Berdazimer Topical

WHY is this medicine prescribed?

Berdazimer topical is used to treat molluscum contagiosum (MC; infection caused by a virus that causes little bumps to form on skin anywhere on the body) in adults and children over the age of 1 year. Berdazimer is in a class of medications called nitric oxide releasing agents. How it works to treat MC is not fully understood.

HOW should this medicine be used?

Berdazimer comes as a gel to be applied to the affected areas of the skin. It is usually applied to each MC skin lesions once daily for up to 12 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use berdazimer exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Berdazimer comes as two tubes and a dosing guide. Squeeze out an equal amount from each tube onto the dosing guide. Follow the directions on the dosing guide for how much berdazimer to apply to the dosing guide. Replace the caps on both tubes tightly and mix together on the dosing guide. Apply berdazimer as a thin layer on all MC lesions. Wash hands (unless treating lesions on hands) and avoid touching eyes or transferring gel to unaffected parts of the body. Allow berdazimer to dry for 10 minutes and avoid swimming, bathing or washing for 1 hour after applying.

Do not apply berdazimer in or around the eyes or place in the mouth or vagina.

Only mix berdazimer right before applying. Discard any unused mixed berdazimer. Do not store for later use.

Take berdazimer for as long as instructed to by your physician to ensure complete clearance of lesions.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using berdazimer,

• tell your doctor and pharmacist if you are allergic to berdazimer, any other medications, or any of the ingredients in berdazimer topical gel. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had skin problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using berdazimer, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Berdazimer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• burning, stinging, flaky skin
• lightening or darkening of the skin
• blisters or irritation
• fever, general unwell feeling, cough, or congestion

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• pain, itching, swelling or redness at application site

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Discard unused portion after 60 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If someone swallows berdazimer, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2024.