Aldara

Aldara is used to treat external warts around the genital and rectal areas called Conyloma Acuminatum. It is not used on warts inside the vagina, penis or rectum.

Imiquimod is also used to treat a skin condition of the face and scalp called Actinic Keratosis (AK), which is caused by too much sun exposure. Imiquimod may be used to treat certain types of skin cancer called superficial basal cell carcinoma (sBCC).

Imiquimod works on the immune system to help the body fight viruses that cause warts. It does not destroy the viruses directly. It is not known how imiquimod works for actinic keratosis or skin cancer.

This medication is only available through your doctor’s prescription.

This product is available in the following forms:

• Cream

• Kit

As with all medicines, the risks must be compared to how much a medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

• Allergies - Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric - Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication to treat external warts in children older than 12 years of age. However, safety and efficacy have not been established in children younger than 12 years of age.No appropriate studies have been performed on the relationship of age to the effects of this medication in children to treat actinic keratosis or skin cancer. Safety and efficacy have not been established.
• Geriatric - Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.
• Pregnancy - This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
• Breastfeeding - There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions - Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.
• Other Interactions - Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
• Other Medical Problems - Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

• • Autoimmune disorders
  • Infection of the skin at or near the place of application
  • Large sores, broken skin or severe skin injury at the place of application.
  • Rheumatoid arthritis, juvenile or adult (chronic)
  • Sun exposure, including sunlamps
  • Recent surgery at the site of application
  • Vulvar swelling (swelling near the opening of the vagina) - The chance of side effects may be increased.
  • Basal cell nervus syndrome
  • Human papilloma virus (cervical, intra-anal, intravaginal, rectal, urethral)
  • Weak immune system
  • Xeroderma pigmentosum (a rare, inherited skin disease) - It is not known if this medication will work in patients with these conditions.

Only take Aldara as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

This medication is for use on the skin only. Do not get it in your eyes, nose, mouth, vagina or anus. Do not use it on skin areas that have cuts, scrapes or burns. If it does get on these areas, rinse it off immediately with water.

This medication should only be used for skin conditions that your doctor is treating. Ask your doctor before using it for other conditions, especially if you think a skin infection may be present. This medication should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

If you are using the Zyclara cream pump for the first time, prime it by pressing the top of the pump until the cream appears.

To Use

• Wash your hands with soap and water before and after using the medication.

• Use 1-2 packets or actuations of the pump of cream for each dose as directed by your doctor.

• Apply a thin layer to the affected area of the skin and rub it in gently just before bedtime.

• Allow the medication to stay on the treated skin for 8 hours for Actinic Keratosis or basal cell carcinoma, or 6-10 hours for genital warts. Do not take a bath, swim or get the treated area wet during this time.

• After the correct amount of time has passed, wash the treated area with mild soap and water.

• Uncircumcised men who are treating genital warts under the foreskin should retract the foreskin and clean the area daily.

• Do not bandage or wrap the skin being treated unless directed to do so by your doctor. Materials that are not airtight, such as cotton gauze or cotton underwear, may be used if needed.

• Throw out any unused cream from the single-dose packet.

Only use the brand of medication prescribed by your doctor. Different brands may not work the same way.

Do not use this medication with any other products containing imiquimod in the same treatment area. This may increase risk for more side effects.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For Actinic Keratosis

• Adults - If you use Zyclara, apply a thin film to the affected area of skin once a day at bedtime for 2 weeks. Your doctor will repeat the treatment after you go 2 weeks without medication. If you use Aldara, apply a thin film to the affected area of skin once a day at bedtime, twice a week for 16 weeks. Your doctor will tell you which days of the week are best.
• Children - Use and dose must be determined by your doctor.

For Skin Cancer

• Adults - Apply a thin film to the affected area of skin once a day at bedtime 5 times per week for 6 weeks. Your doctor will tell you which days of the week are best.
• Children - Use and dose must be determined by your doctor.

For external warts

• Adults and children 12 years of age and older - If you use Zyclara, apply a thin film to the wart once a day at bedtime for up to 8 weeks. If you use Aldara, apply a thin film to the wart once a day at bedtime, 3 times per week. Your doctor will tell you which days of the week are best. Use the medication until the wart is gone, but for no longer than 16 weeks.
• Children younger than 12 years of age - Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage

Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly.

Stop using this medication and inform your doctor immediately if you have a skin

• Rash
• Burning
• Pain
• Redness
• Swelling
• Bleeding
• Oozing
• Scabbing
• Peeling at the site of application

Stop using this medication and inform your doctor immediately if you have severe swelling near the opening of the vagina. This may cause painful urination, trouble passing urine or inability to urinate.

Stop using this medication and inform your doctor immediately if you have severe skin irritation or flu-like symptoms, such as

• Diarrhea
• Fever
• Chills
• Headache
• Nausea
• Muscle or joint pain
• Unusual fatigue or weakness

Avoid exposure to sunlight, sunlamps or tanning beds while using this medication. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats.

If you are being treated for external warts, avoid having genital, oral or anal sex while the medication is on your skin. Make sure you wash the cream off you skin before you engage in any sexual activity. The medication contains oils that can weaken latex condoms and diaphragms, which will prevent them from working properly.

Imiquimod is not a cure for genital warts. New warts may develop while using this cream. Imiquimod will not keep you from spreading genital warts to other people.

Do not use cosmetics or any other skin care products on the treated areas unless directed to do so by a doctor.

Aldara may produce unwanted affects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More Common

• Blisters on the skin
• Body aches or pain
• Chills
• Cough
• Difficulty breathing
• Ear congestion
• Itching in the genital or other skin areas
• Loss of voice
• Open sores or scabs on the skin
• Pain or tenderness around the eyes and cheekbones
• Redness of the skin (severe)
• Scaling
• Skin rash
• Sneezing
• Sore throat
• Stuffy or runny nose
• Tightness of the chest or wheezing
• Unusual fatigue or weakness

Less Common

• Abdominal or stomach pain
• Ankle, knee, or great toe joint pain
• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Chest pain
• Flu-like symptoms
• Difficult, burning, or painful urination
• Dizziness
• Fainting (syncope)
• Fast or irregular heartbeat (tachycardia, arrhythmias)
• Frequent urge to urinate (polyuria)
• Hoarseness
• Joint stiffness or swelling
• Lower back or side pain
• Lump in the abdomen or stomach
• Nervousness
• Persistent non-healing sore
• Pink growth on the skin
• Pounding in the ears (pulsatile tinnitus)
• Reddish patch or irritated area
• Severe headache
• Shiny bump on the skin
• Slow heartbeat (bradycardia)
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• White, yellow or waxy scar-like area

Get emergency help immediately if any of the following symptoms of overdose occur:

• Confusion
• Dizziness, faintness or lightheadedness when standing up from a lying or sitting position.

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More Common

• Burning or stinging of the skin
• Flaking of the skin
• Mild headache
• Pain, soreness or tenderness of the skin
• Rash
• Redness of the skin
• Swelling at the place of application

Less Common

• Back pain
• Lightening of the treated skin

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.