Imiquimod Topical

WHY is this medicine prescribed?

Imiquimod cream is used to treat certain types of actinic keratoses (flat, scaly growths on the skin caused by too much sun exposure), superficial basal cell carcinoma (a type of skin cancer), and warts on the skin of the genital and anal areas.Imiquimod is in a class of medications called immune response modifiers. It may work by increasing the activity of the body's immune system.

Imiquimod cream does not cure warts, and new warts may appear during treatment.It is not known whether imiquimod cream prevents the spread of warts to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Imiquimod comes as a cream to apply to the skin.Your doctor will decide which product is best to treat your condition and tell you how often to use it.Use imiquimod at around the same time(s) each day you are to apply it.

Use imiquimod exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not cover the treated area with a tight bandage or dressing unless told to do so by your doctor. Cotton gauze dressings may be used if needed. Cotton underwear may be worn after treating the genital or anal areas.

If you are using imiquimod cream to treat genital or anal warts, you should avoid sexual (oral, anal, genital) contact while the cream is on your skin. Imiquimod cream may weaken condoms and vaginal diaphragms.

Uncircumcised men who are treating warts under the penis foreskin should pull the foreskin back and clean daily and before each treatment.

Imiquimod cream is only for use on the skin. Do not apply imiquimod cream in or near your eyes, lips, nostrils, vagina, or anus. If you get imiquimod cream in your mouth or eyes, rinse well with water right away.

Imiquimod cream comes in single-use packets. Dispose of any open packets if you do not use all of the cream.

To use the cream, follow these steps:

1. Wash your hands.
2. Wash the area to be treated with mild soap and water and allow it to dry.
3. Apply a thin layer of cream to the area to be treated, just before going to sleep.
4. Rub the cream into the skin until it disappears.
5. Wash your hands.
6. Leave the cream on the area for the amount of time your doctor has told you to do so, usually about 8 hours (between 6 and 10 hours).Do not bathe, shower, or swim during this time.
7. After the treatment time is over, wash the area with mild soap and water to remove any cream.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using imiquimod,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances.Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• 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 a sunburn or if you have or have ever had unusual sensitivity to sunlight, any skin condition or disease, graft vs. host disease, recent surgery to the affected area, or any condition that affects the immune system such as human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using imiquimod, call your doctor. Avoid using imiquimod in areas that an infant would come in contact with while breastfeeding.

• plan to avoid exposure to sunlight as much as possible and to wear protective clothing (such as a hat), sunglasses, and sunscreen if you go outside during daylight hours.Do not use tanning beds or sunlamps.Imiquimod cream may make your skin sensitive to sunlight.

• you should know that imiquimod cream may cause your skin color to become lighter. These changes may not go away after you finish treatment with imiquimod cream. Tell your doctor if you notice any changes in your skin color.

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 cream to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

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

• redness, itching, burning, or bleeding of the treated area
• flaking, scaling, dryness, or thickening of the skin
• swelling, stinging, or pain in the treated area
• blisters, scabs, or bumps on the skin
• headache

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

• skin breakdown or sores that may have drainage, especially during the first week of treatment
• flu-like symptoms such as nausea, fever, chills, tiredness, and muscle weakness or pain

Imiquimod may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

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). Do not freeze. Store pump bottles containing cream upright.

Keep all medication out of sight and reach of children as many containers are not child resistant.Always lock safety caps. Place the medication in a safe location – one that is up andaway and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot takethem. Do not flush this medication down the toilet. Use a medicine take-back program. Talk toyour pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal ofMedicines website (https://goo.gl/c4Rm4p) for more information.

What should I do in case of OVERDOSE?

If someone swallows imiquimod cream, 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.

Symptoms of overdose may include:

• fainting
• dizziness
• blurred vision
• nausea

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. If you are using imiquimod cream to treat superficial basal cell carcinoma, it is important to have regular follow-up visits with your doctor. Ask your doctor how often you should have your skin checked.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicinesvitamins, minerals, and dietary supplements you are taking. Bring this list with you each timeyou visit a doctor or if you are admitted to the hospital. You should carry the list with you incase of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.