Fabior Foam

0.1%, white to off-white foam

Fabior Foam is contraindicated in pregnancy.

Fabior Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1)].

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis:

A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risk. Based on pharmacokinetic data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in rats approximately 2 times the AUC in acne patients treated with 2 mg/cm2 of Fabior Foam 0.1% over a 15% body surface area.

A long-term topical application study of up to 0.1% tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared with vehicle control animals. AUC at the highest dose in mice was 49 times the AUC in acne patients treated with 2 mg/cm2 of Fabior Foam 0.1% over a 15% body surface area.

In evaluation of photocarcinogenicity, median time to onset of tumors was decreased and the number of tumors increased in hairless mice following chronic topical dosing with exposure to ultraviolet radiation at tazarotene concentrations of 0.001%, 0.005%, and 0.01% in a gel formulation for up to 40 weeks.

Mutagenesis:

Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.

Impairment of Fertility:

No impairment of fertility was observed in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure at the 0.125 mg/kg/day dose in rats would be equivalent to 7.6 times the AUC in acne patients treated with 2 mg/cm2 of Fabior Foam 0.1% over a 15% body surface area.

No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene. AUC at the highest dose in rats was 23 times the AUC in acne patients treated with 2 mg/cm2 of Fabior Foam 0.1% over a 15% body surface area.

No effect on parameters of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral doses of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose [see Pregnancy (8.1)]. AUC at the highest dose in rats was 42 times the AUC in acne patients treated with 2 mg/cm2 of Fabior Foam 0.1% over a 15% body surface area.

Reproductive capabilities of F1 animals, including F2 survival and development, were not affected by topical administration of tazarotene gel to female F0 parental rats from gestation day 16 through lactation day 20 at the maximum tolerated dose of 0.125 mg/kg/day. Based on data from another study, the AUC in rats would be equivalent to 7.6 times the AUC in acne patients treated with 2 mg/cm2 of Fabior Foam 0.1% over a 15% body surface area.

In 2 multi-center, randomized, double-blind, vehicle-controlled trials, a total of 1,485 subjects with moderate-to-severe acne vulgaris were randomized 1:1 to Fabior Foam or vehicle applied once daily for 12 weeks. Acne severity was evaluated using lesion counts and the 6-point Investigator's Global Assessment (IGA) scale (see Table 2). At baseline, 80% of subjects were graded as "moderate" or Grade 3 and 20% were graded as "severe" or Grade 4 on the IGA scale. At baseline, subjects had an average of 79.8 total lesions of which the mean number of inflammatory lesions was 31.9 and the mean number of non-inflammatory lesions was 47.8. Subjects ranged in age from 12 to 45 years, with 860 (58%) subjects aged 12 to 17 years; 428 (29%) subjects aged 18 to 25 years; 143 (10%) subjects aged 26 to 35 years and 54 (4%) subjects aged 36 to 45 years. Subjects enrolled in the trials by race were white (77%), black (15%), Asian (4%), and other (4%). Hispanics comprised 18% of the population. An equal number of males (49%) and females (51%) were enrolled. Treatment success was defined as a score of "clear" (Grade 0) or "almost clear" (Grade 1) and at least 2-grade improvement from the baseline score to Week 12.

Absolute and percent reductions in lesion counts and the IGA scale after 12 weeks of treatment in these 2 trials are shown in Table 3. Each trial needed to have a statistically significant reduction in 2 out of 3 lesion counts at Week 12.

IMPORTANT: For skin use only. Do not get Fabior Foam in your eyes, mouth, or vagina.

Read the Patient Information that comes with Fabior Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is Fabior Foam?

Fabior Foam is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.

It is not known if Fabior Foam is safe and effective in children under 12 years of age.

Who should not use Fabior Foam?

Do not use Fabior Foam if you are pregnant or plan to become pregnant. Fabior Foam may harm your unborn baby, if used during pregnancy.

If you are a female who can become pregnant:

• Use an effective method of birth control during treatment with Fabior Foam. Talk with your doctor about birth control methods that are right for you during treatment with Fabior Foam.
• Your doctor should do a blood or urine pregnancy test within 2 weeks before you begin to use Fabior Foam to be sure you are not pregnant.
• If you have menstrual periods, begin using Fabior Foam during a normal menstrual period to help assure that you are not pregnant when you begin use.

Stop using Fabior Foam and call your doctor right away if you become pregnant during treatment with Fabior Foam.

What should I tell my doctor before using Fabior Foam?

Before you use Fabior Foam, tell your doctor if you:

• or a family member have or had skin cancer.
• have eczema.
• have had a reaction to topical products in the past.
• have any condition that makes you sensitive to light.
• have any other medical conditions.
• are pregnant or plan to become pregnant. See "Who should not use Fabior Foam?"
• are breastfeeding or plan to breastfeed. It is not known if tazarotene passes into your breast milk. You and your doctor should decide if you will use Fabior Foam or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you use Fabior Foam.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you:

• use other medicines or products that make your skin dry
• take other medicines that may increase your sensitivity to sunlight

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I use Fabior Foam?

• Use Fabior Foam exactly as your doctor tells you to. Do not use more Fabior Foam than prescribed and do not use it more often than your doctor tells you to.
• If you are a female and have menstrual periods, begin using Fabior Foam during a normal menstrual period to help assure that you are not pregnant when you begin use. See "Who should not use Fabior Foam?"
• Fabior Foam is flammable. Avoid fire, flame, and smoking during and right after you apply Fabior Foam.
• Gently clean the affected area (face and/or upper trunk) with a mild cleanser and dry completely before using Fabior Foam.
• Apply Fabior Foam one time each day, before going to bed, to the affected areas (face and/or upper trunk) where you have acne lesions. Use enough foam to cover the entire affected area with a thin film of Fabior Foam.
• Keep Fabior Foam away from your eyes, mouth, and vagina. If Fabior Foam comes into contact with your eyes, rinse them well with water.
• Wash your hands after applying Fabior Foam.
• If you use too much Fabior Foam, you may get redness, peeling, or skin irritation in the treated area. Call your doctor if this happens, or if you accidentally swallow Fabior Foam.
• Follow your doctor's directions for other routine skin care and the use of make-up.
• You may also use a moisturizer as needed.

Instructions for applying Fabior Foam

1. Shake the Fabior Foam can before use.

2. Remove cap from can. Nozzle should be lined up with black mark on rim of can. If black mark is not lined up with the nozzle, twist nozzle to line up with black mark. See Figure A.

Figure A

3. Hold the Fabior Foam can upright at a slight angle and press the nozzle. See Figure B.

Figure B

4. Dispense a small amount of Fabior Foam into the palm of your hand. See Figure C.

Figure C

5. Use the fingertips of your other hand to apply enough Fabior Foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin. See Figure D.

Figure D

6. Wash hands after applying Fabior Foam. See Figure E.

Figure E

Avoid getting Fabior Foam in your eyes, mouth, or vagina.

What should I avoid while using Fabior Foam?

• Avoid using abrasive soaps or cleansers that might dry or irritate your skin, unless your doctor tells you it is ok.
• Avoid sunlight. Fabior Foam can make your skin sensitive to sunlight and the light from sunlamps or tanning beds. You could get a sunburn. Use sunscreen and protective clothing during the day if you must be in sunlight.
• Avoid using Fabior Foam if you have a sunburn. If you have a sunburn, wait until it is fully healed before using Fabior Foam.
• Talk to your doctor before using Fabior Foam if you are sensitive to sunlight, take medications that increase your sensitivity to sunlight, or you must spend a lot of time in the sun for your job.
• Avoid weather extremes, such as wind and cold, because they may irritate your skin more while you are using Fabior Foam.

What are the possible side effects of Fabior Foam?

Fabior Foam may harm your unborn baby, if used during pregnancy.

• Do not use Fabior Foam during pregnancy. See "Who should not use Fabior Foam?"

The most common side effects of Fabior Foam are:

• burning or stinging
• dry skin
• red skin
• peeling or flaking skin

Sometimes these symptoms can become severe and may be uncomfortable. Tell your doctor if these side effects become uncomfortable for you. Your doctor may tell you to stop using Fabior Foam until your skin heals and your symptoms improve, or to use Fabior Foam less often to help you tolerate it better.

These are not all the possible side effects of Fabior Foam. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

You may also report side effects to Mayne Pharma at 1-844-825-8500.

How should I s tore Fabior Foam?

• Store Fabior Foam at room temperature, between 68°F to 77°F (20°C to 25°C).
• Store Fabior Foam upright.
• Do not freeze Fabior Foam.
• Fabior Foam is flammable. Keep the can away from fire and heat. Do not spray Fabior Foam near fire or direct heat.
• Do not puncture the can or throw it into a fire, even if the can is empty.

Keep Fabior Foam and all medicines out of the reach of children.

General Information about Fabior Foam

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Fabior Foam for a condition for which it was not prescribed. Do not give Fabior Foam to other people even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Fabior Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Fabior Foam that is written for health professionals.

What are the ingredients in Fabior Foam?

Active ingredient: tazarotene

Inactive ingredients: butylated hydroxytoluene, ceteareth-12, citric acid anhydrous, diisopropyl adipate, light mineral oil, potassium citrate monohydrate, potassium sorbate, purified water, and sorbic acid. The foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.

This Patient Information has been approved by the U.S. Food and Drug Administration

FABIOR is a registered trademark of Mayne Pharma LLC.

©2016 Mayne Pharma. All rights reserved. 1240 Sugg Parkway Greenville, NC 27834

Distributed by:
Mayne Pharma
Greenville, NC 27834

November 2016