Azelaic Acid Gel

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in color of skin.
• Shortness of breath.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• If using the pump product, throw away any part not used 8 weeks after opening.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about azelaic acid gel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about azelaic acid gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using azelaic acid gel.

Review Date: October 4, 2017

None.

Hypersensitivity

Cases of adverse skin reactions due to hypersensitivity have been reported during post marketing surveillance. In case of known hypersensitivity to any component of the gel, avoid the use of Azelaic Acid Gel. If hypersensitivity develops during treatment, discontinue Azelaic Acid Gel and institute appropriate therapy.

Skin Reactions

Skin irritation (i.e. pruritus, burning or stinging) may occur during use of Azelaic Acid Gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.

Eye and Mucous Membranes Irritation

Avoid contact with the eyes, mouth and other mucous membranes. If Azelaic Acid Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists [see Adverse Reactions (6.2)].

Mechanism of Action

The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.

Pharmacodynamics

The pharmacodynamics of azelaic acid in association with the treatment of rosacea are unknown.

Pharmacokinetics

The percutaneous absorption of azelaic acid after topical application of Azelaic Acid Gel could not be reliably determined. Mean plasma azelaic acid concentrations in rosacea subjects treated with Azelaic Acid Gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24.0 to 90.5 ng/mL observed in rosacea subjects treated with vehicle only. This indicates that Azelaic Acid Gel does not increase plasma azelaic acid concentration beyond the range derived from nutrition and endogenous metabolism.

In vitro and human data suggest negligible cutaneous metabolism of 3H-azelaic acid after topical application of 20% azelaic acid cream. Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.

Inform patients using Azelaic Acid Gel of the following information and instructions:

• For external use only. • Before applying Azelaic Acid Gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel. • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • Avoid contact with the eyes, mouth and other mucous membranes. If Azelaic Acid Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult your physician if eye irritation persists. • Wash hands immediately following application of Azelaic Acid Gel. • Cosmetics may be applied after the application of Azelaic Acid Gel has dried. • Avoid the use of occlusive dressings or wrappings. • Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of Azelaic Acid Gel, usually during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician. • Report abnormal changes in skin color to your physician. • To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages. • Azelaic Acid Gel comes in a tube and a pump: o Tube instructions: Remove the cap before use. Squeeze the tube to dispense a small amount of Azelaic Acid Gel. o Pump instructions: o Remove the cap before use. Depress the pump to dispense a small amount of Azelaic Acid Gel. At first use, the pump may have to be depressed repeatedly until product is dispensed. o Discard the pump 8 weeks after opening.

© 2015, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981

Manufactured in Italy

Distributed by

Alvogen, Inc.

Pine Brook, NJ 07058