Imiquimod is a topical medication that has antiviral, antitumor, and immune response-modifying properties. It's commonly known by its brand name, Aldara, among others.

Imiquimod (Aldara) is an immune-modulator drug that is used in the treatment of topical skin conditions including genital warts and basal cell carcinoma.

Imiquimod Uses:

• (2.5 percent, 3.75 percent, and 5 percent cream) Actinic keratosis:
  • Topical therapy for immunocompetent adults with clinically typical actinic keratoses that are palpable, visible, and neither hypertrophic nor hyperkeratotic on the entire face or scalp.
• Genital and perianal warts (3.75% and 5% cream):
  • Used to treat external perianal and genital warts caused by condyloma acuminata in people 12 years of age and older.
• Basal cell carcinoma of the skin (Aldara 5% cream):
  • Primary superficial basal cell carcinoma in immunocompetent adults with a maximum tumour diameter of 2 centimetres that is located on the trunk (excluding anogenital skin), neck, or extremities should only be treated with confirmed topical therapy after biopsy if surgical options are medically less suitable and patient follow-up can be reasonably guaranteed (excluding hands and feet).
• Limitations of use:
  • Patients who have had autoimmune diseases in the past should use imiquimod with caution. Imiquimod has been tested in pediatric patients with molluscum contagiosum ages 2 to 12; however, trials did not show efficacy.
  • In immunosuppressed patients, patients with basal cell nevus syndrome or xeroderma pigmentosum, as well as for the transmission or prevention of HPV, efficacy, and safety have not been shown.
• Off Label Use of Imiquimod in Adults:
  • Cutaneous flat wart
  • Acyclovir-resistant herpes simplex virus (HSV) infection,

Imiquimod dose in adults:

Imiquimod Dose in the therapy of Actinic keratosis:

2.5% and 3.75% cream:

• Use once daily before bedtime.
• Put a thin layer on the affected skin area (either the face or the top of the head, but not both).
• Use up to 2 packets or 2 pumps.
• Leave it on for about 8 hours, then wash it off.
• Do this for 2 weeks, then take a break for 2 weeks.
• After the break, do another 2-week treatment.
• Even if the skin looks clear, finish the whole treatment.
• You shouldn’t use more than 56 packets or 2 x 7.5 g pumps in total for both cycles.

5% cream:

• Use two times a week before bedtime.
• Put a thin layer on the affected skin area (either the face or the top of the head, but not both).
• Use up to 1 packet each time.
• Leave it on for about 8 hours, then wash it off.
• Do this for 16 weeks.
• You shouldn’t use more than 36 packets in total for the 16 weeks.

Imiquimod Dose in the treatment of Cutaneous flat warts (off-label):

5% cream for Flat Warts:

• Put on the cream once a day at bedtime.
• Continue using until the warts are completely gone.
• Don't use it for more than 12 weeks.

Treatment for genital and perianal warts with imiquimod dosage:

3.75% cream for Genital and Perianal Warts:

• Put on the cream once every day at bedtime.
• Spread a thin layer and use up to 1 packet or 1 pump each time.
• Let it stay on your skin for about 8 hours, then wash it off.
• Keep using it until the warts are completely gone or up to 8 weeks.
• Don't use more than 56 packets or 2 x 7.5 g pumps for the whole treatment.

5% cream for Genital and Perianal Warts:

• Put on the cream three times a week (like Monday, Wednesday, Friday) at bedtime.
• Spread a thin layer each time.
• Let it stay on your skin for 6 to 10 hours, then wash it off.
• Continue using it until the warts are completely gone or for up to 16 weeks.

Imiquimod Dose in the treatment of acyclovir-resistant Herpes simplex virus (HSV) infection: 

For Herpes Simplex Virus (HSV) Infection that doesn't respond to acyclovir:

• Apply the cream to the herpes sores once a day.
• Do this for 5 days in a row.
• Even though the guidelines don't say which strength to use, in some cases, the 5% cream has been used.

Imiquimod Dose for the therapy of Superficial basal cell carcinoma (Aldara 5% cream):

For Superficial Basal Cell Carcinoma using Aldara 5% cream:

• Put on the cream once a day, 5 days a week (like Monday to Friday).
• Do this before bedtime.
• Leave the cream on your skin for about 8 hours, then wash it off.
• Spread the cream to cover the tumor and an extra 1 cm of skin around it.
• For tumors:
  • 0.5 cm across: Use a droplet of cream about 4 mm wide.
  • 2 cm across: Use a droplet of cream about 7 mm wide.
• Don’t treat tumors larger than 2 cm across with this method.
• For the 6-week treatment, don't use more than 36 packets.
• We don't know if it's safe or works well to use the cream again on an area that's been treated before.

Imiquimod does in children:

Imiquimod Dose in Genital and perianal warts (3.75% and 5% cream):

Children aged 12 years and above and Adolescents:

• Topical: Similar to adult dosing

Imiquimod Dosing adjustment for toxicity:

For children aged 12 and older, including teenagers:

For Skin Reactions (like redness, swelling, raw skin, scabbing):

• If the reaction is very bad or too uncomfortable, pause the treatment for a few days.
• Once the skin gets better, you can think about using the cream again.

For Whole Body Reactions (like feeling unwell, fever, shivering):

• Think about taking a break from the treatment.

For Swelling in the Private Area (vulvar swelling):

• If the swelling is very bad, stop using the cream or take a break.

Pregnancy Risk Factor C

• In studies where animals took Imiquimod by mouth, there were some unwanted effects related to reproduction.
• Also, Imiquimod might make condoms and female barriers (like diaphragms) less effective.
• While Imiquimod seems to have a low risk, pregnant women should avoid using it until we know more about its safety during pregnancy.

Imiquimod use during breastfeeding:

• We don't know if Imiquimod gets into breast milk.
• So, if you're breastfeeding, be careful and talk to your doctor before using Imiquimod.

Imiquimod Dose in Kidney Disease:

•  In the manufacturer's labeling, there are no dosage adjustments provided.

Imiquimod Dose in Liver disease:

• In the manufacturer's labeling, there are no dosage adjustments provided.

Note:

• The severity of the disease being treated, the medication formulation, the number of weekly administrations, and individual sensitivity all affect how frequently reactions occur.

Common Side Effects of Imiquimod:

• Local:
  • Application Site Discharge
  • Local Pruritus
  • Localized Edema
  • Localized Burning
•  
• Respiratory:
  • Upper Respiratory Tract Infection
• Dermatologic:
  • Crusted Skin
  • Xeroderma
  • Localized Vesiculation
  • Dermal Ulcer
  • Skin Sclerosis
  • Excoriation
  • Localized Erythema
• Infection:
  • Fungal Infection

Less Common Side Effects of Imiquimod:

• Cardiovascular:
  • Chest Pain
  • Localized Blanching
• Genitourinary:
  • Bacterial Vaginosis
  • Urinary Tract Infection
• Central Nervous System:
  • Pain
  • Fatigue
  • Rigors
  • Headache
  • Anxiety
  • Tingling Of Skin
  • Dizziness
  • Local Discomfort
• Gastrointestinal:
  • Diarrhea
  • Anorexia
  • Nausea
  • Vomiting
  • Dyspepsia
• Dermatologic:
  • Eczema
  • Cheilitis
  • Alopecia
  • Skin Pain
  • Seborrhoeic Keratosis
  • Tinea
  • Skin Tenderness
  • Stinging Of The Skin
  • Localized Rash
  • Skin Hypertrophy
  • Skin Infection
  • Dermal Hemorrhage
  • Papule
• Endocrine & Metabolic:
  • Increased Serum Glucose
• Local:
  • Local Irritation
• Hematologic & Oncologic:
  • Squamous Cell Carcinoma
  • Lymphadenopathy
• Respiratory:
  • Sinusitis
  • Flu-Like Symptoms
  • Cough
  • Pharyngitis
  • Rhinitis
• Infection:
  • Herpes Simplex
• Neuromuscular & Skeletal:
  • Arthralgia
  • Back Pain
  • Myalgia
• Miscellaneous:
  • Fever

Contraindications to Imiquimod:

• In the U.S., the manufacturer doesn't list any reasons you shouldn't use Imiquimod.

• In Canada, they say don't use it if you're allergic to Imiquimod or anything in it.

Warnings and precautions

Local inflammatory reactions

• After using Imiquimod a few times, some people might have strong skin reactions.
• This can include sore, weeping skin or skin breaking down.
• Sometimes, these skin issues might come with body-wide symptoms like fever, feeling unwell, or muscle pain.
• These reactions can even spread past where you applied the cream.
• Be cautious, as Imiquimod can also make existing skin inflammation problems worse, like the skin issues from graft-versus-host disease.

Photosensitivity

• Because Imiquimod can make your skin more sensitive to sunlight, try to avoid being in the sun during treatment.
• This includes avoiding sunlamps and tanning beds too.
• Wear protective clothes like a hat when you're outside.
• If you have a sunburn, don't use Imiquimod until it's healed.
• If you're often in the sun (maybe due to your job) or if your skin burns easily in the sun, be careful when using Imiquimod.

Systemic reactions

• Some people might feel like they have the flu (with symptoms like joint pain, chills, tiredness, fever, feeling unwell, muscle pain, and nausea) when using Imiquimod.
• These symptoms can come with or before strong skin reactions.
• If this happens, you might need to stop the treatment for a while.

Vulvar swelling

• For women, using Imiquimod on the outer private parts can cause strong inflammation, leading to major swelling and trouble urinating.
• If this happens, you should pause or stop the treatment.

Actinic keratosis:

• Using Imiquimod more than once in the same area for actinic keratosis isn't proven to be safe or effective.
• It's not clear if using Imiquimod on skin areas bigger than 25 cm is safe.
• Some patients treated for actinic keratosis have experienced swollen lymph nodes, but this usually goes away within 4 weeks after treatment is done.

Autoimmune disorders:

• We don't know if Imiquimod is safe or works well for patients with weakened immune systems.
• If you have an autoimmune condition, be careful when using Imiquimod.
• It has been reported to either trigger or make some autoimmune diseases worse.

Basal cell carcinoma

• Imiquimod is only meant for treating certain types of basal cell carcinoma.
• These are the ones on the surface and not bigger than 2 cm.
• It's not proven to work on other types or larger tumors on the face, head, and private area.
• Those with superficial basal cell carcinoma should regularly check the treated area.

Human papillomavirus disease:

• Imiquimod hasn't been tested for treating HPV infections inside the urethra, vagina, cervix, rectum, or anus.
• It's not recommended for these conditions.

Monitoring parameters:

• Periodically see how the therapy is working.
• A decrease in lesion size means the treatment is working.

What to Watch For:

• Skin reactions where the cream was applied.
• Any signs that you might be allergic to Imiquimod.

How to administer Imiquimod?

• Always wash your hands before and after applying.
• It's only for skin use. Don't use in eyes, mouth, inside the anus, or vagina.
• Avoid putting on lips, inside nostrils, and close to the eyes.
• Don't cover the spot where you've applied it with tight bandages.
• For the Zyclara pump, prime it before the first use.
• Get rid of the first bit of cream that comes out. No need to prime it again after.

For Actinic Keratosis:

• Wash and dry the area (wait about 10 minutes after drying).
• Apply the 5% cream on an area about the size of a palm on the face or head. For 2.5% and 3.75% creams, also focus on the face or scalp.
• Don't treat both face and scalp at the same time.
• Gently rub in the cream until it disappears.
• You might notice more spots before they start to go away.

For Genital/Perianal Warts:

• Gently rub a thin layer on the external wart area until it disappears.
• Don't use too much cream.
• If your skin gets irritated, use loose dressings like cotton gauze or cotton underwear.

For Basal Cell Carcinoma (using Aldara):

• Only treat spots no bigger than a thumbprint, but not on the hands, feet, or private parts.
• Include a little extra area (1 cm) around the tumor.

Mechanism of action of Imiquimod:

• Imiquimod is like a wake-up call for the body's defense system.
• When put on the skin, it pushes immune cells into action.
• It works by targeting a specific part of these cells called the Toll-like receptor 7.
• This causes the cells to release signals, like cytokines, that help fight off diseases.

Getting Inside:

• Not much of the cream gets into the body.
• The amount that gets in depends more on where you put it on your skin than how much you use.

Peaking Time:

• It takes around 9 to 12 hours to reach the highest level in the blood.

Leaving the Body:

• Most of what's absorbed comes out in your pee.
• Less than 3% of what you put on your skin ends up in the urine, including imiquimod and its changed forms.

International Brands of Imiquimod:

• Aldara
• Zyclara
• Zyclara Pump
• Aldara P
• APO-Imiquimod
• TARO-Imiquimod Pump
• Vyloma
• Zyclara
• Akdara
• Aldara
• Aldiq
• Aquimod Cream
• Beselna
• Imimore
• Imiquad
• Imoxy
• Imunocare
• Inmuderm
• Miquimod
• Modik
• Perrimod
• Quimara
• Qumara
• You Care
• Youbiqing

Imiquimod Brand Names in Pakistan:

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