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NAVITRUX fosaprepitant 150 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 83831-153-01 (Billing 83831-0153-01)

by AVYXA Pharma, LLC · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of NAVITRUX fosaprepitant 150 mg/5mL Injection, Powder, Lyophilized, For Solution from AVYXA Pharma, LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 83831-0153-01
🏷️ FDA NDC (as labeled) 83831-153-01 billing pads the product 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 Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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) 83831-153-01
Product NDC 83831-153
11-digit billing NDC 83831015301
NCPDP billing unit EA — each (per item)
RxCUI 1731077, 2745874
UNII D35FM8T64X
UPC 0383831153016
Application # NDA220436
SPL Set ID a41b7c3a-1376-43a7-b5b9-6ba2eba1e169
Established class (EPC) Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of action Cytochrome P450 2C9 Inducers; Cytochrome P450 3A4 Inducers; Cytochrome P450 3A4 Inhibitors; Neurokinin 1 Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-23
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance FOSAPREPITANT DIMEGLUMINE
Quick answers
  • RxCUI (RxNorm): 1731077
Why two NDCs? The FDA registers this code as 83831-153-01 — a 5-3-2 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 product segment → 83831-0153-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It helps prevent nausea and vomiting caused by cancer chemotherapy. You get it along with other anti-nausea medicines. It prevents symptoms but is not studied for treating nausea t...
  • A healthcare professional gives it as an IV infusion, usually on the first day of chemotherapy. It finishes about 30 minutes before chemo begins. You will also get a steroid and an...
  • Fatigue, diarrhea, low blood counts and weakness are common. Some people have pain or redness at the IV site. Tell your team about any discomfort at the site.
  • Tell your nurse immediately if you feel flushed, short of breath, faint or have a rash during or after the infusion. Also report severe pain or swelling where the IV is.
📖 Read our full Fosaprepitant Dimeglumine guide →
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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83831-0153-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 5 mL in 1 VIAL 2026-07-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fosaprepitant 150 mg/5mL 43598-0948-11 Dr. 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72205-0083-01 Novadoz 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 68001-0421-22 BluePoint 1 vial — — Discontinued —
Fosaprepitant 150 mg/5mL 72205-0054-01 Novadoz 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 68001-0675-25 BluePoint 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72162-2636-02 Bryant 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 63323-0972-10 Fresenius 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 43598-0859-11 Dr. 1 vial — AP FDA listed —
fosaprepitant 150 mg/5mL 67457-0889-10 Mylan 1 vial — AP FDA listed —
fosaprepitant 150 mg/5mL 71839-0104-01 BE 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72603-0450-01 Northstar 1 vial — AP FDA listed —
Navitrux 150 mg/5mLthis 83831-0153-01 AVYXA 1 vial — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerAVYXA Pharma, LLC
Application holderAVYXA HOLDINGS LLC
FDA applicationNDA220436 (NDA)
Labeler code83831
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio29 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 171 words ▾

1 INDICATIONS AND USAGE NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use NAVITRUX has not been studied for the treatment of established nausea and vomiting.

NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) NAVITRUX has not been studied for treatment of established nausea and vomiting.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Adult Dosage ( 2.1 ) NAVITRUX 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes. ( 2.1 ) Complete the infusion approximately 30 minutes prior to chemotherapy. Recommended Dosage for Pediatric Patients (6 months to 17 years) Weighing at Least 6 kg ( 2.2 ) See Full Prescribing Information for pediatric dosage regimens by age.

For single day chemotherapy regimens : single dose of NAVITRUX on Day 1. For single or multi-day chemotherapy regimens : 3-day fosaprepitant regimen of NAVITRUX on Days 1, 2, and 3. Aprepitant capsules or aprepitant oral suspension may be used as an alternative on Days 2 and 3.

Administer NAVITRUX through a central venous catheter as an intravenous infusion over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years). Complete the infusion approximately 30 minutes prior to chemotherapy. Concomitant Antiemetics See Full Prescribing Information for additional information.

( 2.1 , 2.2 )

2.1Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients The recommended dosage of NAVITRUX, dexamethasone, and a 5-HT 3 antagonist for the prevention of nausea and vomiting associated with administration of HEC or MEC in adults is shown in Table 1 or Table 2, respectively. Administer NAVITRUX as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy. Table 1: Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with HEC a Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4.

Also administer dexamethasone in the evenings on Days 3 and 4. A 50% dosage reduction of dexamethasone on Days 1 and 2 is recommended to account for a drug interaction with NAVITRUX [see Clinical Pharmacology (12.3) ] . Day 1 Day 2 Day 3 Day 4 NAVITRUX 150 mg intravenously over 20 to 30 minutes none none none Dexamethasone a 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily 5-HT 3 antagonist See selected 5-HT 3 antagonist prescribing information for the recommended dosage none none none Table 2: Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with MEC a Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1.

A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with NAVITRUX [see Clinical Pharmacology (12.3) ] . Day 1 NAVITRUX 150 mg intravenously over 20 to 30 minutes Dexamethasone a 12 mg orally 5-HT 3 antagonist See selected 5-HT 3 antagonist prescribing information for the recommended dosage

2.2Prevention of Nausea and Vomiting Associated with HEC and MEC in Pediatric Patients The recommended pediatric dosage regimens of NAVITRUX, to be administered with a 5- HT 3 antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of single or multi-day chemotherapy regimens of HEC or MEC, are shown in Tables 3 and 4. Single-day chemotherapy regimens include regimens in which HEC or MEC is administered for a single day only. Multi-day chemotherapy regimens include chemotherapy regimens in which HEC or MEC is administered for 2 or more days.

NAVITRUX Dosage Regimens for Use with Single-Day Chemotherapy Regimens For pediatric patients weighing at least 6 kg receiving single-day HEC or MEC, NAVITRUX may be administered as: a single dose regimen of NAVITRUX infused through a central venous catheter on Day 1, as shown in Table 3; or as a 3-day NAVITRUX regimen consisting of NAVITRUX as an intravenous infusion through a central venous catheter on Days 1, 2, and 3. Aprepitant capsules or aprepitant oral suspension may be used on Days 2 and 3 instead of NAVITRUX, as shown in Table 4.

Administer NAVITRUX on Day 1 over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years), completing the infusion approximately 30 m… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 150 mg fosaprepitant, white to off-white lyophilized powder in single-dose glass vial for reconstitution. For injection: 150 mg fosaprepitant, lyophilized powder in single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 105 words ▾

4 CONTRAINDICATIONS NAVITRUX is contraindicated in patients: who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ] . taking pimozide. Inhibition of CYP3A4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Warnings and Precautions (5.1) ].

Known hypersensitivity to any component of this drug. ( 4 , 5.2 ) Concurrent use with pimozide. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4; see Full Prescribing Information for recommendations regarding contraindications, risk of adverse reactions, and dosage adjustment of NAVITRUX and concomitant drugs. ( 4 , 5.1 , 7.1 , 7.2 ) Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock): May occur during or soon after infusion. If symptoms occur, discontinue the drug.

Do not reinitiate NAVITRUX if symptoms occur with previous use. ( 4 , 5.2 ) Infusion Site Reactions (including thrombophlebitis, necrosis, and vasculitis): Majority of reactions reported in patients receiving vesicant chemotherapy. Avoid infusion into small veins.

Discontinue infusion and administer treatment if a severe reaction develops. ( 5.3 ) Warfarin (a CYP2C9 substrate): Risk of decreased INR of prothrombin time; monitor INR in 2–week period, particularly at 7 to 10 days, following initiation of NAVITRUX. ( 5.4 , 7.1 ) Hormonal Contraceptives: Efficacy of contraceptives may be reduced during and for 28 days following the last dose of NAVITRUX or oral aprepitant.

Use effective alternative or back-up methods of contraception. ( 5.5 , 7.1 , 8.3 )

5.1Clinically Significant CYP3A4 Drug Interactions Fosaprepitant, a prodrug of aprepitant, is a weak inhibitor of CYP3A4, and aprepitant is a substrate, inhibitor, and inducer of CYP3A4. Use of NAVITRUX with other drugs that are CYP3A4 substrates, may result in increased plasma concentration of the concomitant drug. Use of pimozide with NAVITRUX is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide [ see Contraindications (4) ].

Use of NAVITRUX with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to NAVITRUX. Use of NAVITRUX with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of NAVITRUX. See Table 7 and Table 8 for a listing of potentially significant drug interactions [see Drug Interactions (7.1 , 7.2 )] .

5.2Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, during or soon after infusion of fosaprepitant have occurred. Symptoms including flushing, erythema, dyspnea, hypotension and syncope have been reported [see Adverse Reactions (6.2) ] . Monitor patients during and after infusion.

If hypersensitivity reactions occur, discontinue the infusion and administer appropriate medical therapy. Do not reinitiate NAVITRUX in patients who experience these symptoms with previous use [see Contraindications (4) ] .

5.3Infusion Site Reactions Infusion site reactions (ISRs) have been reported with the use of intravenous fosaprepitant [see Adverse Reactions (6.1) ] . The majority of severe ISRs, including thrombophlebitis and vasculitis, were reported with concomitant vesicant (anthracycline-based) chemotherapy administration, particularly when associated with extravasation. Necrosis was also reported in some patients with concomitant vesicant chemotherapy.

Most ISRs occurred with the first, second or third exposure to single doses of fosaprepitant and in some cases, reactions persisted for two weeks or longer. Treatment of severe ISRs consisted of medical, and in some cases surgical, intervention. Avoid infusion of NAVITRUX into small veins or through a butterfly catheter.

If a severe ISR develops during infusion, discontinue the infusion and administer appropriate medical treatment.

5.4Decrease in INR with Concomitant Warfarin Coadministration of fosaprepitant with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized R… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion Site Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions in adults (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. ( 6.1 ) Adverse reactions in pediatrics are similar to adults. To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 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 clinical practice. The safety of NAVITRUX has been established from adequate and well-controlled studies of another intravenous formulation of fosaprepitant [see Clinical Studies (14) ] . Below is a display of the adverse reactions of fosaprepitant in these studies.

The overall safety of fosaprepitant was evaluated in approximately 1800 adult and pediatric patients. Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with MEC In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of fosaprepitant in combination with ondansetron and dexamethasone (i.e., intravenous fosaprepitant regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy). The most common adverse reactions are listed in Table 6.

Table 6: Most Common Adverse Reactions in Patients Receiving MEC a a Reported in ≥ 2% of patients treated with the intravenous fosaprepitant regimen and at a greater incidence than standard therapy (ondansetron and dexamethasone alone). b Intravenous fosaprepitant regimen c Standard therapy Intravenous fosaprepitant, ondansetron, and dexamethasone b (N=504) Ondansetron and dexamethasone c (N=497) fatigue 15% 13% diarrhea 13% 11% neutropenia 8% 7% asthenia 4% 3% anemia 3% 2% peripheral neuropathy 3% 2% leukopenia 2% 1% dyspepsia 2% 1% urinary tract infection 2% 1% pain in extremity 2% 1% Infusion-site reactions were reported in 2.2% of patients treated with the intravenous fosaprepitant regimen compared to 0.6% of patients treated with standard therapy.

The infusion-site reactions included: infusion-site pain (1.2%, 0.4%), injection-site irritation (0.2%, 0.0%), vessel puncture-site pain (0.2%, 0.0%), and infusion-site thrombophlebitis (0.6%, 0.0%), reported in the intravenous fosaprepitant regimen compared to standard therapy, respectively. Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with HEC In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single dose of intravenous fosaprepitant compared to 1169 patients receiving the 3-day regimen of oral fosaprepitant (aprepitant) [see Clinical Studies (14.1) ] .

The safety profile was generally similar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared to those in the aprepitant group (0.5%). The following additional infusion-site reactions occurred in the HEC study and were not reported in the MEC study described above: infusion- site erythema (0.5%, 0.1%), infusion-site pruritus (0.3%, 0.0%), and infusion-site induration (0.2%, 0.1%), reported in the fosaprepitant group compared to the aprepitant group, respectively.

Adverse Reactions in Pediatric Patients 6 Months to 17 Years of Age for the Prevention of Nausea and Vomiting Associated with HEC or MEC Single-Dose Intravenous Fosaprepitant Regimen The safety… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See Full Prescribing Information for a list of clinically significant drug interactions. ( 4 , 5.1 , 5.4 , 5.5 , 7.1 , 7.2 )

7.1Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs When administered intravenously, fosaprepitant, a prodrug of aprepitant, is converted to aprepitant within 30 minutes. Therefore, drug interactions following administration of fosaprepitant are likely to occur with drugs that interact with oral aprepitant. Fosaprepitant, given as a single 150-mg dose, is a weak inhibitor of CYP3A4, and the weak inhibition of CYP3A4 continues for 2 days after single dose administration.

Single dose fosaprepitant does not induce CYP3A4. Aprepitant is a substrate, an inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9 [see Clinical Pharmacology (12.3) ] .

Some substrates of CYP3A4 are contraindicated with NAVITRUX [see Contraindications (4) ] . Dosage adjustment of some CYP3A4 and CYP2C9 substrates may be warranted, as shown in Table 7. Table 7: Effects of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs CYP3A4 Substrates Pimozide Clinical Impact Increased pimozide exposure Intervention NAVITRUX is contraindicated [see Contraindications (4) ].

Benzodiazepines Clinical Impact Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Intervention Monitor for benzodiazepine-related adverse reactions. Dexamethasone Clinical Impact Increased dexamethasone exposure [see Clinical Pharmacology (12.3) ].

Intervention Reduce the dose of oral dexamethasone by approximately 50% [see Dosage and Administration (2.1) ]. Methylprednisolone Clinical Impact Increased methylprednisolone exposure [see Clinical Pharmacology (12.3) ]. Intervention Reduce the dose of oral methylprednisolone by approximately 50% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC.

Reduce the dose of intravenous methylprednisolone by 25% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC. Chemotherapeutic agents that are metabolized by CYP3A4 Clinical Impact Increased exposure of the chemotherapeutic agent may increase the risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Intervention Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents ● Monitor for chemotherapeutic-related adverse reactions.

Etoposide, vinorelbine, paclitaxel, and docetaxel ● No dosage adjustment needed. Hormonal Contraceptives Clinical Impact Decreased hormonal exposure during administration of and for 28 days after administration of the last dose of fosaprepitant [see Warnings and Precautions (5.5), Use in Specific Populations (8.3), and Clinical Pharmacology (12.3) ]. Intervention Effective alternative or back-up methods of contraception (such as condoms and spermicides) should be used during treatment with NAVITRUX and for 1 month following administration of the last dose of NAVITRUX or oral aprepitant.

Examples birth control pills, transdermal systems, implants CYP2C9 Substrates Warfarin Clinical Impact Decreased warfarin exposure and prolongation of prothrombin time (INR) [see Warnings and Precautions (5.4) , Clinical Pharmacology (12.3) ]. Intervention In patients on chronic warfarin therapy, monitor the prothrombin time (INR) in the 2-week period, particularly at 7 to 10 days, following administration of NAVITRUX with each chemotherapy cycle. Other 5-HT 3 Antagonists Clinical Impact No change in the exposure of the 5-HT 3 antagonist [see Clinical Pharmacology (12.3) ].

Intervention No dosage adjustment needed Examples ondansetron, granisetron, dolasetron

7.2Effect of Other Drugs on the Pharmacokinetics of Fosaprepitant/Aprepitant Aprepitant is a CYP3A4 substrate [see Clinical Pharmacology (12.3) ]. Co-administration of NAVITRUX with drugs that are inhibitors or inducers of CYP3A4 may… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are insufficient data on use of fosaprepitant in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately equivalent to the exposure at the recommended human dose (RHD) of 150 mg (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defects, 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 embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits).

No embryofetal lethality or malformations were observed at any dose level in either species. The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 25 mg/kg/day were approximately equivalent to the exposure at the RHD of 150 mg. Aprepitant crosses the placenta in rats and rabbits.

8.2Lactation There are no data on the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. Aprepitant is present in rat milk. When a drug is present in animal milk, it will likely be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NAVITRUX and any potential adverse effects on the breastfed infant from NAVITRUX or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Upon administration of NAVITRUX, the efficacy of hormonal contraceptives may be reduced. Advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms and spermicides) during treatment with NAVITRUX and for 1 month following the last dose of NAVITRUX or oral aprepitant [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] .

8.4Pediatric Use The safety and effectiveness of a single intravenous dose of NAVITRUX, a 3-day intravenous (IV/IV/IV) regimen of NAVITRUX, anda 3-day regimen of IV NAVITRUX/oral aprepitant/oral aprepitant have been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. Use of NAVITRUX in this age group is supported by evidence from adequate and well controlled studies of intravenous fosaprepitant in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years.

Efficacy and safety were also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. The safety of the 3-day intravenous (IV/IV/IV) regimen in pediatric patients 6 months to 17 years of age was supported by an open-label study in 100 patients receiving HEC or MEC. See the full prescribing information for aprepitant capsules for complete clinical information regarding studies performed with oral aprepitant.

Adverse reactions were similar to those reported in adult patients [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) ]. The safety and effectiveness of NAVITRUX for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. Juvenile Animal Toxicity Data In juvenile dogs treated with fosaprepitant, changes in… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are insufficient data on use of fosaprepitant in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately equivalent to the exposure at the recommended human dose (RHD) of 150 mg (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defects, 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 embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits).

No embryofetal lethality or malformations were observed at any dose level in either species. The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 25 mg/kg/day were approximately equivalent to the exposure at the RHD of 150 mg. Aprepitant crosses the placenta in rats and rabbits.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of a single intravenous dose of NAVITRUX, a 3-day intravenous (IV/IV/IV) regimen of NAVITRUX, anda 3-day regimen of IV NAVITRUX/oral aprepitant/oral aprepitant have been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. Use of NAVITRUX in this age group is supported by evidence from adequate and well controlled studies of intravenous fosaprepitant in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years.

Efficacy and safety were also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. The safety of the 3-day intravenous (IV/IV/IV) regimen in pediatric patients 6 months to 17 years of age was supported by an open-label study in 100 patients receiving HEC or MEC. See the full prescribing information for aprepitant capsules for complete clinical information regarding studies performed with oral aprepitant.

Adverse reactions were similar to those reported in adult patients [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) ]. The safety and effectiveness of NAVITRUX for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. Juvenile Animal Toxicity Data In juvenile dogs treated with fosaprepitant, changes in reproductive organs were observed.

In juvenile rats treated with aprepitant, slight changes in sexual maturation were observed without an effect on reproduction. No effects on neurobehavior, sensory and motor function, or learning and memory were observed in rats. In a toxicity study in juvenile dogs treated with fosaprepitant from postnatal day 14 (equivalent to a newborn human) to day 42 (approximately equivalent to a 2 year old human), decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and edema of vaginal tissues were seen in females from 4 mg/kg/day.

A study was also conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male and female rats lower than the exposure at the recommended pediatric human dose) from the early postnatal period (Postnatal Day 10 (equivalent to a newborn human) through Postnatal Day 58 (approximately equivalent to a 15 year old human)). Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs.

There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Of the 1649 adult cancer patients treated with intravenous fosaprepitant in HEC and MEC clinical studies, 27% were aged 65 and over, while 5% were aged 75 and over. Other reported clinical experience with fosaprepitant has not identified differences in responses between elderly and younger adult patients. No clinically meaningful differences in the pharmacokinetics of oral aprepitant were observed in healthy adult subjects 65 years of age and over compared to younger adult subjects [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 40 words ▾

10 OVERDOSAGE There is no specific information on the treatment of overdosage with fosaprepitant or aprepitant. In the event of overdose, NAVITRUX should be discontinued and general supportive treatment and monitoring should be provided. Aprepitant is not removed by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK-1) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV).

Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors. Animal and human studies have shown that aprepitant augments the antiemetic activity of the 5-HT 3 -receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin-induced emesis.

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, double-blind, positive-controlled, thorough QTc study, a single 200-mg dose of fosaprepitant (approximately 1.3 times the recommended dose) had no effect on the QTc interval.

12.3Pharmacokinetics Aprepitant after Fosaprepitant Administration Following administration of a single intravenous 150-mg dose of fosaprepitant, a prodrug of aprepitant administered as a 20-minute infusion to healthy subjects, the mean AUC 0-∞ of aprepitant was 37.4 (± 14.8) mcg·hr/mL and the mean maximal aprepitant concentration (C max ) was 4.2 (± 1.2) mcg/mL. Plasma concentrations of fosaprepitant are below the limits of quantification (10 ng/mL) within 30 minutes of the completion of infusion. Distribution Aprepitant is greater than 95% bound to plasma proteins.

The mean apparent volume of distribution at steady state (Vdss) was approximately 70 L in humans. Aprepitant crosses the blood brain barrier in humans [see Clinical Pharmacology (12.1) ] . Elimination Metabolism Fosaprepitant is converted to aprepitant in in vitro incubations with human liver preparations and in S9 preparations from multiple other human tissues including kidney, lung and ileum.

Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple extrahepatic tissues in addition to the liver. Aprepitant undergoes extensive metabolism. In vitro studies using human liver microsomes indicate that aprepitant is metabolized primarily by CYP3A4 with minor metabolism by CYP1A2 and CYP2C19.

Metabolism is largely via oxidation at the morpholine ring and its side chains. No metabolism by CYP2D6, CYP2C9, or CYP2E1 was detected. In healthy young adults, aprepitant accounts for approximately 24% of the radioactivity in plasma over 72 hours following a single oral 300-mg dose of [ 14 C]-aprepitant, indicating a substantial presence of metabolites in the plasma.

Seven metabolites of aprepitant, which are only weakly active, have been identified in human plasma. Excretion Following administration of a single intravenous 100-mg dose of [ 14 C]-fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in feces. Aprepitant is eliminated primarily by metabolism; aprepitant is not renally excreted.

The apparent terminal half-life ranged from approximately 9 to 13 hours. Specific Populations Geriatric Patients Following oral administration of a single 125-mg dose of aprepitant on Day 1 and 80 mg once daily on Days 2 through 5, the AUC 0-24hr of aprepitant was 21% higher on Day 1 and 36% higher on Day 5 in elderly (65 years and older) relative to younger adult subjects. The C max was 10% higher on Day 1 and 24% higher on Day 5 in elderly subjects relative to younger adult subjects.

These differences are not considered clinically meaningful [see Use in Specific Populations (8.5) ] . Pediatric Patients Single-Dose Fosaprepitant Regimen: Simulated systemic exposures of aprepitant in patients 2 y… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 138 words ▾

12.1Mechanism of Action Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK-1) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV).

Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors. Animal and human studies have shown that aprepitant augments the antiemetic activity of the 5-HT 3 -receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin-induced emesis.

📦 How Supplied / Storage and Handling 73 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NAVITRUX (fosaprepitant) for injection contains 150 mg of fosaprepitant as a sterile, white to off-white lyophilized powder in a single-dose vial supplied as: NDC 83831-153-01, 1 vial per carton. Storage NAVITRUX vials must be refrigerated, store at 2°C to 8°C (36°F to 46°F). The total storage time of reconstituted NAVITRUX and diluted solutions should not exceed 24 hours at ambient room temperature [see Dosage and Administration (2.3) ]

📋 Description 156 words ▾

11 DESCRIPTION NAVITRUX (fosaprepitant) for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2 R ,3 S )-2-[(1 R )-1-[3,5-bis(trifluoromethyl) phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1 H -1,2,4-triazol-1-yl] phosphonate (2:1) (salt). Its empirical formula is C 23 H 22 F 7 N 4 O 6 P · 2(C 7 H 17 NO 5 ) and its structural formula is: Fosaprepitant dimeglumine is a white to off-white powder with a molecular weight of 1004.83.

It is freely soluble in water and methanol, almost insoluble in isopropanol and acetone. Each vial of NAVITRUX for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: anhydrous lactose (375 mg), edetate disodium (5.4 mg), polysorbate 80 (75 mg) and sodium hydroxide (for pH adjustment). The reconstituted solution is in the pH range 7.0-9.0.

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💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients taking intravenous fosaprepitant. Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, flushing, difficulty in breathing or swallowing, or dizziness, rapid or weak heartbeat or feeling faint [see Warnings and Precautions (5.2) ] .

Infusion Site Reactions Advise patients to seek medical attention if they experience new or worsening signs or symptoms of an infusion site reaction, such as erythema, edema, pain, necrosis, vasculitis, or thrombophlebitis at or near the infusion site [see Warnings and Precautions (5.3) ] . Drug Interactions Advise patients to discuss all medications they are taking, including other prescription, non-prescription medication or herbal products [see Contraindications (4) , Warnings and Precautions (5.1) ]. Warfarin: Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following initiation of NAVITRUX with each chemotherapy cycle [see Warnings and Precautions (5.4) ] .

Hormonal Contraceptives: Advise patients that administration of NAVITRUX may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with NAVITRUX and for 1 month following the last dose of NAVITRUX or oral aprepitant [see Warnings and Precautions (5.5 ), Use in Specific Populations (8.3) ] . Manufactured for: Avyxa Pharma, LLC New Jersey 07054, USA Made in China Image

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Aprepitant after Fosaprepitant Administration Following administration of a single intravenous 150-mg dose of fosaprepitant, a prodrug of aprepitant administered as a 20-minute infusion to healthy subjects, the mean AUC 0-∞ of aprepitant was 37.4 (± 14.8) mcg·hr/mL and the mean maximal aprepitant concentration (C max ) was 4.2 (± 1.2) mcg/mL. Plasma concentrations of fosaprepitant are below the limits of quantification (10 ng/mL) within 30 minutes of the completion of infusion. Distribution Aprepitant is greater than 95% bound to plasma proteins.

The mean apparent volume of distribution at steady state (Vdss) was approximately 70 L in humans. Aprepitant crosses the blood brain barrier in humans [see Clinical Pharmacology (12.1) ] . Elimination Metabolism Fosaprepitant is converted to aprepitant in in vitro incubations with human liver preparations and in S9 preparations from multiple other human tissues including kidney, lung and ileum.

Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple extrahepatic tissues in addition to the liver. Aprepitant undergoes extensive metabolism. In vitro studies using human liver microsomes indicate that aprepitant is metabolized primarily by CYP3A4 with minor metabolism by CYP1A2 and CYP2C19.

Metabolism is largely via oxidation at the morpholine ring and its side chains. No metabolism by CYP2D6, CYP2C9, or CYP2E1 was detected. In healthy young adults, aprepitant accounts for approximately 24% of the radioactivity in plasma over 72 hours following a single oral 300-mg dose of [ 14 C]-aprepitant, indicating a substantial presence of metabolites in the plasma.

Seven metabolites of aprepitant, which are only weakly active, have been identified in human plasma. Excretion Following administration of a single intravenous 100-mg dose of [ 14 C]-fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in feces. Aprepitant is eliminated primarily by metabolism; aprepitant is not renally excreted.

The apparent terminal half-life ranged from approximately 9 to 13 hours. Specific Populations Geriatric Patients Following oral administration of a single 125-mg dose of aprepitant on Day 1 and 80 mg once daily on Days 2 through 5, the AUC 0-24hr of aprepitant was 21% higher on Day 1 and 36% higher on Day 5 in elderly (65 years and older) relative to younger adult subjects. The C max was 10% higher on Day 1 and 24% higher on Day 5 in elderly subjects relative to younger adult subjects.

These differences are not considered clinically meaningful [see Use in Specific Populations (8.5) ] . Pediatric Patients Single-Dose Fosaprepitant Regimen: Simulated systemic exposures of aprepitant in patients 2 years to less than 12 years and observed systemic exposures in patients 6 months to less than 2 years and 12 to 17 years are shown in Table 9, including AUC 0- 24hr , peak plasma concentration (Cmax) on Day 1 and concentrations at the end of Day 1 (C 24 ), Day 2 (C 48 ) and Day 3 (C 72 ). Table 9: Systemic Exposures of Aprepitant for Single-Dose Fosaprepitant Regimen in Pediatric Patients a NE = Not Estimated.

The geometric mean could not be estimated due to values being below the limitation of quantification. b ND = Not Determined. Pharmacokinetic samples were not collected to support the parameter value of interest. Population Single-Dose of Fosaprepitant Regimen Geometric Mean AUC 0-24hr.

(mcg*hr/mL) C max (mcg/mL) C 24 (mcg/mL) C 48 (mcg/mL) C 72 (mcg/mL) 12 Years to 17 Years 150 mg 29.4 3.4

0.7ND b ND b 6 Years to less than 12 Years 4 mg/kg 35.2 3.6 0.7 0.2 0.05 2 Years to less than 6 Years 28.2 3.1 0.4 0.1 0.02 6 Months to less than 2 Years 5 mg/kg 32.7 3.3

0.4NE a ND b 3-Day Regimen of Intravenous Fosaprepitant/Oral Aprepitant/Oral Aprepitant: Simulated aprepitant systemic exposures in patients 6 months to less than 12 years and observed systemic exposures in patients 12 to 17 years are shown in Table 10, including AUC 0-… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 31 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, double-blind, positive-controlled, thorough QTc study, a single 200-mg dose of fosaprepitant (approximately 1.3 times the recommended dose) had no effect on the QTc interval.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of NAVITRUX have been established based on adequate and well-controlled adult studies of another intravenous formulation of fosaprepitant for the prevention and of chemotherapy induced nausea and vomiting. Below is a description of the results of these adequate and well-controlled studies of fosaprepitant.

14.1Prevention of Nausea and Vomiting Associated with HEC in Adults In a randomized, parallel, double-blind, active-controlled study, fosaprepitant 150 mg as a single intravenous infusion (N=1147) was compared to a 3-day oral aprepitant regimen (N=1175) in patients receiving a HEC regimen that included cisplatin (≥70 mg/m 2 ). All patients in both groups received dexamethasone and ondansetron (see Table 12 ). Patient demographics were similar between the two treatment groups.

Of the total 2322 patients, 63% were men, 56% White, 26% Asian, 3% American Indian/Alaska Native, 2% Black, 13% Multi-Racial, and 33% Hispanic/Latino ethnicity. Patient ages ranged from 19 to 86 years of age, with a mean age of 56 years. Other concomitant chemotherapy agents commonly administered were fluorouracil (17%), gemcitabine (16%), paclitaxel (15%), and etoposide (12%).

Table 12: Treatment Regimens in Adult HEC Trial a a Fosaprepitant placebo, aprepitant capsules placebo and dexamethasone placebo (in the evenings on Days 3 and 4) were used to maintain blinding. b Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Dexamethasone was also administered in the evenings on Days 3 and 4. The 12 mg dose of dexamethasone on Day 1 and the 8 mg once daily dose on Day 2 reflects a dosage adjustment to account for a drug interaction with the regimen [see Clinical Pharmacology (12.3) ]. c Ondansetron 32 mg intravenous was used in the clinical trials of fosaprepitant.

Although this dose was used in clinical trials, this is no longer the currently recommended dose. Refer to the ondansetron prescribing information for the current recommended dose. d Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The 12 mg dose of dexamethasone on Day 1 and the 8 mg once daily dose on Days 2 through 4 reflects a dosage adjustment to account for a drug interaction with the oral regimen [see Clinical Pharmacology (12.3) ].

Day 1 Day 2 Day 3 Day 4 Fosaprepitant Regimen Intravenous fosaprepitant 150 mg intravenously over 20 to 30 minutes approximately 30 minutes prior to chemotherapy none none none Oral dexamethasone b 12 mg 8 mg 8 mg twice daily 8 mg twice daily Ondansetron Ondansetron c none none none Oral Aprepitant Regimen Aprepitant capsules 125 mg 80 mg 80 mg none Oral dexamethasone d 12 mg 8 mg 8 mg 8 mg Ondansetron Ondansetron c none none none The efficacy of fosaprepitant was evaluated based on the primary and secondary endpoints listed in Table 13 and was shown to be non-inferior to that of the 3-day oral aprepitant regimen with regard to complete response in each of the evaluated phases.

The pre-specified non-inferiority margin for complete response in the overall phase was 7%. The pre-specified non-inferiority margin for complete response in the delayed phase was 7.3%. The pre-specified non-inferiority margin for no vomiting in the overall phase was 8.2%.

Table 13: Percent of Adult Patients Receiving HEC Responding by Treatment Group and Phase - Cycle 1 a N: Number of patients included in the primary analysis of complete response. b Difference and Confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for Gender. c Complete Response = no vomiting and no use of rescue therapy. d Overall = 0 to 120 hours post-initiation of cisplatin chemotherapy. e Delayed phase = 25 to 120 hours post-initiation of cisplatin chemotherapy.

ENDPOINTS Fosaprepitant Regimen (N = 1106) a % Oral Aprepitant Regimen (N = 1134) a % Difference b (95% CI) PRIMAR… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced systemic exposures to aprepitant approximately equivalent to (female rats) or less than (male rats) the human exposure at the RHD of 150 mg.

Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day.

The highest dose produced a systemic exposure approximately 2 times the adult human exposure at the RHD of 150 mg. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice. Carcinogenicity studies were not conducted with fosaprepitant.

Mutagenesis Aprepitant and fosaprepitant were not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test. Impairment of Fertility Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant.

Oral aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended adult human dose of 150 mg and exposure in female rats approximately equivalent to the human exposure).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced systemic exposures to aprepitant approximately equivalent to (female rats) or less than (male rats) the human exposure at the RHD of 150 mg.

Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day.

The highest dose produced a systemic exposure approximately 2 times the adult human exposure at the RHD of 150 mg. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice. Carcinogenicity studies were not conducted with fosaprepitant.

Mutagenesis Aprepitant and fosaprepitant were not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test. Impairment of Fertility Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant.

Oral aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended adult human dose of 150 mg and exposure in female rats approximately equivalent to the human exposure).

📄 Patient Package Insert ~3 min read ▾

SPL PATIENT PACKAGE INSERT This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: June 2026 Patient Information NAVITRUX TM ( NAH-vih-trux ) (fosaprepitant) for injection, for intravenous use What is NAVITRUX?

NAVITRUX is a prescription medicine used with other medicines that treat nausea and vomiting in people 6 months of age and older to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines. ● NAVITRUX is not used to treat nausea and vomiting that you already have. ● It is not known if NAVITRUX is safe and effective in children less than 6 months of age. Do not receive NAVITRUX if you: ● are allergic to fosaprepitant, aprepitant, or any of the ingredients in NAVITRUX. See the end of this Patient Information leaflet for a complete list of the ingredients in NAVITRUX. ● are taking pimozide (ORAP).

Before receiving NAVITRUX, tell your healthcare provider if you: ● have liver problems. ● are pregnant or plan to become pregnant. It is not known if NAVITRUX can harm your unborn baby. o Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, and implants) should also use a backup method of birth control that does not contain hormones, such as condoms and spermicides, during treatment with NAVITRUX and for 1 month after receiving NAVITRUX or aprepitant taken by mouth (oral). ● are breastfeeding or plan to breastfeed.

It is not known if NAVITRUX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive NAVITRUX. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NAVITRUX may affect the way other medicines work, and other medicines may affect the way NAVITRUX works, causing serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How will I receive NAVITRUX? Adults 18 years of age and older: NAVITRUX will be given on Day 1 of chemotherapy treatment. It will be given to you by intravenous (IV) infusion in your vein about 50 to 60 minutes before you start your chemotherapy treatment.

Children 6 months to 17 years of age: NAVITRUX will be given to your child by intravenous (IV) infusion into a large vein through a type of IV line called a central venous catheter, about 1 hour to 1 ½ hours before the start of their chemotherapy treatment. Depending on the chemotherapy treatment, there are 2 ways that NAVITRUX may be given: 1. NAVITRUX is given on Day 1 only (single day of chemotherapy).

2. NAVITRUX is given on Days 1, 2, and 3 (single or multiple days of chemotherapy). ● Your child may receive capsules of aprepitant or an oral suspension of aprepitant instead of NAVITRUX on Days 2 and 3. If your child will receive either of these, see the Patient Information for aprepitant capsules or aprepitant for oral suspension for further information.

If you take the blood thinner medicine warfarin sodium (COUMADIN, JANTOVEN), your healthcare provider may do blood tests after you receive NAVITRUX to check your blood clotting. What are the possible side effects of NAVITRUX? NAVITRUX may cause serious side effects, including: ● Serious allergic reactions.

Allergic reactions can happen with fosaprepitant given by intravenous (IV) infusion and may be serious. Tell your healthcare provider right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness, a rapid or weak heartbeat, or you feel faint during or soon after you receive NAVITRUX, as you may need emergency medical care. Severe skin reactions, which may include rash, skin peeling, or sores, may occur. ● Infusion site reactions (ISR) at or near the infusion site have happened with fosaprepitant given by intravenous (IV) infusion .

Most severe ISR have happened with… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 40 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NAVITRUX (fosaprepitant) for Injection, 150 mg/vial - Carton Label NAVITRUX (fosaprepitant) for Injection, 150 mg/vial - Container Label NAVITRUX (fosaprepitant) for Injection, 150 mg/vial - Carton Label NAVITRUX (fosaprepitant) for Injection, 150 mg/vial - Container Label

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for NAVITRUX (this brand).

Top reported reactions

Dyspnoea321
Infusion Related Reaction277
Alopecia250
Fatigue238
Hypersensitivity232
Arthralgia224
Pyrexia223

Age at onset

Neonate1
Infant3
Child5
Adolescent15
Adult256
Elderly140

Reporter sex

1,698 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization884
Death370
Life-threatening340
Disabling304
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 200 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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) ✓ 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 AVYXA Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AVYXA Pharma, LLC 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.
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.
← 83831-0149-50 · Avyxa 83831-0159-02 · Avyxa →
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.