CONTACT Azurity Pharmaceuticals

IMPORTANT SAFETY INFORMATION
AND INDICATIONS

INDICATIONS:

FIRVANQ^® is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of:

• Clostridium difficile-associated diarrhea.
• Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

ADDITIONAL IMPORTANT SAFETY INFORMATION:

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.

Contraindications:

FIRVANQ^® is contraindicated in patients with known hypersensitivity to vancomycin.

Warnings and Precautions:

FIRVANQ^® must be given orally for treatment of C. difficile-associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.

Significant systemic absorption has been reported in some patients (e.g., patients with renal insufficiency and/or colitis) who have taken multiple oral doses of vancomycin hydrochloride for C. difficile-associated diarrhea. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. Monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibacterial drug.

Nephrotoxicity has occurred following oral vancomycin hydrochloride therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with FIRVANQ^® to detect potential vancomycin-induced nephrotoxicity.

Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given high intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.

Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear lgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue FIRVANQ at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.

Use of FIRVANQ^® may result in the overgrowth of non-susceptible bacteria. If superinfection occurs during therapy, appropriate measures should be taken.

Prescribing FIRVANQ^® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or intravitreal route have not been established by adequate and well-controlled studies. Vancomycin is not indicated for prophylaxis of endophthalmitis.

Adverse Reactions:

See Full Prescribing Information for additional Adverse Reactions (6).
The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%).

Use in Specific Populations:

See Full Prescribing Information for Additional Information (8).

Geriatric Use
There is an increased risk of nephrotoxicity.
Patients over 65 years of age may take longer to respond to therapy.

This Important Safety Information does not include all the information needed to use FIRVANQ^® safely and effectively. Visit FIRVANQ.com for Full Prescribing Information.

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.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS:

FIRVANQ^® is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of:

• Clostridium difficile-associated diarrhea.
• Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).