Acanya

Name: Acanya

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

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may cause harm if swallowed. If Acanya is swallowed, call a doctor or poison control center right away.
  • Certain acne products that contain benzoyl peroxide or salicylic acid can rarely cause very bad and sometimes life-threatening allergic reactions or very bad irritation. Before first use, you may need to follow certain steps to make sure you do not have an allergic reaction. Use this medicine as you were told by the doctor or read the package label. Talk with the doctor.
  • Use care when putting on. It may bleach hair or colored fabric.
  • Use other pimple (acne) drugs with care. More skin irritation may happen.
  • Talk with your doctor before you use other drugs or products on your skin.
  • 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.
  • Do not use longer than you have been told. A second infection may happen.
  • Diarrhea, bloody diarrhea, and a certain bowel problem (colitis) have happened with Acanya. Very bad colitis may lead to death. Call your doctor right away if you have stomach pain or cramps, very bad or watery diarrhea, or bloody diarrhea. Do not try to treat diarrhea without first checking with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Acanya - Clinical Pharmacology

Mechanisms of Action

Clindamycin: Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology (12.4)].

Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects but the precise mechanism of action is unknown.

Pharmacokinetics

The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of Acanya Gel applied to the face once daily for 30 days. Twelve subjects (75%) had at least one quantifiable clindamycin plasma concentration above the lower limit of quantification (LOQ = 0.5 ng/mL) on Day 1 or Day 30. On Day 1, the mean (± standard deviation) peak plasma concentrations (Cmax) was 0.78 ± 0.22 ng/mL (n=9 with measurable concentrations), and the mean AUC0-t was 5.29 ± 0.81 h.ng/mL (n=4). On Day 30, the mean Cmax was 1.22 ± 0.88 ng/mL (n=10), and the mean AUC0-t was 8.42 ± 6.01 h.ng/mL (n=6). Clindamycin plasma concentrations were below LOQ in all subjects at 24 hours post-dose on the three tested days (Day 1, 15, and 30).

Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

Microbiology

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis.

Clindamycin and benzoyl peroxide individually have been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes is not known.

P. acnes resistance to clindamycin has been documented. Resistance to clindamycin is often associated with resistance to erythromycin.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and impairment of fertility testing of Acanya Gel have not been performed.

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.

Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g Acanya Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g Acanya Gel based on mg/m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Fertility studies have not been performed with Acanya Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g Acanya Gel, based on mg/m2) revealed no effects on fertility or mating ability.

Clinical Studies

The safety and efficacy of once daily use of Acanya Gel were assessed in two 12-week multi-center, randomized, blinded trials in subjects 12 years and older with moderate to severe acne vulgaris. The two trials were identical in design and compared Acanya Gel to clindamycin in the vehicle gel, benzoyl peroxide in the vehicle gel, and the vehicle gel alone.

The co-primary efficacy variables were:

The EGS scoring scale used in all of the clinical trials for Acanya Gel is as follows:

Grade Description

Clear

Normal, clear skin with no evidence of acne vulgaris

Almost Clear

Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)

Mild

Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions)

Moderate

Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one small nodulocystic lesion

Severe

Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulocystic lesions

Very Severe

Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions

The results of Trial 1 at Week 12 are presented in Table 2:

Table 2: Trial 1 Results
Trial 1 Acanya
Gel
Clindamycin
Gel
Benzoyl
Peroxide
Gel
Vehicle
Gel
N = 399 N = 408 N = 406 N = 201

EGSS Clear or Almost Clear

115 (29%)

84 (21%)

76 (19%)

29 (14%)

-----------------

2 grade reduction from baseline

131 (33%)

100 (25%)

96 (24%)

38 (19%)

Inflammatory Lesions:

  Mean
  absolute
  change

14.8

12.2

13.0

9.0

  Mean
  percent (%)
  reduction

55.0%

47.1%

49.3%

34.5%

Non-Inflammatory Lesions:

  Mean
  absolute
  change

22.1

17.9

20.6

13.2

  Mean
  percent (%)
  reduction

45.3%

38.0%

40.2%

28.6%

The results of Trial 2 at Week 12 are presented in Table 3:

Table 3: Trial 2 Results
Trial 2 Acanya
Gel
Clindamycin Gel Benzoyl
Peroxide
Gel
Vehicle Gel
N = 398 N = 404 N = 403 N = 194

EGSS
Clear or Almost Clear

113 (28%)

94 (23%)

94 (23%)

21 (11%)

-------------------------------

2 grade reduction from baseline

147 (37%)

114 (28%)

114 (28%)

27 (14%)

Inflammatory Lesions:

  Mean absolute change

13.7

11.3

11.2

5.7

  Mean percent (%) reduction

54.2%

45.3%

45.7%

23.3%

Non-Inflammatory Lesions:

  Mean absolute change

19.0

14.9

15.2

8.3

  Mean percent (%) reduction

41.2%

34.3%

34.5%

19.2%

Patient counseling information

See FDA-approved patient labeling (Patient Information.)

• Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately. • Acanya Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies. • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used. • Acanya Gel may bleach hair or colored fabric.

PATIENT INFORMATION
Acanya® (AH-CAN΄-YAH)
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%

IMPORTANT: For use on skin only (topical use). Do not get Acanya Gel in your mouth, eyes, or vagina, or on your lips.

Read the Patient Information that comes with Acanya Gel 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 your treatment.

What is Acanya Gel?

Acanya Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older. Acanya Gel contains clindamycin phosphate and benzoyl peroxide.

It is not known if Acanya Gel is safe and effective for use longer than 12 weeks.

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

Who should not use Acanya Gel?

Do not use Acanya Gel if you have:

• Crohn's disease • ulcerative colitis • had inflammation of the colon (colitis), or severe diarrhea with past antibiotic use

Talk with your doctor if you are not sure if you have one of these conditions.

What should I tell my doctor before using Acanya Gel?

Before using Acanya Gel, tell your doctor about all of your medical conditions, including if you:

• have any allergies. • have any other medical conditions • are pregnant or planning to become pregnant. It is not known if Acanya Gel will harm your unborn baby. • are breastfeeding or plan to breast-feed. It is not known if Acanya Gel passes into your breast milk. One of the medicines in Acanya Gel contains clindamycin. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. You and your doctor should decide whether you will use Acanya Gel while breast-feeding.

Tell your doctor about all the medicines and skin products you use. Especially tell your doctor if you will have surgery with general anesthesia. One of the medicines in Acanya Gel (clindamycin) can affect how certain medicines work when used in general anesthesia.

• Acanya Gel should not be used with products that contain erythromycin. • Other skin and topical acne products may increase the irritation of your skin when used with Acanya Gel.

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

How should I use Acanya Gel?

• Use Acanya Gel exactly as prescribed. • Your doctor will tell you how long to use Acanya Gel. • Throw away (discard) any unused Acanya Gel.

Instructions for applying Acanya Gel

• Apply Acanya Gel to your face one time each day as prescribed.
  1. Before you apply Acanya Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. 2. To apply Acanya Gel to your face, use the pump to dispense one pea-sized amount of Acanya Gel onto your fingertip. See Figure 1. One pea-sized amount of Acanya Gel should be enough to cover your entire face.
  Figure 1
3. Dot the one pea-sized amount of Acanya Gel onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2
  Figure 2
4. After applying the Acanya Gel this way, spread the gel over your face and gently rub it in. It is important to spread the gel over your whole face. 5. Wash your hands with soap and water after applying Acanya Gel. 6. If your doctor tells you to put Acanya Gel on other areas of your skin with acne, be sure to ask how much you should use. 7. Do not get Acanya Gel in your mouth, eyes, or nose, or on your lips. If this occurs, rinse the affected area with warm water and call your doctor right away if the area becomes very red, itchy, tender, or swollen. 8. Do not get Acanya Gel on cuts or open wounds. 9. Do not use more Acanya Gel than prescribed.

What should I avoid while using Acanya Gel?

• Limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher. Your doctor can give you more information about why this is important. • Do not wash your face more than 2 to 3 times a day. Washing your face too often or scrubbing it may make your acne worse. • Avoid getting Acanya Gel in your hair or on colored fabric. Acanya Gel may bleach hair or colored fabric.

What are possible side effects with Acanya Gel?

Acanya Gel can cause serious side effects including:

• Inflammation of the colon (colitis). Stop using Acanya Gel and call your doctor right away if you have severe watery diarrhea, or bloody diarrhea. • Allergic reactions. Stop using Acanya Gel, call your doctor and get help right away if you have any of the following symptoms: o severe itching o swelling of your face, eyes, lips, tongue or throat o trouble breathing

Common side effects with Acanya Gel include:

• Skin irritation. Stop using Acanya Gel and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with Acanya Gel. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Valeant Pharmaceuticals North America LLC, at 1-800-321-4576.

How should I store Acanya Gel?

• Store Acanya Gel at room temperature at or below 25°C (77°F). • The expiration date of Acanya Gel is 10 weeks from the date you fill your prescription. • Safely throw away expired Acanya Gel. • Do not freeze. • Keep the container tightly closed.

Keep Acanya Gel and all medicines out of the reach of children.

General information about Acanya Gel

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Acanya Gel for a condition for which it was not prescribed. Do not give Acanya Gel to other people, even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information about Acanya Gel. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Acanya Gel that is written for healthcare professionals.

For more information about Acanya Gel, call 1-800-321-4576.

What are the ingredients in Acanya Gel?

Active Ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 2.5%

Inactive Ingredients: purified water, carbomer 980, propylene glycol, and potassium hydroxide

Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA


By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada

U.S. Patents 8,288,434; 8,663,699; 8,895,070 and 9,078,870

Acanya is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.

©Valeant Pharmaceuticals North America LLC

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

Revised 10/2016

  9387202 50104737C



PRINCIPAL DISPLAY PANEL - 50 gram Pump Label

NDC 13548-132-50

Acanya®
(Clindamycin Phosphate and
Benzoyl Peroxide) Gel, 1.2%/2.5%

Rx only

FOR TOPICAL USE ONLY

One premixed 50-gram pump dispenser

Acanya 
clindamycin phosphate and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13548-132
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clindamycin Phosphate (Clindamycin) Clindamycin 10 mg  in 1 g
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
propylene glycol  
potassium hydroxide  
Packaging
# Item Code Package Description
1 NDC:13548-132-50 1 BOTTLE, PUMP in 1 CARTON
1 50 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050819 07/26/2010
Labeler - Valent Pharmaceuticals North America (010977972)
Registrant - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc 245141858 MANUFACTURE(13548-132)
Establishment
Name Address ID/FEI Operations
Contract Pharmaceuticals Limited Canada 248761249 MANUFACTURE(13548-132)
Revised: 10/2016   Valent Pharmaceuticals North America

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What are some other side effects of this drug?

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:

  • Irritation where this drug is used.
  • Dry skin.
  • Itching.

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.

Benzoyl peroxide / clindamycin topical Breastfeeding Warnings

There are no data on the excretion of benzoyl peroxide or clindamycin into human milk following topical administration; however, clindamycin is excreted following systemic administration. Topically applied clindamycin undergoes absorption from the skin surface. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Dosing & Uses

Dosage Forms & Strengths

clindamycin/benzoyl peroxide

topical gel

  • 1%/5% (BenzaClin)
  • 1.2%/2.5% (Acanya)
  • 1.2%/3.75% (Onexton)
  • 1.2%/5% (Duac)

Acne Vulgaris

BenzaClin: Apply topically q12hr to affected areas after skin is thoroughly washed and patted dry

DUAC: Apply once daily in the evening to affected areas after the skin is thoroughly washed and patted dry

Acanya, Onexton: Apply pea-sized amount qDay to affected areas after skin is thoroughly washed and patted dry

Limitation of use

  • DUAC Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne

Dosage Forms & Strengths

clindamycin/ benzoyl peroxide

topical gel

  • 1%/5% (BenzaClin)
  • 1.2%/2.5% (Acanya)
  • 1.2%/3.75% (Onexton)
  • 1.2%/5% (Duac)

Acne Vulgaris

(web3)