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| Product NDC Code | 0299-5912 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Differin |
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| Type | Brand | ||||||
| Pharm Class | Retinoid [EPC], Retinoids [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| RxCUI drug identifier | 905385, 905387 |
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| Application Number | NDA022502 | ||||||
| Labeler Name | Galderma Laboratories, L.P. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The most common adverse reactions reported (≥ 1%) are dry skin and skin irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience 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. A total of 2141 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Of these, 1068 were exposed to DIFFERIN Lotion during the clinical trials. A total of 1057 subjects completed at least one post treatment evaluation. Related adverse reactions that were reported in at least 1% of subjects treated with DIFFERIN Lotion or with the Vehicle Lotion are presented in Table 1. The majority of cases were transient, mild to moderate in severity and were managed with moisturizers. Table 1: Adverse Reactions Reported in Clinical Trials by At Least 1% of Subjects System Organ Class/Preferred Term Adapalene Lotion 0.1% N = 1068 Vehicle Lotion N = 1073 Subjects with Related AR(s) 10.2% 4.6% Dry Skin 7.7% 3.0% Skin irritation 1.5% 0.7% Skin burning/skin discomfort 0.9% 0.0% Sunburn 0.6% 0.6% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials. Erythema, scaling, dryness, burning/stinging were assessed: Table 2: Incidence of Local Cutaneous Irritation, for Subjects Whose Irritation Score was Higher than at Baseline, in Controlled Clinical Trials Adverse Reactions (DIFFERIN Lotion Group N = 1057*) Combined Trial 1 and Trial 2 Maximum Severity During Treatment (N = 1057) Week 12 Treatment Severity (N = 950) Local Cutaneous Irritation (skin irritation) Mild Moderate Severe Mild Moderate Severe Erythema 21.8% 8.0% 0.2% 7.9% 2.6% 0.2% Scaling 25.3% 6.5% 0.1% 5.3% 1.1% 0% Dryness 36.1% 7.3% 0.3% 7.6% 2.0% 0% Stinging/burning 22.1% 7.0% 0.9% 4.6% 1.0% 0.4% * Data from 11 subjects with missing data are not included Local tolerability scores for erythema, scaling, dryness, burning/stinging rose during the first two weeks of treatment and generally decreased thereafter. In an open label postmarketing pharmacokinetic trial of 13 adolescent subjects, the adverse reaction of pruritus was reported in 8 out of 13 subjects. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
| 10.2% | 4.6% | |
| Dry Skin | 7.7% | 3.0% |
| Skin irritation | 1.5% | 0.7% |
| Skin burning/skin discomfort | 0.9% | 0.0% |
| Sunburn | 0.6% | 0.6% |
| Combined Trial 1 and Trial 2 | Maximum Severity During Treatment (N = 1057) | Week 12 Treatment Severity (N = 950) | ||||
| Local Cutaneous Irritation (skin irritation) | Mild | Moderate | Severe | Mild | Moderate | Severe |
| Erythema | 21.8% | 8.0% | 0.2% | 7.9% | 2.6% | 0.2% |
| Scaling | 25.3% | 6.5% | 0.1% | 5.3% | 1.1% | 0% |
| Dryness | 36.1% | 7.3% | 0.3% | 7.6% | 2.0% | 0% |
| Stinging/burning | 22.1% | 7.0% | 0.9% | 4.6% | 1.0% | 0.4% |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. 12.2 Pharmacodynamics Pharmacodynamics of DIFFERIN Lotion is unknown. 12.3 Pharmacokinetics Systemic exposure of adapalene following a topical application of DIFFERIN Lotion was studied in two pharmacokinetic (PK) clinical trials. The first trial was conducted in 14 adult subjects 18 to 29 years of age with severe acne and the second trial was conducted in 13 adolescent subjects 12 to 17 years of age with moderate to severe acne. In each trial, subjects were treated with 2 g of DIFFERIN Lotion applied once daily to approximately 1000 cm² of acne involved skin for 28 days (adolescent subjects) or 30 days (adult subjects). Serial plasma samples were collected at 24 or 72 hours following application on days 1, 15 and 28/30. Daily topical application of DIFFERIN Lotion resulted in low systemic exposure to adapalene in the two populations (adult and adolescent subjects). In the adult population, all plasma concentrations in 12 out of 14 subjects were below the limit of quantification (LOQ=0.1 ng/mL). One subject had one sample above LOQ at day 30 and the other subject had four plasma samples above LOQ on both days 1 and 15, which ranged from 0.102 and 0.131 ng/mL. In the adolescent population, plasma concentrations were quantifiable (>0.1 ng/mL) in five subjects. On Day 28, the mean C max was 0.128 ± 0.049 ng/mL (range: <0.100 to 0.244 ng/mL) and the mean of AUC 0-24hr was 3.07 ± 1.21 ng.hr/mL (range: 1.86 to 4.93 ng.hr/mL). Adapalene plasma concentrations in all subjects were below the limit of quantification (<0.1 ng/mL) 48 hours after the last application on Day 28.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Pharmacodynamics of DIFFERIN Lotion is unknown.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Systemic exposure of adapalene following a topical application of DIFFERIN Lotion was studied in two pharmacokinetic (PK) clinical trials. The first trial was conducted in 14 adult subjects 18 to 29 years of age with severe acne and the second trial was conducted in 13 adolescent subjects 12 to 17 years of age with moderate to severe acne. In each trial, subjects were treated with 2 g of DIFFERIN Lotion applied once daily to approximately 1000 cm² of acne involved skin for 28 days (adolescent subjects) or 30 days (adult subjects). Serial plasma samples were collected at 24 or 72 hours following application on days 1, 15 and 28/30. Daily topical application of DIFFERIN Lotion resulted in low systemic exposure to adapalene in the two populations (adult and adolescent subjects). In the adult population, all plasma concentrations in 12 out of 14 subjects were below the limit of quantification (LOQ=0.1 ng/mL). One subject had one sample above LOQ at day 30 and the other subject had four plasma samples above LOQ on both days 1 and 15, which ranged from 0.102 and 0.131 ng/mL. In the adolescent population, plasma concentrations were quantifiable (>0.1 ng/mL) in five subjects. On Day 28, the mean C max was 0.128 ± 0.049 ng/mL (range: <0.100 to 0.244 ng/mL) and the mean of AUC 0-24hr was 3.07 ± 1.21 ng.hr/mL (range: 1.86 to 4.93 ng.hr/mL). Adapalene plasma concentrations in all subjects were below the limit of quantification (<0.1 ng/mL) 48 hours after the last application on Day 28.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS DIFFERIN Lotion is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of DIFFERIN Lotion [ see WARNINGS AND PRECAUTIONS ( 5.1 ) ] Contraindicated in patients with known hypersensitivity to adapalene or any excipient of DIFFERIN Lotion. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION DIFFERIN (adapalene) Lotion, for topical use, contains adapalene in a white to off-white oil-in-water emulsion. Adapalene is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4methoxyphenyl]- 2-naphthoic acid). Adapalene has the following structural formula: Adapalene: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.5 Each gram of DIFFERIN Lotion contains 1 mg of adapalene. The lotion also contains the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol. differin structural Formula
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a mild soapless cleanser. Dispense a nickel size amount of DIFFERIN Lotion (3-4 actuations of the pump) and apply a thin film to the entire face and other affected areas of the skin once daily. Avoid application to the areas of skin around eyes, lips and mucous membranes. DIFFERIN Lotion is for topical use only and not for oral, ophthalmic, or intravaginal use. Apply once daily, after washing gently with a mild soapless cleanser. ( 2 ) Dispense a nickel size amount of DIFFERIN Lotion (3-4 actuations of the pump) to cover the entire face and other affected areas of the skin. ( 2 ) Avoid application to the areas of skin around eyes, lips and mucous membranes. ( 2 ) For topical use only and not for oral, ophthalmic, or intravaginal use. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Lotion, 0.1%. Each gram of the lotion contains 1 mg of adapalene in a white to off-white oil-in-water emulsion. DIFFERIN Lotion is available in 2 oz bottle with pump. Lotion, 0.1% in 2 oz bottle with pump. (3)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE DIFFERIN Lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older. DIFFERIN Lotion is a retinoid product indicated for the topical treatment of acne vulgaris in patients 12 years and older.. (1)
Spl product data elements
Usually a list of ingredients in a drug product.Differin adapalene CARBOMER HOMOPOLYMER TYPE A EDETATE DISODIUM MEDIUM-CHAIN TRIGLYCERIDES METHYLPARABEN PHENOXYETHANOL POLOXAMER 124 POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 1500 PROPYLENE GLYCOL PROPYLPARABEN SODIUM HYDROXIDE STEARYL ALCOHOL WATER ADAPALENE ADAPALENE white to off-white
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with DIFFERIN Lotion. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). The highest dose levels are 9.8 (mice) and 7.4 (rats) times the MRHD based on a mg/m 2 comparison. In the rat study, an increased incidence of benign and malignant pheochromocytomas in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (97 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with DIFFERIN Lotion. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). The highest dose levels are 9.8 (mice) and 7.4 (rats) times the MRHD based on a mg/m 2 comparison. In the rat study, an increased incidence of benign and malignant pheochromocytomas in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (97 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL - 2 FL OZ CARTON 2-fl-oz-carton-image
Rx Only NDC 0299-5912-02 Differin® (adapalene) Lotion 0.1% For External Use Only 2 FL OZ (59 mL) GALDERMA For external use only. Not for ophthalmic, oral or intravaginal use. Usual dosage: Apply a thin film on the entire face and other affected areas of the skin once daily. See package insert for complete prescribing information. Each gram contains: adapalene 1 mg (0.1%) in an aqueous based lotion consisting of the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG-12/SMDI copolymer, propylene glycol, propylparaben, sodium hydroxide, stearyl alcohol, and purified water. Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). Do not freeze or refrigerate. Marketed by: GALDERMA LABORATORIES, L.P. Dallas, TX 75201 Made in Canada. All trademarks are the property of their respective owners. P51638-5
Differin: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Patients using DIFFERIN Lotion should receive the following information and instructions: Wash affected areas gently with a mild soapless cleanser. Dispense a nickel size amount of DIFFERIN Lotion (3-4 actuations of the pump) and apply a thin film to the entire face and other affected areas of the skin once daily. Avoid application to the areas of skin around eyes, lips and mucous membranes. Do not apply to cuts, abrasions, eczematous, or sunburned skin. Wax depilation should not be performed on treated skin due to the potential for skin erosions. DIFFERIN Lotion may cause irritation such as erythema, scaling, dryness, stinging or burning. Minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. This product is for external use only. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity. Lactation: Use DIFFERIN Lotion on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply DIFFERIN Lotion to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. [See Use in Specific Populations, Lactation (8.2) ] Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA Made in Canada. All trademarks are property of their respective owners. P51503-X
Patient medication information
Information or instructions to patients about safe use of the drug product, sometimes including a reference to a patient medication guide or counseling materials.PATIENT MEDICATION INFORMATION SECTION Patient Information DIFFERIN® (Dif-er-in) (adapalene) Lotion Important: DIFFERIN Lotion is for use on the skin only (topical). Do not use DIFFERIN Lotion in or on your mouth, eyes, or vagina. What is DIFFERIN Lotion? DIFFERIN Lotion is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. It is not known if DIFFERIN Lotion is safe and effective in children under 12 years of age. Do not use DIFFERIN Lotion if you are allergic to adapalene or any of the ingredients in DIFFERIN Lotion. See the end of this Patient Information leaflet for a complete list of ingredients in DIFFERIN Lotion. Before using DIFFERIN Lotion, tell your healthcare provider about all your medical conditions, including if you: have other skin problems, including cuts, abrasions, sunburn, or skin that is dry, itchy or red are pregnant or plan to become pregnant. It is not known if DIFFERIN Lotion can harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if DIFFERIN Lotion passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use DIFFERIN Lotion. If you use DIFFERIN Lotion while breastfeeding, use DIFFERIN Lotion on the smallest area of the skin and for the shortest time needed. Do not apply DIFFERIN Lotion to areas that may increase the risk of getting DIFFERIN Lotion in your child’s mouth or eyes. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. How should I use DIFFERIN Lotion? Use DIFFERIN Lotion exactly as your healthcare provider tells you to use it. Apply DIFFERIN Lotion 1 time a day. Applying DIFFERIN Lotion: Wash the area where DIFFERIN Lotion will be applied gently with a mild soapless cleanser and pat dry. DIFFERIN Lotion comes in a pump. Dispense a nickel size amount of DIFFERIN Lotion (3 to 4 pumps) and apply a thin layer over the entire face and any other affected area of the skin. Do not apply DIFFERIN Lotion on areas of the skin around your eyes, lips, nose and mouth. Wash your hands after applying DIFFERIN Lotion. What should I avoid while using DIFFERIN Lotion? Avoid spending time in sunlight, including sunlamps. DIFFERIN Lotion can make your skin sensitive to the sun and the light from sunlamps. Use sunscreen and wear a hat and clothes that cover the areas treated with DIFFERIN Lotion if you have to be in sunlight. Cold weather and wind may irritate your skin treated with DIFFERIN Lotion. Do not apply DIFFERIN Lotion to cuts, abrasions, sunburned skin, or skin that is dry, itchy or red. Avoid skin products that may dry or irritate your skin such as harsh soaps or cleansers, soaps and cosmetics that make your skin dry, and products that contain high levels of alcohol, astringents, spices, or limes. Avoid the use of “waxing” as a hair removal method on skin treated with DIFFERIN Lotion. What are the possible side effects of DIFFERIN Lotion? DIFFERIN Lotion may cause serious side effects, including: Allergic reactions. DIFFERIN Lotion may cause serious allergic reactions that sometimes may require medical treatment. Stop using DIFFERIN Lotion and tell your healthcare provider or get medical help right away if you have any of these symptoms of an allergic reaction: skin rash, itching or hives trouble breathing or chest pain swelling of your face, eyes, lips, tongue or throat Skin reactions at the treated site. DIFFERIN Lotion may cause skin reactions including redness, scaling, dryness, stinging, or burning. These skin reactions are most likely to happen during the first 2 weeks of treatment, and usually lessen with continued use of DIFFERIN Lotion. Your healthcare provider may tell you to use a moisturizer, decrease how often you use DIFFERIN Lotion, or stop treatment with DIFFERIN Lotion if you get any skin reactions. If you use a moisturizer, you should avoid moisturizers that contain alpha hydroxy or glycolic acid. Ask your healthcare provider or pharmacist if you are not sure. The most common side effects of DIFFERIN Lotion include dry skin and skin irritation. These are not all the possible side effects of DIFFERIN Lotion. 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 Galderma Laboratories, L.P. at 1-866-735-4137. How should I store DIFFERIN Lotion? Store DIFFERIN Lotion at room temperature between 68° F to 77° F (20° C to 25° C). Do not freeze or refrigerate DIFFERIN Lotion. Keep DIFFERIN Lotion out of light and away from heat. Keep the DIFFERIN Lotion bottle tightly closed. Keep DIFFERIN Lotion and all medicines out of the reach of children. General information about the safe and effective use of DIFFERIN Lotion. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use DIFFERIN Lotion for a condition for which it was not prescribed. Do not give DIFFERIN Lotion to other people, even if they have the same symptoms you have. It may harm them. You can also ask your healthcare provider or pharmacist for information about DIFFERIN Lotion that is written for health professionals. What are the ingredients in DIFFERIN Lotion? Active ingredient: adapalene Inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG-12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol. Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA Made in Canada. GALDERMA is a registered trademark. P51503-X This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 04/2023
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES The safety and efficacy of DIFFERIN Lotion applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical trials of similar design, comparing DIFFERIN Lotion to the lotion vehicle in acne subjects. In Trial 1, 1075 subjects were randomized to DIFFERIN Lotion or vehicle. The median age of these subjects was 16.7 years old and 53.1% were females. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects (91.0%) had a baseline IGA score of ‘Moderate’. In Trial 2, 1066 subjects were randomized to DIFFERIN Lotion or vehicle. The median age of subjects was 16.7 years old and 53.7% were females. At baseline subjects had the same inclusion criteria as in Trial 1 and 95.7% of subjects had a baseline IGA score of ‘Moderate’. The outcome of the two trials is presented in Table 3. Table 3: Clinical Trial Primary Efficacy Results at Week 12 Trial 1 DIFFERIN Lotion (N = 533) Vehicle Lotion (N = 542) IGA Success 140 (26.3%) 95 (17.3%) Total Lesions: Mean Absolute (Percent) Change 37.9 (51.5%) 26.7 (37.1%) Inflammatory Lesions: Mean Absolute (Percent) Change 14.7 (54.9%) 10.6 (40.3%) Non-inflammatory Lesions: Mean Absolute (Percent) Change 23.2 (49.6%) 16.1 (35.7%) Trial 2 DIFFERIN Lotion (N = 535) Vehicle Lotion (N = 531) IGA Success 129 (24.1%) 87 (16.4%) Total Lesions: Mean Absolute (Percent) Change 32.4 (44.6%) 23.4 (32.8%) Inflammatory Lesions: Mean Absolute (Percent) Change 12.7 (46.0%) 10.2 (36.9%) Non-inflammatory Lesions: Mean Absolute (Percent) Change 19.6 (43.1%) 13.1 (30.2%)
| Trial 1 | ||
| DIFFERIN Lotion (N = 533) | Vehicle Lotion (N = 542) | |
| IGA Success | 140 (26.3%) | 95 (17.3%) |
| Total Lesions: Mean Absolute (Percent) Change | 37.9 (51.5%) | 26.7 (37.1%) |
| Inflammatory Lesions: Mean Absolute (Percent) Change | 14.7 (54.9%) | 10.6 (40.3%) |
| Non-inflammatory Lesions: Mean Absolute (Percent) Change | 23.2 (49.6%) | 16.1 (35.7%) |
| Trial 2 | ||
| DIFFERIN Lotion (N = 535) | Vehicle Lotion (N = 531) | |
| IGA Success | 129 (24.1%) | 87 (16.4%) |
| Total Lesions: Mean Absolute (Percent) Change | 32.4 (44.6%) | 23.4 (32.8%) |
| Inflammatory Lesions: Mean Absolute (Percent) Change | 12.7 (46.0%) | 10.2 (36.9%) |
| Non-inflammatory Lesions: Mean Absolute (Percent) Change | 19.6 (43.1%) | 13.1 (30.2%) |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of DIFFERIN Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Lactation Risk Summary There are no data on the presence of topical adapalene lotion or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk ( see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DIFFERIN Lotion and any potential adverse effects on the breastfed child from DIFFERIN Lotion or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use DIFFERIN Lotion on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of DIFFERIN Lotion to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness of DIFFERIN Lotion in pediatric patients under the age of 12 have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary Available data from clinical trials with DIFFERIN Lotion use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 122 and 243 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 24 times the MRHD based on a mg/m2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (122 and 243 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (29 and 58 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from clinical trials with DIFFERIN Lotion use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 122 and 243 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 24 times the MRHD based on a mg/m2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (122 and 243 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (29 and 58 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). 8.2 Lactation Risk Summary There are no data on the presence of topical adapalene lotion or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk ( see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DIFFERIN Lotion and any potential adverse effects on the breastfed child from DIFFERIN Lotion or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use DIFFERIN Lotion on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of DIFFERIN Lotion to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. 8.4 Pediatric Use Safety and effectiveness of DIFFERIN Lotion in pediatric patients under the age of 12 have not been established. 8.5 Geriatric Use Clinical studies of DIFFERIN Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING DIFFERIN (adapalene) Lotion, 0.1%, is a white to off-white liquid packaged in a 2 oz (59 mL) bottle which is equipped with a lotion dispensing pump. DIFFERIN Lotion is supplied as follows: 2 oz bottle pump NDC 0299-5912-02 Storage and handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [see USP Controlled Room Temperature] Do not freeze. Do not refrigerate. Protect from light. Keep out of reach of children. Keep away from heat. Keep bottle tightly closed.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API