NAVITRUX

NAVITRUX is an FDA-registered drug product whose active ingredient is FOSAPREPITANT. It is labelled by AVYXA Pharma, LLC taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 83831-153, application NDA220436, label effective 20260729. It is one of 8 FDA drug label records sharing the active ingredient FOSAPREPITANT. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FOSAPREPITANT are most often described in connection with: delayed nausea, vomiting associated, repeat courses, emetogenic cancer, antiemetic agents, indicated adults, pediatric patients, months age. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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 ) 2.1 Prevention 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 2.2 Prevention 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 minutes prior to chemotherapy. Table 3: NAVITRUX Single-Dose Regimen for the Prevention of Nausea and Vomiting Associated with Single-Day Regimens of HEC or MEC in Pediatric Patients 6 Months a to 17 Years a Dosing in pediatric patients less than 6 kg is not recommended bAdminister dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 Drug Age Regimen NAVITRUX 12 Years to 17 Years 150 mg intravenously over 30 minutes 2 Years to less than 12 Years 4 mg/kg (maximum dose 150 mg) intravenously over 60 minutes 6 Months to less than 2 Years 5 mg/kg (maximum dose 150 mg) intravenously over 60 minutes Dexamethasone b 6 Months to 17 Years If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 and 2. 5-HT 3 antagonist 6 Months to 17 Years See selected 5-HT 3 antagonist prescribing information for the recommended dosage NAVITRUX Dosage Regimen for Use with Multi-Day Chemotherapy Regimens For pediatric patients weighing at least 6 kg receiving multi-day regimens of HEC or MEC, administer NAVITRUX on Days 1, 2, and 3. Administer NAVITRUX as an intravenous infusion through a central venous catheter on Days 1, 2, and 3 as shown in Table 4. Administer NAVITRUX over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years), completing the infusion approximately 30 minutes prior to chemotherapy. Table 4: 3-Day NAVITRUX/Aprepitant Dosage Regimen a for Prevention of Nausea and Vomiting Associated with Single- or Multi-day Regimens of HEC or MEC in Pediatric Patients 6 Months b to 17 Years a 3-day regimen consisting of NAVITRUX on Days 1, 2, and 3. Or a 3-day regimen of NAVITRUX on Day 1 and aprepitant capsules or aprepitant oral suspension on Days 2 and 3. b Dosing in pediatric patients less than 6 kg is not recommended. c For patients 12 years to 17 years who cannot swallow oral capsules, aprepitant for oral suspension can be used instead d For patients less than 12 years of age who weigh at least 40 kg and who are able to swallow oral capsules, aprepitant capsules can be used instead on Days 2 and 3 e Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. Age of Pediatric Population Day 1 Day 2 Day 3 NAVITRUX 12 years to 17 years 115 mg intravenously over 30 minutes 80 mg intravenously over 30 minutes OR 80 mg orally (aprepitant capsules) c 80 mg intravenously over 30 minutes OR 80 mg orally (aprepitant capsules) c 6 months b to less than 12 years 3 mg/kg intravenously over 60 minutes (maximum dose 115 mg) 2 mg/kg intravenously over 60 minutes OR 2 mg/kg orally (aprepitant for oral suspension) d (maximum dose 80 mg) 2 mg/kg intravenously over 60 minutes OR 2 mg/kg orally (aprepitant for oral suspension) d (maximum dose 80 mg) Dexamethasone e 6 months to 17 years If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4. 5-HT 3 antagonist 6 months to 17 years See selected 5-HT 3 antagonist prescribing information for the recommended dosage. 2.3 Preparation and Administration of NAVITRUX Table 5: Preparation Instructions for NAVITRUX (150 mg) Step 1 Reconstitute NAVITRUX to achieve a concentration of 30 mg/mL as follows: Aseptically inject 5 mL 0.9% Sodium Chloride Injection into the vial. Assure that 0.9% Sodium Chloride Injection is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting 0.9% Sodium Chloride Injection into the vial. Prior to further dilution, visually inspect the reconstituted solution in the vial for particulate matter and discoloration. The solution should be clear and colorless. Discard if particulate matter is present or the solution is discolored. Step 2 Aseptically prepare an infusion bag filled with 145 mL of 0.9% Sodium Chloride Injection. Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of 0.9% Sodium Chloride Injection to yield a total volume of 150 mL and a final concentration of 1 mg/mL. Step 4 Gently invert the bag 2 to 3 times. Step 5 Determine the volume to be administered from this prepared infusion bag, based on the recommended dose [see Dosage and Administration (2.1 , 2.2) ] . Adults The entire volume of the prepared infusion bag (150 mL) should be administered. Pediatrics In patients 12 years and older, the volume to be administered is calculated as follows: Volume to administer (mL) equals the recommended dose (mg) In patients 6 months to less than 12 years, the volume to be administered is calculated as follows: ● Volume to administer (mL) = recommended dose (mg/kg) × weight (kg) o Note: Do not exceed the maximum dose [see Dosage and Administration (2.2) ] ● In pediatric patients, the entire volume in the infusion bag may not be required. Step 6 If necessary, for volumes less than 150 mL, the calculated volume can be transferred to an appropriate size bag or syringe prior to administration by infusion. Step 7 Before administration, inspect the bag for particulate matter and discoloration. Discard the bag if particulate and/or discoloration are observed. Caution: Do not mix or reconstitute NAVITRUX with solutions for which physical and chemical compatibility have not been established. NAVITRUX is incompatible with any solutions containing divalent cations (e.g., Ca 2+ , Mg 2+ ), including Lactated Ringer's Solution and Hartmann's Solution. Storage Store reconstituted product (30 mg/mL) at ambient room temperature [at or below 25°C (77°F)] for no longer than 24 hours from the time of reconstitution. Discard the vial after 24 hours. The total storage time of the reconstituted NAVITRUX and the final diluted solution should not exceed 24 hours at ambient room temperature [at or below 25°C (77°F)]. Discard the unused reconstituted or diluted solution after 24 hours from the start of reconstitution.

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 )

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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in 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 of a single dose of intravenous fosaprepitant in pediatric patients (6 months to 17 years) was evaluated in two active-controlled and a single-arm clinical study in patients who received either HEC or MEC. Patients also received ondansetron with or without dexamethasone. The adverse reaction profile was similar to adults. The safety analysis included 69 pediatric patients who received the recommended dose. An additional 70 patients received a single, higher-than-recommended dose. The most common adverse reactions that occurred in >15% of patients who received the recommended dose were anemia, neutropenia, thrombocytopenia, and febrile neutropenia. 3-Day Intravenous Fosaprepitant/Oral Aprepitant/Oral Aprepitant Regimen In pediatric patients 12 to 17 years, the safety of the 3-day intravenous fosaprepitant/oral aprepitant/oral aprepitant regimen was evaluated in a single-arm clinical study including 12 patients who received a regimen of either HEC or MEC. In pediatric patients 6 months to 12 years of age, the safety of the 3-day regimen was not directly evaluated. The safety of a single dose of intravenous fosaprepitant (3 mg/kg) administered on day 1 of the 3-day regimen was evaluated in one active-controlled and one single-arm study including 48 pediatric patients 6 months to 12 years of age who received a regimen of either HEC or MEC. The safety of the 3-day intravenous (IV/IV/IV) regimen of fosaprepitant in pediatric patients (6 months to 17 years) was evaluated in a single-arm clinical study in 100 patients who received either HEC or MEC. In these clinical studies, pediatric patients also received ondansetron with or without dexamethasone. The adverse reaction profile in pediatric patients was similar to the profile in adult patients receiving a single dose of fosaprepitant. Because fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant might also be expected to occur with fosaprepitant. See the full prescribing information for aprepitant capsules for complete safety information regarding studies performed with oral aprepitant. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of fosaprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders : pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis [see Warnings and Precautions (5.2) ] . Immune system disorders : hypersensitivity reactions including anaphylaxis and anaphylactic shock [see Contraindications (4) , Warnings and Precautions (5.2) ] . Nervous system disorders : ifosfamide-induced neurotoxicity reported after fosaprepitant and ifosfamide coadministration.

FDA lists 8 drug label records with FOSAPREPITANT as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is NAVITRUX used for?
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 …

Who makes NAVITRUX?
AVYXA Pharma, LLC is the labeler of record for NAVITRUX. 8 FDA label records share the active ingredient FOSAPREPITANT, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does NAVITRUX come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is NAVITRUX prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FOSAPREPITANT?
Yes. 8 FDA drug label records list FOSAPREPITANT as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has NAVITRUX been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.