Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials,
ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established

You are encouraged to report negative side effects of prescription drugs to the FDA
Visit www.fda.gov/medwatch
or call 1-800-FDA-1088

*30 mg immediate release and 10 mg delayed release beads

“I put off seeing my dermatologist initially, I think I was
nervous. Now I can’t wait to start my treatment plan
and achieve clearer skin!”

NOW LOOK AT ME

Not an actual patient

ROSACEA DISCUSSION GUIDE

HELP GET
YOUR ROSACEA
UNDER CONTROL!

Starting a conversation with your dermatologist is the first part of your journey to help achieve clearer skin…

and we’re here to help

Just as your rosacea is unique to you, your treatment should be too. We’ve created a discussion guide that you can personalize to make your conversation easier and get the right treatment in hand. As you move through the guide, you’ll see frequently raised concerns that many other rosacea sufferers have shared about visiting a dermatologist

Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

*30 mg immediate release and 10 mg delayed release beads
As found in a 9-month clinical study
A multicenter, outpatient, double-blind, placebo-controlled, parallel group trial was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA Capsules. A total of 251 rosacea subjects (≥18 years of age with 10 to 40 papules and pustules and 2 nodules, plus an IGA score of 2 to 4) participated

REFERENCES

1. National Rosacea Society 2020. Rosacea Review. Rosacea now estimated to affect at least 16 million American. Available at: https://www.rosacea.org/rosacea-review/2010/winter/rosacea-now-estimated-to-affect-at-least-16-million-americans. Last accessed: September 2021 2. Rosacea: Beyond the visible report. Available at: https://hosted.bmj.com/rosaceabeyondthevisible. Last accessed: September 2021 3. Del Rosso JQ, et al. Two randomized phase Ill clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791–802. 4. Huynh T. Burden of Disease: The Psychosocial Impact of Rosacea on a Patient’s Quality of Life. Am Health Drug Benefits 2013;6:348-354. 5. Schaller M, et al. Recommendations for rosacea diagnosis, classification and management: Update from the global ROSacea COnsensus (ROSCO) 2019 panel. British Journal of Dermatology. 2019. doi: 10.1111/bjd.18420. [Epub ahead of print]. 6. ORACEA [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; 2014. 7. National Rosacea Society. (2020). All About Rosacea. Available: https://www.rosacea.org/patients/all-about-rosacea. Last accessed: September 2021 8. Preshaw PM, et al. Modified-release sub-antimicrobial dose doxycycline enhances scaling and root planning in subjects with periodontal disease. J Periodontol. 2008;79(3):440–452. 9. Del Rosso JQ, et al. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(8):573–576. 10. Bhatia N. ORACEA 40 mg capsules for papulopustular rosacea. The Dermatologist. 2013;6(21s):1-4. Available at: https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/oracea-40-mg-capsules-papulopustular-rosacea-1. Last accessed: September 2021 11. Theobald K, et al. Anti-inflammatory dose doxycycline (40 mg controlled-release) confers maximum anti-inflammatory efficacy in rosacea. Skinmed. 2007;6(5):221–226. 12. Fowler JF. Anti-inflammatory dose doxycycline for the treatment of rosacea. Expert Rev Dermatol. 2007;2(5):523–531. 13. Baldwin HE. Diagnosis and treatment of rosacea: state of the art. J Drugs Dermatol. 2012;11(6):725–730