FIRVANQ
vancomycin hydrochloride · KIT · Azurity Pharmaceuticals, Inc
Firvanq is a vancomycin hydrochloride kit used to treat certain bacterial infections, particularly those caused by Clostridioides difficile in the colon. It belongs to a class of antibiotics called glycopeptides and works by stopping the growth of bacteria.
Key Facts
- Brand Name
- FIRVANQ
- Generic Name
- vancomycin hydrochloride
- NDC Code (Product)
65628-204- Manufacturer
- Azurity Pharmaceuticals, Inc
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA208910
- Marketing Start
- 01/26/2018
Recall History
Azurity Pharmaceuticals, Inc.
Product Mix-up: Incorrect diluent component included in the kit.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE FIRVANQ is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. FIRVANQ is a glycopeptide anti…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION C. difficile‑ associated diarrhea: Adult Patients (18 years of age and older): 125 mg orally 4 times daily for 10 days. ( 2.2 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.3 ) Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.2 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.3 ) See Full Prescribing Information for preparation and important administration information. ( 2.1 ) 2.1 Important Administration Instructions Prior to oral administration, the supplied FIRVANQ powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [ see Dosage and Administration ( 2.4 ) ]. 2.2 Adults C. difficile ‑associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. …
Contraindications
4 CONTRAINDICATIONS FIRVANQ is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1‑855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to vancomycin hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of C. difficile ‑associated diarrhea. In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%), and 52% were male. Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride‑treated subjects are shown in Table 2 . The most common adverse reactions associated with vancomycin hyd…
Frequently Asked Questions
What is FIRVANQ used for?
Firvanq is a vancomycin hydrochloride kit used to treat certain bacterial infections, particularly those caused by Clostridioides difficile in the colon. It belongs to a class of antibiotics called glycopeptides and works by stopping the growth of bacteria.
Is FIRVANQ a controlled substance?
FIRVANQ is not classified as a controlled substance by the DEA.
What is the generic name for FIRVANQ?
The generic name for FIRVANQ is vancomycin hydrochloride. There are 12 other brand versions of vancomycin hydrochloride.
What is the NDC code for FIRVANQ ?
The NDC (National Drug Code) for FIRVANQ is 65628-204, listed by Azurity Pharmaceuticals, Inc.
Other Vancomycin Brands
See all →- Vancomycin Hydrochloride1 g/172572-029
- Vancomycin Hydrochloride1.5 g/30mL82449-007
- Vancomycin Hydrochloride1.5 g/139822-0470
- Vancomycin Hydrochloride5 g/10143-9358
- VANCOMYCIN HYDROCHLORIDE1.25 g/250mL0338-0122
- VANCOMYCIN HYDROCHLORIDE750 mg/150mL0338-3580
- Vancomycin Hydrochloride100 g/166288-7100
- Vancomycin Hydrochloride10 g/100mL67457-342
- Vancomycin Hydrochloride10 g/168001-407
- Vancomycin Hydrochloride1.5 g/168083-597
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)