Fabior

What is Fabior?

Fabior is a prescription medicine that is used to treat pimples (acne). Fabior may be given to you for other reasons.

Description

FABIOR (tazarotene) Foam, 0.1% contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical use only.

Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The structural formula is represented below:

Molecular Formula: C21H21NO2S Molecular Weight: 351.46

Tazarotene is a pale yellow to yellow substance. FABIOR Foam contains tazarotene, 1 mg/g, in aqueous-based white to off-white foam vehicle consisting of butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. FABIOR Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.

 Mechanism of Action

Tazarotene is a retinoid prodrug that is converted to its active form, the cognate carboxylic acid of tazarotene, by rapid deesterification in animals and man. Tazarotenic acid binds to all 3 members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ but shows relative selectivity for RARβ and RARγ and may modify gene expression. The clinical significance of these findings is unknown.

The mechanism of tazarotene action in acne vulgaris is not defined. However, the basis of tazarotene’s therapeutic effect in acne may be due to its anti-hyperproliferative, normalizing-of-differentiation and anti-inflammatory effects. Tazarotene inhibited corneocyte accumulation in rhino mouse skin and cross- linked envelope formation in cultured human keratinocytes. The clinical significance of these findings is unknown.

Before taking Fabior, tell your doctor:

• If you are allergic to Fabior; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are pregnant or may be pregnant. Do not use Fabior if you are pregnant.
• If you are able to get pregnant and are not using birth control.
• If you are sunburned.
• If you are taking any drugs that may make your skin more sensitive to light. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are using any drugs that may cause dry skin. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Fabior with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fabior?

• Tell all of your health care providers that you take Fabior. This includes your doctors, nurses, pharmacists, and dentists.
• Follow how to take Fabior as you have been told by your doctor. Do not use more than you were told to use.
• Some weather conditions may irritate the skin. Talk with the doctor.
• Skin may look worse before it looks better.
• Talk with your doctor before you use other drugs or products on your skin.
• Use of other skin products while using Fabior may cause more irritation.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may cause harm if swallowed. If Fabior is swallowed, call a doctor or poison control center right away.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Fabior. Talk with your doctor.
• This medicine may cause harm to an unborn baby. Women must use birth control while taking Fabior. If you get pregnant, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• If you are breast-feeding, do not put Fabior right on the nipple or the area right around it.

How is Fabior best taken?

Use Fabior as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Fabior by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put in the vagina.
• If you get Fabior in any of these areas, rinse well with water.
• If you are able to get pregnant, start using Fabior during your normal menstrual period.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on cuts, scrapes, eczema, or damaged skin.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Some products are to be used at bedtime. For some products it does not matter. Check with the pharmacist about how to use Fabior.
• Practice good skin care and avoid the sun.
• Avoid putting on healthy skin.
• Shake well before use.
• Hold upright to use. Do not turn upside down.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Fabior that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Swelling.

What are some other side effects of Fabior?

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 any of these side effects or any other side effects bother you or do not go away:

• It is common to have skin irritation with Fabior. These reactions may include burning, dry skin, itching, peeling, redness, and scaling. Call your doctor if you have skin irritation that is severe, bothers you, or does 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Fabior?

• Store at room temperature. Do not freeze.
• Store upright with the cap on.
• Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 50 GRAM CAN CARTON