discard the solution. Adult Patients Aseptically transfer the contents of the reconstituted vial(s)… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 50 mg, and 100 mg of anidulafungin as a white to off-white sterile lyophilized powder in a single-dose vial for reconstitution. For injection : 50 mg, and 100 mg as a lyophilized powder in a single-dose vial for reconstitution ( 3 )

⛔ Contraindications 72 words ▾

4 CONTRAINDICATIONS ERAXIS is contraindicated in: • Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins [see Warnings and Precautions (5.2) ] • Patients with known or suspected Hereditary Fructose Intolerance (HFI) [see Warnings and Precautions (5.4) ] • Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins ( 4 , 5.2 ) • Known or suspected Hereditary Fructose Intolerance (HFI) ( 4 , 5.4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Hepatic Effects : Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy. ( 5.1 , 13.2 ) • Hypersensitivity : Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute.

( 2.4 , 5.2 ) • Risk of Neonatal Toxicity Associated with Polysorbates : ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. ERAXIS is not approved in pediatric patients younger than 1 month of age.

( 5.3 , 8.4 ) • Hereditary Fructose Intolerance (HFI) : ERAXIS contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before ERAXIS administration.

( 5.4 , 8.4 )

5.1Hepatic Adverse Reactions Laboratory abnormalities in liver tests have been seen in healthy volunteers and pediatric patients treated with ERAXIS. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with ERAXIS, clinically significant hepatic abnormalities have occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to ERAXIS has not been established [see Adverse Reactions (6.1) and Nonclinical Toxicology (13.2) ] .

Patients who develop abnormal liver tests during ERAXIS therapy should be monitored for evidence of worsening hepatic tests and evaluated for risk/benefit of continuing ERAXIS therapy.

5.2Anaphylactic and Hypersensitivity Reactions Anaphylactic reactions, including shock were reported with the use of ERAXIS. If these reactions occur, ERAXIS should be discontinued and appropriate treatment administered [see Adverse Reactions (6) ] . Infusion-related adverse reactions, possibly histamine-mediated, have been reported with ERAXIS, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension [see Adverse Reactions (6) ] .

To reduce occurrence of these reactions, do not exceed a rate of ERAXIS infusion of 1.1 mg/minute [see Dosage and Administration (2.4) ] .

5.3Risk of Neonatal Toxicity Associated with Polysorbates ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis have been reported in low-birth weight infants receiving high doses of polysorbate. Polysorbate toxicity has not been reported with ERAXIS.

ERAXIS is not approved in pediatric patients younger than 1 month of age [see Indications and Usage (1.1 , 1.3) , Use in Specific Populations (8.4) ].

5.4Risk in Patients with Hereditary Fructose Intolerance (HFI) ERAXIS contains fructose, an inactive ingredient, and may precipitate a metabolic crisis that may include, but is not limited to life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure in patients with HFI. Obtain careful history of HFI symptoms (nausea, vomiting, abdominal pain) with fructose/sucrose exposure prior to ERAXIS administration because a diagnosis of HFI may not yet be established in pediatric patients [see Contraindications (4) and Use in Specific Populations (8.4) ] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following most serious adverse reactions are described elsewhere in other labeling sections: • Hepatic Adverse Reactions [see Warnings and Precautions (5.1) ] • Anaphylactic and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Adults • Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension. ( 6.1 ) • Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia.

( 6.1 ) Pediatric Patients (1 month and older) Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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. Clinical Trials Experience in Adults 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 trials (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 (2.3%) and systemic Candida infection (1.5%) 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 Adult Patients Receiving ERAXIS or Fluconazole Therapy for Candidemia/other Candida Infections A patient who experienced multiple reactions within a Body System 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.

Adverse Reaction ERAXIS 100 mg N=131 Fluconazole 400 mg N=125 N (%) N (%) Subjects with a least one adverse reaction 130 (99) 122 (98) 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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Cyclosporine Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered [see Clinical Pharmacology (12.3) ] .

7.2Voriconazole Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered [see Clinical Pharmacology (12.3) ] .

7.3Tacrolimus Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered [see Clinical Pharmacology (12.3) ] .

7.4Rifampin Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with rifampin [see Clinical Pharmacology (12.3) ] .

7.5Amphotericin B Liposome for Injection Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy : Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. Inform pregnant woman of the risk to the fetus. ( 8.1 ) • Pediatric Use : The safety and effectiveness in patients younger than 1 month of age has not been established. ( 8.4 )

8.1Pregnancy Risk Summary Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. There are no available human data on the use of ERAXIS in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area ( see Data ) .

Inform pregnant woman of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data In a combined fertility and embryo-fetal development study in rats dosed with anidulafungin for 4 weeks prior to cohabitation and through cohabitation for males or for 2 weeks prior to cohabitation and continuing through gestation day 19 for females, there was no maternal or embryo-fetal toxicity at intravenous doses up to 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area).

In a rabbit embryo-fetal development study, intravenous administration of anidulafungin (0, 5, 10, and 20 mg/kg/day) from gestation day 7 through 19, resulted in reduced fetal weights and incomplete ossification in the presence of maternal toxicity (decreased body weight gain) at 20 mg/kg/day (equivalent to 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area). In a pre- and postnatal development study, pregnant rats were intravenously administered anidulafungin at doses of 2, 6, or 20 mg/kg/day from gestation day 7 through lactation day 20.

Maternal toxicity was observed at ≥6 mg/kg/day (clinical signs at ≥6 mg/kg/day and reduced body weight gain and food consumption during gestation at 20 mg/kg/day group). There were no effects on the viability or growth and development of the offspring. In this study, anidulafungin was detected in fetal plasma, indicating that it crossed the placental barrier.

8.2Lactation Risk Summary There are no data on the presence of anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Anidulafungin was found in the milk of lactating rats ( see Data ).

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ERAXIS and any potential adverse effects on the breastfed child from ERAXIS or from the underlying maternal condition. Data Animal Data Pregnant rats were intravenously administered anidulafungin at doses of 2, 6, or 20 mg/kg/day from gestation day 7 through lactation day 20. Milk samples were collected from 5 rats per group on lactation day 14 at approximately 1 hours post dose.

Approximately dose-proportional anidulafungin concentrations were found in the milk of lactating rats.

8.4Pediatric Use The safety and effectiveness of ERAXIS for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis, have been established in pediatric patients 1 month of age and older. Use of ERAXIS for this indication in this age group is suppor… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. There are no available human data on the use of ERAXIS in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area ( see Data ) .

Inform pregnant woman of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data In a combined fertility and embryo-fetal development study in rats dosed with anidulafungin for 4 weeks prior to cohabitation and through cohabitation for males or for 2 weeks prior to cohabitation and continuing through gestation day 19 for females, there was no maternal or embryo-fetal toxicity at intravenous doses up to 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area).

In a rabbit embryo-fetal development study, intravenous administration of anidulafungin (0, 5, 10, and 20 mg/kg/day) from gestation day 7 through 19, resulted in reduced fetal weights and incomplete ossification in the presence of maternal toxicity (decreased body weight gain) at 20 mg/kg/day (equivalent to 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area). In a pre- and postnatal development study, pregnant rats were intravenously administered anidulafungin at doses of 2, 6, or 20 mg/kg/day from gestation day 7 through lactation day 20.

Maternal toxicity was observed at ≥6 mg/kg/day (clinical signs at ≥6 mg/kg/day and reduced body weight gain and food consumption during gestation at 20 mg/kg/day group). There were no effects on the viability or growth and development of the offspring. In this study, anidulafungin was detected in fetal plasma, indicating that it crossed the placental barrier.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of ERAXIS for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis, have been established in pediatric patients 1 month of age and older. Use of ERAXIS for this indication in this age group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety data in pediatric patients 1 month of age and older [see Indications and Usage (1) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1) ].

The safety and effectiveness of ERAXIS in patients younger than 1 month of age with candidemia/invasive candidiasis has not been established. Candidemia/invasive candidiasis in pediatric patients younger than 1 month of age has a higher rate of central nervous system (CNS) and multi-organ dissemination than in older patients. In addition, in patients younger than 1 month of age ERAXIS carries a potential risk of life-threatening toxicity associated with high doses of polysorbate 80, an inactive ingredient in ERAXIS [see Warnings and Precautions (5.3) ] .

The safety and effectiveness of ERAXIS in pediatric patients with esophageal candidiasis has not been established. ERAXIS is contraindicated in adult and pediatric patients with HFI. Because a diagnosis of HFI may not yet be established in pediatric patients, obtain a careful history of HFI symptoms with fructose/sucrose exposure prior to administration of ERAXIS [see Warnings and Precautions (5.4) ] .

🧓 Geriatric Use 89 words ▾

8.5Geriatric Use Of the total number of subjects (N = 197) in the pivotal clinical studies of anidulafungin, 35% were 65 years and over, while 18% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustments are not required for geriatric patients [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 120 words ▾

10 OVERDOSAGE During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 × ULN) [see Warnings and Precautions (5.1) ] .

Anidulafungin is not dialyzable. The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Anidulafungin is an anti-fungal drug [see Microbiology (12.4) ].

12.3Pharmacokinetics General Pharmacokinetic Characteristics The pharmacokinetics of anidulafungin following intravenous (IV) administration of ERAXIS have been characterized in healthy subjects, special populations and patients. Systemic exposures of anidulafungin are dose-proportional and have low inter-subject variability (coefficient of variation <25%) as shown in Table 5. The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose) and the estimated plasma accumulation factor at steady state is approximately 2.

Table 5: Mean (%CV) Steady State Pharmacokinetic Parameters of Anidulafungin Following IV Administration of ERAXIS Once Daily for 10 Days in Healthy Adult Subjects C max, ss = the steady state peak concentration AUC ss = the steady state area under concentration vs. time curve CL = clearance t 1/2 = the terminal elimination half-life PK Parameter Parameters were obtained from separate studies Anidulafungin IV Dosing Regimen (LD/MD, mg) LD/MD: loading dose/maintenance dose once daily 70/35 Data were collected on Day 7 , Safety and efficacy of these doses has not been established (N=6) 200/100 (N=10) 260/130 , See OVERDOSAGE (N=10) C max, ss [mg/L] 3.55 (13.2) 8.6 (16.2) 10.9 (11.7) AUC ss [mg∙h/L] 42.3 (14.5) 111.8 (24.9) 168.9 (10.8) CL [L/h] 0.84 (13.5) 0.94 (24.0) 0.78 (11.3) t 1/2 [h] 43.2 (17.7) 52.0 (11.7) 50.3 (9.7) The clearance of anidulafungin is about 1 L/h and anidulafungin has a terminal elimination half-life of 40–50 hours.

Distribution The pharmacokinetics of anidulafungin following IV administration are characterized by a short distribution half-life (0.5–1 hour) and a volume of distribution of 30–50 L that is similar to total body fluid volume. Anidulafungin is extensively bound (>99%) to human plasma proteins. Metabolism Hepatic metabolism of anidulafungin has not been observed.

Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 (CYP450) isoenzymes. It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolized by CYP450 isoenzymes. Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ring-opened peptide that lacks antifungal activity.

The in vitro degradation half-life of anidulafungin under physiologic conditions is about 24 hours. In vivo , the ring-opened product is subsequently converted to peptidic degradants and eliminated. Excretion In a single-dose clinical study, radiolabeled ( 14 C) anidulafungin was administered to healthy subjects.

Approximately 30% of the administered radioactive dose was eliminated in the feces over 9 days, of which less than 10% was intact drug. Less than 1% of the administered radioactive dose was excreted in the urine. Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.

Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and feces 8 weeks post-dose. Specific Populations Patients with fungal infections Population pharmacokinetic analyses from four clinical trials including 107 male and 118 female patients with fungal infections showed that the pharmacokinetic parameters of anidulafungin are not affected by age, race, or the presence of concomitant medications which are known metabolic substrates, inhibitors or inducers. The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects.

The pharmacokinetic parameters of anidulafungin estimated using population pharmacokinetic modeling following IV administration of a maintenance dose of 50 mg/day or 100 mg/day (following a loading dose) of ERAXIS are presented in Table 6. Table 6: Mean (%CV) Steady State Pharmacokinetic Parameters of Anidulafungin Following IV Administration of ERAXIS in Patients with Fungal Infe… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 13 words ▾

12.1Mechanism of Action Anidulafungin is an anti-fungal drug [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 163 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ERAXIS (anidulafungin) for Injection is supplied in a single-dose vial of sterile, lyophilized, preservative-free, white to off-white powder. ERAXIS (anidulafungin) is available in the following packaging configuration: Single-Dose Vial of ERAXIS 50 mg NDC 0049-0114-28 One - 50 mg vial Single-Dose Vial of ERAXIS 100 mg NDC 0049-0116-28 One - 100 mg vial

16.2Storage ERAXIS vials ERAXIS (unreconstituted) vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze. Excursions for 96 hours up to 25°C (77°F) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F).

Reconstituted solution ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours [see Dosage and Administration (2.3) ] . Infusion Solution ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.4) ] .

📦 Storage and Handling 102 words ▾

16.2Storage ERAXIS vials ERAXIS (unreconstituted) vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze. Excursions for 96 hours up to 25°C (77°F) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F).

Reconstituted solution ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours [see Dosage and Administration (2.3) ] . Infusion Solution ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.4) ] .

📋 Description 202 words ▾

11 DESCRIPTION ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans . Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.

ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N 2 -[[4"-(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients: 50 mg/vial – fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.

100 mg/vial – fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment. The empirical formula of anidulafungin is C 58 H 73 N 7 O 17 and the formula weight is 1140.3. The structural formula is: Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline).

Chemical Structure

💬 Information for Patients 171 words ▾

17 PATIENT COUNSELING INFORMATION Hepatic Adverse Reactions Inform patients about the risk of developing abnormal liver function tests and/or hepatic dysfunction. Advise the patient that liver function tests may be monitored during treatment. Anaphylactic and Hypersensitivity Reactions Inform the patient that anaphylactic reactions, including shock were reported with ERAXIS.

Inform the patient if these reactions occur, ERAXIS may be discontinued and appropriate treatment administered. Inform the patient that ERAXIS is also known to cause infusion-related adverse reactions, possibly histamine-mediated. Inform the patient to report symptoms including rash, urticaria, flushing, pruritus, dyspnea, and hypotension to their healthcare provider.

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk of ERAXIS to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy. Patients with Hereditary Fructose Intolerance (HFI) Inform patients and caregivers that ERAXIS contains fructose and can be life-threatening when administered to patients with hereditary fructose intolerance (HFI) [see Warnings and Precautions (5.4) ] .

Inquire for symptoms of fructose and/or sucrose intolerance.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics General Pharmacokinetic Characteristics The pharmacokinetics of anidulafungin following intravenous (IV) administration of ERAXIS have been characterized in healthy subjects, special populations and patients. Systemic exposures of anidulafungin are dose-proportional and have low inter-subject variability (coefficient of variation <25%) as shown in Table 5. The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose) and the estimated plasma accumulation factor at steady state is approximately 2.

Table 5: Mean (%CV) Steady State Pharmacokinetic Parameters of Anidulafungin Following IV Administration of ERAXIS Once Daily for 10 Days in Healthy Adult Subjects C max, ss = the steady state peak concentration AUC ss = the steady state area under concentration vs. time curve CL = clearance t 1/2 = the terminal elimination half-life PK Parameter Parameters were obtained from separate studies Anidulafungin IV Dosing Regimen (LD/MD, mg) LD/MD: loading dose/maintenance dose once daily 70/35 Data were collected on Day 7 , Safety and efficacy of these doses has not been established (N=6) 200/100 (N=10) 260/130 , See OVERDOSAGE (N=10) C max, ss [mg/L] 3.55 (13.2) 8.6 (16.2) 10.9 (11.7) AUC ss [mg∙h/L] 42.3 (14.5) 111.8 (24.9) 168.9 (10.8) CL [L/h] 0.84 (13.5) 0.94 (24.0) 0.78 (11.3) t 1/2 [h] 43.2 (17.7) 52.0 (11.7) 50.3 (9.7) The clearance of anidulafungin is about 1 L/h and anidulafungin has a terminal elimination half-life of 40–50 hours.

Distribution The pharmacokinetics of anidulafungin following IV administration are characterized by a short distribution half-life (0.5–1 hour) and a volume of distribution of 30–50 L that is similar to total body fluid volume. Anidulafungin is extensively bound (>99%) to human plasma proteins. Metabolism Hepatic metabolism of anidulafungin has not been observed.

Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 (CYP450) isoenzymes. It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolized by CYP450 isoenzymes. Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ring-opened peptide that lacks antifungal activity.

The in vitro degradation half-life of anidulafungin under physiologic conditions is about 24 hours. In vivo , the ring-opened product is subsequently converted to peptidic degradants and eliminated. Excretion In a single-dose clinical study, radiolabeled ( 14 C) anidulafungin was administered to healthy subjects.

Approximately 30% of the administered radioactive dose was eliminated in the feces over 9 days, of which less than 10% was intact drug. Less than 1% of the administered radioactive dose was excreted in the urine. Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.

Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and feces 8 weeks post-dose. Specific Populations Patients with fungal infections Population pharmacokinetic analyses from four clinical trials including 107 male and 118 female patients with fungal infections showed that the pharmacokinetic parameters of anidulafungin are not affected by age, race, or the presence of concomitant medications which are known metabolic substrates, inhibitors or inducers. The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects.

The pharmacokinetic parameters of anidulafungin estimated using population pharmacokinetic modeling following IV administration of a maintenance dose of 50 mg/day or 100 mg/day (following a loading dose) of ERAXIS are presented in Table 6. Table 6: Mean (%CV) Steady State Pharmacokinetic Parameters of Anidulafungin Following IV Administration of ERAXIS in Patients with Fungal Infections Estimated Using Population Pharmacokinetic Modeling PK Parameter All the parameters were estimated by popula… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis) Adults Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis) Trial The safety and efficacy of ERAXIS were evaluated in a Phase 3, randomized, double-blind study of patients with candidemia and/or other forms of invasive candidiasis. 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).

Patients were stratified by APACHE II score (≤20 and >20) and the presence or absence of neutropenia. Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were excluded from the study. Treatment was administered for at least 14 and not more than 42 days.

Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medication, were afebrile for at least 24 hours, and the last blood cultures were negative for Candida species. Patients who received at least one dose of study medication and who had a positive culture for Candida species from a normally sterile site before entry into the study (modified intent-to-treat [MITT] population) were included in the analysis of global response at the end of IV therapy.

A successful global response required clinical cure or improvement (significant, but incomplete resolution of signs and symptoms of the Candida infection and no additional antifungal treatment), and documented or presumed microbiological eradication. Patients with an indeterminate outcome were analyzed as failures in this population. Two hundred and fifty-six patients in the intent-to-treat (ITT) population were randomized and received at least one dose of study medication.

In ERAXIS-treated patients, the age range was 16–89 years, the gender distribution was 50% male and 50% female, and the race distribution was 71% White, 20% Black/African American, 7% Hispanic, 2% other races. The median duration of IV therapy was 14 and 11 days in the ERAXIS and fluconazole arms, respectively. For those who received oral fluconazole, the median duration of oral therapy was 7 days for the ERAXIS arm and 5 days for the fluconazole arm.

Patient disposition is presented in Table 9. Table 9: Patient Disposition and Reasons for Discontinuation in Candidemia and other Candida Infections Study ERAXIS Fluconazole n (%) n (%) Treated patients 131 125 Patients completing study through 6 week follow-up 94 (72) 80 (64) DISCONTINUATIONS FROM STUDY MEDICATION Total discontinued from study medication 34 (26) 48 (38) Discontinued due to adverse events 12 (9) 21 (17) Discontinued due to lack of efficacy 11 (8) 16 (13) Two hundred and forty-five patients (127 ERAXIS, 118 fluconazole) met the criteria for inclusion in the MITT population.

Of these, 219 patients (116 ERAXIS, 103 fluconazole) had candidemia only. Risk factors for candidemia among patients in both treatment arms in this study were: presence of a central venous catheter (78%), receipt of broad-spectrum antibiotics (69%), recent surgery (42%), recent hyperalimentation (25%), and underlying malignancy (22%). The most frequent species isolated at baseline was C. albicans (62%), followed by C. glabrata (20%), C. parapsilosis (12%) and C. tropicalis (11%).

The majority (97%) of patients were non-neutropenic (ANC >500) and 81% had APACHE II scores less than or equal to 20. Global success rates in patients with candidemia and other Candida infections are summarized in Table 10. Table 10: Efficacy Analysis: Global Success in patients with Candidemia and other Candida Infections (MITT Population) Time-point ERAXIS (N=127) n (%) Fluconazole (N=118) n (%) Treatment Difference Calculated as ERAXIS minus fluconazole , % (95% C.I.) End of IV Therapy 96 (75.6) 71 (60.2) 15.4 (3.9, 27.0) End of All Therap… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 153 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies of anidulafungin have not been conducted. Anidulafungin was not genotoxic in the following in vitro studies: bacterial reverse mutation assays, a chromosome aberration assay with Chinese hamster ovary cells, and a forward gene mutation assay with mouse lymphoma cells. Anidulafungin was not genotoxic in mice using the in vivo micronucleus assay.

Anidulafungin produced no adverse effects on fertility in male or female rats at intravenous doses of 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area).

13.2Animal Toxicology and/or Pharmacology In 3 month studies, liver toxicity, including single cell hepatocellular necrosis, hepatocellular hypertrophy and increased liver weights were observed in monkeys and rats at doses equivalent to 5–6 times human exposure. For both species, hepatocellular hypertrophy was still noted one month after the end of dosing.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 99 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies of anidulafungin have not been conducted. Anidulafungin was not genotoxic in the following in vitro studies: bacterial reverse mutation assays, a chromosome aberration assay with Chinese hamster ovary cells, and a forward gene mutation assay with mouse lymphoma cells. Anidulafungin was not genotoxic in mice using the in vivo micronucleus assay.

Anidulafungin produced no adverse effects on fertility in male or female rats at intravenous doses of 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area).

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 50 mg Vial Label 1 Sterile Single-dose Vial Eraxis ® (anidulafungin) for Injection 50 mg/vial For Intravenous Infusion Only Pfizer Hospital Distributed by Roerig Division of Pfizer Inc. New York, NY 10001 Rx only PRINCIPAL DISPLAY PANEL - 50 mg Vial Label

PRINCIPAL DISPLAY PANEL - 50 mg Vial Carton NDC 0049-0114-28 Unit Pack Contains: 1 Sterile Single-dose Vial Eraxis ® 50 mg Eraxis ® (anidulafungin) for Injection 50 mg/vial For Intravenous Infusion Only Store Vial in Refrigerator at 2° C - 8° C (36° F - 46° F). Do Not Freeze. Pfizer Hospital Distributed by Roerig Division of Pfizer Inc. New York, NY 10001 Rx only PRINCIPAL DISPLAY PANEL - 50 mg Vial Carton

PRINCIPAL DISPLAY PANEL - 100 mg Vial Label 1 Sterile Single-dose Vial Eraxis ® (anidulafungin) for Injection 100 mg/vial For Intravenous Infusion Only Pfizer Hospital Distributed by Roerig Division of Pfizer Inc. New York, NY 10001 Rx only PRINCIPAL DISPLAY PANEL - 100 mg Vial Label

PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton NDC 0049-0116-28 Unit Pack Contains: 1 Sterile Single-dose Vial Eraxis ® 100 mg Eraxis ® (anidulafungin) for Injection 100 mg/vial For Intravenous Infusion Only Store Vial in Refrigerator at 2° C - 8° C (36° F - 46° F). Do Not Freeze. Pfizer Hospital Distributed by Roerig Division of Pfizer Inc. New York, NY 10001 Rx only PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
438
Units reimbursed last 4 qtrs
881
Gross reimbursed last 4 qtrs
$129.9K
Avg / prescription
$296.68
Avg / unit
$147.50
Latest quarter Q1 2026
104Rx
Fee-for-service vs managed care ⓘ
35% FFS 65% MCO
Fee-for-service · 154 Rx Managed care · 284 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 136 units · 1.4 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 240 units · 1.9 per 100k residents IL Indiana: 82 units · 1.2 per 100k residents IN Ohio: 40 units · 0.3 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 182 units · 2.0 per 100k residents NJ Massachusetts: no data reported MA California: 43 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 21 units · 0.5 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 9 units · 0.0 per 100k residents TX Florida: 128 units · 0.6 per 100k residents FL
Units reimbursed · per 100k residents
0.02.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 2.0 /100k
2 Illinois 1.9 /100k
3 Michigan 1.4 /100k
4 Indiana 1.2 /100k
5 Florida 0.6 /100k
6 Oklahoma 0.5 /100k
7 Ohio 0.3 /100k
8 California 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Eraxis — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Eraxis. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$75K
Claims incl. refills
89
Beneficiaries
29
Spend / beneficiary
$2,587.25
Spend / claim
$843.04
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Roerig. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Roerig is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0348 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.