doryx

1

Please see Selected Safety Information for DORYX® on slide 43, and Full Prescribing Information provided by your sales representative and at www.doryx.com.

PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILINGPROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING

Optimizing Oral Antibiotic Treatment for Acne Vulgaris

DORYX® (Doxycycline Hyclate Delayed-Release Tablets, USP) is indicated as adjunctive therapy for severe acne.DORYX® is a registered trademark of Warner Chilcott Company, LLC.

1


2PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING

Presenter

James Q. Del Rosso, DODermatology Residency Program Director

Valley Hospital Medical CenterLas Vegas, Nevada

Dermatology & Cutaneous SurgeryLas Vegas Skin & Cancer Clinics

Las Vegas and Henderson, Nevada


Table of Contents

Presentation Highlights • Acne Vulgaris: Epidemiology and Classification

• Acne Vulgaris: Impact on Quality of Life (QOL)

• Acne Vulgaris: Treatment Options

• DORYX® (Doxycycline Hyclate Delayed-Release Tablets, USP)

• Efficacy of Doxycycline

• Safety and Tolerability of Doxycycline

• Dermatologists’ Prescribing Trends

• Treatment Challenges for Acne Patients

• Summary of Key Points and Data

DORYX® (Doxycycline Hyclate Delayed-Release Tablets, USP) is indicated as adjunctive therapy for severe acne.

4



Acne Vulgaris:Epidemiology and

Classification

4


Acne Vulgaris Is a Common Dermatologic Condition

• Accounts for 14 million office visits per year1

• Most patients are teenagers2

– 85% of teenagers between the ages of 15 and 17 years have some degree of acne1

• 10% of visits are reported to be for patients 35 to 44 years of age2,3

1. Mancini JA. Johns Hopkins Adv Stud Med. 2008;8:100-105. 2. Del Rosso JQ, Kim G. Dermatol Clin. 2009;27:33-42.3. Weinstock MA, Boyle MM. In: Del Rosso JQ, ed. Year Book of Dermatol and Dermatol Surg 2010. Philadelphia, PA:

Elsevier; 2010:35-50.


Acne Lesion

Healthy Skin

Sebaceous Gland

Hair Follicle

Oily Secretion

s From Sebaceous Gland

Keratinocytes

Inflammation

Anatomy of the Pilosebaceous Follicle1,2

1. Adapted from Management of acne vulgaris. http://healthproductsreviewed.org/management-of-acne-vulgaris.html#more-105. Accessed April 13, 2011.

2. Gollnick H. Drugs. 2003;63:1579-1596.


Types of Acne Lesions

Comedonal Acne Inflammatory Acne

Cysts2,3 Pustule2,4 Papule2,5

Scarring6,7 Hyperpigmentation7,8

Open Comedones1,2

Closed Comedones1,2

1. Acne types. http://www.acne101.org/types.html. Accessed April 13, 2011. 2. Gollnick H, et al. Drugs. 2003;63:1579-1596. 3. Cystic acne treatment. http://www.hbbase.com. Accessed April 13,2011. 4. Teens about acne. http://www.clearupskincare.org/aboutacnea.html. Accessed April 13, 2011. 5. Acne papules treatment - there is a cure. http://www.getacnehomeremedies.info/search/acne-papules-treatment-there-is-a-cure. Accessed April 13, 2011. 6. Facial acne scars. http://www.bioskincream.com. Accessed April 13,2011. 7. Gollnick H, et al. J Am Acad Dermatol. 2003;49(suppl 1):S1-S37. 8. Skin site. http://www.skinsight.com/info/blog/2009/03/12/qa-acne-scars. Accessed April 13, 2011.


MILD2 MODERATE3 SEVERE4

Comedones <20 20-100 >100

Papules/Pustules

<15 15-50

>50

Nodules/Cysts >5

Total <30 30-125 >125

Classification of Acne Vulgaris1

1. Lehmann HP, et al. J Am Acad Dermatol. 2002;47:231-240. 2. How to treat acne marks. http://hubpages.com/hub/How-To-Treat-Acne-Discolorations. Accessed April13, 2011. 3. The skin center. http://lagunaskincare.com. Accessed April 13, 2011. 4. Preventing scars. http://cure-your-acne.com. Accessed April 13, 2011.


Progression of an Acne Lesion

Hair

Skin Surface

Sebum

Hair Follicle

Sebaceous Gland

Dead Skin Cells

Blackhead

Trapped Sebum

Rupture

Inflamed Tissue

Pus

Epidermis

Normal Pilosebaceous UnitFormation of Comedones

(Blackheads and Whiteheads)

Formation of Papules, Pustules, Nodules,

or Cysts; Inflammation; Rupture

Adapted from Wolff K, Johnson RA. Fitzpatrick’s Color Atlas and Synopsis of Clinical Dermatology. 5th ed. New York: McGraw-Hill; 2005.

Pugliese S. Acne: Fact vs Fiction. http://dermhub.com/2009/08/the-411-on-acne. Accessed April 13, 2011.


Acne Lesions and Pathophysiology1

Papule

Pustule

Nodule

Cyst

ACNE2

P. acnesInflammatio

n

Keratinization

Sebum Production

1. Monk E, et al. Pharmacol Res. 2011;63:130-145.2. What is acne? http://www.acne.org. Accessed April 13, 2011.


P. acnes Induces Inflammation1,2

Disruption of Follicular

Epithelium

Neutrophil and Lymphocyte Infiltration

Lipases, Proteases, Other

Enzymes

P. acnes

Chemotactic Factors

Proinflammatory

Mediators

Proinflammatory Mediators

1. Webster GF. J Am Acad Dermatol. 1995;33:247-253.2. Holland DB, Jeremy AHT. Semin Cutan Med Surg. 2005;24:79-83.

SCARRING

INFLAMMATION


Current Consensus: Acne Is an Inflammatory Condition1

1. Kircik L. Pract Dermatol. 2011;3:35-39.2. Jeremy AH, et al. J Invest Dermatol. 2003;121:20-27.

Increase in CD4+ T cells observed near uninvolved follicles from acne patients2

IL-1 and IL-1 receptor expression increased2

• The cause of the increase in IL-1 activity is unknown

• Could be due to low linoleic acid levels

• In the absence of evidence of hyperkeratinization

• T cells were not activated

• Possibly a response to cytokine stimulation of endothelium

IL=interleukin.

13



Acne Vulgaris:Impact on Quality of Life

(QOL)

13


Acne Presents Significant Challenges

Physical1

• Scarring • Hyperpigmentation

Emotional1

• Anxiety• Depression• Suicidal thoughts• Frustration• Anger

• Scarring develops in approximately 95% of patients with clinical acne2

• Emotional impact of acne is particularly difficult during the period of adolescence, when there is pronounced vulnerability1

1. Gollnick H, et al. J Am Acad Dermatol. 2003;49(suppl 1):S1-S37. 2. Layton AM, et al. Clin Exp Dermatol. 1994;19:303-308.


Acne Severely Affects QOL

Klassen AF, et al. J Am Acad Dermatol. 2000;43:229-233.

Anxiety and Depression Are the Biggest Challenges

That Adversely Affect QOL

QOL Areas of Measure


•Acne should be approached as a chronic disease•Acne can be a psychologically damaging

condition that lasts for many years

•Limit the duration of active acne by effective treatment

•Reduce the likelihood of physical and emotional scarring

Consensus of the Global Alliance to Improve Outcomes in Acne Group

Acne should not be dismissed as a natural part of growing up

Early and aggressive treatment of acne is recommended by the Global Alliance to Improve Outcomes in Acne Group

Thiboutot D, et al. J Am Acad Dermatol. 2009;60(suppl 5):S1-S50.

17



Acne Vulgaris:Treatment Options

17


Considerations for Acne Treatment1

Severity of Acne

Presence ofAcne

Scarring

Type of Acne Lesions

Psychologicaland

Social Impact

1. Goulden V. Pediatr Drugs. 2003;5:301-313.2. Kircik L. Pract Dermatol. 2011;3:35-39.

Choice of Therapy

Depends on

A Goal of Acne Therapy Is to Prevent Scarring2


Global Alliance: Acne Treatment Algorithm1,2

Mild Moderate Severe

Comedonal Mixed and

Papular/Pustular

Mixed and Papular/Pustula

r Nodular* Nodular/

Conglobate

Topical retinoid

Topical retinoid + topical antibiotic

Oral antibiotic+ topical retinoid

± BPO

Oral antibiotic + topical retinoid

+ BPO

Oral isotretinoin†

Alt. topical retinoid or azelaic

acid§ or salicylic

acid

Alt. topical antibiotic + alt. topical retinoid or

azelaic acid§

Alt. oral antibiotic

+ alt. topical retinoid ± BPO

Oral isotretinoin or alt.

oral antibiotic + alt. topical

retinoid ± BPO/azelaic

acid§

High-dose oral antibiotic

+ topical retinoid + BPO

See 1st choice See 1st choice

Hormonal therapy,

oral antiandrogen

+ topical retinoid/

azelaic acid§ ± topical antibiotic

Hormonal therapy,

oral antiandrogen+ topical retinoid

± oral antibiotic

± alt. antibiotic

High-dose oral antiandrogen

+ topical retinoid

± alt. topical antibiotic

Topical retinoid Topical retinoid ± BPO

1st Choice

Alternatives‡

Alternatives for

Female Patients‡§

Maintenance Therapy

BPO=benzoyl peroxide. *With small nodules (<0.5-1 cm); †Second course in case of relapse; ‡Consider physical removal of comedones; §There was no consensus on this alternative recommendation; however, in some countries, azelaic acid prescribing is considered appropriate practice.

1. Thiboutot D, et al. J Am Acad Dermatol. 2009;60(suppl 5):S1-S50.2. Gollnick H, et al. J Am Acad Dermatol. 2003;49(suppl 1):S1-S37.


Use of Antibiotics in Dermatology

• Annual number of antibiotic prescriptions written by dermatology practices

• Based on US usage data, 2001 to 2006

8-9 million oral antibiotic prescriptions

• Majority of prescriptions are written for tetracycline derivatives

• Primarily doxycycline and minocycline

Two-thirds of prescriptions

• Most oral antibiotics are prescribed for treating acne vulgaris and rosacea

Acne vulgaris and rosacea

• Annual number of topical antibiotic prescriptions written by dermatology practices

• Based on US usage data, 2001 to 2006

3-4 million topical antibiotic

prescriptions

Del Rosso JQ, Kim G. Dermatol Clin. 2009;27:33-42.


Actions of Acne Therapies1-3

Anti-comedonal

Effect Anti-P. acnesAnti-

inflammatory

Oral antibiotics + +++ +++

Topical antibiotics + benzoyl peroxide

+ +++ +

Topical retinoids +++ – ++

1. Bikowski J. Pract Dermatol Ped. 2011;1:23-26.2. Kircik L. Pract Dermatol. 2011;3:35-39.3. Sapadin AN, Fleischmajer R. J Am Acad Dermatol. 2006;54:258-265.


Oral Antibiotics for Treatment of Acne

1. IMS Health, Inc. National Prescription Data: July 2004–July 2009 (estimate derived from the use of information under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying). 2. Del Rosso JQ, Kim G. Dermatol Clin. 2009;27:33-42. 3. Strauss JS, et al. J Am Acad Dermatol. 2007;56:651-663. 4. DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. 5. Tetracycline hydrochloride [package insert]. Corona, CA: Watson Pharma, Inc.; 2010. 6. Minocycline hydrochloride [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; 2010.

•More effective than first-generation tetracyclines3

•Less bacterial resistance than first- generation tetracyclines or erythromycin2

•More convenient dosing4-6

Minocycline and doxycycline are the most frequently prescribed antibiotics for acne in the United States1,2


Effects of Tetracycline

1. Ochsendorf F. Am J Clin Dermatol. 2010;11:327-341.2. Sapadin AN, Fleischmajer R. J Am Acad Dermatol. 2006;54:258-265.


Doxycycline

• Highly lipophilic drug with excellent tissue penetration1,2

– More lipophilic than first-generation tetracyclines3

• Almost completely absorbed after oral administration1,2

– Absorption is largely unaffected by foods4

• Several different formulations3,5

– Doxycycline monohydrate

– Doxycycline hyclate

1. DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.2. Saivin S, Houin G. Clin Pharmacokinet. 1988;15:355-366. 3. Cunha BA, et al. Ther Drug Monit. 1982;4:115-135. 4. Welling PG, et al. Antimicrob Agents Chemother. 1977;11:462-469.5. Kitzes-Cohen R, et al. Curr Ther Res. 1998;59:315-323.

25






• Enteric-coated: contains specially coated pellets of doxycycline hyclate

• Indicated as adjunctive therapy for severe acne

• Primarily bacteriostatic and exerts its antimicrobial effect by the inhibition of protein synthesis

• Effective against a wide range of gram-positive and gram-negative bacteria and other pathogens

• Effective against P. acnes

DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.Please see Selected Safety Information for DORYX® on slide 45, and Full Prescribing Information provided by your sales representative and at www.doryx.com.



• Tablets contain an enteric-coated delivery system of delayed-release, specially coated pellets of doxycycline hyclate

– The enteric coating is pH sensitive; it does not dissolve in acidic pH environments such as the stomach

– When the pellets are exposed to a more alkaline pH such as found in the small intestine, the enteric coating dissolves and the active drug is released and absorbed

• Designed to minimize the exposure of the upper gastrointestinal tract to doxycycline

– Tablets dissolve in the stomach, and the enteric-coated pellets are dispersed

– Enteric-coated pellets dissolve in the small intestine, where the doxycycline is absorbed

27




Dosing flexibility• Scored tablets facilitate dose titration

• Tablets may be taken at any time during the day, and do not need to be taken with milk or food

• Tablets can be taken more easily by patients who have difficulty swallowing

– DORYX® tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release pellets) on a spoonful of applesauce

DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.Please see Selected Safety Information for DORYX® on slide 45, and Full Prescribing Information provided by yoursales representative and at www.doryx.com.


29



Efficacy of Doxycycline

29

Please see Selected Safety Information for DORYX® on slide 45, and Full Prescribing Information provided by yoursales representative and at www.doryx.com.


Doxycycline and Minocycline Have Comparable Efficacy in Acne

• Randomized, double-blind study†

• 3 months of treatment

• Comparable efficacy

P>0.75

*Score included grading for extension of symptoms; seborrhea; comedones and whiteheads; papules and pustules; infiltration; and abscesses, before treatment and after 3 months.

†n=18.

Smit F. Dermatologica. 1978;157:186-190.

Mean

Diff

ere

nce i

n E

fficacy S

core

*

Please see Selected Safety Information for DORYX® on slide 45, and Full Prescribing Information provided by yoursales representative and at www.doryx.com.


Consistent Results: Comparable Efficacy

• 12-week, randomized, double-blind study*

• Doxycycline 50 mg BID (4 weeks), 50 mg QD (8 weeks) was as effective as minocycline 50 mg BID (4 weeks), 50 mg QD (8 weeks)

Ólafsson JH, et al. J Dermatolog Treat. 1989;1:15-17.

Figure 1. The number of all lesions (with SEM) in all three areas (All) as well as the sum of all lesions on the face, back, and chest during treatment with doxycycline and minocycline.*n=79

Doxycycline

Minocycline


32



Safety and Tolerability of Doxycycline

32



Tetracycline-class AEs: Class Effects*

*All tetracyclines carry common labeling with regard to adverse reactions.

AE=adverse event, GI=gastrointestinal.

Tetracycline Minocycline Doxycycline

Class Effects

GI upset Yes1-3 Yes1,2,4-6 Yes1,2,5,7

Photosensitivity Yes1-3 Yes4,5 Yes1,2,5,7

Known or possible P. acnes resistance

Yes1,2 Yes1,2 Yes1,2,7

Tooth discoloration in children ≤8 years or in developing fetuses

Yes1-3,8 Yes1,2,4,5,8 Yes1,2,5,7

Pseudotumor cerebri Yes2,9 Yes1,2,4,9 Yes2,7,9

Clostridium difficile– associated diarrhea (CDAD)

Yes10,11 Yes4,10,11 Yes7,10,11

1. Ochsendorf F. Am J Clin Dermatol. 2010;11:327-341. 2. Zouboulis CC, Piquero-Martin J. Dermatology. 2003;206:37-53. 3. Tetracycline hydrochloride [package insert]. Corona, CA:Watson Pharma., Inc.;2010. 4. Minocycline hydrochloride [package insert]. Morgantown, WV; Mylan Pharmaceuticals Inc.;2010. 5. Kircik LH. J Drugs Dermatol. 2010;9:1407-1411. 6. Schlienger RG, et al. Dermatology. 2000;200:223-231. 7. DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. 8. Sánchez AR, et al. Int Soc Dermatol. 2004;43:709-715. 9. Friedman DI. Am J Clin Dermatol. 2005;6:29-37. 10. Delaney JAC, et al. Emerg Inf Dis. 2007;13:761-763. 11. Bartlett JG. Clin Infect Dis. 2008;46(Suppl1):S4-S11.Please see Selected Safety Information for DORYX® on slide 45, and Full Prescribing Information provided by your sales representative and at www.doryx.com.


Tetracycline-class AEs: Drug-specific Effects*

*There are some important differences in drug-specific AEs between doxycycline and minocycline.

Tetracycline Minocycline Doxycycline

Drug-specific Effects

Vertigo No Yes1-4 No

Skin hyperpigmentation No Yes1-5 No

Autoimmune hepatitis No Yes1-3,5 No

Hypersensitivity reactions Rare3 Yes1-5 Rare3,6

Drug-induced lupus-like syndrome No Yes1-5,7 No

1. Smith K, Leyden JJ. Clin Ther. 2005;27:1329-1342. 2. Ochsendorf F. Am J Clin Dermatol. 2010;11:327-341. 3. Zouboulis CC, Piquero-Martin J. Dermatology. 2003;206:37-53. 4. Kircik LH. J Drugs Dermatol. 2010;9:1407-1411 5. Schlienger RG, et al. Dermatology. 2000;200:223-231. 6. DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. 7. Margolis DJ, et al. Br J Dermatol. 2007:157:540-546.



Doxycycline Safety/Tolerability Compared With That of Minocycline

• Doxycycline was written 3 times more often than minocycline

• Over 5 times as many AEs were reported with minocycline

• Minocycline-specific AEs and warnings– Skin hyperpigmentation– CNS side effects (vertigo,

dizziness)– Lupus-like syndrome– Hepatitis

• Doxycycline-specific AEs and warnings– Esophageal erosion– Skin side effects (photosensitivity

and photo-onycholysis)– CNS side effects (intracranial

hypertension)– Hypoglycemia

Rep

ort

ed

AEs/M

illion

New

Pre

scri

pti

on

s D

isp

en

sed

US AE Rates, FDA Reports (1998-2003)*

n=628 AEs Reported

n=1099 AEs Reported

†

†

Smith K, Leyden JJ. Clin Ther. 2005;27:1329-1342.

*Based on spontaneous reporting.†Calculated AEs.‡Central Nervous System


36



Dermatologists’Prescribing Trends

36


Dermatologists Prefer Doxycycline

IMS Health, Inc. National Prescription Data: April 2005–April 2010 (estimate derived from the use of information under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying).

Doxycycline: Prescribed by Dermatologists More Often Than Minocycline*

New

Pre

scri

pti

on

s,

million

s

*Includes brand and generic.

Years(April 2005 – April 2010)

38



Treatment Challengesfor Acne Patients

38


Issues With Compliance to Acne Therapy

Thiboutot D, et al. J Am Acad Dermatol. 2009;60(suppl 5):S1-S50.

•48% compliance was reported in a study of college-aged patients using BPO (over the counter)

•44% of patients (with dermatologic conditions) reported that they did not follow their prescription regimen exactly

Poor compliance may be a major contributor to

treatment failure

• In a study, 87% of patients took a QD dose on schedule, whereas only 39% were able to take a QID dose on schedule

Frequency of administration is

negatively correlated with

compliance


For the Adolescent, Acne Therapy Is Only as Good as Compliance

• Acne is most common in adolescence

– 58% of patients are aged 10 to 19 years2

• Adolescents are a high-risk group for noncompliance3

– Dosing – BID dosing and administration restrictions discourage compliance3,4

– AEs – lead to missed doses3

– Delayed onset of action – leads to frustration and noncompliance3

• Female patients are more adherent than male patients5

– 71% vs 60%, P<0.00011. Zaghloul SS, et al. Br J Dermatol. 2005;152:1015-1021. 2. IMS Health, Inc. NDTI Audit: July 2006–June 2007 (estimate derived from the use of information under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying). 3. Baldwin HE. Dermatol Therapy. 2006;19:224-236. 4. McNabb JJ, et al. AIDS. 2003;17:1763-1767. 5. Thiboutot D, et al. J Am Acad Dermatol. 2009;60(suppl 5):S1-S50.

Mean

Med

icati

on

Ad

here

nce,

%

Compliance Among Acne Patients Who Reported These Reasons for Missing

Treatment (n=403)1

Treatment Success = Efficacy + Tolerability + Compliance

Rationale for Noncompliance


GI Side Effects: #1 Reason for Noncompliance in Teenagers

Physicians’ Opinions, AAD 2008: Ranking of Causes of Teenaged Acne Patients’

Noncompliance With Oral Antibiotics

Acne survey conducted at the 66th Annual Meeting of the American Academy of Dermatology (n=100); February 1-5, 2008; San Antonio, TX. Report # RD07-M028. Rockaway, NJ: Warner Chilcott (US), LLC.

CNS=central nervous system; GI=gastrointestinal.

*eg, take with food.

42



DORYX®: Summary of Key Points and Data

42




• DORYX® is indicated as adjunctive therapy for severe acne1

Indication

• Comparable efficacy to minocycline2-5

• Effective against a wide range of gram-positive and gram-negative bacteria and other pathogens1

Doxycycline Efficacy

• Well tolerated2

• No CNS (vestibular) warnings (dizziness, lightheadedness, vertigo, problems driving or operating machinery)1

• No drug-induced lupus-like syndrome1

• No reported skin hyperpigmentation1

Doxycycline Safety

1. DORYX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. 2. Kircik LH. J Drugs Dermatol. 2010;9:1407-1411. 3. Harrison PV. Clin Exp Dermatol. 1988;13:242-244. 4. Smit F. Dermatologica. 1978;157:186-190. 5. Ólafsson JH, et al. J Dermatol Treat. 1989;1:15-17.

PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING 43




• Delivery system of pH-sensitive enteric-coated pellets of doxycycline hyclate

• Designed to minimize the exposure of the upper gastrointestinal tract to doxycycline

Delayed-release enteric-coated pellets

• Can be taken once daily, at any time of the day, whenever it is most convenient

• Can be administered without regard to food or milk• Scored tablets can be broken/cut to allow for easier

administration or dose titration• For patients who have difficulty swallowing tablets,

the tablet can be broken apart and sprinkled over applesauce

Dosing flexibility




Selected Safety Information:

DORYX® (Doxycycline Hyclate Delayed-Release Tablets, USP) is indicated as adjunctive therapy for severe acne

Selected Safety Information about DORYX®

Doxycycline is contraindicated in patients who have shown hypersensitivity to any of the tetracyclines and, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. Tetracycline-class antibiotics used during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years), may cause permanent discoloration of teeth and should not be used unless other drugs are not likely to be effective or are contraindicated. Oral antibiotics may lessen the effectiveness of oral contraceptives.

Patients should be advised that photosensitivity can occur with tetracycline-class drugs. Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents including doxycycline, and may range from mild diarrhea to fatal colitis. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of DORYX® and other antibacterial drugs, DORYX® should be used only as indicated.

Please see Full Prescribing Information from your sales representative and at www.doryx.com.




SPEAKER TRAINING CERTIFICATIONDoryx® (doxycycline hyclate delayed-release tablets, USP)

1. I have completed the Warner Chilcott Product training on Doryx® and I reviewed the Regulatory Compliance Training slides on the rules and regulations governing speaking on behalf of Warner Chilcott.

2. I have read and understand the prescribing information for Doryx® (doxycycline hyclate delayed-release tablets, USP).

3. I understand Doryx® is a tetracycline-class antimicrobial indicated for adjunctive therapy for severe acne.

Next



4. I understand the following safety information about Doryx®:– Doxycycline is contraindicated in patients who have shown

hypersensitivity to any of the tetracyclines and, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. Tetracycline-class antibiotics used during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years), may cause permanent discoloration of teeth and should not be used unless other drugs are not likely to be effective or are contraindicated.

– Patients should be advised that photosensitivity can occur with tetracycline-class drugs.

– Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents including doxycycline, and may range from mild diarrhea to fatal colitis.

– To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of Doryx® and other antibacterial drugs, Doryx® should be used only as indicated.

– Oral antibiotics may lessen the effectiveness of birth control pills.

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SubmitI Agree I Disagree


5. I understand that when presenting information about Doryx® as a speaker for Warner Chilcott, I must only use Warner Chilcott-approved slides and must follow all applicable rules and regulations for speakers.

6. I understand that when presenting information about Doryx® as a speaker for Warner Chilcott, I must present only information contained in the product label or new drug application. If an unsolicited question requires an answer that is off-label, I will briefly answer the question, state that the answer is off-label and derived from my professional experience, and return to the Warner Chilcott-approved presentation and messaging.

doryx

Health & Medicine

severe acne

acne types

degree of acne

acne marks

classification acne

management of acne vulgaris

acne papules treatment

cystic acne treatment