Safety profile

Safety Profile
  • Safety data derived from XERESE® clinical studies reflect exposure to XERESE in 1,056 subjects with recurrent herpes labialis who were treated 5 times daily for 5 days
  • Most common adverse reactions (<1%) were local skin reactions and occurred in the area of application
  • Most common adverse reactions included:
    • Drying or flaking of the skin
    • Burning or tingling following application
    • Erythema
    • Pigmentation changes
    • Application site reactions, including signs and symptoms of inflammation
  • No photoallergic or phototoxicity potential was identified for XERESE in 2 studies involving 50 and 30 healthy volunteers, respectively

XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth.

There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Encourage patients to seek medical advice when a cold sore fails to heal within 2 weeks.

XERESE has a potential for irritation and contact sensitization.

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‡BRING THIS COUPON TO YOUR PHARMACIST FOR COPAY SAVINGS.

TO THE PATIENT:
You must present this coupon along with your prescription to participate in this program. You must activate this coupon before using by calling 1-866-686-0122, texting "XERESE" to 24109, or by visiting https://copaysavingsprogram.com/110/Xerese.

When you use this coupon you are certifying that you understand and agree to the program rules, regulations, eligibility requirements, and terms and conditions.

This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs or for anyone 65 years of age or older without commercial insurance.

TO THE PHARMACIST:
When you use this coupon, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental programs for this prescription.

Submit the claim to the primary Third Party Payer first, then submit the balance due to DST Pharmacy Solutions as a Secondary Payer as a copay only billing using BIN 019158 and a valid Other Coverage Code (e.g. 8). Reimbursement will be received from DST Pharmacy Solutions.

Cash paying patients, submit this claim to DST Pharmacy Solutions using BIN 019158. A valid Other Coverage Code(e.g. 1) is required.

For any questions regarding DST Pharmacy Solutions online processing, please call the Help Desk at 1-844-373-0987

This offer is only valid for patients with commercial insurance and eligible uninsured patients.

Cash Discount Cards and other non-insurance plans are not valid as primary under this offer. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer.

When you use this coupon you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is not valid for any person eligible for reimbursement of prescriptions in whole or in part, by any of these programs.

By accepting this coupon and submitting claims for any of the products specified here in you agree to the program terms and conditions, which are posted at www.xeresesavings.com.

This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs.

OraPharma affiliated entities reserves the right to rescind, revoke, terminate, or amend this offer at any time, without notice. This offer expires on December 31, 2019.

REFERENCE: 1. XERESE® (acyclovir and hydrocortisone) cream 5%/1% Prescribing Information. January, 2014.

XERESE® (acyclovir and hydrocortisone) cream 5%/1% is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in patients 6 years of age and older.
 

Important Safety Information

INDICATION

XERESE® (acyclovir and hydrocortisone) cream 5%/1% is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in patients 6 years of age and older.

Important safety information
  • XERESE (acyclovir and hydrocortisone) cream 5%/1% is intended for cutaneous use only, on the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.
  • Systemic exposure to acyclovir and hydrocortisone following topical administration is minimal. However, caution should be exercised when XERESE is administered to women who are pregnant or nursing. The benefit of XERESE has not been adequately assessed in immunocompromised patients.
  • XERESE has a potential for irritation and contact sensitization.
  • In clinical trials, the most common adverse reactions in the area of the application site included drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation. Each event occurred in less than 1% of patients.
  • Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.