Fluticasone Lotion

Fluticasone Propionate Lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 1 year of age or older.

Additional pediatric use information for patients ages 3 months to 1 year is approved for Fougera Pharmaceuticals, Inc.’s fluticasone propionate lotion product. However, due to Fougera Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Lotion, 0.05%. Each gram of Fluticasone Propionate Lotion, 0.05% contains 0.5 mg fluticasone propionate in a white to off-white lotion base. Fluticasone Propionate Lotion, 0.05% is supplied in 60 mL bottles.

None.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects

Topical corticosteroids, including Fluticasone Propionate Lotion, 0.05%, can produce reversible HPA axis suppression with the potential for glucocorticoid insufficiency. Risk factors that predispose to HPA axis suppression include the use of high-potency topical corticosteroids, large treatment surface areas, prolonged use, use under occlusion, concomitant use of more than one corticosteroid-containing product, altered skin barrier, and liver failure. Pediatric patients may be at greater risk of HPA axis suppression due to their higher skin surface area to body mass ratios [see Use in Specific Populations (8.4)].

HPA axis suppression may occur during or after withdrawal of treatment. If HPA axis suppression is suspected, gradually withdraw the drug, reduce the frequency of application, or substitute a less potent topical corticosteroid. Evaluation of HPA axis suppression may be done by using the cosyntropin stimulation test.

The effects of fluticasone propionate lotion, 0.05% on HPA axis function in pediatric patients were investigated in two trials. Among a total of 89 evaluable subjects from the two trials who were treated with fluticasone propionate lotion, 0.05% twice daily for 3 to 4 weeks, a single subject with >90% body surface area treated showed laboratory evidence of transient suppression immediately post-treatment. The post cosyntropin stimulation test serum cortisol returned to a normal level (22.1 μg/dL) within one week of the final treatment visit [see Use In Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.

Local Adverse Reactions

Fluticasone Propionate Lotion, 0.05% may cause local adverse reactions, including skin atrophy [see Adverse Reactions (6.1, 6.2)]. The risk is greater with use under occlusion and with higher potency products.

Fluticasone Propionate Lotion, 0.05% contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. Avoid using Fluticasone Propionate Lotion, 0.05% in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.

If irritation develops, discontinue Fluticasone Propionate Lotion, 0.05% and institute appropriate therapy.

Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation can be corroborated with appropriate diagnostic patch testing. Discontinue Fluticasone Propionate Lotion, 0.05% if appropriate.

Concomitant Skin Infections

If skin infections are present or develop at the treatment site, an appropriate antimicrobial agent should be used. If a favorable response does not occur promptly, discontinue use of Fluticasone Propionate Lotion, 0.05% until the infection has been adequately controlled.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• HPA Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1)] • Local Adverse Reactions [see Warnings and Precautions (5.2)] • Concomitant Skin Infections [see Warnings and Precautions (5.3)]

Clinical Trials Experience: Controlled Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 multicenter vehicle-controlled clinical trials of once-daily application of fluticasone propionate lotion, 0.05% by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. These were local cutaneous reactions, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and included were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection. See Table 1.

The incidence of adverse reactions between the 242 pediatric subjects (age 3 months to < 17 years) and 196 adult subjects (17 years or older) was similar (4% and 5%, respectively).

Table 1: Adverse Reactions from Controlled Clinical Trials (N=438)

Adverse Reactions	Fluticasone Propionate Lotion, 0.05% n=221	Vehicle n=217
Burning/Stinging skin	4 (2%)	3 (1%)
Contact Dermatitis	0	1 (<1%)
Exacerbation of Atopic dermatitis	0	1 (<1%)
Folliculitis of legs	2 (<1%)	0
Irritant Contact Dermatitis	0	1 (<1%)
Pruritus	1 (<1%)	1 (<1%)
Pustules on Arms	1 (<1%)	0
Rash	1 (<1%)	2 (<1%)
Skin Infection	0	3 (1%)

During the clinical trials, eczema herpeticum occurred in a 33-year old male patient treated with fluticasone propionate lotion, 0.05%.

Table 2 summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in the phase 3 controlled clinical trials.

Table 2: Adverse Events Occurring in ≥1% of Patients from Either Arm from Controlled Clinical Trials (n=438)

Body System	Fluticasone Propionate Lotion, 0.05% (N=221)	Vehicle Lotion (N=217)
Any Adverse Event	77 (35%)	82 (38%)
Skin
Burning and Stinging	4 (2%)	3 (1%)
Pruritus	3 (1%)	5 (2%)
Rash	2 (<1%)	3 (1%)
Skin Infection	0	3 (1%)
Ear, Nose, Throat
Common Cold	9 (4%)	5 (2%)
Ear Infection	3 (1%)	3 (1%)
Nasal Sinus Infection	2 (<1%)	4 (2%)
Rhinitis	1 (<1%)	3 (1%)
Upper Respiratory Tract Infection	6 (3%)	7 (3%)
Gastrointestinal
Normal Tooth Eruption	2 (<1%)	3 (1%)
Diarrhea	3 (1%)	0
Vomiting	3 (1%)	2 (<1%)
Lower Respiratory
Cough	7 (3%)	6 (3%)
Influenza	5 (2%)	0
Wheeze	0	3 (1%)
Neurology
Headache	4 (2%)	5 (2%)
Non-Site Specific
Fever	8 (4%)	8 (4%)
Seasonal Allergy	2 (<1%)	3 (1%)

Clinical Trials Experience: Pediatric Open Label Trials

In an open label HPA axis suppression trial of 44 pediatric subjects (ages ≥3 months to ≤6 years) fluticasone propionate lotion, 0.05% was applied twice daily (rather than the indicated dosing regimen of once daily) to at least 35% of body surface area for 3 or 4 weeks. Subjects whose lesions cleared after 2 or 3 weeks of treatment continued to apply fluticasone propionate lotion, 0.05% for an additional week. The overall incidence of adverse reactions was 14%. These were local, cutaneous reactions and included dry skin (7%), stinging at application site (5%), and excoriation (2%). Additionally, a 4-month-old patient treated with fluticasone propionate lotion, 0.05% had marked elevations of the hepatic enzymes AST and ALT. [see Use in Specific Populations (8.4)]

Additional pediatric use information for patients ages 3 months to 1 year is approved for Fougera Pharmaceuticals, Inc.’s fluticasone propionate lotion product. However, due to Fougera Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Postmarketing Experience

The following local adverse reactions have been identified during post-approval use of fluticasone propionate lotion, 0.05%: erythema, edema/swelling, and bleeding.

The following systemic adverse reactions have been identified during post-approval use of fluticasone propionate cream and fluticasone propionate ointment: immunosuppression/Pneumocystis jirovecii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following local adverse reactions have also been reported with the use of topical corticosteroids, and they may occur more frequently with the use of occlusive dressings or higher potency corticosteroids. These reactions include: acneiform eruptions, hypopigmentation, perioral dermatitis, skin atrophy, striae, hypertrichosis and miliaria.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Fluticasone Propionate Lotion, 0.05%

Important: Fluticasone Propionate Lotion, 0.05% is for use on skin only (topical). Do not get Fluticasone Propionate Lotion, 0.05% near or in your eyes, mouth, or vagina.

Read this Patient Information before you start using Fluticasone Propionate Lotion, 0.05% and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is Fluticasone Propionate Lotion, 0.05%?

Fluticasone Propionate Lotion, 0.05% is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions, including atopic dermatitis and eczema in people 1 year of age and older.

It is not known if Fluticasone Propionate Lotion, 0.05% is safe and effective in children under 3 months of age.

Before using Fluticasone Propionate Lotion, 0.05%, tell your healthcare provider about all of your medical conditions, including if you:

• have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • have adrenal gland problems • have liver problems • have diabetes • have thinning skin (atrophy) at the site to be treated • are allergic to formaldehyde. If you are allergic to formaldehyde, Fluticasone Propionate Lotion, 0.05% may cause skin irritation, prevent your skin from healing or worsen your skin condition. • are pregnant or plan to become pregnant. It is not known if Fluticasone Propionate Lotion, 0.05% will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Fluticasone Propionate Lotion, 0.05% can pass into your breast milk and harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.

How should I use Fluticasone Propionate Lotion, 0.05%?

• Use Fluticasone Propionate Lotion, 0.05% exactly as your healthcare provider tells you to use it. • Apply a thin film of Fluticasone Propionate Lotion, 0.05% to the affected area 1 time each day. Gently rub into your skin. • Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Do not apply Fluticasone Propionate Lotion, 0.05% to dermatitis in the diaper area unless your healthcare provider tells you to. • Wash your hands after applying Fluticasone Propionate Lotion, 0.05%, unless your hands are being treated. • Tell your healthcare provider if your symptoms get worse with Fluticasone Propionate Lotion, 0.05% or if your symptoms do not improve after 2 weeks of treatment. It is not known if Fluticasone Propionate Lotion, 0.05% is safe or effective when used more than 4 weeks.

What are possible side effects with Fluticasone Propionate Lotion, 0.05%?

Fluticasone Propionate Lotion, 0.05% may cause serious side effects, including:

• Fluticasone Propionate Lotion, 0.05% can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Fluticasone Propionate Lotion, 0.05% for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Fluticasone Propionate Lotion, 0.05%. • Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skin reactions such as pain, tenderness, swelling, or healing problems.

The most common side effects of Fluticasone Propionate Lotion, 0.05% include burning and stinging at the treatment site.

These are not all the possible side effects with Fluticasone Propionate Lotion, 0.05%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Fluticasone Propionate Lotion, 0.05%?

• Store Fluticasone Propionate Lotion, 0.05% at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. • Do not refrigerate. • Keep the bottle tightly closed.

Keep Fluticasone Propionate Lotion, 0.05% and all medicines out of the reach of children.

General information about the safe and effective use of Fluticasone Propionate Lotion, 0.05%.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fluticasone Propionate Lotion, 0.05% for a condition for which it was not prescribed. Do not give Fluticasone Propionate Lotion, 0.05% to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Fluticasone Propionate Lotion, 0.05% that is written for health professionals.

What are the ingredients in Fluticasone Propionate Lotion, 0.05%?

Active ingredient: fluticasone propionate

Inactive ingredients: anhydrous citric acid, cetomacrogol 1000, cetostearyl alcohol, dimethicone 360, imidurea, isopropyl myristate, methylparaben, mineral oil, propylene glycol, propylparaben, purified water, and sodium citrate

For more information, go to www.perrigo.com or call 1-866-634-9120.

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

Additional pediatric use information for patients ages 3 months to 1 year is approved for Fougera Pharmaceuticals, Inc.’s fluticasone propionate lotion product. However, due to Fougera Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Made in Israel

Manufactured by Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 11-15

: 8K800 RC J3