IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS:

FIRVANQ^® (vancomycin hydrochloride for oral solution)

FIRVANQ is a prescription medicine that contains vancomycin hydrochloride, a type of glycopeptide antibacterial.

FIRVANQ is used to treat 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).

Important Limitations of Use:

Orally administered vancomycin hydrochloride is not effective for the 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 bacteria.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Do not receive FIRVANQ if you are:

• Allergic to FIRVANQ, or any of the ingredients in FIRVANQ

What are the possible side effects of FIRVANQ?
FIRVANQ can cause serious side effects, including:

• Oral Use Only. FIRVANQ must be given orally for the approved treatment indications. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
• Increased or varying levels of vancomycin. This occurred in some patients with a condition where their kidney isn’t working properly (renal insufficiency) and/or swelling and sores in the digestive tract (colitis) who have taken multiple oral doses of vancomycin hydrochloride for C. difficile-associated diarrhea. Contact your doctor right away if you experience any stomach pain, nausea, cramps, slow or random heartbeat.
• A type of kidney problem (Nephrotoxicity). Kidney problems have occurred following oral vancomycin hydrochloride therapy and can occur either during or after completion of therapy. The risk is increased in patients over 65 years of age, including those with normal renal function prior to treatment. Contact your doctor right away if you experience urinary changes, swelling in the feet, ankles, legs or face, fatigue, nausea, vomiting, or confusion.
• A type of ear problem (Ototoxicity). Ear damage has occurred in patients receiving vancomycin. It may last briefly or be permanent. Contact your doctor right away if you experience any hearing loss, ringing, buzzing, or balance problems.
• Severe skin reactions. FIRVANQ may cause rash or itching during treatment. Call your doctor right away if you experience severe or worsening rash or itching.
• Overgrowth in other bacteria. Use of FIRVANQ may result in the overgrowth of bacteria that is not sensitive to vancomycin. Contact your doctor right away if you experience fever or your symptoms worsen.
• A type of eye problem (hemorrhagic occlusive retinal vasculitis). Permanent loss of vision and other eye problems have occurred in patients receiving vancomycin during or after eye surgery.

Before taking FIRVANQ, tell your doctor about all your medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using FIRVANQ with certain other medicines can affect each other.

Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine.

The most common side effects of FIRVANQ include:

• nausea
• stomach pain
• low potassium

These are not all the possible side effects of FIRVANQ. Please see Full Prescribing Information for a full list.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

FIRVANQ^® is a registered trademark of Azurity Pharmaceuticals, Inc.

©2025 Azurity Pharmaceuticals, Inc.

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